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Prazosin


Pronunciation: PRAZ-oh-sin
Generic Name: Prazosin
Brand Name: Minipress
Prazosin is used for:

Treating high blood pressure or benign prostatic hyperplasia (BPH). It may also be used for other conditions as determined by your doctor.

Prazosin is an alpha-blocker. It works by causing the blood vessels and the muscles around the urethra (the tube leading out of the bladder) to relax. This helps to lower blood pressure and to improve urinary symptoms associated with enlargement of the prostate (BPH).

Do NOT use Prazosin if: you are allergic to any ingredient in Prazosin

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

Before using Prazosin:

Some medical conditions may interact with Prazosin. 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 chest pain, heart disease, narcolepsy, or kidney problems if you will be having eye surgery

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

Diuretics (eg, furosemide, hydrochlorothiazide) or verapamil because they may increase the risk of Prazosin's side effects Beta-blockers (eg, propranolol) or phosphodiesterase inhibitors (eg, sildenafil) because their actions and the risk of their side effects may be increased by Prazosin

This may not be a complete list of all interactions that may occur. Ask your health care provider if Prazosin 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 Prazosin:

Use Prazosin as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Prazosin by mouth with or without food. If you miss a dose of Prazosin, 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 Prazosin.

Important safety information: Prazosin may cause dizziness, lightheadedness, or fainting after the first dose. Take the first dose at bedtime. If you get up during the night, sit up and stand slowly. Continue to sit up and stand slowly while you are taking Prazosin. Prazosin may cause dizziness, drowsiness, lightheadedness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Prazosin with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Prazosin 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. Avoid engaging in any hazardous tasks for at least 24 hours after taking the first dose, missing several doses, increasing the dose, or taking other high blood pressure medications. Before drinking alcohol, discuss it with your doctor. Tell your doctor or dentist that you take Prazosin before you receive any medical or dental care, emergency care, or surgery. 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. Prazosin may interfere with certain lab tests, including tests for pheochromocytoma (an adrenal gland tumor). Be sure your doctor and lab personnel know you are taking Prazosin. Use Prazosin with extreme caution in the ELDERLY; they may be more sensitive to its effects. Prazosin should not be used 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 Prazosin while you are pregnant. Prazosin is found in breast milk. If you are or will be breast-feeding while you use Prazosin, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Prazosin:

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; drowsiness; dry mouth; frequent urination; headache; lack of energy; lightheadedness; nasal congestion; nausea; weakness.

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); blurred vision; fainting; fast or irregular heartbeat; depression; severe or persistent dizziness; swelling of the hands or feet.

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: Prazosin 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 dizziness; severe drowsiness; weakness.

Proper storage of Prazosin:

Store Prazosin at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, light, and moisture. Keep Prazosin out of the reach of children and away from pets.

General information: If you have any questions about Prazosin, please talk with your doctor, pharmacist, or other health care provider. Prazosin 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 Prazosin. 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 Prazosin resources Prazosin Side Effects (in more detail) Prazosin Use in Pregnancy & Breastfeeding Drug Images Prazosin Drug Interactions Prazosin Support Group 14 Reviews for Prazosin - Add your own review/rating Prazosin Prescribing Information (FDA) Prazosin Professional Patient Advice (Wolters Kluwer) prazosin Concise Consumer Information (Cerner Multum) prazosin Advanced Consumer (Micromedex) - Includes Dosage Information Minipress Monograph (AHFS DI) Minipress Prescribing Information (FDA) Compare Prazosin with other medications Anxiety and Stress Benign Prostatic Hyperplasia Heart Failure High Blood Pressure Post Traumatic Stress Disorder Raynaud's Syndrome
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Cardura


Generic Name: doxazosin (dox AY zo sin)
Brand Names: Cardura, Cardura XL

What is doxazosin?

Doxazosin is in a group of drugs called alpha-adrenergic (AL-fa ad-ren-ER-jik) blockers. Doxazosin relaxes your veins and arteries so that blood can more easily pass through them. It also relaxes the muscles in the prostate and bladder neck, making it easier to urinate.

