amlodipine and valsartan
 

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aliskiren and amlodipine


Generic Name: aliskiren and amlodipine (AL is KYE ren and am LOE de peen)
Brand Names: Tekamlo

What is this drug?

Aliskiren is an anti-hypertensive (blood pressure lowering) medication. It works by decreasing substances in the body that narrow blood vessels and raise blood pressure.

Amlodipine is in a group of drugs called calcium channel blockers. Amlodipine relaxes (widens) blood vessels and improves blood flow.

The combination of aliskiren and amlodipine is used to treat high blood pressure (hypertension).

Aliskiren and amlodipine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about this drug? Do not use aliskiren and amlodipine if you are pregnant. It could harm the unborn baby. Stop using this medication and tell your doctor right away if you become pregnant. You should not take this medication if you are allergic to aliskiren or amlodipine, or if you are also using cyclosporine (Gengraf, Neoral, Sandimmune) or itraconazole (Sporanox).

Before you take aliskiren and amlodipine, tell your doctor if you have kidney or liver disease, congestive heart failure, coronary artery disease, an electrolyte imbalance (such as low potassium or magnesium), if you are on a low-salt diet, or if you have ever had an allergic reaction to a blood pressure medication.

Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life. What should I discuss with my health care provider before taking this drug? You should not take this medication if you are allergic to aliskiren or amlodipine, or if you are also using cyclosporine (Gengraf, Neoral, Sandimmune) or itraconazole (Sporanox).

To make sure you can safely take aliskiren and amlodipine, tell your doctor if you have any of these other conditions:

kidney disease (or if you are on dialysis);

liver disease;

congestive heart failure;

coronary artery disease (hardened arteries);

an electrolyte imbalance (such as low levels of potassium or magnesium in your blood);

if you are on a low-salt diet; or

if you have ever had an allergic reaction to a blood pressure medication, such as benazepril (Lotensin), candesartan (Atacand), enalapril (Vasotec), lisinopril (Prinivil, Zestril), losartan (Cozaar, Hyzaar), olmesartan (Benicar, Azor), quinapril (Accupril), ramipril (Altace), telmisartan (Micardis, Twynsta), valsartan (Diovan, Exforge), and others.

FDA pregnancy category D. Do not use aliskiren and amlodipine if you are pregnant. Stop using this medication and tell your doctor right away if you become pregnant. Aliskiren and amlodipine can cause injury or death to the unborn baby if you take the medicine during your second or third trimester. Use effective birth control while taking aliskiren and amlodipine. It is not known whether this medication passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are taking aliskiren and amlodipine. How should I take this drug?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your chest pain may become worse when you first start taking amlodipine or when your dose is increased. Call your doctor if your chest pain is severe or ongoing.

Aliskiren and amlodipine may be taken with or without food, but take it the same way each time.

Your blood pressure will need to be checked often. Visit your doctor regularly.

Conditions that may cause very low blood pressure include: vomiting, diarrhea, heavy sweating, heart disease, dialysis, a low-salt diet, or taking diuretics (water pills). Tell your doctor if you have a prolonged illness that causes diarrhea or vomiting.

Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life. Store at room temperature away from moisture and heat.

See also: Aliskiren and amlodipine dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include rapid heartbeats, severe dizziness, warmth or tingly feeling, and fainting.

What should I avoid while taking this drug?

Avoid taking this medication with foods that are high in fat, which can make it harder for your body to absorb aliskiren.

This drug side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

swelling in your hands, ankles, or feet;

feeling like you might pass out; or

chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling.

Less serious side effects may include:

diarrhea;

stomach pain, upset stomach; or

cough.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Aliskiren and amlodipine Dosing Information

Usual Adult Dose for Hypertension:

Initial or add-on therapy: 150 mg/5 mg orally once a day. Titrate as needed up to a maximum of 300 mg/10 mg.
The blood pressure lowering effect is largely attained within 1 to 2 weeks.
Maximum dose: 300 mg/10 mg

What other drugs will affect this drug?

Tell your doctor about all other heart or blood pressure medications you are taking.

Tell your doctor about all other medicines you use, especially:

atorvastatin (Lipitor, Caduet), simvastatin (Zocor, Simcor, Vytorin, Juvisync);

antifungal medication such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), or voriconazole (Vfend);

a potassium supplement such as K-Dur, Klor-Con;

salt substitutes that contain potassium; or

a diuretic (water pill).

This list is not complete and other drugs may interact with aliskiren and amlodipine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More aliskiren and amlodipine resources Aliskiren and amlodipine Side Effects (in more detail) Aliskiren and amlodipine Dosage Aliskiren and amlodipine Use in Pregnancy & Breastfeeding Aliskiren and amlodipine Drug Interactions Aliskiren and amlodipine Support Group 0 Reviews for Aliskiren and amlodipine - Add your own review/rating Compare aliskiren and amlodipine with other medications High Blood Pressure Where can I get more information? Your pharmacist can provide more information about aliskiren and amlodipine.

See also: aliskiren and amlodipine side effects (in more detail)


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amlodipine and valsartan


am-LOE-di-peen BES-i-late, val-SAR-tan

Oral route(Tablet)

When pregnancy is detected, discontinue amlodipine besylate/valsartan as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus .

Commonly used brand name(s)

In the U.S.

Exforge

Available Dosage Forms:

Tablet

Therapeutic Class: Antihypertensive

Pharmacologic Class: Amlodipine

Chemical Class: Amlodipine

Uses For amlodipine and valsartan

Amlodipine and valsartan is a combination of medicines that are used to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a heart failure or kidney failure. Lowering blood pressure reduces the risk of strokes and heart attacks.

Amlodipine is a calcium channel blocker. It affects the movement of calcium into the cells of the heart and blood vessels. As a result, amlodipine relaxes the blood vessels and increases the supply of blood and oxygen to the heart while reducing its workload.

Valsartan is an angiotensin II receptor blocker. It works by blocking a substance in the body that causes blood vessels to tighten. As a result, valsartan relaxes the blood vessels. This lowers blood pressure and increases the supply of blood and oxygen to the heart.

amlodipine and valsartan is available only with your doctor's prescription.

Before Using amlodipine and valsartan

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For amlodipine and valsartan, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to amlodipine and valsartan or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of amlodipine and valsartan combination in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of amlodipine and valsartan combination in the elderly. However, elderly patients may be more sensitive to the effects of amlodipine and valsartan than younger adults, which may require caution in patients receiving amlodipine and valsartan combination.

Pregnancy Pregnancy Category Explanation All Trimesters D Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk. Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking amlodipine and valsartan, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using amlodipine and valsartan with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Amiodarone Atazanavir Benazepril Conivaptan Dantrolene Droperidol Enalapril Enalaprilat Lisinopril Lithium Moexipril Perindopril Quinapril Ramipril Simvastatin Telaprevir Trandolapril

Using amlodipine and valsartan with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acebutolol Alprenolol Atenolol Betaxolol Bevantolol Bisoprolol Bromfenac Bucindolol Carteolol Carvedilol Celecoxib Celiprolol Clopidogrel Dalfopristin Diclofenac Diflunisal Dilevalol Diltiazem Esmolol Etodolac Fenoprofen Fluconazole Flurbiprofen Ibuprofen Imatinib Indinavir Indomethacin Itraconazole Ketoconazole Ketoprofen Ketorolac Labetalol Levobunolol Magnesium Salicylate Meclofenamate Mefenamic Acid Meloxicam Mepindolol Metipranolol Metoprolol Nabumetone Nadolol Naproxen Nebivolol Nepafenac Oxaprozin Oxprenolol Penbutolol Pindolol Piroxicam Propranolol Quinupristin Rifapentine Ritonavir Salsalate Sotalol St John's Wort Sulindac Talinolol Tertatolol Timolol Tolmetin Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of amlodipine and valsartan. Make sure you tell your doctor if you have any other medical problems, especially:

Angina (severe chest pain) or Electrolyte imbalances (e.g., low levels of salt or sodium in the body) or Fluid imbalances (caused by dehydration, vomiting, or diarrhea) or Gallstones, or history of or Heart attack, recent or Heart failure—Use with caution. May make these conditions worse. Heart failure or Kidney disease or Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body. Proper Use of amlodipine and valsartan

Amlodipine and valsartan combination is used when a single medicine to lower your blood pressure is not enough. It is also used as the first medicine to treat your condition if your doctor feels that you need to take more than one blood pressure medicine.

amlodipine and valsartan comes with a patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.

In addition to the use of amlodipine and valsartan, treatment for your high blood pressure may include weight control and changes in the types of foods you eat, especially foods high in sodium (salt). Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.

Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well.

Remember that amlodipine and valsartan will not cure your high blood pressure, but it does help control it. You must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease.

You may take amlodipine and valsartan with or without food.

Dosing

The dose of amlodipine and valsartan will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of amlodipine and valsartan. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (tablets): For high blood pressure: Adults—One tablet once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than amlodipine 10 milligrams (mg) and valsartan 320 mg per day. Children—Use and dose must be determined by your doctor. Missed Dose

If you miss a dose of amlodipine and valsartan, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using amlodipine and valsartan

It is very important that your doctor check your progress at regular visits to make sure amlodipine and valsartan is working properly. Blood and urine tests may be needed to check for unwanted effects.

Using amlodipine and valsartan while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

Dizziness, lightheadedness, or fainting may occur, especially if you have been taking a diuretic (water pill). Make sure you know how you react to amlodipine and valsartan before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help.

Check with your doctor right away if you become sick while taking amlodipine and valsartan, especially with severe or continuing nausea, vomiting, or diarrhea. These conditions may cause you to lose too much water or salt.

Check with your doctor right away if you experience dizziness, fainting, confusion, muscle pain, weakness, and/or a fast heartbeat. Use extra care if you exercise or if the weather is hot. Heavy sweating can cause dehydration (loss of too much water) or electrolyte imbalances (loss of sodium or salt in the body).

amlodipine and valsartan may worsen the symptoms of angina (chest pain) or cause a heart attack in certain patients with severe heart or blood vessel disease. Check with your doctor right away if you are having chest pain or discomfort; fast or uneven heartbeat; nausea or vomiting; shortness of breath; pain or discomfort in the arms, jaw, back, or neck; shortness of breath; or sweating.

Make sure any doctor or dentist who treats you knows that you are using amlodipine and valsartan. You may need to stop using amlodipine and valsartan several days before having surgery or medical tests.

Do not take other medicines unless they have been discussed with your doctor. This especially includes over-the-counter (nonprescription) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, since they may tend to increase your blood pressure.

amlodipine and valsartan Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common Bloating or swelling of the face, arms, hands, lower legs, or feet rapid weight gain tingling of the hands or feet unusual weight gain or loss Less common Body aches or pain chills cough difficulty with breathing dizziness ear congestion fever headache loss of voice muscle aches sneezing sore throat stuffy or runny nose unusual tiredness or weakness Rare Abnormal or decreased touch sensation ankle, knee, or great toe joint pain bladder pain bleeding after defecation bloody nose bloody or cloudy urine blurred or loss of vision burning feeling in the chest or stomach burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings burning, numbness, pain, or tingling in all fingers except smallest finger chest pain cold sweats confusion congestion cough producing mucus diarrhea difficult, burning, or painful urination disturbed color perception dizziness, faintness, or lightheadedness when getting up from a lying or sitting position double vision dry mouth dryness of the throat fast, irregular, pounding, or racing heartbeat or pulse flushed, dry skin frequent urge to urinate fruit-like breath odor general feeling of discomfort or illness halos around lights heart murmur hives hoarseness increased hunger increased thirst increased urination indigestion irritation itching joint pain, stiffness, or swelling labored breathing loss of appetite loss of consciousness lower back or side pain muscle pains nausea night blindness overbright appearance of lights pain in the lower back, bottom, or hips pain in the upper leg pain or tenderness around the eyes and cheekbones rash redness of the skin shivering shortness of breath or troubled breathing stomach cramps, tenderness, or pain stomachache sweating swelling of the eyelids, face, lips, hands, or feet swelling with pits or depressions on the skin swollen, painful, or tender lymph glands in the neck, armpit, or groin tenderness in the stomach area tightness of the chest or wheezing tooth or gum pain trouble in swallowing trouble sleeping tunnel vision uncomfortable swelling around anus voice changes vomiting watery or bloody diarrhea weakness

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose Chest discomfort cold, clammy skin fast, weak pulse flushing lightheadedness or fainting slow heartbeat

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Rare Acid or sour stomach back pain belching bone pain continuing ringing or buzzing or other unexplained noise in the ears decreased interest in sexual intercourse difficulty having a bowel movement (stool) difficulty with moving discouragement excess air or gas in the stomach or intestines fear or nervousness feeling of constant movement of self or surroundings feeling sad or empty full or bloated feeling hearing loss heartburn inability to have or keep an erection increased sensitivity to sunlight irritability itching, pain, redness, or swelling of the eye or eyelid lack or loss of strength loss in sexual ability, desire, drive, or performance loss of interest or pleasure muscle aching or cramping muscle spasms or stiffness pain in the arms or legs passing gas pressure in the stomach redness in the joints redness of the skin sensation of spinning skin rash, encrusted, scaly, and oozing sleepiness or unusual drowsiness sleeplessness stomach soreness, discomfort, or upset swelling of the abdominal or stomach area tiredness toothache trouble concentrating unable to sleep unusually warm skin watering of the eyes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: amlodipine and valsartan side effects (in more detail)

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More amlodipine and valsartan resources Amlodipine and valsartan Side Effects (in more detail)Amlodipine and valsartan DosageAmlodipine and valsartan Use in Pregnancy & BreastfeedingAmlodipine and valsartan Drug InteractionsAmlodipine and valsartan Support Group27 Reviews for Amlodipine and valsartan - Add your own review/rating Compare amlodipine and valsartan with other medications High Blood Pressure


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amlodipine, valsartan, and hydrochlorothiazide


am-LOE-di-peen BES-i-late, val-SAR-tan, hye-droe-klor-oh-THYE-a-zide

Oral route(Tablet)

Drugs that act directly on the renin-angiotensin system can cause injury or death to the developing fetus when used during the second and third trimesters. Stop therapy as soon as possible when pregnancy is detected .

Commonly used brand name(s)

In the U.S.

Exforge HCT

Available Dosage Forms:

Tablet

Therapeutic Class: Antihypertensive

Pharmacologic Class: Amlodipine

Chemical Class: Amlodipine

Uses For amlodipine, valsartan, and hydrochlorothiazide

Amlodipine, valsartan, and hydrochlorothiazide is a combination of medicines that is used to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a heart failure or kidney failure. Lowering blood pressure reduces the risk of strokes and heart attacks.

Amlodipine is a calcium channel blocker. It affects the movement of calcium into the cells of the heart and blood vessels. As a result, amlodipine relaxes the blood vessels and increases the supply of blood and oxygen to the heart while reducing its workload.

Valsartan is an angiotensin II receptor blocker. It works by blocking a substance in the body that causes blood vessels to tighten. As a result, valsartan relaxes the blood vessels. This lowers blood pressure and increases the supply of blood and oxygen to the heart.

Hydrochlorothiazide is a thiazide diuretic (water pill). It reduces the amount of water in the body by increasing the flow of urine, which helps lower the blood pressure.

amlodipine, valsartan, and hydrochlorothiazide is available only with your doctor's prescription.

Before Using amlodipine, valsartan, and hydrochlorothiazide

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For amlodipine, valsartan, and hydrochlorothiazide, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to amlodipine, valsartan, and hydrochlorothiazide or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of amlodipine, valsartan, and hydrochlorothiazide combination in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of amlodipine, valsartan, and hydrochlorothiazide combination in the elderly.

Pregnancy Pregnancy Category Explanation All Trimesters D Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk. Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking amlodipine, valsartan, and hydrochlorothiazide, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using amlodipine, valsartan, and hydrochlorothiazide with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Dofetilide

Using amlodipine, valsartan, and hydrochlorothiazide with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acetyldigoxin Amiodarone Arsenic Trioxide Atazanavir Benazepril Conivaptan Dantrolene Deslanoside Digitalis Digitoxin Digoxin Droperidol Enalapril Enalaprilat Flecainide Ketanserin Levomethadyl Lisinopril Lithium Metildigoxin Moexipril Ouabain Perindopril Proscillaridin Quinapril Ramipril Simvastatin Sotalol Telaprevir Trandolapril

Using amlodipine, valsartan, and hydrochlorothiazide with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acebutolol Alacepril Alprenolol Apazone Aspirin Atenolol Benazepril Bepridil Betaxolol Bevantolol Bisoprolol Bromfenac Bucindolol Captopril Carbamazepine Carteolol Carvedilol Celecoxib Celiprolol Chlorpropamide Cholestyramine Cilazapril Clopidogrel Cyclophosphamide Dalfopristin Delapril Diclofenac Diflunisal Dilevalol Diltiazem Enalaprilat Enalapril Maleate Esmolol Etodolac Fenoprofen Fluconazole Flurbiprofen Fosinopril Ginkgo Glipizide Gossypol Ibuprofen Ibuprofen Lysine Imatinib Imidapril Indinavir Indomethacin Itraconazole Ketoconazole Ketoprofen Ketorolac Labetalol Levobunolol Licorice Lisinopril Magnesium Salicylate Meclofenamate Mefenamic Acid Meloxicam Mepindolol Metipranolol Metoprolol Moexipril Nabumetone Nadolol Naproxen Nebivolol Nepafenac Oxaprozin Oxprenolol Penbutolol Pentopril Perindopril Pindolol Piroxicam Propranolol Quinapril Quinupristin Ramipril Rifapentine Ritonavir Salicylic Acid Salsalate Sotalol Spirapril St John's Wort Sulindac Talinolol Temocapril Tertatolol Timolol Tolmetin Topiramate Trandolapril Zofenopril Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of amlodipine, valsartan, and hydrochlorothiazide. Make sure you tell your doctor if you have any other medical problems, especially:

Angina (severe chest pain) or Diabetes or Electrolyte imbalances (e.g., low levels of salt or sodium in the body) or Fluid imbalances (caused by dehydration, vomiting, or diarrhea) or Gallstones, or history of or Glaucoma, acute angle-closure or Gout, history of or Heart attack, history of or Heart or blood vessel disease (e.g., severe obstructive coronary artery disease) or Hypercalcemia (high calcium in the blood) or Hypercholesterolemia (high cholesterol in the blood) or Hypertriglyceridemia (high triglycerides or fats in the blood) or Systemic lupus erythematosus (an autoimmune disorder)—Use with caution. May make these conditions worse. Anuria (not able to form urine) or Kidney disease, severe or Liver disease, severe or Sulfonamide allergy (antibiotic or stomach medicines, e.g., sulfamethoxazole, sulfasalazine, sulfisoxazole, Azulfidine®, Bactrim®, or Septra®)—Should not be used in patients with these conditions. Aortic or mitral stenosis (problem with heart valve), severe or Asthma, history of—May cause side effects to become worse. Heart failure or Kidney disease or Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body. Proper Use of amlodipine, valsartan, and hydrochlorothiazide

amlodipine, valsartan, and hydrochlorothiazide should not be the first medicine you use to treat your condition. It is meant to be used only after you have tried other medicines that have not worked or have caused unwanted side effects.

amlodipine, valsartan, and hydrochlorothiazide comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

In addition to the use of amlodipine, valsartan, and hydrochlorothiazide, treatment for your high blood pressure may include weight control and a change in the types of foods you eat, especially foods high in sodium (salt). Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.

Many patients who have high blood pressure will not notice any symptoms of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well.

Remember that amlodipine, valsartan, and hydrochlorothiazide will not cure your high blood pressure, but it does help control it. You must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease.

You may take amlodipine, valsartan, and hydrochlorothiazide with or without food.

Dosing

The dose of amlodipine, valsartan, and hydrochlorothiazide will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of amlodipine, valsartan, and hydrochlorothiazide. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (tablets): For high blood pressure: Adults—One tablet once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than amlodipine 10 milligrams (mg), valsartan 320 mg, and hydrochlorothiazide 25 mg per day. Children—Use and dose must be determined by your doctor. Missed Dose

If you miss a dose of amlodipine, valsartan, and hydrochlorothiazide, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using amlodipine, valsartan, and hydrochlorothiazide

It is very important that your doctor check your progress at regular visits to make sure amlodipine, valsartan, and hydrochlorothiazide is working properly. Blood and urine tests may be needed to check for unwanted effects.

Using amlodipine, valsartan, and hydrochlorothiazide while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help. These symptoms are more likely to occur when you begin taking amlodipine, valsartan, and hydrochlorothiazide, or when the dose is increased.

Check with your doctor right away if you become sick while taking amlodipine, valsartan, and hydrochlorothiazide, especially with severe or continuing nausea, vomiting, or diarrhea. These conditions may cause you to lose too much water or salt.

Check with your doctor right away if you experience dizziness, fainting, confusion, muscle pain, weakness, and/or a fast heartbeat. Use extra care if you exercise or if the weather is hot. Heavy sweating can cause dehydration (loss of too much water) or electrolyte imbalances (loss of sodium, potassium, or magnesium in the body).

amlodipine, valsartan, and hydrochlorothiazide may worsen the symptoms of angina (chest pain) or cause a heart attack in certain patients with severe heart or blood vessel disease. Check with your doctor right away if you are having chest pain or discomfort; fast or uneven heartbeat; nausea or vomiting; shortness of breath; pain or discomfort in the arms, jaw, back, or neck; shortness of breath; or sweating.

Stop using amlodipine, valsartan, and hydrochlorothiazide and check with your doctor immediately if blurred vision, difficulty in reading, eye pain, or any other change in vision occurs during or after treatment. This could be a sign of a serious eye problem. Your doctor will want you to have your eyes checked by an ophthalmologist (eye doctor).

Make sure any doctor or dentist who treats you knows that you are using amlodipine, valsartan, and hydrochlorothiazide. You may need to stop using amlodipine, valsartan, and hydrochlorothiazide several days before having surgery or medical tests.

Make sure any doctor or dentist who treats you knows that you are using amlodipine, valsartan, and hydrochlorothiazide. amlodipine, valsartan, and hydrochlorothiazide may affect the results of certain medical tests.

Do not use medicines, supplements, or salt substitutes that contain potassium without first checking with your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or over-the-counter (nonprescription ) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, since they may increase your blood pressure.

amlodipine, valsartan, and hydrochlorothiazide Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common Swelling Rare Bladder pain bloody or cloudy urine blurred vision burning while urinating burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings chest pain chills cold sweats coma confusion convulsions cough cough producing mucus decreased urination decreased urine output diarrhea difficult or labored breathing difficult, burning, or painful urination dizziness dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position dry mouth ear congestion or pain fainting fast, pounding, or irregular heartbeat or pulse fever flushed, dry skin frequent urge to urinate fruit-like breath odor general feeling of discomfort or illness head congestion headache hoarseness or other voice changes increased hunger increased sweating increased thirst increased urination joint pain lightheadedness loss of appetite loss of consciousness lower back or side pain mood changes muscle aches and pains nausea or vomiting numbness or tingling in the hands, feet, or lips rapid breathing runny nose shivering shortness of breath sneezing sore throat stomachache stuffy nose sunken eyes sweating swelling of the face, ankles, or hands tightness in the chest trouble with sleeping unexplained weight loss unusual tiredness or weakness wheezing wrinkled skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common Acid or sour stomach back pain belching heartburn indigestion muscle spasms stomach discomfort, upset, or pain Rare Bleeding after defecation body aches or pain burning feeling in the chest or stomach burning, numbness, pain, or tingling in all fingers except smallest finger change in taste congestion continuing ringing or buzzing or other unexplained noise in the ears decreased interest in sexual intercourse decreased weight depression difficulty having a bowel movement (stool) difficulty with moving fear or nervousness feeling of constant movement of self or surroundings hearing loss inability to have or keep an erection increased appetite itching skin lack or loss of strength loss in sexual ability, desire, drive, or performance loss of taste muscle weakness neck pain pain in the arms or legs pain, swelling, or redness in the joints rash sensation of spinning shakiness in the legs, arms, hands, or feet sleepiness or unusual drowsiness sleeplessness sneezing stomach upset swelling of the joints tender, swollen glands in the neck tenderness in the stomach area toothache trembling or shaking of the hands or feet trouble with swallowing unable to sleep uncomfortable swelling around the anus unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness upper abdominal or stomach pain voice changes weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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More amlodipine, valsartan, and hydrochlorothiazide resources Amlodipine, valsartan, and hydrochlorothiazide Dosage Amlodipine, valsartan, and hydrochlorothiazide Use in Pregnancy & Breastfeeding Amlodipine, valsartan, and hydrochlorothiazide Drug Interactions Amlodipine, valsartan, and hydrochlorothiazide Support Group 1 Review for Amlodipine, valsartan, and hydrochlorothiazide - Add your own review/rating Compare amlodipine, valsartan, and hydrochlorothiazide with other medications High Blood Pressure


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Aliskiren/Amlodipine/Hydrochlorothiazide


Pronunciation: a-lis-KYE-ren/am-LOE-di-peen/HYE-droe-KLOR-oh-THYE-a-zide
Generic Name: Aliskiren/Amlodipine/Hydrochlorothiazide
Brand Name: Amturnide

Aliskiren/Amlodipine/Hydrochlorothiazide may cause birth defects or fetal and newborn death if you take it while you are pregnant. If you think you may be pregnant, contact your doctor right away.


Aliskiren/Amlodipine/Hydrochlorothiazide is used for:

Treating high blood pressure. It may also be used for other conditions as determined by your doctor.

Aliskiren/Amlodipine/Hydrochlorothiazide is a renin inhibitor, calcium channel blocker, and thiazide diuretic combination. It works by relaxing the blood vessels and helping the kidneys remove fluid from the body.

Do NOT use Aliskiren/Amlodipine/Hydrochlorothiazide if: you are allergic to any ingredient in Aliskiren/Amlodipine/Hydrochlorothiazide or to any other sulfonamide medicine (eg, sulfamethoxazole) you have a history of angioedema (swelling of the hands, face, lips, eyes, throat, or tongue; difficulty swallowing or breathing; or hoarseness) caused by treatment with Aliskiren/Amlodipine/Hydrochlorothiazide you are pregnant you have severe kidney problems or are unable to urinate you are taking cyclosporine, dofetilide, itraconazole, or ketanserin

Contact your doctor or health care provider right away if any of these apply to you.