Doxazosin is used to treat hypertension (high blood pressure), or to improve urination in men with benign prostatic hyperplasia (enlarged prostate).

Doxazosin may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about doxazosin? You should not use this medication if you are allergic to doxazosin or similar medicines such as alfuzosin (Uroxatral), prazosin (Minipress), silodosin (Rapaflo), tamsulosin (Flomax), or terazosin (Hytrin). Doxazosin may cause dizziness or fainting, especially when you first start taking it or when you start taking it again. Be careful if you drive or do anything that requires you to be alert. Avoid standing for long periods of time or becoming overheated during exercise and in hot weather. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. If you stop taking doxazosin for any reason, call your doctor before you start taking it again. You may need a dose adjustment.

Doxazosin can affect your pupils during cataract surgery. Tell your eye surgeon ahead of time that you are using this medication. Do not stop using doxazosin before surgery unless your surgeon tells you to.

Tell your doctor about all other medications you use, especially other blood pressure medications including diuretics (water pills).

What should I discuss with my doctor before taking doxazosin? You should not use this medication if you are allergic to doxazosin or similar medicines such as alfuzosin (Uroxatral), prazosin (Minipress), silodosin (Rapaflo), tamsulosin (Flomax), or terazosin (Hytrin).

If you have liver disease or a history of prostate cancer, you may need a dose adjustment or special tests to safely take doxazosin.

Doxazosin can affect your pupils during cataract surgery. Tell your eye surgeon ahead of time that you are using this medication. Do not stop using doxazosin before surgery unless your surgeon tells you to.

FDA pregnancy category C. It is not known whether doxazosin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether doxazosin passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I take doxazosin?

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 doctor may occasionally change your dose to make sure you get the best results.

Doxazosin lowers blood pressure and may cause dizziness or fainting, especially when you first start taking it, or when you start taking it again. Call your doctor if you have severe dizziness or feel like you might pass out.

You may feel very dizzy when you first wake up. Be careful when standing or sitting up from a lying position.

If you stop taking doxazosin for any reason, call your doctor before you start taking it again. You may need a dose adjustment.

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

If you are being treated for high blood pressure, keep using this medication 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.

Some things can cause your blood pressure to get too low. This includes 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.

Store at room temperature away from moisture and heat. 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.

If you miss your doses for several days in a row, contact your doctor before restarting the medication. You may need a lower 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 extreme dizziness or fainting.

What should I avoid while taking doxazosin? Doxazosin may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

To prevent dizziness, avoid standing for long periods of time or becoming overheated during exercise and in hot weather.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Drinking alcohol can increase certain side effects of doxazosin. Doxazosin 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:

feeling like you might pass out;

fast or pounding heartbeats, fluttering in your chest;

trouble breathing;

swelling in your hands, ankles, or feet; or

penis erection that is painful or lasts 4 hours or longer.

Less serious side effects may include:

mild dizziness;

tired feeling, drowsiness;

headache;

nausea; or

runny nose.

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.

What other drugs will affect doxazosin?

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

sildenafil (Viagra, Revatio)

tadalafil (Cialis);

vardenafil (Levitra); or

other blood pressure medications, including diuretics (water pills).

This list is not complete and other drugs may interact with doxazosin. 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 Cardura resources Cardura Side Effects (in more detail) Cardura Use in Pregnancy & Breastfeeding Drug Images Cardura Drug Interactions Cardura Support Group 3 Reviews for Cardura - Add your own review/rating Cardura Monograph (AHFS DI) Cardura Prescribing Information (FDA) Cardura Consumer Overview Cardura Advanced Consumer (Micromedex) - Includes Dosage Information Cardura MedFacts Consumer Leaflet (Wolters Kluwer) Doxazosin Prescribing Information (FDA) Cardura XL Prescribing Information (FDA) Cardura XL Extended-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer) Compare Cardura with other medications Benign Prostatic Hyperplasia High Blood Pressure Raynaud's Syndrome Where can I get more information? Your pharmacist can provide more information about doxazosin.

See also: Cardura side effects (in more detail)


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tamsulosin


Generic Name: tamsulosin (tam soo LOE sin)
Brand Names: Flomax

What is tamsulosin?

Tamsulosin is in a group of drugs called alpha-adrenergic (AL-fa ad-ren-ER-jik) blockers. Tamsulosin relaxes the muscles in the prostate and bladder neck, making it easier to urinate.

Tamsulosin is used to improve urination in men with benign prostatic hyperplasia (enlarged prostate).

Tamsulosin may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about tamsulosin? You should not use this medication if you are allergic to tamsulosin. Do not take tamsulosin with other similar medicines such as alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), silodosin (Rapaflo), or terazosin (Hytrin). Tamsulosin may cause dizziness or fainting, especially when you first start taking it or when you start taking it again. Be careful if you drive or do anything that requires you to be alert. Avoid standing for long periods of time or becoming overheated during exercise and in hot weather. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. If you stop taking tamsulosin for any reason, call your doctor before you start taking it again. You may need a dose adjustment.

Tamsulosin can affect your pupils during cataract surgery. Tell your eye surgeon ahead of time that you are using this medication. Do not stop using tamsulosin before surgery unless your surgeon tells you to.

There are many other drugs that can interact with tamsulosin. Tell your doctor about all medications you use. What should I discuss with my healthcare provider before taking tamsulosin? You should not use this medication if you are allergic to tamsulosin. Do not take tamsulosin with other similar medicines such as alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), silodosin (Rapaflo), or terazosin (Hytrin).

If you have a history of prostate cancer, you may need a dose adjustment or special tests to safely take this tamsulosin.

Tamsulosin can affect your pupils during cataract surgery. Tell your eye surgeon ahead of time that you are using this medication. Do not stop using tamsulosin before surgery unless your surgeon tells you to.

Although this medication is not for use in women, tamsulosin is not expected to harm an unborn baby. If you are a woman using this medication, tell your doctor if you are pregnant or breast-feeding. Tamsulosin is not for use in children. How should I take tamsulosin?

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 doctor may occasionally change your dose to make sure you get the best results.

Tamsulosin is usually taken once a day, approximately 30 minutes after a meal. Try to take this medication at the same time each day. Do not crush, chew, or open a tamsulosin capsule. Swallow it whole. Tamsulosin lowers blood pressure and may cause dizziness or fainting, especially when you first start taking it, or when you start taking it again. Call your doctor if you have severe dizziness or feel like you might pass out.

You may feel very dizzy when you first wake up. Be careful when standing or sitting up from a lying position.

If you stop taking tamsulosin for any reason, call your doctor before you start taking it again. You may need a dose adjustment.

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

Some things can cause your blood pressure to get too low. This includes 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.

Store at room temperature away from moisture and heat.

See also: Tamsulosin 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.

If you miss your doses for several days in a row, contact your doctor before restarting the medication. You may need a lower 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 extreme dizziness or fainting.

What should I avoid while taking tamsulosin? Tamsulosin may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

To prevent dizziness, avoid standing for long periods of time or becoming overheated during exercise and in hot weather.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall. Drinking alcohol can increase certain side effects of tamsulosin. Tamsulosin 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.

Stop using tamsulosin and call your doctor at once if you have any of these serious side effects:

feeling like you might pass out;

chest pain;

fever, chills, body aches, or flu symptoms; or

penis erection that is painful or lasts 4 hours or longer.

Less serious side effects may include:

mild dizziness;

weakness, drowsiness;

headache;

nausea, diarrhea;

back pain;

blurred vision;

dental problems;

sleep problems (insomnia);

abnormal ejaculation, decreased sex drive; or

runny nose, sore throat, cough.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Tamsulosin Dosing Information

Usual Adult Dose for Benign Prostatic Hyperplasia:

0.4 mg orally once daily one-half hour following the same meal each day

What other drugs will affect tamsulosin?