Before using Aliskiren/Amlodipine/Hydrochlorothiazide:

Some medical conditions may interact with Aliskiren/Amlodipine/Hydrochlorothiazide. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you are a woman of childbearing age if you have a history of angioedema (swelling of the hands, face, lips, eyes, throat, or tongue; difficulty swallowing or breathing; hoarseness), especially when taking an angiotensin-converting enzyme (ACE) inhibitor (eg, lisinopril) or an angiotensin receptor blocker (ARB) (eg, losartan) if you have had an allergic reaction to a penicillin antibiotic (eg, amoxicillin) if you are dehydrated, have low blood volume, have swelling or fluid retention, are on a low-salt (sodium) diet, or have high or low blood electrolyte levels (eg, sodium, magnesium, potassium, calcium) if you have a history of gallbladder or liver problems, kidney problems (eg, renal artery stenosis, kidney stones), a stroke, a heart attack, seizures, asthma, gout or high blood levels of uric acid, lupus, parathyroid gland problems, low blood pressure, blood vessel problems, or heart problems (eg, heart failure, angina, narrowing of heart blood vessels) if you have diabetes, especially if you are also taking an ACE inhibitor (eg, lisinopril) or an angiotensin receptor blocker (eg, losartan) if you are on dialysis or will be having surgery, or you have recently had nerve surgery if you are taking another medicine for blood pressure or heart problems if you have never taken another medicine for blood pressure

Some MEDICINES MAY INTERACT with Aliskiren/Amlodipine/Hydrochlorothiazide. Tell your health care provider if you are taking any other medicines, especially any of the following:

ACE inhibitors (eg, ramipril) or angiotensin receptor blockers (eg, losartan) because the risk of high blood potassium levels may be increased Digoxin, dofetilide, or ketanserin because the risk of irregular heartbeat may be increased Adrenocorticotropic hormone (ACTH), atorvastatin, azole antifungals (eg, itraconazole, ketoconazole), barbiturates (eg, phenobarbital), corticosteroids (eg, prednisone), cyclosporine, diuretics (eg, furosemide), HIV protease inhibitors (eg, ritonavir), narcotic pain relievers (eg, morphine), sildenafil, vasopressin receptor antagonists (eg, tolvaptan), or other medicines for high blood pressure because they may increase the risk of Aliskiren/Amlodipine/Hydrochlorothiazide's side effects Cholestyramine, colestipol, or nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen) because they may decrease Aliskiren/Amlodipine/Hydrochlorothiazide's effectiveness Diazoxide, lithium, potassium-sparing diuretics (eg, triamterene), potassium supplements, or simvastatin because the risk of their side effects and toxic effects may be increased by Aliskiren/Amlodipine/Hydrochlorothiazide Insulin or other diabetes medicines (eg, glipizide, metformin) because their effectiveness may be decreased by Aliskiren/Amlodipine/Hydrochlorothiazide

This may not be a complete list of all interactions that may occur. Ask your health care provider if Aliskiren/Amlodipine/Hydrochlorothiazide may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Aliskiren/Amlodipine/Hydrochlorothiazide:

Use Aliskiren/Amlodipine/Hydrochlorothiazide as directed by your doctor. Check the label on the medicine for exact dosing instructions.

An extra patient leaflet is available with Aliskiren/Amlodipine/Hydrochlorothiazide. Talk to your pharmacist if you have questions about this information. Take Aliskiren/Amlodipine/Hydrochlorothiazide by mouth with or without food. However, it is important to take it consistently with regard to meals. If you take Aliskiren/Amlodipine/Hydrochlorothiazide on an empty stomach, always take it on an empty stomach. If you take it with food, always take it with food. Be sure to drink enough liquids while you are taking Aliskiren/Amlodipine/Hydrochlorothiazide. If you do not, you may become dehydrated, which may increase your risk of low blood pressure. Discuss any questions or concerns with your doctor. Take Aliskiren/Amlodipine/Hydrochlorothiazide on a regular schedule to get the most benefit from it. Taking Aliskiren/Amlodipine/Hydrochlorothiazide at the same time each day will help you remember to take it. Continue to take Aliskiren/Amlodipine/Hydrochlorothiazide even if you feel well. Do not miss any doses. If you miss a dose of Aliskiren/Amlodipine/Hydrochlorothiazide, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Aliskiren/Amlodipine/Hydrochlorothiazide.

Important safety information: Aliskiren/Amlodipine/Hydrochlorothiazide may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Aliskiren/Amlodipine/Hydrochlorothiazide with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Aliskiren/Amlodipine/Hydrochlorothiazide may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects. Patients who take medicine for high blood pressure often feel tired or run down for a few weeks after starting treatment. Be sure to take your medicine even if you may not feel "normal." Tell your doctor if you develop any new symptoms. Aliskiren/Amlodipine/Hydrochlorothiazide may cause a serious side effect called angioedema. Contact your doctor at once if you develop swelling of the hands, face, lips, eyes, throat, or tongue; difficulty swallowing or breathing; or hoarseness. Your doctor may also prescribe a potassium supplement for you. If so, take the potassium supplement exactly as prescribed. Do not start taking additional potassium on your own or change your diet to include more potassium without first checking with your doctor. Check with your doctor before you use a salt substitute or a product that has potassium in it. If you have high blood pressure, do not use nonprescription products that contain stimulants. These products may include diet pills or cold medicines. Contact your doctor if you have any questions or concerns. High-fat meals may decrease the amount of Aliskiren/Amlodipine/Hydrochlorothiazide that is absorbed into your body. Discuss any questions or concerns with your doctor. Be sure you take Aliskiren/Amlodipine/Hydrochlorothiazide consistently with regard to meals. If vomiting, diarrhea, or excessive sweating occur, you will need to take care not to become dehydrated. This could increase your risk of low blood pressure. Contact your doctor for instructions. Aliskiren/Amlodipine/Hydrochlorothiazide may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Aliskiren/Amlodipine/Hydrochlorothiazide. Use a sunscreen or wear protective clothing if you must be outside for more than a short time. Diabetes patients - Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine. Tell your doctor or dentist that you take Aliskiren/Amlodipine/Hydrochlorothiazide before you receive any medical or dental care, emergency care, or surgery. Talk with your doctor or pharmacist about all of your blood pressure medicines and how to use them. Do not start, stop, or change the dose of any blood pressure medicine unless your doctor tells you to. Lab tests, including blood pressure, kidney function, and blood electrolyte levels, may be performed while you use Aliskiren/Amlodipine/Hydrochlorothiazide. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. Use Aliskiren/Amlodipine/Hydrochlorothiazide with caution in the ELDERLY; they may be more sensitive to its effects. Aliskiren/Amlodipine/Hydrochlorothiazide should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed. PREGNANCY and BREAST-FEEDING: Aliskiren/Amlodipine/Hydrochlorothiazide may cause birth defects, or fetal or newborn death if you take it while you are pregnant. If you think you may be pregnant, contact your doctor right away. Aliskiren/Amlodipine/Hydrochlorothiazide is found in breast milk. Do not breast-feed while taking Aliskiren/Amlodipine/Hydrochlorothiazide. Possible side effects of Aliskiren/Amlodipine/Hydrochlorothiazide:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; headache; mild diarrhea; sore throat; stuffy or runny nose.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); change in the amount of urine produced; chest, jaw, or left arm pain; confusion; eye pain; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; mental or mood changes (eg, depression); muscle pain, weakness, or cramps; numbness of an arm or leg; red, swollen, blistered, or peeling skin; seizures; severe or persistent dizziness, drowsiness, or lightheadedness; severe or persistent stomach pain; shortness of breath; sudden, severe headache or vomiting; sudden, unexplained weight gain; swelling of the feet, ankles, or hands; unusual bruising or bleeding; unusual thirst, tiredness, or weakness; vision changes (eg, blurred vision); worsening of angina pain (eg, longer, more often, more severe); yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Aliskiren/Amlodipine/Hydrochlorothiazide side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include confusion; fainting; fast or slow heartbeat; flushing; muscle pain, weakness, or cramps; seizures; severe dizziness, drowsiness, or lightheadedness; very dry mouth.

Proper storage of Aliskiren/Amlodipine/Hydrochlorothiazide:

Store Aliskiren/Amlodipine/Hydrochlorothiazide at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store in the original container, away from heat, moisture, and light. Do not store in the bathroom. Keep Aliskiren/Amlodipine/Hydrochlorothiazide out of the reach of children and away from pets.

General information: If you have any questions about Aliskiren/Amlodipine/Hydrochlorothiazide, please talk with your doctor, pharmacist, or other health care provider. Aliskiren/Amlodipine/Hydrochlorothiazide is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Aliskiren/Amlodipine/Hydrochlorothiazide. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Aliskiren/Amlodipine/Hydrochlorothiazide resources Aliskiren/Amlodipine/Hydrochlorothiazide Side Effects (in more detail) Aliskiren/Amlodipine/Hydrochlorothiazide Use in Pregnancy & Breastfeeding Aliskiren/Amlodipine/Hydrochlorothiazide Drug Interactions Aliskiren/Amlodipine/Hydrochlorothiazide Support Group 0 Reviews for Aliskiren/Amlodipine/Hydrochlorothiazide - Add your own review/rating Amturnide Prescribing Information (FDA) Amturnide Advanced Consumer (Micromedex) - Includes Dosage Information Amturnide Consumer Overview Compare Aliskiren/Amlodipine/Hydrochlorothiazide with other medications High Blood Pressure


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Valsartan / hydrochlorothiazide 80 mg / 12.5 mg film-coated tablets


1. Name Of The Medicinal Product

Valsartan/hydrochlorothiazide 80 mg/12.5 mg film-coated tablets

2. Qualitative And Quantitative Composition

Each film-coated tablet contains 80 mg valsartan and 12.5 mg hydrochlorothiazide.

Excipient:

One tablet contains 16.27 mg lactose.

3. Pharmaceutical Form

Film-coated tablet.

The film-coated tablets are pink, oval, biconvex.

4. Clinical Particulars 4.1 Therapeutic Indications

Treatment of essential hypertension in adults.

Valsartan/hydrochlorothiazide fixed-dose combination is indicated in patients whose blood pressure is not adequately controlled on valsartan or hydrochlorothiazide monotherapy.

4.2 Posology And Method Of Administration

Posology

The recommended dose of Valsartan/hydrochlorothiazide 80 mg/12.5 mg is one film coated tablet once daily. Dose titration with the individual components is recommended. In each case, up- titration of individual components to the next dose should be followed in order to reduce the risk of hypotension and other adverse events.

When clinically appropriate direct change from monotherapy to the fixed dose combination may be considered in patients whose blood pressure is not adequately controlled on valsartan or hydrochlorothiazide monotherapy, provided the recommended dose titration sequence for the individual components is followed.

The clinical response to Valsartan/hydrochlorothiazide should be evaluated after initiating therapy and if blood pressure remains uncontrolled, the dose may be increased by increasing either one of the components to a maximum dose of valsartan/hydrochlorothiazide 320 mg/25 mg.

The antihypertensive effect is substantially present within 2 weeks.

In most patients, maximal effects are observed within 4 weeks. However, in some patients, 4-8 weeks treatment may be required. This should be taken into account during dose-titration.

Method of administration

Valsartan/hydrochlorothiazide can be taken with or without food and should be administered with water.

Special populations

Renal impairment

No dosage adjustment is required for patients with mild to moderate renal impairment (creatinine clearance

Hepatic impairment

In patients with mild to moderate hepatic impairment without cholestasis the dose of valsartan should not exceed 80 mg (see section 4.4). Valsartan/hydrochlorothiazide is contraindicated in patients with severe hepatic impairment (see sections 4.3, 4.4 and 5.2).

Elderly

No dose adjustment is required in elderly patients.

Paediatric patients

Valsartan/hydrochlorothiazide is not recommended for use in children below the age of 18 years due to a lack of data on safety and efficacy.

4.3 Contraindications

- Hypersensitivity to valsartan, hydrochlorothiazide, other sulfonamide-derived medicinal products or to any of the excipients.

- Second and third trimester of pregnancy (section 4.4 and 4.6).

- Severe hepatic impairment, biliary cirrhosis and cholestasis.

- Severe renal impairment (creatinine clearance <30 ml/min), anuria.

- Refractory hypokalaemia, hyponatraemia, hypercalcaemia, and symptomatic hyperuricaemia.

4.4 Special Warnings And Precautions For Use

Serum electrolyte changes

Valsartan

Concomitant use with potassium supplements, potassium sparing diuretics, salt substitutes containing potassium, or other agents that may increase potassium levels (heparin, etc.) is not recommended. Monitoring of potassium should be undertaken as appropriate.

Hydrochlorothiazide

Hypokalaemia has been reported under treatment with thiazide diuretics, including hydrochlorothiazide. Frequent monitoring of serum potassium is recommended.

Treatment with thiazide diuretics, including hydrochlorothiazide, has been associated with hyponatraemia and hypochloroaemic alkalosis. Thiazides, including hydrochlorothiazide, increase the urinary excretion of magnesium, which may result in hypomagnesaemia. Calcium excretion is decreased by thiazide diuretics. This may result in hypercalcaemia.

As for any patient receiving diuretic therapy, periodic determination of serum electrolytes should be performed at appropriate intervals.

Sodium and/or volume-depleted patients

Patients receiving thiazide diuretics, including hydrochlorothiazide, should be observed for clinical signs of fluid or electrolyte imbalance.

In severely sodium-depleted and/or volume-depleted patients such as those receiving high doses of diuretics, symptomatic hypotension may occur in rare cases after initiation of therapy with valsartan and hydrochlorothiazide. Sodium and/or volume depletion should be corrected before starting treatment with combination of valsartan and hydrochlorothiazide.

Patients with severe chronic heart failure or other conditions with stimulation the renin-angiotensin-aldosterone-system

In patients whose renal function may depend on the activity of the renin-angiotensin-aldosterone system (e.g. patients with severe congestive heart failure), treatment with angiotensin converting enzyme inhibitors has been associated with oliguria and/or progressive azotemia and in rare cases with acute renal failure. The use of combination of valsartan and hydrochlorothiazide in patients with severe chronic heart failure has not been established.

Hence it cannot be excluded that because of the inhibition of the renin-angiotensin-aldosterone system the application of valsartan and hydrochlorothiazide as well may be associated with impairment of the renal function. Valsartan/hydrochlorothiazide should not be used in these patients.

Renal artery stenosis

Valsartan/hydrochlorothiazide should not be used to treat hypertension in patients with unilateral or bilateral renal artery stenosis or stenosis to a solitary kidney, since blood urea and serum creatinine may increase in such patients.

Primary hyperaldosteronism

Patients with primary aldosteronism should not be treated with Valsartan/hydrochlorothiazide as their renin-angiotensin system is not activated.

Aortic and mitral valve stenosis, hypertrophic cardiomyopathy

As with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or hypertrophic obstructive cardiomyopathy (HOCM).

Renal impairment

No doseage adjustment is required for patients with renal impairment with a creatinine clearance

Kidney transplantation

There is currently no experience on the safe use of Valsartan/hydrochlorothiazide in patients who have recently undergone kidney transplantation.

Hepatic impairment

In patients with mild to moderate hepatic impairment without cholestasis Valsartan/hydrochlorothiazide should be used with caution (see sections 4.2 and 5.2).

Systemic lupus erythematosus

Thiazide diuretics, including hydrochlorothiazide, have been reported to exacerbate or activate systemic lupus erythematosus.

Other metabolic disturbances

Thiazide diuretics, including hydrochlorothiazide, may alter glucose tolerance and raise serum levels of cholesterol, triglycerides, and uric acid. In diabetic patients dosage adjustments of insulin or oral hypoglycaemic agents may be required.

Thiazides may reduce urinary calcium excretion and cause an intermittent and slight elevation of serum calcium in the absence of known disorders of calcium metabolism. Marked hypercalcaemia may be evidence of underlying hyperparathyroidism. Thiazides should be discontinued before carrying out tests for parathyroid function.

Photosensitivity

Cases of photosensitivity reactions have been reported with thiazides diuretics (see section 4.8). If photosensitivity reaction occurs during treatment, it is recommended to stop the treatment. If a re-administration of the diuretic is deemed necessary, it is recommended to protect exposed areas to the sun or to artificial UVA.

Pregnancy

Angiotensin II Receptor Antagonists (AIIRAs) should not be initiated during pregnancy. Unless continued AIIRAs therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and 4.6).

General

Caution should be exercised in case of prior hypersensitivity to other angiotensin II receptor antagonists. Hypersensitivity reactions to are more likely in patients with allergy or asthma.

Lactose

This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Interactions related to both valsartan and hydrochlorothiazide

Concomitant use not recommended

Lithium

Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant use of ACE inhibitors and thiazides, including hydrochlorothiazide. Due to the lack of experience with concomitant use of valsartan and lithium, this combination is not recommended. If the combination proves necessary, careful monitoring of serum lithium levels is recommended.

Concomitant use requiring caution

Other antihypertensive agents

Valsartan and hydrochlorothiazide combination may increase the effects of other agents with antihypertensive properties (e.g ACEI, beta-blockers, calcium channel blockers).

Pressor amines (e.g. noradrenaline, adrenaline)

Possible decreased response to pressor amines but not sufficient to preclude their use.

Non-steroidal anti-inflammatory medicines (NSAIDs), including selective COX-2 inhibitors, acetylsalicylic acid >3 g/day), and non-selective NSAIDs

NSAIDS can attenuate the antihypertensive effect of both angiotensin II antagonists and hydrochlorothiazide when administered simultaneously. Furthermore, concomitant use of Valsartan/hydrochlorothiazide and NSAIDs may lead to worsening of renal function and an increase in serum potassium. Therefore, monitoring of renal function at the beginning of the treatment is recommended, as well as adequate hydration of the patient.

Interactions related to valsartan

Concomitant use not recommended

Potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium and other substances that may increase potassium levels

If a medicinal product that affects potassium levels is considered necessary in combination with valsartan, monitoring of potassium plasma levels is advised.

No interaction

In drug interaction studies with valsartan, no interactions of clinical significance have been found with valsartan or any of the following substances: cimetidine, warfarin, furosemide, digoxin, atenolol, indomethacin, hydrochlorothiazide, amlodipine, glibenclamide. Digoxin and indomethacin could interact with the hydrochlorothiazide component of Valsartan/hydrochlorothiazide (see interactions related to hydrochlorothiazide).

Interactions related to hydrochlorothiazide

Concomitant use requiring caution

Medicinal products associated with potassium loss and hypokalaemia (e.g. kaliuretic diuretics, corticosteroids, laxatives, ACTH, amphotericin, carbenoxolone, penicillin G, salicylic acid and derivatives).

If these medicinal products are to be prescribed with the hydrochlorothiazide-valsartan combination, monitoring of potassium plasma levels is advised. These medicinal products may potentiate the effect of hydrochlorothiazide on serum potassium (see section 4.4).

Medicinal products that could induce torsades de pointes

- Class Ia antiarrhythmics (e.g. quinidine, hydroquinidine, disopyramide)

- Class III antiarrhythmics (e.g. amiodarone, sotalol, dofetilide, ibutilide)

- Some antipsychotics: (e.g. thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, sulpiride, sultopride, amisulpride, tiapride, pimozide, haloperidol, droperidol)

- Others: (e.g. bepridil, cisapride, diphemanil, erythromycin i.v., halofantrin, ketanserin, mizolastin, pentamidine, sparfloxacine, terfenadine, vincamine i.v.).

Due to the risk of hypokalemia, hydrochlorothiazide should be administered with caution when associated with medicinal products that could induce torsades de pointes.

Digitalis glycosides

Thiazide-induced hypokalaemia or hypomagnesaemia may occur as unwanted effect favoring the onset of digitalis-induced cardiac arrhythmias.

Calcium salts and vitamin D

Administration of thiazide diuretics, including hydrochlorothiazide, with vitamin D or with calcium salts may potentiate the rise in serum calcium.

Antidiabetic medicinal agents products (oral medicinal products and insulin)

The treatment with a thiazide may influence the glucose tolerance. Dose adjustment of the antidiabetic medicinal product may be necessary.

Metformin should be used with caution because of the risk of lactic acidosis induced by possible functional renal failure linked to hydrochlorothiazide.

Beta-blockers and diazoxide

Concomitant use of thiazide diuretics, including hydrochlorothiazide, with betablockers may increase the risk of hyperglycaemia. Thiazide diuretics, including hydrochlorothiazide, may enhance the hyperglycaemic effect of diazoxide.

Medicinal products used in the treatment of gout (probenecid, sulfinpyrazone and allopurinol)

Dosage adjustment of uricosuric medications may be necessary as hydrochlorothiazide may raise the level of serum uric acid. Increase of dosage of probenecid or sulfinpyrazone may be necessary. Co-administration of thiazide diuretics, including hydrochlorothiazide, may increase the incidence of hypersensitivity reactions to allopurinol.

Anticholinergic agents (e.g. atropine, biperiden)

The bioavailability of thiazide-type diuretics may be increased by anticholinergic agents, apparently due to a decrease in gastrointestinal motility and the stomach emptying rate.

Amantadine

Thiazides, including hydrochlorothiazide, may increase the risk of adverse effects caused by amantadine.

Colestyramine and colestipol resins

Absorption of thiazide diuretics, including hydrochlorothiazide, is impaired in the presence of anionic exchange resins.

Cytotoxic agents (e.g. cyclophosamide, methotrexate)

Thiazides, including hydrochlorothiazide, may reduce renal excretion of cytotoxic medicinal products and potentiate their myelosuppressive effects.

Nondepolarizing skeletal muscle relaxants (e.g. tubocurarine)

Thiazides, including hydrochlorothiazide, potentiate the action of curare derivatives.

Ciclosporin

Concomitant treatment with ciclosporin may increase the risk of hyperuricaemia and gout-type complications.

Alcohol, anaesthetics and sedatives

Potentiation of orthostatic hypotension may occur.

Methyldopa

There have been isolated reports of haemolytic anaemia in patients receiving concomitant treatment with methyldopa and hydrochlorothiazide.

Carbamazepine

Patients receiving hydrochlorothiazide concomitantly with carbamazepine may develop hyponatremia. Such patients should therefore be advised about the possibility of hyponatraemic reactions, and should be monitored accordingly.

Iodine contrast media

In case of diuretic-induced dehydration, there is an increased risk of acute renal failure, especially with high doses of the iodine product. Patients should be rehydrated before the administration.

4.6 Pregnancy And Lactation

Pregnancy

Given the effects of the individual components in this combination product on pregnancy, the use of Valsartan/hydrochlorothiazide is not recommended during the first trimester of pregnancy (see section 4.4). The use of < Product name > is contra-indicated during the 2nd and 3rd trimester of pregnancy (see section 4.3 and 4.4).

The use of AIIRAs is not recommended during the first trimester of pregnancy (see section 4.4). The use of AIIRAs is contra-indicated during the 2nd and 3rd trimester of pregnancy (see section 4.3 and 4.4).

Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded. Whilst there is no controlled epidemiological data on the risk with Angiotensin II Receptor Inhibitors (AIIRAs), similar risks may exist for this class of drugs. Unless continued ARB therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately and, if appropriate, alternative therapy should be started.

Exposure to AIIRA therapy during the second and third trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia). (See also 5.3 'Preclinical safety data')

Should exposure to AIIRAs have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.

Infants whose mothers have taken AIIRAs should be closely observed for hypotension (see also section 4.3 and 4.4).

There is limited experience with hydrochlorothiazide during pregnancy, especially during the first trimester. Animal studies are insufficient.

Hydrochlorothiazide crosses the placenta. Based on the pharmacological mechanism of action of hydrochlorothiazide its use during the second and third trimester may compromise foeto-placental perfusion and may cause foetal and neonatal effects like icterus, disturbance of electrolyte balance and thrombocytopenia.

Hydrochlorothiazide should not be used for gestational oedema, gestational hypertension or preeclampsia due to the risk of decreased plasma volume and placental hypoperfusion, without a beneficial effect on the course of the disease.

Hydrochlorothiazide should not be used for essential hypertension in pregnant women except in rare situations where no other treatment could be used.

Lactation

Because no information is available regarding the use of Valsartan/hydrochlorothiazide during breastfeeding, Valsartan/hydrochlorothiazide is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.

4.7 Effects On Ability To Drive And Use Machines

No studies on the effects of valsartan-hydrochlorothiazide combination, on the ability to drive and use machines have been performed. When driving vehicles or operating machines it should be taken into account that occasionally dizziness or weariness may occur.

4.8 Undesirable Effects

Fixed-dose combination

Adverse reactions reported in clinical trials and laboratory findings occurring more frequently with valsartan plus hydrochlorothiazide versus placebo and individual postmarketing reports are presented below according to system organ class. Adverse reactions known to occur with each component given individually but which have not been seen in clinical trials may occur during treatment with valsartan /hydrochlorothiazide.

Adverse reactions are ranked by frequency, the most frequent first, using the following convention: very common (

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Table 1. Frequency of adverse reactions with valsartan/hydrochlorothiazide

Metabolism and nutrition disorders

 

Uncommon

Dehydration

Nervous system disorders

 

Very rare

Dizziness

Uncommon

Paraesthesia

Not known

Syncope

Eye disorders

 

Uncommon

Vision blurred

Ear and labyrinth disorders

 

Uncommon

Tinnitus

Vascular disorders

 

Uncommon

Hypotension

Respiratory, thoracic and mediastinal disorders

 

Uncommon

Cough

Not known

Non cardiogenic pulmonary oedema

Gastrointestinal disorders

 

Very rare

Diarrhoea

Musculoskeletal and connective tissue disorders

 

Uncommon

Myalgia

Very rare

Arthralgia

Renal and urinary disorders

 

Not known

Impaired renal function

General disorders and administration site conditions

 

Uncommon

Fatigue

Investigations

 

Not known

Serum uric acid increased, Serum bilirubin and Serum creatinine increased, Hypokalaemia, Hyponatraemia, Elevation of Blood Urea Nitrogen, Neutropenia

Additional information on individual components

Adverse reactions previously reported with one of the individual components may be potential undesirable effects with combination ofvalsartan and hydrochlorothiazide as well, even if not observed in clinical trials or during postmarketing period.

Table 2. Frequency of adverse reactions with valsartan

Blood and lymphatic system disorders

 

Not known

Decrease in haemoglobin, decrease in haematocrit, thrombocytopenia

Immune system disorders

 

Not known

Other hypersensitivity/allergic reactions including serum sickness

Metabolism and nutrition disorders

 

Not known

Increase of serum potassium

Ear and labyrinth disorders

 

Uncommon

Vertigo

Vascular disorders

 

Not known

Vasculitis

Gastrointestinal disorders

 

Uncommon

Abdominal pain

Hepatobiliary disorders

 

Not known

Elevation of liver function values

Skin and subcutaneous tissue disorders

 

Not known

Angioedema, rash, pruritus

Renal and urinary disorders

 

Not known

Renal failure

Table 3. Frequency of adverse reactions with hydrochlorothiazide

Hydrochlorothiazide has been extensively prescribed for many years, frequently in higher doses than those administered with Valsartan/hydrochlorothiazide. The following adverse reactions have been reported in patients treated with monotherapy of thiazide diuretics, including hydrochlorothiazide:

Blood and lymphatic system disorders

 

Rare

Thrombocytopenia sometimes with purpura

Very rare

Agranulocytosis, leucopenia, haemolytic anaemia, bone marrow depression

Immune system disorders

 

Very rare

Hypersenstivity reactions

Psychiatric disorders

 

Rare

Depression, sleep disturbances

Nervous system disorders

 

Rare

Headache

Cardiac disorders

 

Rare

Cardiac arrhythmias

Vascular disorders

 

Common

Postural hypotension

Respiratory, thoracic and mediastinal disorders

 

Very rare

Respiratory distress including pneumonitis and pulmonary oedema

Gastrointestinal disorders

 

Common

Loss of appetite, mild nausea and vomiting

Rare

Constipation, gastrointestinal discomfort

Very rare

Pancreatitis

Hepatobiliary disorders

 

Rare

Intrahepatic cholestasis or jaundice

Skin and subcutaneous tissue disorders

 

Common

Urticaria and other forms of rash

Rare

Photosensitisation

Very rare

Necrotising vasculitis and toxic epidermal necrolysis, cutaneous lupus erythematosus-like reactions, reactivation of cutaneous lupus erythematosus

Reproductive system and breast disorders

 

Common

Impotence

4.9 Overdose

Symptoms

Overdose with valsartan may result in marked hypotension, which could lead to depressed level of consciousness, circulatory collapse and/or shock. In addition, the following signs and symptoms may occur due to an overdose of the hydrochlorothiazide component: nausea, somnolence, hypovolaemia, and electrolyte disturbances associated with cardiac arrhythmias and muscle spasms.

Treatment

The therapeutic measures depend on the time of ingestion and the type and severity of the symptoms, stabilisation of the circulatory condition being of prime importance.

If hypotension occurs, the patient should be placed in the supine position and salt and volume supplementation should be given rapidly.

Valsartan cannot be eliminated by means of haemodialysis because of its strong plasma binding behaviour whereas clearance of hydrochlorothiazide will be achieved by dialysis.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: angiotensin II antagonists and diuretics, ATC code: C09DA03.

Valsartan/hydrochlorothiazide

In a double-blind, randomised, active-controlled trial in patients not adequately controlled on hydrochlorothiazide 12.5 mg, significantly greater mean systolic/diastolic BP reductions were observed with the combination of valsartan/hydrochlorothiazide 80/12.5 mg (14.9/11.3 mmHg) compared to hydrochlorothiazide 12.5 mg (5.2/2.9 mmHg) and hydrochlorothiazide 25 mg (6.8/5.7 mmHg). In addition, a significantly greater percentage of patients responded (diastolic BP <90 mmHg or reduction

In a double-blind, randomised, active-controlled trial in patients not adequately controlled on valsartan 80 mg, significantly greater mean systolic/diastolic BP reductions were observed with the combination of valsartan/hydrochlorothiazide 80/12.5 mg (9.8/8.2 mmHg) compared to valsartan 80 mg (3.9/5.1 mmHg) and valsartan 160 mg (6.5/6.2 mmHg). In addition, a significantly greater percentage of patients responded (diastolic BP <90 mmHg or reduction

In a double-blind, randomised, placebo-controlled, factorial design trial comparing various dose combinations of valsartan/hydrochlorothiazide to their respective components, significantly greater mean systolic/diastolic BP reductions were observed with the combination of valsartan/hydrochlorothiazide 80/12.5 mg (16.5/11.8 mmHg) compared to placebo (1.9/4.1 mmHg) and both hydrochlorothiazide 12.5 mg (7.3/7.2 mmHg) and valsartan 80 mg (8.8/8.6 mmHg). In addition, a significantly greater percentage of patients responded (diastolic BP <90 mmHg or reduction

Dose-dependent decreases in serum potassium occurred in controlled clinical studies with valsartan + hydrochlorothiazide. Reduction in serum potassium occurred more frequently in patients given 25 mg hydrochlorothiazide than in those given 12.5 mg hydrochlorothiazide. In controlled clinical trials with valsartan/hydrochlorothiazide the potassium lowering effect of hydrochlorothiazide was attenuated by the potassium-sparing effect of valsartan.

Beneficial effects of valsartan in combination with hydrochlorothiazide on cardiovascular mortality and morbidity are currently unknown.

Epidemiological studies have shown that long-term treatment with hydrochlorothiazide reduces the risk of cardiovascular mortality and morbidity.

Valsartan

Valsartan is an orally active and specific angiotensin II (Ang II) receptor antagonist. It acts selectively on the AT1 receptor subtype, which is responsible for the known actions of angiotensin II. The increased plasma levels of Ang II following AT1 receptor blockade with valsartan may stimulate the unblocked AT2 receptor, which appears to counterbalance the effect of the AT1 receptor. Valsartan does not exhibit any partial agonist activity at the AT1 receptor and has much (about 20,000 fold) greater affinity for the AT1 receptor than for the AT2 receptor. Valsartan is not known to bind to or block other hormone receptors or ion channels known to be important in cardiovascular regulation.

Valsartan does not inhibit ACE, also known as kininase II, which converts Ang I to Ang II and degrades bradykinin. Since there is no effect on ACE and no potentiation of bradykinin or substance P, angiotensin II antagonists are unlikely to be associated with coughing. In clinical trials where valsartan was compared with an ACE inhibitor, the incidence of dry cough was significantly (P <0.05) lower in patients treated with valsartan than in those treated with an ACE inhibitor (2.6% versus 7.9% respectively). In a clinical trial of patients with a history of dry cough during ACE inhibitor therapy, 19.5% of trial subjects receiving valsartan and 19.0% of those receiving a thiazide diuretic experienced cough compared to 68.5% of those treated with an ACE inhibitor (P <0.05).

Administration of valsartan to patients with hypertension results in reduction of blood pressure without affecting pulse rate. In most patients, after administration of a single oral dose, onset of antihypertensive activity occurs within 2 hours, and the peak reduction of blood pressure is achieved within 4-6 hours. The antihypertensive effect persists over 24 hours after dosing. During repeated dosing, the maximum reduction in blood pressure with any dose is generally attained within 2-4 weeks and is sustained during long-term therapy. Combined with hydrochlorothiazide, a significant additional reduction in blood pressure is achieved.

Abrupt withdrawal of valsartan has not been associated with rebound hypertension or other adverse clinical events.

In hypertensive patients with type 2 diabetes and microalbuminuria, valsartan has been shown to reduce the urinary excretion of albumin. The MARVAL (Micro Albuminuria Reduction with Valsartan) study assessed the reduction in urinary albumin excretion (UAE) with valsartan (80-160 mg/od) versus amlodipine (5-10 mg/od), in 332 type 2 diabetic patients (mean age: 58 years; 265 men) with microalbuminuria (valsartan: 58 ?g/min; amlodipine: 55.4 ?g/min), normal or high blood pressure and with preserved renal function (blood creatinine <120 ?mol/l). At 24 weeks, UAE was reduced (p <0.001) by 42% (–24.2 ?g/min; 95% CI: –40.4 to –19.1) with valsartan and approximately 3% (–1.7 ?g/min; 95% CI: –5.6 to 14.9) with amlodipine despite similar rates of blood pressure reduction in both groups. The Diovan Reduction of Proteinuria (DROP) study further examined the efficacy of valsartan in reducing UAE in 391 hypertensive patients (BP=150/88 mmHg) with type 2 diabetes, albuminuria (mean=102 ?g/min; 20–700 ?g/min) and preserved renal function (mean serum creatinine = 80 ?mol/l). Patients were randomised to one of 3 doses of valsartan (160, 320 and 640 mg/od) and treated for 30 weeks. The purpose of the study was to determine the optimal dose of valsartan for reducing UAE in hypertensive patients with type 2 diabetes. At 30 weeks, the percentage change in UAE was significantly reduced by 36% from baseline with valsartan 160 mg (95%CI: 22 to 47%), and by 44% with valsartan 320 mg (95%CI: 31 to 54%). It was concluded that 160-320 mg of valsartan produced clinically relevant reductions in UAE in hypertensive patients with type 2 diabetes.

Hydrochlorothiazide

The site of action of thiazide diuretics is primarily in the renal distal convoluted tubule. It has been shown that there is a high-affinity receptor in the renal cortex as the primary binding site for the thiazide diuretic action and inhibition of NaCl transport in the distal convoluted tubule. The mode of action of thiazides is through inhibition of the Na+Cl- symporter perhaps by competing for the Cl- site, thereby affecting electrolyte reabsorption mechanisms: directly increasing sodium and chloride excretion to an approximately equal extent, and indirectly by this diuretic action reducing plasma volume, with consequent increases in plasma renin activity, aldosterone secretion and urinary potassium loss, and a decrease in serum potassium. The renin-aldosterone link is mediated by angiotensin II, so with co-administration of valsartan the reduction in serum potassium is less pronounced as observed under monotherapy with hydrochlorothiazide.

5.2 Pharmacokinetic Properties

Valsartan/hydrochlorothiazide

The systemic availability of hydrochlorothiazide is reduced by about 30% when co-administered with valsartan. The kinetics of valsartan are not markedly affected by the co-administration of hydrochlorothiazide. This observed interaction has no impact on the combined use of valsartan and hydrochlorothiazide, since controlled clinical trials have shown a clear anti-hypertensive effect, greater than that obtained with either active substance given alone, or placebo.

Valsartan

Absorption

Following oral administration of valsartan alone, peak plasma concentrations of valsartan are reached in 2–4 hours. Mean absolute bioavailability is 23%. Food decreases exposure (as measured by AUC) to


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Exforge HCT


Generic Name: amlodipine, valsartan, and hydrochlorothiazide (Oral route)

am-LOE-di-peen BES-i-late, val-SAR-tan, hye-droe-klor-oh-THYE-a-zide

Oral route(Tablet)

Drugs that act directly on the renin-angiotensin system can cause injury or death to the developing fetus when used during the second and third trimesters. Stop therapy as soon as possible when pregnancy is detected .

Commonly used brand name(s)

In the U.S.

Exforge HCT

Available Dosage Forms:

Tablet

Therapeutic Class: Antihypertensive

Pharmacologic Class: Amlodipine

Chemical Class: Amlodipine

Uses For Exforge HCT

Amlodipine, valsartan, and hydrochlorothiazide is a combination of medicines that is used to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a heart failure or kidney failure. Lowering blood pressure reduces the risk of strokes and heart attacks.

Amlodipine is a calcium channel blocker. It affects the movement of calcium into the cells of the heart and blood vessels. As a result, amlodipine relaxes the blood vessels and increases the supply of blood and oxygen to the heart while reducing its workload.

Valsartan is an angiotensin II receptor blocker. It works by blocking a substance in the body that causes blood vessels to tighten. As a result, valsartan relaxes the blood vessels. This lowers blood pressure and increases the supply of blood and oxygen to the heart.

Hydrochlorothiazide is a thiazide diuretic (water pill). It reduces the amount of water in the body by increasing the flow of urine, which helps lower the blood pressure.

This medicine is available only with your doctor's prescription.

Before Using Exforge HCT

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of amlodipine, valsartan, and hydrochlorothiazide combination in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of amlodipine, valsartan, and hydrochlorothiazide combination in the elderly.

Pregnancy Pregnancy Category Explanation All Trimesters D Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk. Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Dofetilide

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acetyldigoxin Amiodarone Arsenic Trioxide Atazanavir Benazepril Conivaptan Dantrolene Deslanoside Digitalis Digitoxin Digoxin Droperidol Enalapril Enalaprilat Flecainide Ketanserin Levomethadyl Lisinopril Lithium Metildigoxin Moexipril Ouabain Perindopril Proscillaridin Quinapril Ramipril Simvastatin Sotalol Telaprevir Trandolapril

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acebutolol Alacepril Alprenolol Apazone Aspirin Atenolol Benazepril Bepridil Betaxolol Bevantolol Bisoprolol Bromfenac Bucindolol Captopril Carbamazepine Carteolol Carvedilol Celecoxib Celiprolol Chlorpropamide Cholestyramine Cilazapril Clopidogrel Cyclophosphamide Dalfopristin Delapril Diclofenac Diflunisal Dilevalol Diltiazem Enalaprilat Enalapril Maleate Esmolol Etodolac Fenoprofen Fluconazole Flurbiprofen Fosinopril Ginkgo Glipizide Gossypol Ibuprofen Ibuprofen Lysine Imatinib Imidapril Indinavir Indomethacin Itraconazole Ketoconazole Ketoprofen Ketorolac Labetalol Levobunolol Licorice Lisinopril Magnesium Salicylate Meclofenamate Mefenamic Acid Meloxicam Mepindolol Metipranolol Metoprolol Moexipril Nabumetone Nadolol Naproxen Nebivolol Nepafenac Oxaprozin Oxprenolol Penbutolol Pentopril Perindopril Pindolol Piroxicam Propranolol Quinapril Quinupristin Ramipril Rifapentine Ritonavir Salicylic Acid Salsalate Sotalol Spirapril St John's Wort Sulindac Talinolol Temocapril Tertatolol Timolol Tolmetin Topiramate Trandolapril Zofenopril Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Angina (severe chest pain) or Diabetes or Electrolyte imbalances (e.g., low levels of salt or sodium in the body) or Fluid imbalances (caused by dehydration, vomiting, or diarrhea) or Gallstones, or history of or Glaucoma, acute angle-closure or Gout, history of or Heart attack, history of or Heart or blood vessel disease (e.g., severe obstructive coronary artery disease) or Hypercalcemia (high calcium in the blood) or Hypercholesterolemia (high cholesterol in the blood) or Hypertriglyceridemia (high triglycerides or fats in the blood) or Systemic lupus erythematosus (an autoimmune disorder)—Use with caution. May make these conditions worse. Anuria (not able to form urine) or Kidney disease, severe or Liver disease, severe or Sulfonamide allergy (antibiotic or stomach medicines, e.g., sulfamethoxazole, sulfasalazine, sulfisoxazole, Azulfidine®, Bactrim®, or Septra®)—Should not be used in patients with these conditions. Aortic or mitral stenosis (problem with heart valve), severe or Asthma, history of—May cause side effects to become worse. Heart failure or Kidney disease or Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body. Proper Use of Exforge HCT

This medicine should not be the first medicine you use to treat your condition. It is meant to be used only after you have tried other medicines that have not worked or have caused unwanted side effects.

This medicine comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

In addition to the use of this medicine, treatment for your high blood pressure may include weight control and a change in the types of foods you eat, especially foods high in sodium (salt). Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.

Many patients who have high blood pressure will not notice any symptoms of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well.

Remember that this medicine will not cure your high blood pressure, but it does help control it. You must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease.

You may take this medicine with or without food.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (tablets): For high blood pressure: Adults—One tablet once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than amlodipine 10 milligrams (mg), valsartan 320 mg, and hydrochlorothiazide 25 mg per day. Children—Use and dose must be determined by your doctor. Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Exforge HCT

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help. These symptoms are more likely to occur when you begin taking this medicine, or when the dose is increased.

Check with your doctor right away if you become sick while taking this medicine, especially with severe or continuing nausea, vomiting, or diarrhea. These conditions may cause you to lose too much water or salt.

Check with your doctor right away if you experience dizziness, fainting, confusion, muscle pain, weakness, and/or a fast heartbeat. Use extra care if you exercise or if the weather is hot. Heavy sweating can cause dehydration (loss of too much water) or electrolyte imbalances (loss of sodium, potassium, or magnesium in the body).

This medicine may worsen the symptoms of angina (chest pain) or cause a heart attack in certain patients with severe heart or blood vessel disease. Check with your doctor right away if you are having chest pain or discomfort; fast or uneven heartbeat; nausea or vomiting; shortness of breath; pain or discomfort in the arms, jaw, back, or neck; shortness of breath; or sweating.

Stop using this medicine and check with your doctor immediately if blurred vision, difficulty in reading, eye pain, or any other change in vision occurs during or after treatment. This could be a sign of a serious eye problem. Your doctor will want you to have your eyes checked by an ophthalmologist (eye doctor).

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery or medical tests.

Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.

Do not use medicines, supplements, or salt substitutes that contain potassium without first checking with your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or over-the-counter (nonprescription ) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, since they may increase your blood pressure.

Exforge HCT Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common Swelling Rare Bladder pain bloody or cloudy urine blurred vision burning while urinating burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings chest pain chills cold sweats coma confusion convulsions cough cough producing mucus decreased urination decreased urine output diarrhea difficult or labored breathing difficult, burning, or painful urination dizziness dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position dry mouth ear congestion or pain fainting fast, pounding, or irregular heartbeat or pulse fever flushed, dry skin frequent urge to urinate fruit-like breath odor general feeling of discomfort or illness head congestion headache hoarseness or other voice changes increased hunger increased sweating increased thirst increased urination joint pain lightheadedness loss of appetite loss of consciousness lower back or side pain mood changes muscle aches and pains nausea or vomiting numbness or tingling in the hands, feet, or lips rapid breathing runny nose shivering shortness of breath sneezing sore throat stomachache stuffy nose sunken eyes sweating swelling of the face, ankles, or hands tightness in the chest trouble with sleeping unexplained weight loss unusual tiredness or weakness wheezing wrinkled skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common Acid or sour stomach back pain belching heartburn indigestion muscle spasms stomach discomfort, upset, or pain Rare Bleeding after defecation body aches or pain burning feeling in the chest or stomach burning, numbness, pain, or tingling in all fingers except smallest finger change in taste congestion continuing ringing or buzzing or other unexplained noise in the ears decreased interest in sexual intercourse decreased weight depression difficulty having a bowel movement (stool) difficulty with moving fear or nervousness feeling of constant movement of self or surroundings hearing loss inability to have or keep an erection increased appetite itching skin lack or loss of strength loss in sexual ability, desire, drive, or performance loss of taste muscle weakness neck pain pain in the arms or legs pain, swelling, or redness in the joints rash sensation of spinning shakiness in the legs, arms, hands, or feet sleepiness or unusual drowsiness sleeplessness sneezing stomach upset swelling of the joints tender, swollen glands in the neck tenderness in the stomach area toothache trembling or shaking of the hands or feet trouble with swallowing unable to sleep uncomfortable swelling around the anus unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness upper abdominal or stomach pain voice changes weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Exforge HCT side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Exforge HCT resources Exforge HCT Side Effects (in more detail)Exforge HCT Use in Pregnancy & BreastfeedingExforge HCT Drug InteractionsExforge HCT Support Group1 Review for Exforge HCT - Add your own review/rating Exforge HCT Prescribing Information (FDA) Exforge HCT MedFacts Consumer Leaflet (Wolters Kluwer) Exforge HCT Consumer Overview Compare Exforge HCT with other medications High Blood Pressure


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aliskiren, amlodipine, and hydrochlorothiazide


a-lis-KYE-ren, am-LOE-di-peen BES-i-late, hye-droe-klor-oh-THYE-a-zide

Oral route(Tablet)

When pregnancy is detected, discontinue aliskiren/amlodipine/hydrochlorothiazide as soon as possible. Drugs that act directly on the renin-angiotensin-aldosterone system can cause injury and even death to the developing fetus .

Commonly used brand name(s)

In the U.S.

Amturnide

Available Dosage Forms:

Tablet

Therapeutic Class: Antihypertensive

Pharmacologic Class: Renin Inhibitor

Chemical Class: Amlodipine

Uses For aliskiren, amlodipine, and hydrochlorothiazide

Aliskiren, amlodipine, and hydrochlorothiazide is a combination of medicines that may be used alone or with other medicines to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled.

Aliskiren is a renin inhibitor. It works by blocking an enzyme in the body that is necessary to produce a substance that causes blood vessels to tighten. As a result, the blood vessels relax and decreases the blood pressure. When the blood pressure is lowered, the amount of blood and oxygen is increased to the heart.

Amlodipine is a calcium channel blocker. It affects the movement of calcium into the cells of the heart and blood vessels. As a result, amlodipine relaxes blood vessels and increases the supply of blood and oxygen to the heart while reducing its workload.

Hydrochlorothiazide is a diuretic (water pill). It reduces the amount of water in the body by increasing the flow of urine, which helps lower the blood pressure.

aliskiren, amlodipine, and hydrochlorothiazide is available only with your doctor's prescription.

Before Using aliskiren, amlodipine, and hydrochlorothiazide

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For aliskiren, amlodipine, and hydrochlorothiazide, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to aliskiren, amlodipine, and hydrochlorothiazide or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of aliskiren, amlodipine, and hydrochlorothiazide combination in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of aliskiren, amlodipine, and hydrochlorothiazide combination in the elderly.

Pregnancy Pregnancy Category Explanation All Trimesters D Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk. Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking aliskiren, amlodipine, and hydrochlorothiazide, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using aliskiren, amlodipine, and hydrochlorothiazide with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Dofetilide

Using aliskiren, amlodipine, and hydrochlorothiazide with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acetyldigoxin Amiodarone Arsenic Trioxide Atazanavir Conivaptan Cyclosporine Dantrolene Deslanoside Digitalis Digitoxin Digoxin Droperidol Flecainide Itraconazole Ketanserin Levomethadyl Lithium Metildigoxin Ouabain Proscillaridin Simvastatin Sotalol Telaprevir

Using aliskiren, amlodipine, and hydrochlorothiazide with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acebutolol Alacepril Alprenolol Apazone Aspirin Atenolol Benazepril Bepridil Betaxolol Bevantolol Bisoprolol Bromfenac Bucindolol Captopril Carbamazepine Carteolol Carvedilol Celecoxib Celiprolol Chlorpropamide Cholestyramine Cilazapril Clopidogrel Cyclophosphamide Dalfopristin Delapril Diclofenac Diflunisal Dilevalol Diltiazem Enalapril Enalaprilat Enalapril Maleate Esmolol Etodolac Fenoprofen Fluconazole Flurbiprofen Fosinopril Ginkgo Glipizide Gossypol Ibuprofen Ibuprofen Lysine Imatinib Imidapril Indinavir Indomethacin Itraconazole Ketoconazole Ketoprofen Ketorolac Labetalol Levobunolol Licorice Lisinopril Magnesium Salicylate Meclofenamate Mefenamic Acid Meloxicam Mepindolol Metipranolol Metoprolol Moexipril Nabumetone Nadolol Naproxen Nebivolol Nepafenac Oxaprozin Oxprenolol Penbutolol Pentopril Perindopril Pindolol Piroxicam Propranolol Quinapril Quinupristin Ramipril Rifampin Rifapentine Ritonavir Salicylic Acid Salsalate Sotalol Spirapril St John's Wort Sulindac Talinolol Temocapril Tertatolol Timolol Tolmetin Topiramate Trandolapril Zofenopril Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using aliskiren, amlodipine, and hydrochlorothiazide with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use aliskiren, amlodipine, and hydrochlorothiazide, or give you special instructions about the use of food, alcohol, or tobacco.

Grapefruit Juice Other Medical Problems

The presence of other medical problems may affect the use of aliskiren, amlodipine, and hydrochlorothiazide. Make sure you tell your doctor if you have any other medical problems, especially:

Airway surgery, history of—At risk for severe complications from angioedema (swelling of the face, lips, tongue, throat, arms, or legs). Angioedema (swelling of the face, lips, tongue, throat, arms, or legs), history of—May increase the risk of this condition occurring again. Anuria (not able to pass urine) or Kidney disease, severe or Sulfa drug allergy (e.g., sulfamethoxazole, Bactrim®, Septra®)—Should not be used in patients with these conditions. Asthma, history of—May increase likelihood of having an allergic reaction. Heart or blood vessel disease (e.g., severe obstructive coronary artery disease)—Use with caution. May increase the risk of experiencing chest pain or heart attacks. Kidney disease or Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body. Systemic lupus erythematosus (SLE)—Use with caution. May make this condition worse. Proper Use of aliskiren, amlodipine, and hydrochlorothiazide

aliskiren, amlodipine, and hydrochlorothiazide should not be the first medicine you use to treat your condition. It is meant to be used only after you have tried other medicines that have not worked or have caused unwanted side effects.

aliskiren, amlodipine, and hydrochlorothiazide comes with a patient information insert. Read the information carefully and make sure you understand it before taking aliskiren, amlodipine, and hydrochlorothiazide. Ask your doctor if you have any questions.

In addition to the use of aliskiren, amlodipine, and hydrochlorothiazide, treatment for your high blood pressure may include weight control and a change in the types of foods you eat, especially foods high in sodium (salt). Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.

Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well.

Remember that aliskiren, amlodipine, and hydrochlorothiazide will not cure your high blood pressure, but it does help control it. You must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease.

You may take aliskiren, amlodipine, and hydrochlorothiazide with or without food, but try to take it consistently. High-fat meals may affect absorption of aliskiren, amlodipine, and hydrochlorothiazide.

Dosing

The dose of aliskiren, amlodipine, and hydrochlorothiazide will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of aliskiren, amlodipine, and hydrochlorothiazide. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (tablets): For high blood pressure: Adults—Your doctor will determine your starting dose and may increase your dose as needed. However, the dose is usually not more than 300 milligrams (mg) of aliskiren, 10 mg of amlodipine, and 25 mg of hydrochlorothiazide once a day. Children—Use and dose must be determined by your doctor. Missed Dose

If you miss a dose of aliskiren, amlodipine, and hydrochlorothiazide, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using aliskiren, amlodipine, and hydrochlorothiazide

It is very important that your doctor check your progress at regular visits to make sure aliskiren, amlodipine, and hydrochlorothiazide is working properly. Blood tests may be needed to check for unwanted effects.

Using aliskiren, amlodipine, and hydrochlorothiazide while you are pregnant (especially in your second or third trimester) can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using aliskiren, amlodipine, and hydrochlorothiazide, tell your doctor right away.

Stop using aliskiren, amlodipine, and hydrochlorothiazide and call your doctor right away if you have swelling of the face, arms, legs, eyes, lips, or tongue, or problems with swallowing or breathing. These are symptoms of a condition called angioedema.

Dizziness, lightheadedness, or fainting may occur after the first dose, especially if you have been taking a diuretic (water pill). Make sure you know how you react to the medicine before you drive, use machines, or do other things that could be dangerous if you are dizzy or not alert.

You should not use this medication (unless your doctor specifically tells you to) if you are also receiving itraconazole (Sporanox®), cyclosporine (Gengraf®, Neoral®, Sandimmune®), or lithium (Eskalith®, Lithobid®).

Check with your doctor right away if you experience dizziness, fainting, confusion, muscle pain, weakness, or a fast heartbeat. Use extra care if you exercise or if the weather is hot. Heavy sweating can cause dehydration (loss of too much water) or electrolyte imbalances (loss of sodium or potassium in the body).

Check with your doctor right away if you become sick while taking aliskiren, amlodipine, and hydrochlorothiazide, especially with severe or continuing nausea, vomiting, or diarrhea. These conditions may cause you to lose too much water or salt which may cause low blood pressure.

aliskiren, amlodipine, and hydrochlorothiazide may worsen the symptoms of angina (chest pain) or cause a heart attack, especially in patients with severe heart or blood vessel disease. Check with your doctor right away if you are having chest pain or discomfort; fast or irregular heartbeat; nausea or vomiting; pain or discomfort in the arms, jaw, back, or neck; shortness of breath; or sweating.

Hyperkalemia (high potassium in the blood) may occur while you are using aliskiren, amlodipine, and hydrochlorothiazide. Check with your doctor right away if you have the following symptoms: abdominal or stomach pain; confusion; difficulty with breathing; irregular heartbeat; nausea or vomiting; nervousness; numbness or tingling in the hands, feet, or lips; shortness of breath; or weakness or heaviness of the legs. Do not use salt substitutes containing potassium without first checking with your doctor.

Check with your doctor immediately if blurred vision, difficulty in reading, eye pain, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

aliskiren, amlodipine, and hydrochlorothiazide Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common Bloating or swelling of the face, arms, hands, lower legs, or feet rapid weight gain tingling of hands or feet unusual weight gain or loss Less common Dizziness Rare Blurred vision confusion dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position sweating unusual tiredness or weakness Incidence not known Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common Fever headache muscle aches sore throat stuffy or runny nose

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: aliskiren, amlodipine, and hydrochlorothiazide side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More aliskiren, amlodipine, and hydrochlorothiazide resources Aliskiren, amlodipine, and hydrochlorothiazide Side Effects (in more detail) Aliskiren, amlodipine, and hydrochlorothiazide Dosage Aliskiren, amlodipine, and hydrochlorothiazide Use in Pregnancy & Breastfeeding Aliskiren, amlodipine, and hydrochlorothiazide Drug Interactions Aliskiren, amlodipine, and hydrochlorothiazide Support Group 0 Reviews for Aliskiren, amlodipine, and hydrochlorothiazide - Add your own review/rating Compare aliskiren, amlodipine, and hydrochlorothiazide with other medications High Blood Pressure


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amlodipine


am-LOE-di-peen

Commonly used brand name(s)

In the U.S.

Norvasc

Available Dosage Forms:

Tablet Tablet, Disintegrating

Therapeutic Class: Cardiovascular Agent

Pharmacologic Class: Calcium Channel Blocker

Chemical Class: Dihydropyridine

Uses For amlodipine

Amlodipine is used alone or together with other medicines to treat angina (chest pain) and high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled.

Amlodipine is a calcium channel blocker. It affects the movement of calcium into the cells of the heart and blood vessels. As a result, amlodipine relaxes blood vessels and increases the supply of blood and oxygen to the heart while reducing its workload.

amlodipine is available only with your doctor's prescription.

Before Using amlodipine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For amlodipine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to amlodipine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of amlodipine to treat high blood pressure in children younger than 6 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of amlodipine in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving amlodipine.

Pregnancy Pregnancy Category Explanation All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking amlodipine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using amlodipine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Amiodarone Atazanavir Conivaptan Dantrolene Droperidol Simvastatin Telaprevir

Using amlodipine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acebutolol Alprenolol Atenolol Betaxolol Bevantolol Bisoprolol Bucindolol Carteolol Carvedilol Celiprolol Clopidogrel Dalfopristin Dilevalol Diltiazem Esmolol Fluconazole Imatinib Indinavir Itraconazole Ketoconazole Labetalol Levobunolol Mepindolol Metipranolol Metoprolol Nadolol Nebivolol Oxprenolol Penbutolol Pindolol Propranolol Quinupristin Rifapentine Ritonavir Sotalol St John's Wort Talinolol Tertatolol Timolol Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of amlodipine. Make sure you tell your doctor if you have any other medical problems, especially:

Angina (chest pain) or Heart attack, acute or Heart or blood vessel disease (e.g., coronary artery disease) or Hypotension (low blood pressure)—Use with caution. May make these conditions worse. Heart disease or other heart problems (e.g., aortic stenosis)—Use with caution. The blood pressure-lowering effects of amlodipine may be increased. Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body. Proper Use of amlodipine

Take amlodipine exactly as directed even if you feel well and do not notice any chest pain. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Do not miss any doses.

For patients taking amlodipine for high blood pressure:

In addition to the use of the medicine, treatment for your high blood pressure may include weight control and a change in the types of food you eat, especially foods high in sodium (salt). Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet. Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well. Remember that amlodipine will not cure your high blood pressure but it does help control it. Therefore, you must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life . If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease.

You may take amlodipine with or without food.

Take amlodipine at the same time each day.

Dosing

The dose of amlodipine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of amlodipine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (tablets): For angina (chest pain): Adults—5 to 10 milligrams (mg) once a day. Children—Use and dose must be determined by your doctor. For high blood pressure: Adults—At first, 2.5 to 5 milligrams (mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 10 mg once a day. Children 6 to 17 years of age—2.5 to 5 mg once a day. Children younger than 6 years of age—Use and dose must be determined by your doctor. Missed Dose

If you miss a dose of amlodipine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Do not take amlodipine if it has been more than 12 hours since you missed your last dose.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using amlodipine

It is very important that your doctor check your progress at regular visits to make sure amlodipine is working properly. Blood tests may be needed to check for unwanted effects. a

Dizziness, lightheadedness, or fainting may also occur if you exercise or if the weather is hot. Heavy sweating can cause loss of too much water and result in low blood pressure. Use extra care during exercise or hot weather.

If you have been using amlodipine regularly for several weeks, do not suddenly stop using it. Stopping suddenly may cause your chest pain or high blood pressure to come back or get worse. Check with your doctor for the best way to reduce gradually the amount you are taking before stopping completely.

Chest pain resulting from exercise or physical exertion is usually reduced or prevented by amlodipine. This may tempt you to be too active. Make sure you discuss with your doctor a safe amount of exercise for your medical problem.

After taking a dose of amlodipine you may get a headache that lasts for a short time. This should become less noticeable after you have taken amlodipine for a while. If this effect continues, or if the headaches are severe, check with your doctor.

In some patients, tenderness, swelling, or bleeding of the gums may appear soon after treatment with amlodipine is started. Brushing and flossing your teeth carefully and regularly and massaging your gums may help prevent this. See your dentist regularly to have your teeth cleaned. Check with your doctor or dentist if you have any questions about how to take care of your teeth and gums, or if you notice any tenderness, swelling, or bleeding of your gums.

Do not take other medicines unless they have been discussed with your doctor. This especially includes over-the-counter (nonprescription) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, since they may increase your blood pressure.

amlodipine Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common Swelling of the ankles or feet Less common Difficult or labored breathing dizziness fast, irregular, pounding, or racing heartbeat or pulse feeling of warmth redness of the face, neck, arms, and occasionally, upper chest shortness of breath tightness in the chest wheezing Rare Black, tarry stools bleeding gums blistering, peeling, or loosening of the skin blood in the urine or stools blurred vision burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings chest pain or discomfort chills cold and clammy skin cold sweats confusion dark yellow urine cough diarrhea dilated neck veins dizziness or lightheadedness when getting up from a lying or sitting position extra heartbeats extreme fatigue fainting fever itching of the skin joint or muscle pain large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs numbness and tingling of the face, fingers, or toes pain in the arms, legs, or lower back, especially pain in the calves or heels upon exertion painful or difficult urination pale, bluish-colored, or cold hands or feet pinpoint red or purple spots on the skin red, irritated eyes redness of the face, neck, arms, and occasionally, upper chest redness, soreness or itching skin shakiness in the legs, arms, hands, or feet slow or irregular heartbeat sore throat sores, ulcers, or white spots on the lips or in the mouth sores, welting, or blisters sudden sweating sweating swelling of the face, fingers, feet, or lower legs swollen glands trembling or shaking of the hands or feet unsteadiness or awkwardness unusual bleeding or bruising unusual tiredness or weakness weak or absent pulses in the legs weakness in the arms, hands, legs, or feet weight gain yellow eyes or skin Incidence not known Abdominal or stomach pain clay-colored stools diarrhea headache loss of appetite nausea rash unpleasant breath odor vomiting of blood yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common Acid or sour stomach belching heartburn indigestion lack or loss of strength muscle cramps sleepiness or unusual drowsiness stomach discomfort, upset, or pain Rare Abnormal dreams anxiety back pain bad unusual or unpleasant (after) taste bleeding gums blistering, crusting, irritation, itching, or reddening of the skin bloating bloody nose burning feeling in the chest or stomach burning while urinating burning, dry, or itching eyes change in color of the treated skin change in sense of smell change in taste changes in vision constipation continuing ringing or buzzing or other unexplained noise in the ears cracked, dry, or scaly skin decreased sexual performance or desire depression difficulty with moving difficulty with swallowing discharge, excessive tearing double vision dry mouth dryness of the skin excess air or gas in the stomach or intestines excessive muscle tone eye pain feeling of constant movement of self or surroundings feeling of unreality feeling unusually cold flushed, dry skin fruit-like breath odor full feeling general feeling of discomfort or illness hair loss or thinning of the hair headache, severe and throbbing hearing loss hyperventilation increased appetite increased hunger increased sweating increased thirst increased urge to urinate during the night increased urination irritability irritation in the mouth lack of feeling or emotion loose stools loss of memory muscle pains or stiffness muscle tension or tightness muscle weakness nervousness pain pains in the stomach, side, or abdomen, possibly radiating to the back passing gas problems with memory redness and swelling of the gums redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid restlessness runny nose seeing double sensation of spinning sense of detachment from self or body shakiness and unsteady walk shivering sleeplessness sneezing stuffy nose sweating swollen joints tenderness in the stomach area thirst trouble in holding or releasing urine trouble sleeping twitching unable to sleep uncaring unexplained weight loss unsteadiness, trembling, or other problems with muscle control or coordination waking to urinate at night weight loss Incidence not known Swelling of the breasts or breast soreness in both females and males

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: amlodipine side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More amlodipine resources Amlodipine Side Effects (in more detail) Amlodipine Use in Pregnancy & Breastfeeding Drug Images Amlodipine Drug Interactions Amlodipine Support Group 66 Reviews for Amlodipine - Add your own review/rating Amlodipine Prescribing Information (FDA) Amlodipine MedFacts Consumer Leaflet (Wolters Kluwer) Amlodipine Professional Patient Advice (Wolters Kluwer) Amlodipine Besylate Monograph (AHFS DI) Norvasc Prescribing Information (FDA) Norvasc Consumer Overview Compare amlodipine with other medications Angina Coronary Artery Disease Heart Failure High Blood Pressure Migraine Prevention Raynaud's Syndrome


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telmisartan and amlodipine


tel-mi-SAR-tan, am-LOE-di-peen BES-i-late

Oral route(Tablet)

When pregnancy is detected, discontinue telmisartan/amlodipine besylate as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus .

Commonly used brand name(s)

In the U.S.

Twynsta

Available Dosage Forms:

Tablet

Therapeutic Class: Antihypertensive

Pharmacologic Class: Angiotensin II Receptor Antagonist

Chemical Class: Amlodipine

Uses For telmisartan and amlodipine

Telmisartan and amlodipine is a combination of medicines that may be used alone or with other medicines to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled.

Telmisartan is an angiotensin II receptor blocker. It works by blocking a substance in the body that causes blood vessels to tighten. As a result, telmisartan relaxes blood vessels. This lowers blood pressure and increases the supply of blood and oxygen to the heart.

Amlodipine is a calcium channel blocker. It affects the movement of calcium into the cells of the heart and blood vessels. As a result, amlodipine relaxes blood vessels and increases the supply of blood and oxygen to the heart while reducing its workload.

telmisartan and amlodipine is available only with your doctor's prescription.

Before Using telmisartan and amlodipine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For telmisartan and amlodipine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to telmisartan and amlodipine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of telmisartan and amlodipine combination in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of telmisartan and amlodipine combination in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require starting at a lower dose in these patients.

Pregnancy Pregnancy Category Explanation 1st Trimester C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. 2nd Trimester D Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk. 3rd Trimester D Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk. Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking telmisartan and amlodipine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using telmisartan and amlodipine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Amiodarone Atazanavir Benazepril Conivaptan Dantrolene Droperidol Enalapril Enalaprilat Lisinopril Moexipril Perindopril Quinapril Ramipril Simvastatin Telaprevir Trandolapril

Using telmisartan and amlodipine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acebutolol Alprenolol Atenolol Betaxolol Bevantolol Bisoprolol Bromfenac Bucindolol Carteolol Carvedilol Celecoxib Celiprolol Clopidogrel Dalfopristin Diclofenac Diflunisal Digoxin Dilevalol Diltiazem Esmolol Etodolac Fenoprofen Fluconazole Flurbiprofen Ibuprofen Imatinib Indinavir Indomethacin Itraconazole Ketoconazole Ketoprofen Ketorolac Labetalol Levobunolol Lithium Magnesium Salicylate Meclofenamate Mefenamic Acid Meloxicam Mepindolol Metipranolol Metoprolol Nabumetone Nadolol Naproxen Nebivolol Nepafenac Oxaprozin Oxprenolol Penbutolol Pindolol Piroxicam Propranolol Quinupristin Rifapentine Ritonavir Salsalate Sotalol St John's Wort Sulindac Talinolol Tertatolol Timolol Tolmetin Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of telmisartan and amlodipine. Make sure you tell your doctor if you have any other medical problems, especially:

Kidney Problems or Congestive heart failure—Use with caution. May make these conditions worse. Electrolyte imbalances (e.g., low levels of salt or sodium in the body) or Fluid imbalances (caused by dehydration, vomiting, or diarrhea) or Heart problems (e.g., aortic stenosis)—Use with caution. The blood pressure-lowering effects of telmisartan and amlodipine may be increased. Heart or blood vessel disease (e.g., severe obstructive coronary artery disease)—Use with caution. May increase the risk of experiencing chest pain or heart attacks. Liver disease (including biliary obstructive disorders)—Use with caution. The effects may be increased because of slower removal of the medicine from the body. Proper Use of telmisartan and amlodipine

telmisartan and amlodipine comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

In addition to the use of telmisartan and amlodipine, treatment for your high blood pressure may include weight control and a change in the types of foods you eat, especially foods high in sodium (salt). Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.

Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well.

Remember that telmisartan and amlodipine will not cure your high blood pressure, but it does help control it. You must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease.

You may take telmisartan and amlodipine with or without food.

Dosing

The dose of telmisartan and amlodipine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of telmisartan and amlodipine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (tablets): For high blood pressure: Adults—At first, one tablet containing 40 milligrams (mg) or 80 mg of telmisartan and 5 mg of amlodipine once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 80 mg of telmisartan and 10 mg of amlodipine once a day. Children—Use and dose must be determined by your doctor. Missed Dose

If you miss a dose of telmisartan and amlodipine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using telmisartan and amlodipine

It is very important that your doctor check your progress at regular visits to make sure telmisartan and amlodipine is working properly. Blood tests may be needed to check for unwanted effects.

Using telmisartan and amlodipine while you are pregnant can harm your unborn baby. If you think you have become pregnant while using telmisartan and amlodipine, tell your doctor right away.

Dizziness, lightheadedness, or fainting may occur after the first dose of telmisartan and amlodipine, especially if you have been taking a diuretic (water pill). Make sure you know how you react to telmisartan and amlodipine before you drive, use machines, or do anything else that could be dangerous if you are not alert.

Check with your doctor right away if you experience dizziness, fainting, confusion, muscle pain, weakness, and/or a fast heartbeat. Use extra care if you exercise or if the weather is hot. Heavy sweating can cause dehydration (loss of too much water) or electrolyte imbalances (loss of sodium or potassium in the body).

Check with your doctor right away if you become sick while taking telmisartan and amlodipine, especially with severe or continuing nausea, vomiting, or diarrhea. These conditions may cause you to lose too much water or salt which may cause low blood pressure.

Hyperkalemia (high potassium in the blood) may occur in certain people receiving telmisartan and amlodipine. Check with your doctor right away if you have the following symptoms: abdominal or stomach pain; confusion; difficulty with breathing; irregular heartbeat; nausea or vomiting; nervousness; numbness or tingling in the hands, feet, or lips; shortness of breath; or weakness or heaviness of the legs.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

telmisartan and amlodipine Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common Bloating or swelling of the face, arms, hands, lower legs, or feet body aches or pain chills cough difficulty with breathing ear congestion fever headache loss of voice nasal congestion rapid weight gain runny nose sneezing sore throat tingling of the hands or feet unusual tiredness or weakness unusual weight gain or loss Less common Bladder pain bloody or cloudy urine blurred vision chest pain diarrhea difficult, burning, or painful urination dizziness frequent urge to urinate general feeling of discomfort or illness joint pain loss of appetite lower back or side pain muscle aches and pains nausea nervousness pounding in the ears shivering slow or fast heartbeat sweating trouble with sleeping vomiting Rare Abdominal or stomach pain arm, back, or jaw pain black, tarry stools bleeding gums blistering, peeling, or loosening of the skin blood in the urine or stools burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings chest tightness or heaviness cold sweats confusion constipation cough or hoarseness dark urine difficult or labored breathing difficulty with swallowing dilated neck veins dry mouth extreme fatigue fast, irregular, pounding, or racing heartbeat or pulse feeling of warmth flushed, dry skin fruit-like breath odor hives increased hunger increased sweating increased thirst increased volume of pale, dilute urine indigestion irregular heartbeat irritation in the mouth joint or muscle pain large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs lightheadedness, dizziness, or fainting loss of consciousness muscle cramps or stiffness pale, bluish-colored, or cold hands or feet pinpoint red spots on the skin rash redness and swelling of the gums redness, soreness, or itching skin severe or sudden headache sudden loss of coordination sudden slurring of speech swollen glands tightness in the chest trembling or shaking of the hands or feet troubled breathing unexplained weight loss unsteadiness, trembling, or other problems with muscle control or coordination unusual bleeding or bruising vomiting of blood waking to urinate at night weakness in the arms, hands, legs, or feet weight gain yellow eyes or skin Incidence not known Decreased urine output nervousness puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue weakness or heaviness of the legs

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common Acid or sour stomach belching difficulty with moving heartburn indigestion pain or tenderness around the eyes and cheekbones sleepiness or unusual drowsiness Rare Abnormal dreams abnormal ejaculation ankle, knee, or great toe joint pain anxiety bad, unusual, or unpleasant (after) taste bleeding after defecation blistering, crusting, irritation, itching, or reddening of the skin bloody nose burning feeling in the chest or stomach burning, dry, or itching eyes changes in vision cold and clammy skin continuing ringing or buzzing or other unexplained noise in the ears cough producing mucus cracked, dry, or scaly skin decreased sexual performance or desire depression discharge or excessive tearing dry mouth dryness of the eyes dryness of the skin earache excess air or gas in the stomach or intestines feeling of constant movement of self or surroundings feeling of unreality feeling of warmth full feeling hair loss or thinning of the hair headache, severe and throbbing hearing loss hives or welts hyperventilation inability to have or keep an erection increased appetite irritability lack of feeling or emotion lack or loss of strength loose stools loss of memory pinpoint red or purple spots on the skin redness of the face, neck, arms, and occasionally, upper chest redness of the skin redness or swelling in the ear redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid restlessness tenderness in the stomach area toothache unable to sleep uncomfortable swelling around the anus Incidence not known Decreased interest in sexual intercourse swelling of the breasts or breast soreness in both females and males

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More telmisartan and amlodipine resources Telmisartan and amlodipine DosageTelmisartan and amlodipine Use in Pregnancy & BreastfeedingTelmisartan and amlodipine Drug InteractionsTelmisartan and amlodipine Support Group2 Reviews for Telmisartan and amlodipine - Add your own review/rating Compare telmisartan and amlodipine with other medications High Blood Pressure


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Lotrel


Generic Name: amlodipine and benazepril (Oral route)

am-LOE-di-peen BES-i-late, ben-AZ-e-pril hye-droe-KLOR-ide

Oral route(Capsule)

When pregnancy is detected, discontinue amlodipine besylate/benazepril hydrochloride as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus .

Commonly used brand name(s)

In the U.S.

Lotrel

Available Dosage Forms:

Capsule

Therapeutic Class: ACE Inhibitor/Calcium Channel Blocker Combination

Pharmacologic Class: Amlodipine

Chemical Class: Amlodipine

Uses For Lotrel

Amlodipine and benazepril is a combination of medicines that is used to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled.

Amlodipine is a calcium channel blocker. It affects the movement of calcium into the cells of the heart and blood vessels. As a result, amlodipine relaxes blood vessels and increases the supply of blood and oxygen to the heart while reducing its workload.

Benazepril is an angiotensin-converting enzyme (ACE) inhibitor. It works by blocking a substance in the body that causes blood vessels to tighten. As a result, benazepril relaxes blood vessels. This lowers blood pressure and increases the supply of blood and oxygen to the heart.

This medicine is available only with your doctor's prescription.

Before Using Lotrel

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of amlodipine and benazepril combination in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of amlodipine and benazepril combination in the elderly. However, elderly patients are more likely to have age-related kidney or liver problems, which may require caution and an adjustment in the dose for patients receiving amlodipine and benazepril combination.

Pregnancy Pregnancy Category Explanation All Trimesters D Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk. Breast Feeding Amlodipine

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Benazepril

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Alteplase, Recombinant Amiloride Amiodarone Atazanavir Azathioprine Azilsartan Medoxomil Candesartan Cilexetil Canrenoate Conivaptan Dantrolene Droperidol Eplerenone Eprosartan Losartan Olmesartan Medoxomil Potassium Simvastatin Spironolactone Telaprevir Telmisartan Triamterene Valsartan

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acebutolol Aceclofenac Acemetacin Alclofenac Aliskiren Alprenolol Apazone Atenolol Azosemide Bemetizide Bendroflumethiazide Benoxaprofen Benzthiazide Betaxolol Bevantolol Bisoprolol Bromfenac Bucindolol Bufexamac Bumetanide Bupivacaine Buthiazide Capsaicin Carprofen Carteolol Carvedilol Celiprolol Chlorothiazide Chlorthalidone Clometacin Clonixin Clopamide Clopidogrel Cyclopenthiazide Cyclothiazide Dalfopristin Dexketoprofen Diclofenac Diflunisal Dilevalol Diltiazem Dipyrone Droxicam Esmolol Ethacrynic Acid Etodolac Etofenamate Felbinac Fenbufen Fenoprofen Fentiazac Floctafenine Fluconazole Flufenamic Acid Flurbiprofen Furosemide Gold Sodium Thiomalate Hydrochlorothiazide Hydroflumethiazide Ibuprofen Imatinib Indapamide Indinavir Indomethacin Indoprofen Isoxicam Itraconazole Ketoconazole Ketoprofen Ketorolac Labetalol Levobunolol Lithium Lornoxicam Meclofenamate Mefenamic Acid Meloxicam Mepindolol Methyclothiazide Metipranolol Metolazone Metoprolol Nabumetone Nadolol Naproxen Nebivolol Nesiritide Niflumic Acid Nimesulide Oxaprozin Oxprenolol Oxyphenbutazone Penbutolol Phenylbutazone Pindolol Pirazolac Piretanide Piroxicam Pirprofen Polythiazide Propranolol Propyphenazone Proquazone Quinethazone Quinupristin Rifapentine Ritonavir Sotalol St John's Wort Sulindac Suprofen Talinolol Tenidap Tenoxicam Tertatolol Tiaprofenic Acid Timolol Tolmetin Torsemide Trichlormethiazide Xipamide Zomepirac Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Angina (chest pain) or Heart attack, acute or Heart or blood vessel disease (e.g., coronary artery disease) or Hypotension (low blood pressure)—Use with caution. May make these conditions worse. Angioedema (swelling of the face, lips, tongue, or throat), history of—Should not be used in patients with these conditions. Bee-sting allergy treatments or Dialysis—Increased risk of serious allergic reaction occurring. Dehydration or Heart failure or other heart problems (e.g., aortic stenosis) or Hyponatremia (low sodium in the blood) or Hypovolemia (low blood volume)—Use with caution. The blood pressure-lowering effects of this medicine may be increased. Diabetes—Increased risk of potassium levels in the body becoming too high. Kidney disease or Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body. Kidney disease, severe or Scleroderma (an autoimmune disease) or Systemic lupus erythematosus (SLE), history of—Increased risk of blood problems caused by ACE inhibitors. Proper Use of Lotrel

In addition to the use of this medicine, treatment for your high blood pressure may include weight control and a change in the types of foods you eat, especially foods high in sodium (salt). Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.

Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well.

Remember that this medicine will not cure your high blood pressure, but it does help control it. You must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (capsules): For high blood pressure: Adults—At first, one capsule containing 2.5 milligrams (mg) of amlodipine and 10 mg of benazepril once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 10 mg of amlodipine and 40 mg of benazepril per day. Children—Use and dose must be determined by your doctor. Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Lotrel

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. If you think you have become pregnant while using this medicine, tell your doctor right away.

This medicine may cause serious allergic reactions including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, lips, tongue, or throat while you are using this medicine.

Check with your doctor right away if you have a strong stomach pain (with or without nausea or vomiting). This could be a symptom of a condition called intestinal angioedema.

Dizziness, lightheadedness, or fainting may occur after the first dose, especially if you have been taking a diuretic (water pill). Make sure you know how you react to the medicine before you drive, use machines, or do other things that could be dangerous if you are dizzy or not alert.

Dizziness, lightheadedness, or fainting may also occur if you exercise or if the weather is hot. Heavy sweating can cause loss of too much water and result in low blood pressure. Use extra care during exercise or hot weather.

Check with your doctor if you notice any signs of fever, sore throat, or chills. These could be symptoms of an infection resulting from low white blood cell counts.

Check with your doctor if you become sick while taking this medicine, especially with severe or continuing nausea, vomiting, or diarrhea. These conditions may cause you to lose too much water, possibly resulting in low blood pressure.

Liver problems may occur while you are using this medicine. Stop using this medicine and check with your doctor right away if you are having more than one of these symptoms: abdominal pain or tenderness; clay-colored stools; dark urine; decreased appetite; fever; headache; itching; loss of appetite; nausea and vomiting; skin rash; swelling of the feet or lower legs; unusual tiredness or weakness; or yellow eyes or skin.

Hyperkalemia (high potassium in the blood) may occur while you are using this medicine. Check with your doctor right away if you have the following symptoms: abdominal or stomach pain; confusion; difficulty with breathing; irregular heartbeat; nausea or vomiting; nervousness; numbness or tingling in the hands, feet, or lips; shortness of breath; or weakness or heaviness of the legs.

In some patients, tenderness, swelling, or bleeding of the gums may appear soon after treatment with this medicine is started. Brushing and flossing your teeth carefully and regularly and massaging your gums may help prevent this. See your dentist regularly to have your teeth cleaned. Check with your doctor or dentist if you have any questions about how to take care of your teeth and gums, or if you notice any tenderness, swelling, or bleeding of your gums.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the doctor or dentist in charge that you are taking this medicine.

Black patients may be less sensitive to the blood pressure-lowering effects of this medicine. In addition, the risk of a serious allergic reaction involving swelling of the face, mouth, hands, or feet may be increased.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Lotrel Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common Dizziness, lightheadedness, or fainting swelling of the ankles, feet, or lower legs Signs and symptoms of too much potassium in the body Confusion irregular heartbeat nervousness numbness or tingling in the hands, feet, or lips shortness of breath weakness or heaviness of the legs Rare Bleeding gums blisters in the mouth spreading to the trunk, scalp, or other areas chills fever nausea or vomiting nosebleeds pale skin sore throat sores in the mouth, or on the arms, feet, hands, legs, or lips (sudden) stomach pain or bloating with fever, nausea, or vomiting swelling of the face, mouth, hands, or feet trouble with swallowing or breathing (sudden) or hoarseness unusual bleeding or bruising unusual tiredness or weakness yellow eyes or skin Incidence not known Chest pain difficulty with swallowing heartburn pain or burning in the throat sores, ulcers, or white spots on the lips, tongue, or inside the mouth

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common Awareness of heartbeat cough (dry, continuing) feeling of warmth redness of the face, neck, arms, and occasionally upper chest sleepiness Incidence not known Acid or sour stomach belching blistering, crusting, irritation, itching, or reddening of the skin body aches or pain congestion cracked, dry, or scaly skin decreased interest in sexual intercourse difficulty having a bowel movement (stool) fear frequent urination inability to have or keep an erection increased volume of pale, dilute urine indigestion lack or loss of strength loss in sexual ability, desire, drive, or performance muscle or bone pain runny nose shakiness in the legs, arms, hands, or feet sleeplessness small lump under the skin stomach discomfort or upset sudden sweating swelling tender, swollen glands in the neck trembling or shaking of the hands or feet trouble with sleeping trouble with swallowing unable to sleep voice changes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Lotrel side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Lotrel resources Lotrel Side Effects (in more detail) Lotrel Use in Pregnancy & Breastfeeding Drug Images Lotrel Drug Interactions Lotrel Support Group 20 Reviews for Lotrel - Add your own review/rating Lotrel Prescribing Information (FDA) Lotrel MedFacts Consumer Leaflet (Wolters Kluwer) Lotrel Consumer Overview Compare Lotrel with other medications High Blood Pressure


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Tenif


Tenif 50 mg/20 mg Capsules

atenolol 50 mg, nifedipine 20 mg

Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Tenif is and what it is used for 2. Before you take Tenif 3. How to take Tenif 4. Possible side effects 5. How to store Tenif 6. Further information What Tenif is and what it is used for

The name of your medicine is Tenif. It contains atenolol and nifedipine. Each of these works in a different way.

Atenolol belongs to a group of medicines called beta-blockers. It works by making your heart beat more slowly and with less force. This helps to prevent chest pain. Nifedipine belongs to a group of medicines called dihydropyridines.
Dihydropyridines are a type of calcium channel blocker. They work by making your blood vessels widen. This helps to prevent chest pain and lowers your blood pressure.

Tenif is used to treat high blood pressure (hypertension) or to prevent chest pain (angina).

Before you take Tenif Do not take Tenif if: You are having an angina attack (sudden chest pain). Tenif cannot treat an angina attack, but it can help you get fewer attacks if you take it regularly. You are allergic (hypersensitive) to Tenif, Tenormin, atenolol, nifedipine, or anything else in this medicine (see Section 6: Further information). You are allergic (hypersensitive) to other dihydropyridines such as amlodipine or felodipine. You have any of the following heart problems: heart failure which is not under control (this usually makes you breathless and causes your ankles or legs to swell) second- or third-degree heart block (a condition which may be treated with a pacemaker) a very slow or very uneven heart beat, very low blood pressure or very poor circulation a heart attack within the last month a heart condition called sick sinus syndrome, or unstable angina, or aortic stenosis a condition where the heart is unable to supply enough blood to the body (cardiogenic shock). You have problems with your kidneys. You have a tumour called phaeochromocytoma that is not being treated. This is usually near your kidney and can cause high blood pressure. Your doctor has told you that you have higher than normal levels of acid in your blood (metabolic acidosis). You have not been eating much recently. You are taking a medicine called rifampicin. You are taking a medicine that is a certain type of calcium channel blocker such as verapamil or diltiazem. You are a woman at an age where you could get pregnant, or you are pregnant or breast-feeding (see the section on "Pregnancy and breast-feeding" below).

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Tenif.

Take special care with Tenif

Before you take Tenif, tell your doctor if:

You have asthma, wheezing or similar breathing problems, or you get allergic reactions, such as to insect stings. If you have ever had asthma or wheezing, do not take this medicine without first checking with your doctor. You have a type of chest pain (angina) called Prinzmetal's angina. You have poor blood circulation or controlled heart failure. You have first-degree heart block (a condition which may be treated by a pacemaker). You have liver problems. Your doctor may need to do tests during your treatment with Tenif to check how well your liver is working. You have diabetes. Your medicine may change how you respond to having low blood sugar. You may feel your heart beating faster. You have thyrotoxicosis (a condition caused by an overactive thyroid gland). Your medicine may hide the symptoms of thyrotoxicosis. You are a man whose female partner is having IVF (in-vitro fertilisation treatment). This is because Tenif can affect your sperm.

If you give a urine sample, it is important to tell your doctor that you are taking Tenif. This is because Tenif may interfere with the urine test results.

Taking other medicines

Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines. This includes herbal medicines and medicines that you buy without a prescription. Tenif can affect the way that some other medicines work and some medicines can have an effect on Tenif.

You must not take Tenif if you are taking any of the following medicines:

Rifampicin (for tuberculosis). Other dihydropyridines such as amlodipine or felodipine (for high blood pressure or heart problems). Certain calcium channel blockers such as verapamil or diltiazem (for high blood pressure or chest pain).

Tell your doctor or pharmacist if you are taking any of the following medicines:

Clonidine (for high blood pressure or migraine). If you are taking clonidine and Tenif together, do not stop taking clonidine unless your doctor tells you to do so. If you have to stop taking clonidine, your doctor will tell you how to do it. Disopyramide, quinidine or amiodarone (for an uneven heart beat). Digoxin or digitoxin (for heart problems). Adrenaline, also known as epinephrine (a medicine that stimulates the heart). Ibuprofen or indometacin (for pain and inflammation). Insulin or medicines that you take by mouth for diabetes. Medicines to treat nose and sinus congestion or other cold remedies (including those you buy in the pharmacy). Cimetidine (for stomach problems).

If you go into hospital to have an operation, tell the anaesthetist or doctor that you are taking Tenif. This is because you can get low blood pressure (hypotension) if you are given certain anaesthetics while you are taking Tenif.

Pregnancy and breast-feeding Do not take Tenif if you are pregnant or at an age where you could get pregnant. This is because Tenif can harm your unborn baby. Do not take Tenif if you are breast-feeding. Driving and using machines Your medicine is not likely to affect driving or using tools or machines. However, it is best to wait to see how your medicine affects you before trying these activities. If you feel dizzy or tired when taking this medicine, ask your doctor for advice. Taking Tenif with food and drink

Do not drink grapefruit juice within 2 hours of taking Tenif. This is because your blood pressure may be reduced too much, which may make you feel dizzy.

How to take Tenif

Always use your medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Swallow the capsules with a drink of water. Your doctor will tell you how many capsules to take each day and when to take them. Also read the label on the carton. Adults with high blood pressure (hypertension)

The usual dose is one capsule each day.

Adults with chest pain (angina)

The usual dose is one capsule every 12 hours.

Older people (aged over 65 years)

High blood pressure (hypertension): The dose should not be more than one capsule each day.

Chest pain (angina): The dose should not be more than one capsule every 12 hours.

People with liver problems

The dose should not be more than one capsule each day.

Children

Your medicine must never be given to children.

If you take more Tenif than you should

If you have taken more of your medicine than prescribed by your doctor, tell your doctor or go to the nearest hospital casualty department straight away. Take the medicine packaging with you.

If you forget to take Tenif

If you forget to take a dose, take it as soon as you remember. If it is almost time to take the next dose, wait until then. Do not take a double dose.

If you stop taking Tenif

Do not stop taking your medicine without first talking to your doctor. In some cases, you may need to stop taking it gradually.

Tenif Side Effects

Like all medicines, Tenif can cause side effects, although not everybody gets them.

Important side effects to look out for:

If you get any of the following, see a doctor straight away:

Raised lumps on your skin (weals) or swelling of your face, lips, mouth, tongue or throat. This means that you are having an allergic reaction. Pain in your chest when you start taking Tenif. Other possible side effects:

Heart and circulation: swelling of the feet or ankles or other parts of the body; slower, faster, or uneven heart beat; pounding heart beat (palpitations); angina (pain in chest) made worse; feeling faint (especially when standing up); cold hands and feet; feeling numb with spasms in your fingers (Raynaud's disease); heart block (which can cause dizziness or fainting); pain in the muscles of the leg that occurs off and on, usually while walking or exercising; decreased blood pressure in patients on kidney dialysis.

Nervous system: feeling tired or confused; headache; feeling dizzy; mood changes; nightmares; changes in personality; hallucinations; difficulty in sleeping; tingling hands or feet.

Chest: feeling breathless or wheezy.

Blood: a reduced number of platelets in your blood which may make you bleed more easily; a severe reduction in the number of white blood cells which makes infections more likely.

Digestive system: dry mouth; enlarged gums; diarrhoea; feeling sick; liver problems and jaundice (yellowing of your skin or the whites of your eyes).

Skin and hair: flushing of your skin; bruising more easily or purple marks on your skin; skin rashes; lumpy rash (hives); flaking or peeling skin; being sensitive to sunlight; hair loss; a condition called erythromelalgia, the signs include redness, swelling, and burning pain in the hands and feet.

Sexual: being unable to get an erection (impotence); enlarged breasts in older men.

Eyes: problems with your sight; dry eyes.

Urinary: passing water (urine) more often.

Muscles: muscle pain; shaking (tremor); burning pain in your legs.

Conditions that may get worse

If you have any of the following conditions, they may get worse when you start to take your medicine:

Psoriasis (a skin condition). Being short of breath or having swollen ankles (if you have heart failure). Asthma or breathing problems. Poor blood circulation.

Do not be concerned by this list of possible side effects. You may not get any of them. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How to store Tenif Keep out of the reach and sight of children. Do not store this medicine above 30°C. Store in the original package. Keep the blister pack in the outer carton. This will protect your medicine from light and moisture. Do not use your medicine after the expiry date that is stated on the packaging.
The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further information What Tenif Capsules contain The active ingredients are 50 mg atenolol and 20 mg nifedipine per capsule. The other ingredients are gelatin, iron oxide (E172), lactose, macrogol, magnesium carbonate, magnesium stearate, maize starch, methylhydroxypropylcellulose, microcrystalline cellulose, polysorbate, sodium laurilsulfate and titanium dioxide (E171). What Tenif Capsules look like and contents of the pack

Tenif Capsules are a reddish-brown colour. They come in a blister pack containing 28 capsules.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation for Tenif Capsules is held by

AstraZeneca UK Ltd. 600 Capability Green Luton LU1 3LU UK

Tenif Capsules are manufactured by

AstraZeneca UK Ltd. Silk Road Business Park Macclesfield Cheshire SK10 2NA UK

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK only)

Please be ready to give the following information:

Product name Tenif Capsules
Reference number 17901/0047

This is a service provided by the Royal National Institute of Blind People.

Leaflet prepared: October 2009.

© AstraZeneca 2009

Tenif is a trade mark of the AstraZeneca group of companies.

CV 09 0089a

P026068


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Telmisartan


Class: Angiotensin II Receptor Antagonists
VA Class: CV805
Chemical Name: 4? - [1(1,4? - Dimethyl - 2? - propyl[2,6? - bi - 1H - benzimidazol] - 1? - yl)methyl] - [1,1? - biphenyl] - 2 - carboxylic acid
Molecular Formula: C33H30N4O2
CAS Number: 144701-48-4
Brands: Micardis, Micardis HCT

May cause fetal and neonatal morbidity and mortality if used during pregnancy.1 2 49 50 (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

If pregnancy is detected, discontinue as soon as possible.1 2 50

Introduction

Angiotensin II receptor (AT1) antagonist.1 2 3 16

Uses for Telmisartan Hypertension

Management of hypertension (alone or in combination with other classes of antihypertensive agents).1 2 3 17 19

One of several preferred initial therapies in hypertensive patients with chronic kidney disease, diabetes mellitus, or heart failure.43

Can be used as monotherapy for initial management of uncomplicated hypertension; however, thiazide diuretics are preferred by JNC 7.43

Diabetic Nephropathy

A first-line agent in the treatment of diabetic nephropathy† in hypertensive patients with type 2 diabetes mellitus.

CHF

A second-line agent in the treatment of CHF†; should be used only in those intolerant of ACE inhibitors.

Telmisartan Dosage and Administration General Hypertension

Fixed-combination telmisartan/hydrochlorothiazide tablets should not be used for initial treatment of hypertension.2

Administration Oral Administration

Administer orally once daily without regard to meals.1 2

Dosage Adults Hypertension Monotherapy Oral

Initially, 40 mg once daily in adults without intravascular volume depletion.1 Adjust dosage at approximately monthly intervals (more aggressively in high-risk patients) to achieve BP control.43

Usual dosage: 20–80 mg once daily; no additional therapeutic benefit with higher dosages.1

Combination Therapy Oral

If BP is not adequately controlled by monotherapy with telmisartan 80 mg daily, can switch to fixed-combination tablets (telmisartan 80 mg and hydrochlorothiazide 12.5 mg; then telmisartan 160 mg and hydrochlorothiazide 25 mg), administered once daily.2

If BP is not adequately controlled by monotherapy with hydrochlorothiazide 25 mg or if BP is controlled but hypokalemia is problematic at this dosage, can use fixed-combination tablets containing telmisartan 80 mg and hydrochlorothiazide 12.5 mg, administered once daily.2 Can increase dosage to telmisartan 160 mg and hydrochlorothiazide 25 mg, if needed, to control BP.2

Special Populations Hepatic Impairment

Initiate therapy under close medical supervision in patients with obstructive biliary disease or hepatic impairment.1

If fixed-combination tablets are used in patients with obstructive biliary disease or hepatic impairment, recommended initial dosage is telmisartan 40 mg and hydrochlorothiazide 12.5 mg daily.2 Use of fixed combination not recommended in those with severe hepatic impairment.2

Renal Impairment

No initial dosage adjustments necessary in patients with Clcr >30 mL/minute.1 2 Manufacturer makes no specific recommendations regarding telmisartan monotherapy in those with Clcr ?30 mL/minute.1

Telmisartan/hydrochlorothiazide fixed combination not recommended in patients with Clcr <30 mL/minute.2

Geriatric Patients

No initial dosage adjustments necessary.1 2

Volume- and/or Salt-Depleted Patients

Correct volume and/or salt depletion prior to initiation of therapy or initiate therapy under close medical supervision using lower initial dosage.1 2

Cautions for Telmisartan Contraindications

Known hypersensitivity to telmisartan or any ingredient in the formulation.1 2 7

Warnings/Precautions Warnings Hypotension

Possible symptomatic hypotension, particularly in volume- and/or salt-depleted patients (e.g., those treated with diuretics or undergoing dialysis).1 2 (See Volume- and/or Salt-Depleted Patients under Dosage and Administration.)

Transient hypotension is not a contraindication to additional doses; may reinstate therapy cautiously after BP is stabilized (e.g., with volume expansion).1 2

Fetal/Neonatal Morbidity and Mortality

Possible fetal and neonatal morbidity and mortality when used during pregnancy.1 2 50 (See Boxed Warning.) Such potential risks occur throughout pregnancy, especially during the second and third trimesters.50

Also may increase the risk of major congenital malformations when administered during the first trimester of pregnancy.49 50

Discontinue as soon as possible when pregnancy is detected, unless continued use is considered lifesaving.49 50 Nearly all women can be transferred successfully to alternative therapy for the remainder of their pregnancy.13

Malignancies

In July 2010, FDA initiated a safety review of angiotensin II receptor antagonists after a published meta-analysis found a modest but statistically significant increase in risk of new cancer occurrence in patients receiving an angiotensin II receptor antagonist compared with control.120 121 123 126 However, subsequent studies, including a larger meta-analysis conducted by FDA, have not shown such risk.126 127 128 129 Based on currently available data, FDA has concluded that angiotensin II receptor antagonists do not increase the risk of cancer.126

Sensitivity Reactions

Anaphylactoid reactions and/or angioedema possible;1 2 7 14 not recommended in patients with a history of angioedema associated with or unrelated to ACE inhibitor or angiotensin II receptor antagonist therapy.b

General Precautions Renal Effects

Possible oliguria, progressive azotemia and, rarely, acute renal failure and/or death in patients with severe CHF.1 2

Increases in BUN and Scr possible in patients with unilateral or bilateral renal artery stenosis.1 2

Use of Fixed Combinations

When used in fixed combination with hydrochlorothiazide, consider the cautions, precautions, and contraindications associated with hydrochlorothiazide.2

Specific Populations Pregnancy

Category C (1st trimester); Category D (2nd and 3rd trimesters).1 2 (See Boxed Warning.)

Lactation

Distributed into milk in rats; not known whether distributed into human milk.1 2 Discontinue nursing or the drug.1 2

Pediatric Use

Safety and efficacy not established in children <18 years of age.1 2 21

Geriatric Use

No substantial differences in safety or efficacy relative to younger adults, but increased sensitivity cannot be ruled out.1 2

Hepatic Impairment

Plasma telmisartan concentrations may be increased in patients with obstructive biliary disease or hepatic impairment.1 2 (See Special Populations under Absorption, in Pharmacokinetics.) Dosage adjustments may be necessary.2 (See Hepatic Impairment under Dosage and Administration.)

Use of telmisartan in fixed combination with hydrochlorothiazide is not recommended in patients with severe hepatic impairment.2

Renal Impairment

Deterioration of renal function may occur.1 2 (See Renal Effects under Cautions.)

Use of telmisartan in fixed combination with hydrochlorothiazide is not recommended in patients with Clcr <30 mL/minute.2

Blacks

BP reduction may be smaller in black patients compared with non-black patients; use in combination with a diuretic.1 43

Common Adverse Effects

Upper respiratory tract infection, sinusitis, pharyngitis, back pain, diarrhea.1

Interactions for Telmisartan

Not metabolized by CYP isoenzymes; has no effect on CYP isoenzymes except for some inhibition of CYP2C19 in vitro.1 2

Specific Drugs

Drug

Interaction

Comment

Acetaminophen

Interactions unlikely1 2

Amlodipine

Interactions unlikely1 2

Digoxin

Increased plasma digoxin concentrations1 2

Monitor serum digoxin concentrations when telmisartan therapy is initiated, adjusted, or discontinued in patients stabilized on digoxin1 2 3 21

Glyburide

Interactions unlikely1 2

Hydrochlorothiazide

Additive hypotensive effects1 2

Ibuprofen

Interactions unlikely1 2

Simvastatin

Interactions unlikely1 2

Warfarin

Possible decreased plasma warfarin concentrations; INR not affected1 2

Telmisartan Pharmacokinetics Absorption Bioavailability

Absolute bioavailability is dose dependent: 42% at 40 mg, 58% at 160 mg.1 2

Peak plasma concentration generally reached at 0.5–1 hour following oral administration.1 2

Onset

Antihypertensive effect evident within 2 weeks, with maximum BP reduction after 4 weeks.1

Food

Food slightly reduces bioavailability.1 2

Special Populations

In patients with hepatic insufficiency, plasma telmisartan concentrations are increased and absolute bioavailability approaches 100%.1 2

Distribution Extent

Crosses the placenta and is distributed in the fetus in animals.1 2

Distributed into milk in rats; not known whether distributed into human milk.1 2

Plasma Protein Binding

>99.5% (principally albumin and ?1-acid glycoprotein).1 2

Elimination Metabolism

Metabolized in liver (via conjugation) to inactive metabolite.1 2

Not metabolized by CYP isoenzymes.1 2

Elimination Route

Eliminated mainly (>97%) as unchanged drug in feces (via bile); small amounts (<1%) eliminated in urine.1 2

Half-life

Biphasic; terminal half-life is approximately 24 hours.1 2

Special Populations

Not removed from blood by hemofiltration.1 2

Stability Storage Oral Tablets

25°C (may be exposed to 15–30°C).1 2 Do not remove tablets from blisters until immediately before administration.1 2

Actions

Blocks the physiologic actions of angiotensin II, including vasoconstrictor and aldosterone-secreting effects.1 2

Does not interfere with response to bradykinins and substance P.1 2

Does not share the ACE inhibitor common adverse effect of dry cough.1 2 33

Advice to Patients

Risks of use during pregnancy.1 2 49 50

Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.1 2

Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.1 2

Importance of informing patients of other important precautionary information.1 2 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Telmisartan

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets

20 mg

Micardis (with povidone)

Boehringer Ingelheim, (also promoted by Abbott)

40 mg

Micardis (with povidone)

Boehringer Ingelheim, (also promoted by Abbott)

80 mg

Micardis (with povidone)

Boehringer Ingelheim, (also promoted by Abbott)

Telmisartan Combinations

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets

40 mg with Hydrochlorothiazide 12.5 mg

Micardis HCT (with povidone)

Boehringer Ingelheim, (also promoted by Abbott)

80 mg with Hydrochlorothiazide 12.5 mg

Micardis HCT (with povidone)

Boehringer Ingelheim, (also promoted by Abbott)

80 mg with Hydrochlorothiazide 25 mg

Micardis HCT (with povidone)

Boehringer Ingelheim, (also promoted by Abbott)

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 01/2012. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Micardis 20MG Tablets (BOEHRINGER INGELHEIM): 30/$123.19 or 90/$337.09

Micardis 40MG Tablets (BOEHRINGER INGELHEIM): 30/$123.99 or 90/$355.97

Micardis 80MG Tablets (BOEHRINGER INGELHEIM): 30/$122.99 or 90/$325.95

Micardis HCT 40-12.5MG Tablets (BOEHRINGER INGELHEIM): 30/$123.99 or 90/$339.96

Micardis HCT 80-12.5MG Tablets (BOEHRINGER INGELHEIM): 30/$122.00 or 90/$331.99

Micardis HCT 80-25MG Tablets (BOEHRINGER INGELHEIM): 30/$123.99 or 90/$349.97

Twynsta 80-5MG Tablets (BOEHRINGER INGELHEIM): 30/$129.99 or 90/$365.98

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2012, Selected Revisions December 23, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

1. Boehringer Ingelheim. Micardis (telmisartan) tablets prescribing information. Ridgefield, CT; 2004 Mar 5.

2. Boehringer Ingelheim. Micardis HCT (telmisartan and hydrochlorothiazide) tablets prescribing information. Ridgefield, CT; 2004 Apr 19.

3. McClellan KJ, Markham A. Telmisartan. Drugs. 1998; 56:1039-44. [PubMed 9878991]

4. National Heart, Lung, and Blood Institute National High Blood Pressure Education Program. The sixth report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC VI). Bethesda, MD: National Institutes of Health; 1997 Nov. (NIH publication No. 98-4080.)

5. Anon. Drugs for hypertension. Med Lett Drugs Ther. 2001; 43:17-22. [PubMed 11242494]

6. Anon. Consensus recommendations for the management of chronic heart failure. On behalf of the membership of the advisory council to improve outcomes nationwide in heart failure. Part II. Management of heart failure: approaches to the prevention of heart failure. Am J Cardiol. 1999; 83:9-38A.

7. Warner KK, Visconti JA, Tschampel MM. Angiotensin II receptor blockers in patients with ACE inhibitor-induced angioedema. Ann Pharmacother. 2000; 34:526-8. [IDIS 443518] [PubMed 10772441]

8. Anon. Telmisartan tablets, Micardis: Summary basis of approval equivalent NDA number: 20-850. Rockville, MD: US Food and Drug Administration; 1998. (IDIS 453559)

9. Unger T. Significance of angiotensin type 1 receptor blockade: why are angiotensin II receptor blockers different? Am J Cardiol. 1999; 84:9-15S.

10. Martineau P, Goulet J. New competition in the realm of renin-angiotensin axis inhibition; the angiotensin II receptor antagonists in congestive heart failure. Ann Pharmacother. 2001; 35:71-84. [IDIS 457649] [PubMed 11197588]

11. Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure. The fifth report of the Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure (JNC V). Arch Intern Med. 1993; 153:154-83. [IDIS 309043] [PubMed 8422206]

12. Parker AB, Azevedo ER, Baird MG et al. ARCTIC: assessment of haemodynamic response in patients with congestive heart failure to telmisartan: a multicentre dose-ranging study in Canada. Am Heart J. 1999; 138:843-8. [IDIS 438270] [PubMed 10539814]

13. US Food and Drug Administration. Dangers of ACE inhibitors during second and third trimesters of pregnancy. FDA Med Bull. 1992; 22:2.

14. Mazzolai L, Burnier M. Comparative safety and tolerability of angiotensin II receptor antagonists. Drug Safety. 1999; 21:23-33. [PubMed 10433351]

15. Kirk JK. Therapy with angiotensin II receptor antagonists. Clin Geriatrics. From the MultiMedia Health Care website ().

16. Stangier J, Su CPF, Sch?ndorfer G et al. Pharmacokinetics and safety of intravenous and oral telmisartan 20 mg and 120 mg in subjects with hepatic impairment compared with healthy volunteers. J Clin Pharmacol. 2000; 40:1355-64. [IDIS 455811] [PubMed 11185634]

17. Neutel JM, Smith DHG. Dose response and antihypertensive efficacy of the AT1 receptor antagonist telmisartan in patients with mild to moderate hypertension. Adv Ther. 1998;15:206-17.

18. Elliott HL. The efficacy and safety of telmisartan compared to atenolol and placebo in patients with hypertension. Am J Hypertens. 1998; 11(Part 2): 124A.

19. Smith DHG, Neutel JM, Morgenstern P. Once-daily telmisartan compared with enalapril in the treatment of hypertension. Adv Ther. 1998; 15:229-40.

20. Littlejohn T, Mroczek W, Marbury T et al. A prospective, randomized, open-label trial comparing telmisartan 80 mg with valsartan 80 mg in patients with mild to moderate hypertension using ambulatory blood pressure monitoring. Can J Cardiol. 2000; 16:1123-32. [PubMed 11021956]

21. Boehringer Ingelheim, Ridgefield, CT: Personal communication.

22. AstraZeneca, Wayne, PA: Personal communication on candesartan.

23. American Diabetes Association. Treatment of hypertension in adults with diabetes. Diabetes Care. 2002; 25:134-47. [IDIS 479088] [PubMed 11772914]

24. Brenner BM, Cooper ME, de Zeeuw D et al. Effects of losartan on renal and cardiovascular outcomes in patients with type 2 diabetes and nephropathy. N Engl J Med. 2001; 345:861-9. [IDIS 469607] [PubMed 11565518]

25. Lewis EJ, Hunsicker LG, Claarke WR et al. Renoprotective effect of the angiotensin-receptor antagonist irbesartan in patients with nephropathy due to type 2 diabetes. N Engl J Med. 2001; 345:851-60. [IDIS 469606] [PubMed 11565517]

26. Sica DA, Bakris GL. Type 2 diabetes: RENAAL and IDNT—the emergence of new treatment options. J Clin Hypertens (Greenwich). 2002; 4:52-7. [PubMed 11821641]

27. Parving HH, Brenner BM, Cooper ME et al. [Effect of losartan on renal and cardiovascular complications of patients with type 2 diabetes and nephropathy.] (Danish; with English abstract.) Ugeskr Laeger. 2001; 163:5514-9.

28. Weekers L, Krzesinski JM. [Clinical study of the month. Nephroprotective role of angiotensin II receptor antagonists in type 2 diabetes: results of IDNT and RENAAL trials.] (French with English abstract.) Rev Med Liege. 2001; 56:723-6.

29. Parving HH, Lehnert H, Brochner-Mortensen J et al and the Irbesartan in Patients with Type 2 Diabetes and Microalbuminuria Study Group. The effect of irbesartan on the development of diabetic nephropathy in patients with type 2 diabetes. N Engl J Med. 2001; 345:870-8. [IDIS 469608] [PubMed 11565519]

30. Walser M. Angiotensin-receptor blockers, type 2 diabetes, and renoprotection. N Engl J Med. 2002; 346:706.

31. American Diabetes Association. Standards of medical care for patients with diabetes mellitus. Diabetes Care. 2002; 25(Suppl 1):S33-43.

32. American Diabetes Association. Clinical Practice Recommendations 2002. Position Statement. Diabetic nephropathy. Diabetes Care. 2002; 25(Suppl 1):S85-9.

33. Hunt SA, Baker DW, Chin MH et al. ACC/AHA guidelines for the evaluation and management of chronic heart failure in the adult. A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Revise the 1995 Guidelines for the Evaluation and Management of Heart Failure). 2001. Available at: . Accessed July 25, 2002.

34. Lewis EJ, Hunsicker LG, Bain RP et al. The effect of angiotensin-converting-enzyme inhibition on diabetic nephropathy. N Engl J Med. 1993; 329:1456-62. [IDIS 321612] [PubMed 8413456]

35. Remuzzi G. Slowing the progression of diabetic nephropathy. N Engl J Med. 1993; 329:1496-7. [PubMed 8413463]

36. Kaplan NM. Choice of initial therapy for hypertension. JAMA. 1996; 275:1577-80. [IDIS 365188] [PubMed 8622249]

37. Viberti G, Mogensen CE, Groop LC et al. Effect of captopril on progression to clinical proteinuria in patients with insulin-dependent diabetes mellitus and microalbuminuria. JAMA. 1994; 271:275-9. [IDIS 324307] [PubMed 8295285]

38. Joint National Committee on Detection, Evaluation. The 1984 report of the Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure. Arch Intern Med. 1984; 144:1045-57. [IDIS 184763] [PubMed 6143542]

39. Joint National Committee on Detection, Evaluation. The 1988 report of the Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure. Arch Intern Med. 1988; 148:1023-38. [IDIS 242588] [PubMed 3365073]

41. Appel LJ. The verdict from ALLHAT—thiazide diuretics are the preferred initial therapy for hypertension. JAMA. 2002; 288:3039-60. [IDIS 490723] [PubMed 12479770]

42. The ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group. Major outcomes in high-risk hypertensive patients randomized to angiotensin-converting enzyme inhibitor or calcium channel blocker vs diuretic: the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). JAMA. 2002; 288:2981-97. [IDIS 490721] [PubMed 12479763]

43. National Heart, Lung, and Blood Institute National High Blood Pressure Education Program. The seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC VII) Express. Bethesda, MD: May 14 2003. From NIH website. (). (Also published in JAMA. 2003; 289.

44. Izzo JL, Levy D, Black HR. Importance of systolic blood pressure in older Americans. Hypertension. 2000; 35:1021-4. [PubMed 10818056]

45. Frohlich ED. Recognition of systolic hypertension for hypertension. Hypertension. 2000; 35:1019-20. [PubMed 10818055]

46. Bakris GL, Williams M, Dworkin L et al. Preserving renal function in adults with hypertension and diabetes: a consensus approach. Am J Kidney Dis. 2000; 36:646-61. [IDIS 452007] [PubMed 10977801]

47. American Diabetes Association. Treatment of hypertension in adults with diabetes. Diabetes Care. 2003; 26(Suppl 1):S80-2.

48. Guidelines Committee. 2003 European Society of Hypertension–European Society of Cardiology guidelines for the management of arterial hypertension. J Hypertension. 2003; 21:1011-53.

49. Cooper WO, Hernandez-Diaz S, Arbogast PG et al. Major congenital malformations after first-trimester exposure to ACE inhibitors. N Engl J Med. 2006; 354:2443-51. [PubMed 16760444]

50. Food and Drug Administration. FDA public health advisory: angiotensin-converting enzyme inhibitor (ACE inhibitor) drugs and pregnancy. From FDA website.

120. Food and Drug Administration. FDA drug safety communication: ongoing safety review of the angiotensin receptor blockers and cancer. Rockville, MD; 2010 Jul 15. From FDA website.

121. Sipahi I, Debanne SM, Rowland DY et al. Angiotensin-receptor blockade and risk of cancer: meta-analysis of randomised controlled trials. Lancet Oncol. 2010; 11:627-36. [PubMed 20542468]

122. Nissen SE. Angiotensin-receptor blockers and cancer: urgent regulatory review needed. Lancet Oncol. 2010; 11:605-6. [PubMed 20542469]

123. Sica DA. Angiotensin receptor blockers and the risk of malignancy: a note of caution. Drug Saf. 2010; 33:709-12. [PubMed 20701404]

126. Food and Drug Administration. FDA drug safety communication: No increase in risk of cancer with certain blood pressure drugs-angiotensin receptor blockers (ARBs). Rockville, MD; 2011 Jun 2. Available from FDA website. Accessed 2011 Jun 15.

127. Bangalore S, Kumar S, Kjeldsen SE et al. Antihypertensive drugs and risk of cancer: network meta-analyses and trial sequential analyses of 324,168 participants from randomised trials. Lancet Oncol. 2011; 12:65-82. [PubMed 21123111]

128. ARB Trialists Collaboration. Effects of telmisartan, irbesartan, valsartan, candesartan, and losartan on cancers in 15 trials enrolling 138,769 individuals. J Hypertens. 2011; 29:623-35. [PubMed 21358417]

129. Pasternak B, Svanstr?m H, Callr?us T et al. Use of angiotensin receptor blockers and the risk of cancer. Circulation. 2011; 123:1729-36. [PubMed 21482967]

130. Volpe M, Morganti A. 2010 Position Paper of the Italian Society of Hypertension (SIIA): Angiotensin Receptor Blockers and Risk of Cancer. High Blood Press Cardiovasc Prev. 2011; 18:37-40. [PubMed 21612311]

131. Siragy HM. A current evaluation of the safety of angiotensin receptor blockers and direct renin inhibitors. Vasc Health Risk Manag. 2011; 7:297-313. [PubMed 21633727]

b. Howes LG, Tran D. Can angiotensin receptor antagonists be used safely in patients with previous ACE inhibitor-induced angioedema? Drug Saf. 2002; 25:73-6.

More Telmisartan resources Telmisartan Side Effects (in more detail) Telmisartan Dosage Telmisartan Use in Pregnancy & Breastfeeding Telmisartan Drug Interactions Telmisartan Support Group 18 Reviews for Telmisartan - Add your own review/rating Telmisartan MedFacts Consumer Leaflet (Wolters Kluwer) Telmisartan Professional Patient Advice (Wolters Kluwer) telmisartan Advanced Consumer (Micromedex) - Includes Dosage Information Micardis Prescribing Information (FDA) Micardis Consumer Overview Compare Telmisartan with other medications Cardiovascular Risk Reduction High Blood Pressure Prevention of Cardiovascular Disease


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Micardis


Generic Name: Telmisartan
Class: Angiotensin II Receptor Antagonists
VA Class: CV805
Chemical Name: 4? - [1(1,4? - Dimethyl - 2? - propyl[2,6? - bi - 1H - benzimidazol] - 1? - yl)methyl] - [1,1? - biphenyl] - 2 - carboxylic acid
Molecular Formula: C33H30N4O2
CAS Number: 144701-48-4

May cause fetal and neonatal morbidity and mortality if used during pregnancy.1 2 49 50 (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

If pregnancy is detected, discontinue as soon as possible.1 2 50

Introduction

Angiotensin II receptor (AT1) antagonist.1 2 3 16

Uses for Micardis Hypertension

Management of hypertension (alone or in combination with other classes of antihypertensive agents).1 2 3 17 19

One of several preferred initial therapies in hypertensive patients with chronic kidney disease, diabetes mellitus, or heart failure.43

Can be used as monotherapy for initial management of uncomplicated hypertension; however, thiazide diuretics are preferred by JNC 7.43

Diabetic Nephropathy

A first-line agent in the treatment of diabetic nephropathy† in hypertensive patients with type 2 diabetes mellitus.

CHF

A second-line agent in the treatment of CHF†; should be used only in those intolerant of ACE inhibitors.

Micardis Dosage and Administration General Hypertension

Fixed-combination telmisartan/hydrochlorothiazide tablets should not be used for initial treatment of hypertension.2

Administration Oral Administration

Administer orally once daily without regard to meals.1 2

Dosage Adults Hypertension Monotherapy Oral

Initially, 40 mg once daily in adults without intravascular volume depletion.1 Adjust dosage at approximately monthly intervals (more aggressively in high-risk patients) to achieve BP control.43

Usual dosage: 20–80 mg once daily; no additional therapeutic benefit with higher dosages.1

Combination Therapy Oral

If BP is not adequately controlled by monotherapy with telmisartan 80 mg daily, can switch to fixed-combination tablets (telmisartan 80 mg and hydrochlorothiazide 12.5 mg; then telmisartan 160 mg and hydrochlorothiazide 25 mg), administered once daily.2

If BP is not adequately controlled by monotherapy with hydrochlorothiazide 25 mg or if BP is controlled but hypokalemia is problematic at this dosage, can use fixed-combination tablets containing telmisartan 80 mg and hydrochlorothiazide 12.5 mg, administered once daily.2 Can increase dosage to telmisartan 160 mg and hydrochlorothiazide 25 mg, if needed, to control BP.2

Special Populations Hepatic Impairment

Initiate therapy under close medical supervision in patients with obstructive biliary disease or hepatic impairment.1

If fixed-combination tablets are used in patients with obstructive biliary disease or hepatic impairment, recommended initial dosage is telmisartan 40 mg and hydrochlorothiazide 12.5 mg daily.2 Use of fixed combination not recommended in those with severe hepatic impairment.2

Renal Impairment

No initial dosage adjustments necessary in patients with Clcr >30 mL/minute.1 2 Manufacturer makes no specific recommendations regarding telmisartan monotherapy in those with Clcr ?30 mL/minute.1

Telmisartan/hydrochlorothiazide fixed combination not recommended in patients with Clcr <30 mL/minute.2

Geriatric Patients

No initial dosage adjustments necessary.1 2

Volume- and/or Salt-Depleted Patients

Correct volume and/or salt depletion prior to initiation of therapy or initiate therapy under close medical supervision using lower initial dosage.1 2

Cautions for Micardis Contraindications

Known hypersensitivity to telmisartan or any ingredient in the formulation.1 2 7

Warnings/Precautions Warnings Hypotension

Possible symptomatic hypotension, particularly in volume- and/or salt-depleted patients (e.g., those treated with diuretics or undergoing dialysis).1 2 (See Volume- and/or Salt-Depleted Patients under Dosage and Administration.)

Transient hypotension is not a contraindication to additional doses; may reinstate therapy cautiously after BP is stabilized (e.g., with volume expansion).1 2

Fetal/Neonatal Morbidity and Mortality

Possible fetal and neonatal morbidity and mortality when used during pregnancy.1 2 50 (See Boxed Warning.) Such potential risks occur throughout pregnancy, especially during the second and third trimesters.50

Also may increase the risk of major congenital malformations when administered during the first trimester of pregnancy.49 50

Discontinue as soon as possible when pregnancy is detected, unless continued use is considered lifesaving.49 50 Nearly all women can be transferred successfully to alternative therapy for the remainder of their pregnancy.13

Malignancies

In July 2010, FDA initiated a safety review of angiotensin II receptor antagonists after a published meta-analysis found a modest but statistically significant increase in risk of new cancer occurrence in patients receiving an angiotensin II receptor antagonist compared with control.120 121 123 126 However, subsequent studies, including a larger meta-analysis conducted by FDA, have not shown such risk.126 127 128 129 Based on currently available data, FDA has concluded that angiotensin II receptor antagonists do not increase the risk of cancer.126

Sensitivity Reactions

Anaphylactoid reactions and/or angioedema possible;1 2 7 14 not recommended in patients with a history of angioedema associated with or unrelated to ACE inhibitor or angiotensin II receptor antagonist therapy.b

General Precautions Renal Effects

Possible oliguria, progressive azotemia and, rarely, acute renal failure and/or death in patients with severe CHF.1 2

Increases in BUN and Scr possible in patients with unilateral or bilateral renal artery stenosis.1 2

Use of Fixed Combinations

When used in fixed combination with hydrochlorothiazide, consider the cautions, precautions, and contraindications associated with hydrochlorothiazide.2

Specific Populations Pregnancy

Category C (1st trimester); Category D (2nd and 3rd trimesters).1 2 (See Boxed Warning.)

Lactation

Distributed into milk in rats; not known whether distributed into human milk.1 2 Discontinue nursing or the drug.1 2

Pediatric Use

Safety and efficacy not established in children <18 years of age.1 2 21

Geriatric Use

No substantial differences in safety or efficacy relative to younger adults, but increased sensitivity cannot be ruled out.1 2

Hepatic Impairment

Plasma telmisartan concentrations may be increased in patients with obstructive biliary disease or hepatic impairment.1 2 (See Special Populations under Absorption, in Pharmacokinetics.) Dosage adjustments may be necessary.2 (See Hepatic Impairment under Dosage and Administration.)

Use of telmisartan in fixed combination with hydrochlorothiazide is not recommended in patients with severe hepatic impairment.2

Renal Impairment

Deterioration of renal function may occur.1 2 (See Renal Effects under Cautions.)

Use of telmisartan in fixed combination with hydrochlorothiazide is not recommended in patients with Clcr <30 mL/minute.2

Blacks

BP reduction may be smaller in black patients compared with non-black patients; use in combination with a diuretic.1 43

Common Adverse Effects

Upper respiratory tract infection, sinusitis, pharyngitis, back pain, diarrhea.1

Interactions for Micardis

Not metabolized by CYP isoenzymes; has no effect on CYP isoenzymes except for some inhibition of CYP2C19 in vitro.1 2

Specific Drugs

Drug

Interaction

Comment

Acetaminophen

Interactions unlikely1 2

Amlodipine

Interactions unlikely1 2

Digoxin

Increased plasma digoxin concentrations1 2

Monitor serum digoxin concentrations when telmisartan therapy is initiated, adjusted, or discontinued in patients stabilized on digoxin1 2 3 21

Glyburide

Interactions unlikely1 2

Hydrochlorothiazide

Additive hypotensive effects1 2

Ibuprofen

Interactions unlikely1 2

Simvastatin

Interactions unlikely1 2

Warfarin

Possible decreased plasma warfarin concentrations; INR not affected1 2

Micardis Pharmacokinetics Absorption Bioavailability

Absolute bioavailability is dose dependent: 42% at 40 mg, 58% at 160 mg.1 2

Peak plasma concentration generally reached at 0.5–1 hour following oral administration.1 2

Onset

Antihypertensive effect evident within 2 weeks, with maximum BP reduction after 4 weeks.1

Food

Food slightly reduces bioavailability.1 2

Special Populations

In patients with hepatic insufficiency, plasma telmisartan concentrations are increased and absolute bioavailability approaches 100%.1 2

Distribution Extent

Crosses the placenta and is distributed in the fetus in animals.1 2

Distributed into milk in rats; not known whether distributed into human milk.1 2

Plasma Protein Binding

>99.5% (principally albumin and ?1-acid glycoprotein).1 2

Elimination Metabolism

Metabolized in liver (via conjugation) to inactive metabolite.1 2

Not metabolized by CYP isoenzymes.1 2

Elimination Route

Eliminated mainly (>97%) as unchanged drug in feces (via bile); small amounts (<1%) eliminated in urine.1 2

Half-life

Biphasic; terminal half-life is approximately 24 hours.1 2

Special Populations

Not removed from blood by hemofiltration.1 2

Stability Storage Oral Tablets

25°C (may be exposed to 15–30°C).1 2 Do not remove tablets from blisters until immediately before administration.1 2

Actions

Blocks the physiologic actions of angiotensin II, including vasoconstrictor and aldosterone-secreting effects.1 2

Does not interfere with response to bradykinins and substance P.1 2

Does not share the ACE inhibitor common adverse effect of dry cough.1 2 33

Advice to Patients

Risks of use during pregnancy.1 2 49 50

Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.1 2

Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.1 2

Importance of informing patients of other important precautionary information.1 2 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Telmisartan

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets

20 mg

Micardis (with povidone)

Boehringer Ingelheim, (also promoted by Abbott)

40 mg

Micardis (with povidone)

Boehringer Ingelheim, (also promoted by Abbott)

80 mg

Micardis (with povidone)

Boehringer Ingelheim, (also promoted by Abbott)

Telmisartan Combinations

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets

40 mg with Hydrochlorothiazide 12.5 mg

Micardis HCT (with povidone)

Boehringer Ingelheim, (also promoted by Abbott)

80 mg with Hydrochlorothiazide 12.5 mg

Micardis HCT (with povidone)

Boehringer Ingelheim, (also promoted by Abbott)

80 mg with Hydrochlorothiazide 25 mg

Micardis HCT (with povidone)

Boehringer Ingelheim, (also promoted by Abbott)

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 01/2012. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Micardis 20MG Tablets (BOEHRINGER INGELHEIM): 30/$123.19 or 90/$337.09

Micardis 40MG Tablets (BOEHRINGER INGELHEIM): 30/$123.99 or 90/$355.97

Micardis 80MG Tablets (BOEHRINGER INGELHEIM): 30/$122.99 or 90/$325.95

Micardis HCT 40-12.5MG Tablets (BOEHRINGER INGELHEIM): 30/$123.99 or 90/$339.96

Micardis HCT 80-12.5MG Tablets (BOEHRINGER INGELHEIM): 30/$122.00 or 90/$331.99

Micardis HCT 80-25MG Tablets (BOEHRINGER INGELHEIM): 30/$123.99 or 90/$349.97

Twynsta 80-5MG Tablets (BOEHRINGER INGELHEIM): 30/$129.99 or 90/$365.98

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2012, Selected Revisions December 23, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

1. Boehringer Ingelheim. Micardis (telmisartan) tablets prescribing information. Ridgefield, CT; 2004 Mar 5.

2. Boehringer Ingelheim. Micardis HCT (telmisartan and hydrochlorothiazide) tablets prescribing information. Ridgefield, CT; 2004 Apr 19.

3. McClellan KJ, Markham A. Telmisartan. Drugs. 1998; 56:1039-44. [PubMed 9878991]

4. National Heart, Lung, and Blood Institute National High Blood Pressure Education Program. The sixth report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC VI). Bethesda, MD: National Institutes of Health; 1997 Nov. (NIH publication No. 98-4080.)

5. Anon. Drugs for hypertension. Med Lett Drugs Ther. 2001; 43:17-22. [PubMed 11242494]

6. Anon. Consensus recommendations for the management of chronic heart failure. On behalf of the membership of the advisory council to improve outcomes nationwide in heart failure. Part II. Management of heart failure: approaches to the prevention of heart failure. Am J Cardiol. 1999; 83:9-38A.

7. Warner KK, Visconti JA, Tschampel MM. Angiotensin II receptor blockers in patients with ACE inhibitor-induced angioedema. Ann Pharmacother. 2000; 34:526-8. [IDIS 443518] [PubMed 10772441]

8. Anon. Telmisartan tablets, Micardis: Summary basis of approval equivalent NDA number: 20-850. Rockville, MD: US Food and Drug Administration; 1998. (IDIS 453559)

9. Unger T. Significance of angiotensin type 1 receptor blockade: why are angiotensin II receptor blockers different? Am J Cardiol. 1999; 84:9-15S.

10. Martineau P, Goulet J. New competition in the realm of renin-angiotensin axis inhibition; the angiotensin II receptor antagonists in congestive heart failure. Ann Pharmacother. 2001; 35:71-84. [IDIS 457649] [PubMed 11197588]

11. Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure. The fifth report of the Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure (JNC V). Arch Intern Med. 1993; 153:154-83. [IDIS 309043] [PubMed 8422206]

12. Parker AB, Azevedo ER, Baird MG et al. ARCTIC: assessment of haemodynamic response in patients with congestive heart failure to telmisartan: a multicentre dose-ranging study in Canada. Am Heart J. 1999; 138:843-8. [IDIS 438270] [PubMed 10539814]

13. US Food and Drug Administration. Dangers of ACE inhibitors during second and third trimesters of pregnancy. FDA Med Bull. 1992; 22:2.

14. Mazzolai L, Burnier M. Comparative safety and tolerability of angiotensin II receptor antagonists. Drug Safety. 1999; 21:23-33. [PubMed 10433351]

15. Kirk JK. Therapy with angiotensin II receptor antagonists. Clin Geriatrics. From the MultiMedia Health Care website ().

16. Stangier J, Su CPF, Sch?ndorfer G et al. Pharmacokinetics and safety of intravenous and oral telmisartan 20 mg and 120 mg in subjects with hepatic impairment compared with healthy volunteers. J Clin Pharmacol. 2000; 40:1355-64. [IDIS 455811] [PubMed 11185634]

17. Neutel JM, Smith DHG. Dose response and antihypertensive efficacy of the AT1 receptor antagonist telmisartan in patients with mild to moderate hypertension. Adv Ther. 1998;15:206-17.

18. Elliott HL. The efficacy and safety of telmisartan compared to atenolol and placebo in patients with hypertension. Am J Hypertens. 1998; 11(Part 2): 124A.

19. Smith DHG, Neutel JM, Morgenstern P. Once-daily telmisartan compared with enalapril in the treatment of hypertension. Adv Ther. 1998; 15:229-40.

20. Littlejohn T, Mroczek W, Marbury T et al. A prospective, randomized, open-label trial comparing telmisartan 80 mg with valsartan 80 mg in patients with mild to moderate hypertension using ambulatory blood pressure monitoring. Can J Cardiol. 2000; 16:1123-32. [PubMed 11021956]

21. Boehringer Ingelheim, Ridgefield, CT: Personal communication.

22. AstraZeneca, Wayne, PA: Personal communication on candesartan.

23. American Diabetes Association. Treatment of hypertension in adults with diabetes. Diabetes Care. 2002; 25:134-47. [IDIS 479088] [PubMed 11772914]

24. Brenner BM, Cooper ME, de Zeeuw D et al. Effects of losartan on renal and cardiovascular outcomes in patients with type 2 diabetes and nephropathy. N Engl J Med. 2001; 345:861-9. [IDIS 469607] [PubMed 11565518]

25. Lewis EJ, Hunsicker LG, Claarke WR et al. Renoprotective effect of the angiotensin-receptor antagonist irbesartan in patients with nephropathy due to type 2 diabetes. N Engl J Med. 2001; 345:851-60. [IDIS 469606] [PubMed 11565517]

26. Sica DA, Bakris GL. Type 2 diabetes: RENAAL and IDNT—the emergence of new treatment options. J Clin Hypertens (Greenwich). 2002; 4:52-7. [PubMed 11821641]

27. Parving HH, Brenner BM, Cooper ME et al. [Effect of losartan on renal and cardiovascular complications of patients with type 2 diabetes and nephropathy.] (Danish; with English abstract.) Ugeskr Laeger. 2001; 163:5514-9.

28. Weekers L, Krzesinski JM. [Clinical study of the month. Nephroprotective role of angiotensin II receptor antagonists in type 2 diabetes: results of IDNT and RENAAL trials.] (French with English abstract.) Rev Med Liege. 2001; 56:723-6.

29. Parving HH, Lehnert H, Brochner-Mortensen J et al and the Irbesartan in Patients with Type 2 Diabetes and Microalbuminuria Study Group. The effect of irbesartan on the development of diabetic nephropathy in patients with type 2 diabetes. N Engl J Med. 2001; 345:870-8. [IDIS 469608] [PubMed 11565519]

30. Walser M. Angiotensin-receptor blockers, type 2 diabetes, and renoprotection. N Engl J Med. 2002; 346:706.

31. American Diabetes Association. Standards of medical care for patients with diabetes mellitus. Diabetes Care. 2002; 25(Suppl 1):S33-43.

32. American Diabetes Association. Clinical Practice Recommendations 2002. Position Statement. Diabetic nephropathy. Diabetes Care. 2002; 25(Suppl 1):S85-9.

33. Hunt SA, Baker DW, Chin MH et al. ACC/AHA guidelines for the evaluation and management of chronic heart failure in the adult. A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Revise the 1995 Guidelines for the Evaluation and Management of Heart Failure). 2001. Available at: . Accessed July 25, 2002.

34. Lewis EJ, Hunsicker LG, Bain RP et al. The effect of angiotensin-converting-enzyme inhibition on diabetic nephropathy. N Engl J Med. 1993; 329:1456-62. [IDIS 321612] [PubMed 8413456]

35. Remuzzi G. Slowing the progression of diabetic nephropathy. N Engl J Med. 1993; 329:1496-7. [PubMed 8413463]

36. Kaplan NM. Choice of initial therapy for hypertension. JAMA. 1996; 275:1577-80. [IDIS 365188] [PubMed 8622249]

37. Viberti G, Mogensen CE, Groop LC et al. Effect of captopril on progression to clinical proteinuria in patients with insulin-dependent diabetes mellitus and microalbuminuria. JAMA. 1994; 271:275-9. [IDIS 324307] [PubMed 8295285]

38. Joint National Committee on Detection, Evaluation. The 1984 report of the Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure. Arch Intern Med. 1984; 144:1045-57. [IDIS 184763] [PubMed 6143542]

39. Joint National Committee on Detection, Evaluation. The 1988 report of the Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure. Arch Intern Med. 1988; 148:1023-38. [IDIS 242588] [PubMed 3365073]

41. Appel LJ. The verdict from ALLHAT—thiazide diuretics are the preferred initial therapy for hypertension. JAMA. 2002; 288:3039-60. [IDIS 490723] [PubMed 12479770]

42. The ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group. Major outcomes in high-risk hypertensive patients randomized to angiotensin-converting enzyme inhibitor or calcium channel blocker vs diuretic: the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). JAMA. 2002; 288:2981-97. [IDIS 490721] [PubMed 12479763]

43. National Heart, Lung, and Blood Institute National High Blood Pressure Education Program. The seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC VII) Express. Bethesda, MD: May 14 2003. From NIH website. (). (Also published in JAMA. 2003; 289.

44. Izzo JL, Levy D, Black HR. Importance of systolic blood pressure in older Americans. Hypertension. 2000; 35:1021-4. [PubMed 10818056]

45. Frohlich ED. Recognition of systolic hypertension for hypertension. Hypertension. 2000; 35:1019-20. [PubMed 10818055]

46. Bakris GL, Williams M, Dworkin L et al. Preserving renal function in adults with hypertension and diabetes: a consensus approach. Am J Kidney Dis. 2000; 36:646-61. [IDIS 452007] [PubMed 10977801]

47. American Diabetes Association. Treatment of hypertension in adults with diabetes. Diabetes Care. 2003; 26(Suppl 1):S80-2.

48. Guidelines Committee. 2003 European Society of Hypertension–European Society of Cardiology guidelines for the management of arterial hypertension. J Hypertension. 2003; 21:1011-53.

49. Cooper WO, Hernandez-Diaz S, Arbogast PG et al. Major congenital malformations after first-trimester exposure to ACE inhibitors. N Engl J Med. 2006; 354:2443-51. [PubMed 16760444]

50. Food and Drug Administration. FDA public health advisory: angiotensin-converting enzyme inhibitor (ACE inhibitor) drugs and pregnancy. From FDA website.

120. Food and Drug Administration. FDA drug safety communication: ongoing safety review of the angiotensin receptor blockers and cancer. Rockville, MD; 2010 Jul 15. From FDA website.

121. Sipahi I, Debanne SM, Rowland DY et al. Angiotensin-receptor blockade and risk of cancer: meta-analysis of randomised controlled trials. Lancet Oncol. 2010; 11:627-36. [PubMed 20542468]

122. Nissen SE. Angiotensin-receptor blockers and cancer: urgent regulatory review needed. Lancet Oncol. 2010; 11:605-6. [PubMed 20542469]

123. Sica DA. Angiotensin receptor blockers and the risk of malignancy: a note of caution. Drug Saf. 2010; 33:709-12. [PubMed 20701404]

126. Food and Drug Administration. FDA drug safety communication: No increase in risk of cancer with certain blood pressure drugs-angiotensin receptor blockers (ARBs). Rockville, MD; 2011 Jun 2. Available from FDA website. Accessed 2011 Jun 15.

127. Bangalore S, Kumar S, Kjeldsen SE et al. Antihypertensive drugs and risk of cancer: network meta-analyses and trial sequential analyses of 324,168 participants from randomised trials. Lancet Oncol. 2011; 12:65-82. [PubMed 21123111]

128. ARB Trialists Collaboration. Effects of telmisartan, irbesartan, valsartan, candesartan, and losartan on cancers in 15 trials enrolling 138,769 individuals. J Hypertens. 2011; 29:623-35. [PubMed 21358417]

129. Pasternak B, Svanstr?m H, Callr?us T et al. Use of angiotensin receptor blockers and the risk of cancer. Circulation. 2011; 123:1729-36. [PubMed 21482967]

130. Volpe M, Morganti A. 2010 Position Paper of the Italian Society of Hypertension (SIIA): Angiotensin Receptor Blockers and Risk of Cancer. High Blood Press Cardiovasc Prev. 2011; 18:37-40. [PubMed 21612311]

131. Siragy HM. A current evaluation of the safety of angiotensin receptor blockers and direct renin inhibitors. Vasc Health Risk Manag. 2011; 7:297-313. [PubMed 21633727]

b. Howes LG, Tran D. Can angiotensin receptor antagonists be used safely in patients with previous ACE inhibitor-induced angioedema? Drug Saf. 2002; 25:73-6.

More Micardis resources Micardis Side Effects (in more detail) Micardis Use in Pregnancy & Breastfeeding Drug Images Micardis Drug Interactions Micardis Support Group 18 Reviews for Micardis - Add your own review/rating Micardis Prescribing Information (FDA) Micardis Consumer Overview Micardis Advanced Consumer (Micromedex) - Includes Dosage Information Micardis MedFacts Consumer Leaflet (Wolters Kluwer) Telmisartan Professional Patient Advice (Wolters Kluwer) Compare Micardis with other medications Cardiovascular Risk Reduction High Blood Pressure Prevention of Cardiovascular Disease


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Nimodipine


Pronunciation: nye-MOE-di-peen
Generic Name: Nimodipine
Brand Name: Generic only. No brands available.

Nimodipine should only be taken by mouth. Life-threatening and sometimes fatal side effects may occur if Nimodipine is administered by injection.


Nimodipine is used for:

Reducing problems due to lack of oxygen caused by bleeding from a blood vessel in the brain. It may also be used for other conditions as determined by your doctor.

Nimodipine is a calcium channel blocking agent. Exactly how Nimodipine works is unknown.

Do NOT use Nimodipine if: you are allergic to any ingredient in Nimodipine

Contact your doctor or health care provider right away if any of these apply to you.

Before using Nimodipine:

Some medical conditions may interact with Nimodipine. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have liver problems, heart problems (eg, slow heartbeat), shock due to serious heart problems, low blood pressure, fluid in your lungs, or if you have a history of heart attack

Some MEDICINES MAY INTERACT with Nimodipine. Tell your health care provider if you are taking any other medicines, especially any of the following:

Calcium channel blockers (eg, amlodipine) or other blood pressure medicines because actions and side effects may be increased by Nimodipine

This may not be a complete list of all interactions that may occur. Ask your health care provider if Nimodipine may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Nimodipine:

Use Nimodipine as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Nimodipine on an empty stomach at least 1 hour before or 2 hours after eating. Avoid eating grapefruit or drinking grapefruit juice while taking Nimodipine. If you miss a dose of Nimodipine, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Nimodipine.

Important safety information: Nimodipine may cause dizziness or lightheadedness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Nimodipine. Using Nimodipine alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks. LAB TESTS, including blood pressure, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and laboratory appointments. Use Nimodipine with caution in the ELDERLY because they may be more sensitive to its effects. Use Nimodipine with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Nimodipine during pregnancy. It is unknown if Nimodipine is excreted in breast milk. Do not breast-feed while you are using Nimodipine. Possible side effects of Nimodipine:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; flushing; headache; nausea.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black or bloody stools; depression; fast, slow, or irregular heartbeat; severe dizziness; shortness of breath; severe or persistent constipation; swelling of the feet or hands; unusual bruising or bleeding; unusual tiredness or weakness; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Nimodipine side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include fainting; loss of consciousness; rapid, slow, or irregular heartbeat; severe dizziness.

Proper storage of Nimodipine:

Store Nimodipine at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store in the original foil pack away from heat, moisture, and light. Do not store in the bathroom. Keep Nimodipine out of the reach of children and away from pets.

General information: If you have any questions about Nimodipine, please talk with your doctor, pharmacist, or other health care provider. Nimodipine is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Nimodipine. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Nimodipine resources Nimodipine Side Effects (in more detail)Nimodipine DosageNimodipine Use in Pregnancy & BreastfeedingDrug ImagesNimodipine Drug InteractionsNimodipine Support Group2 Reviews for Nimodipine - Add your own review/rating Nimodipine Professional Patient Advice (Wolters Kluwer) Nimodipine Monograph (AHFS DI) Nimodipine Prescribing Information (FDA) Nimotop Prescribing Information (FDA) nimodipine Concise Consumer Information (Cerner Multum) nimodipine Advanced Consumer (Micromedex) - Includes Dosage Information Compare Nimodipine with other medications Ischemic StrokeMigraine PreventionSubarachnoid Hemorrhage


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Isradipine


Pronunciation: iz-RA-di-peen
Generic Name: Isradipine
Brand Name: Generic only. No brands available.
Isradipine is used for:

Treating high blood pressure. Isradipine may be used alone on in combination with other high blood pressure medications. It may also be used for other conditions as determined by your doctor.

Isradipine is a calcium channel blocker. It works by dilating (widening) the arteries.

Do NOT use Isradipine if: you are allergic to any ingredient in Isradipine or other dihydropyridines (eg, amlodipine)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Isradipine:

Some medical conditions may interact with Isradipine. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have heart problems (eg, congestive heart failure, ventricle problems, or a slow heartbeat), kidney or liver problems, or a history of low blood pressure, or you have recently had a heart attack if you have shock due to serious heart problems if you have narrowing of the stomach or intestines

Some MEDICINES MAY INTERACT with Isradipine. Tell your health care provider if you are taking any other medicines, especially any of the following:

Fentanyl because the risk of severe low blood pressure may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Isradipine may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Isradipine:

Use Isradipine as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Isradipine by mouth with or without food. Taking Isradipine at the same time each day will help you remember to take it. Continue to use Isradipine even if you feel well. Do not miss any doses. If you miss a dose of Isradipine, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Isradipine.

Important safety information: Isradipine may cause drowsiness, dizziness, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Isradipine with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Patients who take medicine for high blood pressure often feel tired or run down for a few weeks after starting treatment. Be sure to take your medicine even if you may not feel "normal. "Tell your doctor if you develop any new symptoms. You may notice the tablet shell in your stool . This is normal and not a cause for concern. Use Isradipine with caution in the ELDERLY; they may be more sensitive to its effects. Isradipine should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Isradipine while you are pregnant. It is not known if Isradipine is found in breast milk. Do not breast-feed while taking Isradipine.

If you stop taking Isradipine suddenly, you may have WITHDRAWAL symptoms. These may include chest pain.

Possible side effects of Isradipine:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; dizziness; flushing; headache; heartburn; lightheadedness; sinus infection; stomach upset; tiredness; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; hoarseness; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; chills, fever, or persistent sore throat; confusion; decreased urination; fast or irregular heartbeat; numbness of an arm or leg; numbness or tingling of the skin; shortness of breath; speech problems; sudden severe headache, dizziness, vomiting, or fainting; swelling of the feet or hands; tender, bleeding, or swollen gums.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Isradipine side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include confusion; severe or persistent dizziness or drowsiness; slowed or irregular heartbeat; slurred speech; weakness.

Proper storage of Isradipine:

Store Isradipine at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Isradipine out of the reach of children and away from pets.

General information: If you have any questions about Isradipine, please talk with your doctor, pharmacist, or other health care provider. Isradipine is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Isradipine. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Isradipine resources Isradipine Side Effects (in more detail) Isradipine Dosage Isradipine Use in Pregnancy & Breastfeeding Drug Images Isradipine Drug Interactions Isradipine Support Group 1 Review for Isradipine - Add your own review/rating Isradipine Prescribing Information (FDA) Isradipine Professional Patient Advice (Wolters Kluwer) Isradipine Monograph (AHFS DI) isradipine Concise Consumer Information (Cerner Multum) isradipine Advanced Consumer (Micromedex) - Includes Dosage Information DynaCirc Prescribing Information (FDA) DynaCirc CR Prescribing Information (FDA) Compare Isradipine with other medications Angina Pectoris Prophylaxis High Blood Pressure Raynaud's Syndrome


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Vaprisol


Pronunciation: KOE-ni-VAP-tan
Generic Name: Conivaptan
Brand Name: Vaprisol
Vaprisol is used for:

Treating low blood sodium levels in certain patients.

Vaprisol is an arginine vasopressin receptor antagonist. It works by increasing fluid removal from the body, which helps to normalize blood sodium levels.

Do NOT use Vaprisol if: you are allergic to any ingredient in Vaprisol or to corn or corn products you have low blood sodium levels along with low blood or fluid volume you have severe kidney problems or you are not able to urinate you are taking certain azole antifungals (eg, ketoconazole, itraconazole), an HIV protease inhibitor (eg, indinavir, ritonavir), certain macrolide antibiotics (eg, clarithromycin), nefazodone, or telithromycin

Contact your doctor or health care provider right away if any of these apply to you.

Before using Vaprisol:

Some medical conditions may interact with Vaprisol. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have congestive heart failure, liver problems, or kidney problems if you have poor nutrition or you have an alcohol addiction

Some MEDICINES MAY INTERACT with Vaprisol. Tell your health care provider if you are taking any other medicines, especially any of the following:

Azole antifungals (eg, itraconazole, ketoconazole), HIV protease inhibitors (eg, indinavir, ritonavir), macrolides (eg, clarithromycin), nefazodone, or telithromycin because they may increase the risk of Vaprisol's side effects Amlodipine, benzodiazepines (eg, alprazolam, midazolam), or digoxin because the risk of their side effects may be increased by Vaprisol HMG-CoA reductase inhibitors (eg, atorvastatin) because the risk of serious muscle problems may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Vaprisol may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Vaprisol:

Use Vaprisol as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Vaprisol is given as an injection at your doctor's office, hospital, or clinic. Do not use Vaprisol if it contains particles, is cloudy or discolored, or if the container is cracked or damaged. If you miss a dose of Vaprisol, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Vaprisol.

Important safety information: Vaprisol may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Vaprisol with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Vaprisol may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects. Severe side effects may occur if your blood sodium levels rise too quickly. Contact your doctor right away if you develop abnormal speech (eg, you are unable to speak), trouble swallowing, mental or mood changes, seizures, sluggishness, or weakness in the arms and legs. Diabetes patients - Vaprisol may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine. Lab tests, including blood sodium levels and neurologic tests, may be performed while you use Vaprisol. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. Vaprisol should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed. PREGNANCY and BREAST-FEEDING: Vaprisol may cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Vaprisol while you are pregnant. It is not known if Vaprisol is found in breast milk. Do not breast-feed while taking Vaprisol. Possible side effects of Vaprisol:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dry mouth; headache; increased thirst; nausea; trouble sleeping; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the urine; confusion; drowsiness; fast or irregular heartbeat; fever; increased or painful urination; increased sweating; mental or mood changes; muscle pain, weakness, or cramping; pain, irritation, redness, or swelling at the injection site; rapid breathing; severe or persistent dizziness; severe or persistent increase in thirst; tremor; unusual tiredness or weakness; white patches in the mouth.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Vaprisol side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org ), or emergency room immediately. Symptoms may include fainting; severe or persistent dizziness; severe or persistent increase in thirst.

Proper storage of Vaprisol:

Vaprisol is usually handled and stored by a health care provider. If you are using Vaprisol at home, store Vaprisol as directed by your pharmacist or health care provider. Keep Vaprisol out of the reach of children and away from pets.

General information: If you have any questions about Vaprisol, please talk with your doctor, pharmacist, or other health care provider. Vaprisol is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Vaprisol. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Vaprisol resources Vaprisol Side Effects (in more detail) Vaprisol Use in Pregnancy & Breastfeeding Vaprisol Drug Interactions Vaprisol Support Group 1 Review for Vaprisol - Add your own review/rating Vaprisol Prescribing Information (FDA) Vaprisol Monograph (AHFS DI) Vaprisol Advanced Consumer (Micromedex) - Includes Dosage Information Vaprisol Consumer Overview Compare Vaprisol with other medications Euvolemic Hyponatremia SIADH


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Conivaptan


Pronunciation: KOE-ni-VAP-tan
Generic Name: Conivaptan
Brand Name: Vaprisol
Conivaptan is used for:

Treating low blood sodium levels in certain patients.

Conivaptan is an arginine vasopressin receptor antagonist. It works by increasing fluid removal from the body, which helps to normalize blood sodium levels.

Do NOT use Conivaptan if: you are allergic to any ingredient in Conivaptan or to corn or corn products you have low blood sodium levels along with low blood or fluid volume you have severe kidney problems or you are not able to urinate you are taking certain azole antifungals (eg, ketoconazole, itraconazole), an HIV protease inhibitor (eg, indinavir, ritonavir), certain macrolide antibiotics (eg, clarithromycin), nefazodone, or telithromycin

Contact your doctor or health care provider right away if any of these apply to you.

Before using Conivaptan:

Some medical conditions may interact with Conivaptan. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have congestive heart failure, liver problems, or kidney problems if you have poor nutrition or you have an alcohol addiction

Some MEDICINES MAY INTERACT with Conivaptan. Tell your health care provider if you are taking any other medicines, especially any of the following:

Azole antifungals (eg, itraconazole, ketoconazole), HIV protease inhibitors (eg, indinavir, ritonavir), macrolides (eg, clarithromycin), nefazodone, or telithromycin because they may increase the risk of Conivaptan's side effects Amlodipine, benzodiazepines (eg, alprazolam, midazolam), or digoxin because the risk of their side effects may be increased by Conivaptan HMG-CoA reductase inhibitors (eg, atorvastatin) because the risk of serious muscle problems may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Conivaptan may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Conivaptan:

Use Conivaptan as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Conivaptan is given as an injection at your doctor's office, hospital, or clinic. Do not use Conivaptan if it contains particles, is cloudy or discolored, or if the container is cracked or damaged. If you miss a dose of Conivaptan, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Conivaptan.

Important safety information: Conivaptan may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Conivaptan with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Conivaptan may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects. Severe side effects may occur if your blood sodium levels rise too quickly. Contact your doctor right away if you develop abnormal speech (eg, you are unable to speak), trouble swallowing, mental or mood changes, seizures, sluggishness, or weakness in the arms and legs. Diabetes patients - Conivaptan may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine. Lab tests, including blood sodium levels and neurologic tests, may be performed while you use Conivaptan. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. Conivaptan should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed. PREGNANCY and BREAST-FEEDING: Conivaptan may cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Conivaptan while you are pregnant. It is not known if Conivaptan is found in breast milk. Do not breast-feed while taking Conivaptan. Possible side effects of Conivaptan:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dry mouth; headache; increased thirst; nausea; trouble sleeping; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the urine; confusion; drowsiness; fast or irregular heartbeat; fever; increased or painful urination; increased sweating; mental or mood changes; muscle pain, weakness, or cramping; pain, irritation, redness, or swelling at the injection site; rapid breathing; severe or persistent dizziness; severe or persistent increase in thirst; tremor; unusual tiredness or weakness; white patches in the mouth.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Conivaptan side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org ), or emergency room immediately. Symptoms may include fainting; severe or persistent dizziness; severe or persistent increase in thirst.

Proper storage of Conivaptan:

Conivaptan is usually handled and stored by a health care provider. If you are using Conivaptan at home, store Conivaptan as directed by your pharmacist or health care provider. Keep Conivaptan out of the reach of children and away from pets.

General information: If you have any questions about Conivaptan, please talk with your doctor, pharmacist, or other health care provider. Conivaptan is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Conivaptan. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Conivaptan resources Conivaptan Side Effects (in more detail) Conivaptan Use in Pregnancy & Breastfeeding Conivaptan Drug Interactions Conivaptan Support Group 1 Review for Conivaptan - Add your own review/rating conivaptan Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information Conivaptan Hydrochloride Monograph (AHFS DI) Vaprisol Prescribing Information (FDA) Vaprisol Consumer Overview Compare Conivaptan with other medications Euvolemic Hyponatremia SIADH


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Simvastatin 20mg


1. Name Of The Medicinal Product

Simvastatin 20 mg film-coated tablets

2. Qualitative And Quantitative Composition

Each film-coated tablet contains 20 mg simvastatin.

Excipient: Lactose monohydrate

One film-coated tablet contains 140 mg lactose monohydrate.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Film-coated tablet.

Light pink, round and biconvex film-coated tablets with the inscription “A” debossed on one side and “02” on the other side.

4. Clinical Particulars 4.1 Therapeutic Indications

Hypercholesterolaemia

Treatment of primary hypercholesterolaemia or mixed dyslipidaemia, as an adjunct to diet, when response to diet and other non-pharmacological treatments (such as exercise, weight reduction) is inadequate.

Treatment of homozygous familial hypercholesterolaemia as an adjunct to diet and other lipid-lowering treatments (e.g. LDL-apheresis) or if such treatments are not appropriate.

Cardiovascular prevention

Reduction of cardiovascular mortality and morbidity in patients with manifest atherosclerotic cardiovascular disease or diabetes mellitus, with either normal or increased cholesterol levels, as an adjunct to correction of other risk factors and other cardioprotective therapy (see section 5.1).

4.2 Posology And Method Of Administration

The dosage range is 5-80 mg/day given orally as a single dose in the evening. Adjustments of dosage, if required, should be made at intervals of not less than 4 weeks, to a maximum of 80 mg/day given as a single dose in the evening. The 80 mg dose is only recommended in patients with severe hypercholesterolaemia and high risk for cardiovascular complications who have not achieved their treatment goals on lower doses and when the benefits are expected to outweigh the potential risks (see sections 4.4 and 5.1).

Hypercholesterolaemia

The patient should be placed on a standard cholesterol-lowering diet, and should continue with this diet during treatment with Simvastatin. The usual starting dose is 10-20 mg/day given as a single dose in the evening. Patients who require a large reduction in LDC-C (more than 45%) may be started at 20-40-mg/ day given as a single dose in the evening. Adjustments of dosage, if required, should be made as specified above.

Homozygous familial hypercholesterolaemia

Based on the results of a controlled clinical study, the recommended simvastatin dose is 40 mg/day in the evening or 80 mg/day in 3 divided doses of 20 mg, 20 mg, and an evening dose of 40 mg. Simvastatin should be used as an adjunct to other lipid-lowering treatments (e.g. LDL-apheresis) in these patients or if such treatments are unavailable.

Cardiovascular prevention

The usual dose of Simvastatin is 20 to 40 mg/day given as a single dose in the evening in patients at high risk of coronary heart disease (CHD, with or without hyperlipidaemia). Drug therapy can be initiated simultaneously with diet and exercise. Adjustments of dosage, if required, should be made as specified above.

Concomitant treatment

Simvastatin is effective alone or in combination with bile acid sequestrants. Dosing should occur either > 2 hours before or > 4 hours after administration of a bile acid sequestrant.

In patients taking cyclosporin, danazol, gemfibrozil or other fibrates (except fenofibrate) concomitantly with Simvastatin, the dose of Simvastatin should not exceed 10 mg/day. In patients taking amiodarone or verapamil concomitantly with Simvastatin, the dose of Simvastatin should not exceed 20 mg/day. (See sections 4.4 and 4.5). In patients taking diltiazem or amlodipine concomitantly with Simvastatin, the dose of Simvastatin should not exceed 40 mg/day (see sections 4.4 & 4.5).

Dosage in renal insufficiency

No modification of dosages should be necessary in patients with moderate renal insufficiency.

In patients with severe renal insufficiency (creatinine clearance < 30 ml/min), doses above 10 mg/day should be carefully considered and, if deemed necessary, implemented cautiously.

Use in the elderly

No dosage adjustment is necessary.

Use in children and adolescents (10-17 years of age)

For children and adolescents (boys Tanner Stage II and above and girls who are at least one year post menarche, 10-17 years of age) with heterozygous familial hypercholesterolaemia, the recommended usual starting dose is 10 mg once a day in the evening. Children and adolescents should be placed on a standard cholesterol-lowering diet before simvastatin treatment initiation; this diet should be continued during simvastatin treatment.

The recommended dosing range is 10-40 mg/day; the maximum recommended dose is 40 mg/day. Doses should be individualized according to the recommended goal of therapy as recommended by the paediatric treatment recommendations (see sections 4.4 and 5.1). Adjustments should be made at intervals of 4 weeks or more.

The experience of simvastatin in pre-pubertal children is limited.

4.3 Contraindications

• Hypersensitivity to the simvastatin or to any of the excipients

• Active liver disease or unexplained persistent elevations of serum transaminases

• Pregnancy and lactation (see section 4.6)

• Concomitant administration of potent CYP3A4 inhibitors (e.g. itraconazole, ketoconazole, fluconazole, posaconazole, HIV protease inhibitors (e.g. nelfinavir), erythromycin, clarithromycin, telithromycin and nefazodone) (see section 4.5).

4.4 Special Warnings And Precautions For Use

Myopathy/Rhabdomyolysis

Simvastatin, like other inhibitors of HMG-CoA reductase, occasionally causes myopathy manifested as muscle pain, tenderness or weakness with creatine kinase (CK) above ten times the upper limit of normal (ULN). Myopathy sometimes takes the form of rhabdomyolysis with or without acute renal failure secondary to myoglobinuria, and very rare fatalities have occurred. The risk of myopathy is increased by high levels of HMG-CoA reductase inhibitory activity in plasma.

As with other HMG-CoA reductase inhibitors, the risk of myopathy/rhabdomyolysis is dose related. In a clinical trial database in which 41,413 patients were treated with simvastatin, 24,747 (approximately 60%) of whom were enrolled in studies with a median follow-up of at least 4 years, the incidence of myopathy was approximately 0.03%, 0.08% and 0.31% at 20, 40 and 80 mg/day, respectively. In these trials, patients were carefully monitored and some interacting medicinal products were excluded.

In a clinical trial in which patients with a history of myocardial infarction were treated with simvastatin 80 mg/day (mean follow-up 6.7 years), the incidence of myopathy was approximately 1.0 % compared with 0.02 % for patients on 20 mg/day. Approximately half of these myopathy cases occurred during the first year of treatment. The incidence of myopathy during each subsequent year of treatment was approximately 0.1 % (see sections 4.8 and 5.1).

Creatine kinase measurement

Creatine Kinase (CK) should not be measured following strenuous exercise or in the presence of any plausible alternative cause of CK increase as this makes value interpretation difficult. If CK levels are significantly elevated at baseline (> 5 x ULN), levels should be re-measured within 5 to 7 days later to confirm the results.

Before the treatment

All patients starting therapy with simvastatin, or whose dose of simvastatin is being increased, should be advised of the risk of myopathy and told to report promptly any unexplained muscle pain, tenderness or weakness.

Caution should be exercised in patients with pre-disposing factors for rhabdomyolysis. In order to establish a reference baseline value, a CK level should be measured before starting a treatment in the following situations:

• Elderly (age > 65 years)

• Female gender

• Renal impairment

• Uncontrolled hypothyroidism

• Personal or familial history of hereditary muscular disorders

• Previous history of muscular toxicity with a statin or fibrate

• Alcohol abuse.

In such situations, the risk of treatment should be considered in relation to possible benefit, and clinical monitoring is recommended. If a patient has previously experienced a muscle disorder on a fibrate or a statin, treatment with a different member of the class should only be initiated with caution. If CK levels are significantly elevated at baseline (> 5 x ULN), treatment should not be started.

Whilst on treatment

If muscle pain, weakness or cramps occur whilst a patient is receiving treatment with a statin, their CK levels should be measured. If these levels are found, in the absence of strenuous exercise, to be significantly elevated (> 5 x ULN), treatment should be stopped. If muscular symptoms are severe and cause daily discomfort, even if CK levels are < 5 x ULN, treatment discontinuation may be considered. If myopathy is suspected for any other reason, treatment should be discontinued.

If symptoms resolve and CK levels return to normal, then re-introduction of the statin or introduction of an alternative statin may be considered at the lowest dose and with close monitoring.

A higher rate of myopathy has been observed in patients titrated to the 80 mg dose (see section 5.1). Periodic CK measurements are recommended as they may be useful to identify subclinical cases of myopathy. However, there is no assurance that such monitoring will prevent myopathy.

Therapy with simvastatin should be temporarily stopped a few days prior to elective major surgery and when any major medical or surgical condition supervenes.

Measures to reduce the risk of myopathy caused by medicinal product interactions (see also section 4.5)

The risk of myopathy and rhabdomyolysis is significantly increased by concomitant use of simvastatin with potent inhibitors of CYP3A4 (such as itraconazole, ketoconazole, fluconazole, posaconazole, erythromycin, clarithromycin, telithromycin, HIV-protease inhibitors [e.g. nelfinavir], nefazodone), as well as gemfibrozil, cyclosporin and danazol (see section 4.2).

The risk of myopathy and rhabdomyolysis is also increased by concomitant use of other fibrates or by concomitant use of amiodarone or verapamil with higher doses of simvastatin (see sections 4.2 and 4.5). The risk is increased by concomitant use of diltiazem or amlodipine with simvastatin 80 mg (see sections 4.2 and 4.5). The risk of myopathy, including rhabdomyolysis, may be increased by concomitant administration of fusidic acid with statins (see section 4.5).

Consequently, regarding CYP3A4 inhibitors, the use of simvastatin concomitantly with itraconazole, ketoconazole, fluconazole, posaconazole, HIV protease inhibitors (e.g. nelfinavir), erythromycin, clarithromycin, telithromycin and nefazodone is contraindicated (see sections 4.3 and 4.5). If treatment with itraconazole, ketoconazole, fluconazole, posaconazole, erythromycin, clarithromycin or telithromycin is unavoidable, therapy with simvastatin must be suspended during the course of treatment. Moreover, caution should be exercised when combining simvastatin with certain other less potent CYP3A4 inhibitors: cyclosporin, verapamil, diltiazem (see sections 4.2 and 4.5).

Concomitant intake of grapefruit juice and simvastatin should be avoided.

The dose of simvastatin should not exceed 10 mg daily in patients receiving concomitant medication with cyclosporin, danazol or gemfibrozil. The combined use of simvastatin with gemfibrozil should be avoided, unless the benefits are likely to outweigh the increased risks of this drug combination. The benefits of the combined use of simvastatin 10 mg daily with other fibrates (except fenofibrate), cyclosporin or danazol should be carefully weighed against the potential risks of these combinations. (see sections 4.2 and 4.5)

Caution should be used when prescribing fenofibrate with simvastatin, as either agent can cause myopathy when given alone.

The combined use of simvastatin at doses higher than 20 mg daily with amiodarone or verapamil should be avoided unless the clinical benefit is likely to outweigh the increased risk of myopathy (see sections 4.2 and 4.5).

The combined use of simvastatin at doses higher than 40 mg daily with diltiazem or amlodipine should be avoided unless the clinical benefit is likely to overweigh the increased risk of myopathy (see sections 4.2 and 4.5).

Rare cases of myopathy/rhabdomyolysis have been associated with concomitant administration of HMG-CoA reductase inhibitors and lipid-modifying doses (

Physicians contemplating combined therapy with simvastatin and lipid-modifying doses (

In an interim analysis of an ongoing clinical outcomes study, an independent safety monitoring committee identified a higher than expected incidence of myopathy in Chinese patients taking simvastatin 40 mg and nicotinic acid/laropiprant 2000 mg/40 mg. Therefore, caution should be used when treating Chinese patients with simvastatin (particularly doses of 40 mg or higher) co-administered with lipid-modifying doses (

If the combination proves necessary, patients on fusidic acid and simvastatin should be closely monitored (see section 4.5). Temporary suspension of simvastatin treatment may be considered.

Hepatic effects

In clinical studies, persistent increases (to > 3 x ULN) in serum transaminases have occurred in a few adult patients who received simvastatin. When simvastatin was interrupted or discontinued in these patients, the transaminase levels usually fell slowly to pre-treatment levels.

It is recommended that liver function tests be performed before treatment begins and thereafter when clinically indicated. Patients titrated to the 80-mg dose should receive an additional test prior to titration, 3 months after titration to the 80-mg dose, and periodically thereafter (e.g., semi-annually) for the first year of treatment. Special attention should be paid to patients who develop elevated serum transaminase levels, and in these patients, measurements should be repeated promptly and then performed more frequently. If the transaminase levels show evidence of progression, particularly if they rise to 3 x ULN and are persistent, simvastatin should be discontinued.

The medicinal product should be used with caution in patients who consume substantial quantities of alcohol.

As with other lipid-lowering agents, moderate (< 3 x ULN) elevations of serum transaminases have been reported following therapy with simvastatin. These changes appeared soon after initiation of therapy with simvastatin, were often transient, were not accompanied by any symptoms and interruption of treatment was not required.

Interstitial lung disease

Exceptional cases of interstitial lung disease have been reported with some statins, especially with long term therapy (see section 4.8). Presenting features can include dyspnoea, non-productive cough and deterioration in general health (fatigue, weight loss and fever). If it is suspected a patient has developed interstitial lung disease, statin therapy should be discontinued.

Use in children and adolescents (10-17 years of age)

Safety and effectiveness of simvastatin in patients 10-17 years of age with heterozygous familial hypercholesterolaemia have been evaluated in a controlled clinical trial in adolescent boys Tanner Stage II and above and in girls who were at least one year post-menarche. Patients treated with simvastatin had an adverse experience profile generally similar to that of patients treated with placebo. Doses greater than 40 mg have not been studied in this population. In this limited 3 controlled study, there was no detectable effect on growth or sexual maturation in the adolescent boys or girls, or any effect on menstrual cycle length in girls. (See sections 4.2, 4.8, and 5.1.) Adolescent females should be counselled on appropriate contraceptive methods while on simvastatin therapy (see sections 4.3 and 4.6). In patients aged <18 years, efficacy and safety have not been studied for treatment periods >48 weeks' duration and long-term effects on physical, intellectual, and sexual maturation are unknown. Simvastatin has not been studied in patients younger than 10 years of age, nor in pre-pubertal children and pre-menarchal girls.

Excipient

This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Interaction studies have only been performed in adults.

Pharmacodynamic interactions

Interactions with lipid-lowering medicinal products that can cause myopathy when given alone

The risk of myopathy, including rhabdomyolysis, is increased during concomitant administration with fibrates. Additionally, there is a pharmacokinetic interaction with gemfibrozil resulting in increased simvastatin plasma levels (see below Pharmacokinetic interactions and sections 4.2 and 4.4). When simvastatin and fenofibrate are given concomitantly, there is no evidence that the risk of myopathy exceeds the sum of the individual risks of each agent. Adequate pharmacovigilance and pharmacokinetic data are not available for other fibrates. Rare cases of myopathy/rhabdomyolysis have been associated with simvastatin co-administered with lipid-modifying doses (

Pharmacokinetic interactions

Prescribing recommendations for interacting agents are summarised in the table below (further details are provided in the text; see also sections 4.2, 4.3 and 4.4).

Drug Interactions Associated with Increased Risk of Myopathy/Rhabdomyolysis

 

Interacting agents

Prescribing recommendations

Potent CYP3A4 inhibitors:

Itraconazole

Ketoconazole

Posaconazole, fluconazole

Erythromycin

Clarithromycin

Telithromycin

HIV protease inhibitors (e.g. nelfinavir)

Nefazodone

 

 

Contraindicated with simvastatin

Gemfibrozil

Avoid but if necessary, do not exceed 10 mg simvastatin daily

Cyclosporin

Danazol

Other fibrates (except fenofibrate)

Do not exceed 10 mg simvastatin daily

Amiodarone

Verapamil

Do not exceed 20 mg simvastatin daily

Diltiazem

Amlodipine

Do not exceed 40mg simvastatin daily

Fusidic acid

Patients should be closely monitored. Temporary suspension of simvastatin treatment may be considered.

Grapefruit juice

Avoid grapefruit juice when taking simvastatin

Effects of other medicinal products on simvastatin

Interactions involving inhibitors of CYP3A4

Simvastatin is a substrate of cytochrome P450 3A4. Potent inhibitors of cytochrome P450 3A4 increase the risk of myopathy and rhabdomyolysis by increasing the concentration of HMG-CoA reductase inhibitory activity in plasma during simvastatin therapy. Such inhibitors include itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, HIV-protease inhibitors and nefazodone. Concomitant administration of itraconazole resulted in a more than 10-fold increase in exposure to simvastatin acid (the active beta-hydroxyacid metabolite). Telithromycin caused an 11-fold increase in exposure to simvastatin acid.

Therefore, combination with itraconazole, ketoconazole, HIV-protease inhibitors, erythromycin, clarithromycin, telithromycin and nefazodone is contraindicated. If treatment with itraconazole, ketoconazole, erythromycin, clarithromycin or telithromycin is unavoidable, therapy with simvastatin must be suspended during the course of treatment. Caution should be exercised when combining simvastatin with certain other less potent CYP3A4 inhibitors: cyclosporin, verapamil and diltiazem (see sections 4.2 and 4.4).

Cyclosporin

The risk of myopathy/rhabdomyolysis is increased by concomitant administration of cyclosporin particularly with higher doses of simvastatin (see sections 4.2 and 4.4). Therefore, the dose of simvastatin should not exceed 10 mg daily in patients receiving concomitant medication with cyclosporin. Although the mechanism is not fully understood, cyclosporin has been shown to increase the AUC of HMG-CoA reductase inhibitors. The increase inAUC for simvastatin acid is presumably due, in part, to inhibition of CYP3A4.

Danazol

The risk of myopathy and rhabdomyolysis is increased by concomitant administration of danazol with higher doses of simvastatin (see sections 4.2 and 4.4).

Gemfibrozil

Gemfibrozil increases the AUC of simvastatin acid by 1.9-fold, possibly due to inhibition of the glucuronidation pathway (see sections 4.2 and 4.4).

Amiodarone

The risk of myopathy and rhabdomyolysis is increased by concomitant administration of amiodarone with higher doses of simvastatin (see section 4.4). In a clinical trial, myopathy was reported in 6% of patients receiving simvastatin 80 mg and amiodarone. Therefore, the dose of simvastatin should not exceed 20 mg daily in patients receiving concomitant medication with amiodarone, unless the clinical benefit is likely to outweigh the increased risk of myopathy and rhabdomyolysis.

Calcium Channel Blockers

Verapamil

The risk of myopathy and rhabdomyolysis is increased by concomitant administration of verapamil with simvastatin 40 mg or 80 mg (see section 4.4). In a pharmacokinetic study, concomitant administration with verapamil resulted in a 2.3-fold increase in exposure of simvastatin acid, presumably due, in part, to inhibition of CYP3A4. Therefore, the dose of simvastatin should not exceed 20 mg daily in patients receiving concomitant medication with verapamil, unless the clinical benefit is likely to outweigh the increased risk of myopathy and rhabdomyolysis.

Diltiazem

The risk of myopathy and rhabdomyolysis is increased by concomitant administration of diltiazem with simvastatin 80 mg (see section 4.4). The risk of myopathy in patients taking simvastatin 40 mg was not increased by concomitant diltiazem (see section 4.4). In a pharmacokinetic study, concomitant administration of diltiazem caused a 2.7-fold increase in exposure of simvastatin acid, presumably due to inhibition of CYP3A4. Therefore, the dose of simvastatin should not exceed 40 mg daily in patients receiving concomitant medication with diltiazem, unless the clinical benefit is likely to outweigh the increased risk of myopathy and rhabdomyolysis.

Amlodipine

Patients on amlodipine treated concomitantly with simvastatin 80 mg have an increased risk of myopathy. The risk of myopathy in patients taking simvastatin 40 mg was not increased by concomitant amlodipine. In a pharmacokinetic study, concomitant administration of amlodipine caused a 1.6-fold increase in exposure of simvastatin acid. Therefore, the dose of simvastatin should not exceed 40 mg daily in patients receiving concomitant medication with amlodipine, unless the clinical benefit is likely to outweigh the increased risk of myopathy and rhabdomyolysis.

Niacin (nicotinic acid)

Rare cases of myopathy/rhabdomyolysis have been associated with simvastatin co-administered with lipid-modifying doses (max of simvastatin acid plasma concentrations.

Fusidic acid

The risk of myopathy may be increased by concomitant administration of fusidic acid with statins, including simvastatin. Isolated cases of rhabdomyolysis have been reported with simvastatin. Temporary suspension of simvastatin treatment may be considered. If it proves necessary, patients on fusidic acid and simvastatin should be closely monitored (see section 4.4).

Grapefruit juice

Grapefruit juice inhibits cytochrome P4503A4. Concomitant intake of large quantities (over 1 litre daily) of grapefruit juice and simvastatin resulted in a 7-fold increase in exposure to simvastatin acid. Intake of 240 ml of grapefruit juice in the morning and simvastatin in the evening also resulted in a 1.9-fold increase. Intake of grapefruit juice during treatment with simvastatin should therefore be avoided.

Colchicine

There have been reports of myopathy with the concomitant administration of colchicine and simvastatin, however the data are limited.

Rifampicin

Because rifampicin is an inducer of P450 3A4, patients undertaking long-term rifampicin therapy (e.g. treatment of tuberculosis) concomitantly with simvastatin should have their plasma cholesterol levels monitored. Appropriate adjustment of simvastatin dosage may be warranted to ensure a satisfactory reduction in lipid levels. In a pharmacokinetic study of normal volunteers, the area under the plasma concentration curve (AUC) for simvastatin acid was decreased by 93% with concomitant administration of rifampicin.

Effects of simvastatin on the pharmacokinetics of other medicinal products

Simvastatin does not have an inhibitory effect on cytochrome P450 3A4. Therefore, simvastatin is not expected to affect plasma concentrations of substances metabolised via cytochrome P450 3A4.

Oral anticoagulants

In two clinical studies, one in normal volunteers and the other in hypercholesterolaemic patients, simvastatin 20-40 mg/day modestly potentiated the effect of coumarin anticoagulants: the prothrombin time, reported as International Normalized Ratio (INR), increased from a baseline of 1.7 to 1.8 and from 2.6 to 3.4 in the volunteer and patient studies, respectively. Very rare cases of elevated INR have been reported. In patients taking coumarin anticoagulants, prothrombin time should be determined before starting simvastatin and frequently enough during early therapy to ensure that no significant alteration of prothrombin time occurs. Once a stable prothrombin time has been documented, prothrombin times can be monitored at the intervals usually recommended for patients on coumarin anticoagulants. If the dose of simvastatin is changed or discontinued, the same procedure should be repeated. Simvastatin therapy has not been associated with bleeding or with changes in prothrombin time in patients not taking anticoagulants.

4.6 Pregnancy And Lactation

Pregnancy

Simvastatin is contraindicated during pregnancy (see section 4.3).

Safety in pregnant women has not been established. No controlled clinical trials with simvastatin have been conducted in pregnant women. Rare reports of congenital anomalies following intrauterine exposure to HMG-CoA reductase inhibitors have been received. However, in an analysis of approximately 200 prospectively followed pregnancies exposed during the first trimester to simvastatin or another closely related HMG-CoA reductase inhibitor, the incidence of congenital anomalies was comparable to that seen in the general population. This number of pregnancies was statistically sufficient to exclude a 2.5-fold or greater increase in congenital anomalies over the background incidence.

Although there is no evidence that the incidence of congenital anomalies in offspring of patients taking simvastatin or another closely related HMG-CoA reductase inhibitor differs from that observed in the general population, maternal treatment with simvastatin may reduce the foetal levels of mevalonate which is a precursor of cholesterol biosynthesis. Atherosclerosis is a chronic process, and ordinarily discontinuation of lipid-lowering medicinal products during pregnancy should have little impact on the long-term risk associated with primary hypercholesterolaemia. For these reasons, Simvastatin must not be used in women who are pregnant, trying to become pregnant or suspect they are pregnant. Treatment with Simvastatin must be suspended for the duration of pregnancy or until it has been determined that the woman is not pregnant. (see sections 4.3 and 5.3).

Lactation

It is not known whether simvastatin or its metabolites are excreted in human milk. Because many medicinal products are excreted in human milk and because of the potential for serious adverse reactions, women taking Simvastatin must not breast-feed their infants (see section 4.3).

4.7 Effects On Ability To Drive And Use Machines

Simvastatin has no or negligible influence on the ability to drive and use machines. However, when driving vehicles or operating machines, it should be taken into account that dizziness has been reported rarely in post-marketing experiences.

4.8 Undesirable Effects

The frequencies of the following adverse events, which have been reported during clinical studies and/or post-marketing use, are categorized based on an assessment of their incidence rates in large, long-term, placebo-controlled, clinical trials including Heart Protection Study (HPS) and Scandinavian Simvastatin Survival Study (4S) with 20,536 and 4,444 patients, respectively (see section 5.1). For HPS, only serious adverse events were recorded as well as myalgia, increases in serum transaminases and CK. For 4S, all the adverse events listed below were recorded. If the incidence rates on simvastatin were less than or similar to that of placebo in these trials, and there were similar reasonably causally related spontaneous report events, these adverse events are categorized as “rare”.

In HPS (see section 5.1) involving 20,536 patients treated with 40 mg/day of simvastatin (n = 10,269) or placebo (n = 10,267), the safety profiles were comparable between patients treated with simvastatin 40 mg and patients treated with placebo over the mean 5 years of the study. Discontinuation rates due to side effects were comparable (4.8 % in patients treated with simvastatin 40 mg compared with 5.1 % in patients treated with placebo). The incidence of myopathy was < 0.1 % in patients treated with simvastatin 40 mg. Elevated transaminases (> 3 x ULN confirmed by repeat test) occurred in 0.21 % (n = 21) of patients treated with simvastatin 40 mg compared with 0.09 % (n = 9) of patients treated with placebo.

The frequency of the adverse events are ranked according to the following:

Very common (

Common (

Uncommon (

Rare (

Very rare (<1/10,000),

Not known (cannot be estimated from the available data)

Investigations:

Rare: increases in serum transaminases (alanine-aminotransferase, aspartate aminotransferase, ?Hepatic effects), elevated alkaline phosphatase, increase in serum CK levels (see section 4.4).

Blood and lymphatic system disorders:

Rare: anaemia

Nervous system disorders:

Rare: headache, paraesthesia, dizziness, peripheral neuropathy

Uncommon: sleep disorders including insomnia, nightmares, depression, memory loss

Very rare: memory impairment

Respiratory, Thoracic and Mediastinal disorder:

Very rare: interstitial lung disease.

Gastrointestinal disorders:

Rare: constipation, abdominal pain, flatulence, dyspepsia, diarrhoea, nausea, vomiting, pancreatitis

Skin and subcutaneous tissue disorders:

Rare: rash, pruritus, alopecia

Musculoskeletal, connective tissue and bone disorders:

Rare: myopathy* (including myositis), rhabdomyolysis with or without acute renal failure (see section 4.4), myalgia, muscle cramps

* In a clinical trial, myopathy occurred commonly in patients treated with simvastatin 80 mg/day compared to patients treated with 20 mg/day (1.0 % vs 0.02 %, respectively).

Reproductive System disorders:

Uncommon: sexual dysfunction

General disorders and administration site conditions:

Rare: asthenia

An apparent hypersensitivity syndrome has been reported rarely which has included some of the following features: angioedema, lupus-like syndrome, polymyalgia rheumatica, dermatomyositis, vasculitis, thrombocytopenia, eosinophilia, (ESR) increased, arthritis and arthralgia, urticaria, photosensitivity, fever, flushing, dyspnoea and malaise.

Hepato-biliary disorders:

Rare: hepatitis/jaundice

Very rare: hepatic failure

Psychiatric disorders:

Very rare: insomnia

Children and adolescents (10-17 years of age)

In a 48-week study involving children and adolescents (boys Tanner Stage II and above and girls who were at least one year post-menarche) 10-17 years of age with heterozygous familial hypercholesterolaemia (n=175), the safety and tolerability profile of the group treated with simvastatin was generally similar to that of the group treated with placebo. The long-term effects on physical, intellectual, and sexual maturation are unknown. No sufficient data are currently available after one year of treatment. (See sections 4.2, 4.4, and 5.1).

4.9 Overdose

To date, a few cases of overdosage have been reported; the maximum dose taken was 3.6 g. All patients recovered without sequelae. There is no specific treatment in the event of overdose. In this case, symptomatic and supportive measures should be adopted.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: HMG-CoA-reductase inhibitor

ATC code: C10A A01

After oral administration, simvastatin, which is an inactive lactone, is hydrolyzed in the liver to the corresponding active beta-hydroxyacid form which has a potent activity in inhibiting HMG-CoA reductase (3 hydroxy – 3 methylglutaryl-CoA-reductase). This enzyme catalyses the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in the biosynthesis of cholesterol.

Simvastatin has been shown to reduce both normal and elevated LDL-C concentrations. LDL is formed from very-low-density protein (VLDL) and is catabolised predominantly by the high affinity LDL receptor. The mechanism of the LDL-lowering effect of simvastatin may involve both reduction of VLDL-cholesterol (VLDL-C) concentration and induction of the LDL receptor, leading to reduced production and increased catabolism of LDL-C. Apolipoprotein B also falls substantially during treatment with simvastatin. In addition, simvastatin moderately increases HDL-C and reduces plasma TG. As a result of these changes the ratios of total- to HDL-C and LDL- to HDL-C are reduced.

High risk of coronary heart disease (CHD) or existing coronary heart disease

In the Heart Protection Study (HPS), the effects of therapy with simvastatin were assessed in 20,536 patients (age 40-80 years), with or without hyperlipidaemia and with coronary heart disease, other occlusive arterial disease or diabetes mellitus. In this study, 10,269 patients were treated with simvastatin 40 mg/day and 10,267 patients were treated with placebo for a mean duration of 5 years. At baseline, 6,793 patients (33 %) had LDL-C levels below 116 mg/dL; 5,063 patients (25 %) had levels between 116 mg/dL and 135 mg/dL; and 8,680 patients (42 %) had levels greater than 135 mg/dL.

Treatment with simvastatin 40 mg/day compared with placebo significantly reduced the risk of all cause mortality (1328 [12.9 %] for simvastatin-treated patients versus 1507 [14.7 %] for patients given placebo; p = 0.0003), due to an 18 % reduction in coronary death rate (587 [5.7 %] versus 707 [6.9 %]; p = 0.0005; absolute risk reduction of 1.2 %). The reduction in non-vascular deaths did not reach statistical significance. Simvastatin also decreased the risk of major coronary events (a composite endpoint comprised of non-fatal MI or CHD death) by 27 % (p < 0.0001). Simvastatin reduced the need for undergoing coronary revascularization procedures (including coronary artery bypass grafting or percutaneous transluminal coronary angioplasty) and peripheral and other non-coronary revascularization procedures by 30 % (p < 0.0001) and 16 % (p = 0.006), respectively. Simvastatin reduced the risk of stroke by 25 % (p < 0.0001), attributable to a 30 % reduction in ischemic stroke (p < 0.0001). In addition, within the subgroup of patients with diabetes, simvastatin reduced the risk of developing macrovascular complications, including peripheral revascularization procedures (surgery or angioplasty), lower limb amputations, or leg ulcers by 21 % (p = 0.0293). The proportional reduction in event rate was similar in each subgroup of patients studied, including those without coronary disease but who had cerebrovascular or peripheral artery disease, men and women, those aged either under or over 70 years at entry into the study, presence or absence of hypertension, and notably those with LDL cholesterol below 3.0 mmol/l at inclusion.

In the Scandinavian Simvastatin Survival Study (4S), the effect of therapy with simvastatin on total mortality was assessed in 4,444 patients with CHD and baseline total cholesterol 212-309 mg/dL (5.5-8.0 mmol/L). In this multicenter, randomised, double-blind, placebo-controlled study, patients with angina or a previous myocardial infarction (MI) were treated with diet, standard care, and either simvastatin 20-40 mg/day (n = 2,221) or placebo (n = 2,223) for a median duration of 5.4 years. Simvastatin reduced the risk of death by 30 % (absolute risk reduction of 3.3 %). The risk of CHD death was reduced by 42 % (absolute risk reduction of 3.5 %). Simvastatin also decreased the risk of having major coronary events (CHD death plus hospital-verified and silent nonfatal MI) by 34 %. Furthermore, Simvastatin significantly reduced the risk of fatal plus nonfatal cerebrovascular events (stroke and transient ischemic attacks) by 28 %. There was no statistically significant difference between groups in non-cardiovascular mortality.

The Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH) evaluated the effect of treatment with simvastatin 80 mg versus 20 mg (median follow-up 6.7 yrs) on major vascular events (MVEs; defined as fatal CHD, non-fatal MI, coronary revascularization procedure, non-fatal or fatal stroke, or peripheral revascularization procedure) in 12,064 patients with a history of myocardial infarction. There was no significant difference in the incidence of MVEs between the 2 groups; simvastatin 20 mg (n = 1553; 25.7 %) vs. simvastatin 80 mg (n = 1477; 24.5 %); RR 0.94, 95 % CI: 0.88 to 1.01. The absolute difference in LDL-C between the two groups over the course of the study was 0.35 ± 0.01 mmol/L. The safety profiles were similar between the two treatment groups except that the incidence of myopathy was approximately 1.0 % for patients on simvastatin 80 mg compared with 0.02 % for patients on 20 mg. Approximately half of these myopathy cases occurred during the first year of treatment. The incidence of myopathy during each subsequent year of treatment was approximately 0.1 %.

Primary hypercholesterolaemia and combined hyperlipidaemia

In studies comparing the efficacy and safety of simvastatin 10, 20, 40 and 80 mg daily in patients with hypercholesterolemia, the mean reductions of LDL-C were 30, 38, 41 and 47 %, respectively. In studies of patients with combined (mixed) hyperlipidaemia on simvastatin 40 mg and 80 mg, the median reductions in triglycerides were 28 and 33 % (placebo: 2 %), respectively, and mean increases in HDL-C were 13 and 16 % (placebo: 3 %), respectively.

Clinical Studies in Children and Adolescents (10-17 years of age)

In a double-blind, placebo-controlled study, 175 patients (99 boys Tanner Stage II and above and 76 girls who were at least one year post-menarche) 10-17 years of age (mean age 14.1 years) with heterozygous familial hypercholesterolaemia (heFH) were randomized to simvastatin or placebo for 24 weeks (base study). Inclusion in the study required a baseline LDL-C level between 160 and 400 mg/dL and at least one parent with an LDL-C level >189 mg/dL. The dosage of simvastatin (once daily in the evening) was 10 mg for the first 8 weeks, 20 mg for the second 8 weeks, and 40 mg thereafter. In a 24-week extension, 144 patients elected to continue therapy and received simvastatin 40 mg or placebo.

Simvastatin significantly decreased plasma levels of LDL-C, TG, and Apo B. Results from the extension at 48 weeks were comparable to those observed in the base study.

After 24 weeks of treatment, the mean achieved LDL-C value was 124.9 mg/dL (range: 64.0-289.0 mg/dL) in the simvastatin 40 mg group compared to 207.8 mg/dL (range: 128.0-334.0 mg/dL) in the placebo group.

After 24 weeks of simvastatin treatment (with dosages increasing from 10, 20 and up to 40 mg daily at 8-week intervals), simvastatin decreased the mean LDL-C by 36.8% (placebo: 1.1% increase from baseline), Apo B by 32.4% (placebo: 0.5%), and median TG levels by 7.9% (placebo: 3.2%) and increased mean HDL-C levels by 8.3% (placebo: 3.6%). The long-term benefits of simvastatin on cardiovascular events in children with heFH are unknown.

The safety and efficacy of doses above 40 mg daily have not been studied in children with heterozygous familial hypercholesterolaemia. The long-term efficacy of simvastatin therapy in childhood to reduce morbidity and mortality in adulthood has not been established.

5.2 Pharmacokinetic Properties

Simvastatin is an inactive lactone which is readily hydrolysed in vivo to the corresponding beta-hydroxyacid, a potent inhibitor of HMG-CoA-reductase. Hydrolysis takes place mainly in the liver; the rate of hydrolysis in human plasma is very slow.

The pharmacokinetic properties have been evaluated in adults. Pharmacokinetic data in children and adolescents are not available.

Absorption

In man simvastatin is well absorbed and undergoes extensive hepatic first-pass extraction. The extraction in the liver is dependent on the hepatic blood flow. The liver is the primary site of action of the active form. The availability of the beta-hydroxyacid to the systemic circulation following an oral dose of simvastatin was found to be less than 5% of the dose. Maximum plasma concentration of active inhibitors is reached approximately 1-2 hours after administration of simvastatin. Concomitant food intake does not affect the absorption.

The pharmacokinetics of single and multiple doses of simvastatin showed that no accumulation of medicinal product occurred after multiple dosing.

Distribution

The protein binding of simvastatin and its active metabolite is > 95%.

Elimination

Simvastatin is a substrate of CYP3A4 (see sections 4.3 and 4.5). The major metabolites of simvastatin present in human plasma are the beta-hydroxyacid and four additional active metabolites. Following an oral dose of radioactive simvastatin to man, 13% of the radioactivity was excreted in the urine and 60% in the faeces within 96 hours. The amount recovered in the faeces represents absorbed medicinal


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