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

cimetidine (Tagamet);

conivaptan (Vaprisol);

cyclosporine (Gengraf, Neoral, Sandimmune);

imatinib (Gleevec);

isoniazid (for treating tuberculosis);

methimazole (Tapazole);

pioglitazone (Actos);

ropinirole (Requip);

ticlopidine (Ticlid);

warfarin (Coumadin);

an antibiotic such as clarithromycin (Biaxin), dalfopristin/quinupristin (Synercid), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), metronidazole (Flagyl, Protostat), telithromycin (Ketek), or terbinafine (Lamisil);

an antidepressant such as citalopram (Celexa), clomipramine (Anafranil), desipramine (Norpramin), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), imipramine (Tofranil), nefazodone, paroxetine (Paxil), sertraline (Zoloft), or tranylcypromine (Parnate);

antifungal medication such as clotrimazole (Mycelex Troche), itraconazole (Sporanox), ketoconazole (Extina, Ketozole, Nizoral, Xolegal), or voriconazole (Vfend);

anti-malaria medication such as chloroquine (Arelan) or pyrimethamine (Daraprim), or quinine (Qualaquin);

erectile dysfunction medicine such as sildenafil (Viagra), tadalafil (Cialis), or vardenafil (Levitra);

heart or blood pressure medication such as diltiazem (Cartia, Cardizem), felodipine (Plendil), nicardipine (Cardene), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan), and others;

a heart rhythm medication such as amiodarone (Cordarone, Pacerone) or quinidine (Quin-G);

HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Invirase), or ritonavir (Norvir); or

medicine to treat psychiatric disorders, such as aripiprazole (Abilify), chlorpromazine (Thorazine), clozapine (Clozaril, FazaClo), fluphenazine (Permitil, Prolixin), haloperidol (Haldol), perphenazine (Trilafon), or thioridazine (Mellaril).

This list is not complete and there are many other drugs that can interact with tamsulosin. 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. Keep a list of all your medicines and show it to any healthcare provider who treats you. More tamsulosin resources Tamsulosin Side Effects (in more detail)Tamsulosin DosageTamsulosin Use in Pregnancy & BreastfeedingDrug ImagesTamsulosin Drug InteractionsTamsulosin Support Group65 Reviews for Tamsulosin - Add your own review/rating tamsulosin Advanced Consumer (Micromedex) - Includes Dosage Information Tamsulosin MedFacts Consumer Leaflet (Wolters Kluwer) Tamsulosin Prescribing Information (FDA) Flomax Prescribing Information (FDA) Flomax Monograph (AHFS DI) Flomax Consumer Overview Compare tamsulosin with other medications Benign Prostatic HyperplasiaOveractive BladderUrinary Tract Stones Where can I get more information? Your pharmacist can provide more information about tamsulosin.

See also: tamsulosin side effects (in more detail)


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Tarka


Generic Name: trandolapril and verapamil (tran DOL a pril and ver AP a mil)
Brand Names: Tarka

What is Tarka (trandolapril and verapamil)?

Trandolapril is an ACE inhibitor. ACE stands for angiotensin converting enzyme.

Verapamil is a calcium channel blocker. It works by relaxing the muscles of your heart and blood vessels.

The combination of trandolapril and verapamil is used to treat high blood pressure (hypertension).

Trandolapril and verapamil may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Tarka (trandolapril and verapamil)? Do not use trandolapril and verapamil 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 use this medicine if you have certain serious heart problems, or if you are allergic to trandolapril (Mavik) or similar medicines such as benazepril (Lotensin), captopril (Capoten), fosinopril (Monopril), enalapril (Vasotec), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), or ramipril (Altace).

There are many other drugs that can interact with trandolapril and verapamil. Tell your doctor about all medications you use.

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.

Tell your doctor if you have a prolonged illness that causes diarrhea or vomiting. What should I discuss with my healthcare provider before taking Tarka (trandolapril and verapamil)? You should not use this medicine if you are allergic to trandolapril (Mavik) or verapamil (Calan, Covera, Isoptin, Verelan), or if you have:

certain serious heart conditions, especially "sick sinus syndrome" or "AV block" (unless you have a pacemaker);

a heart rhythm disorder;

low blood pressure; or

if you are allergic to any other ACE inhibitor, such as benazepril (Lotensin), captopril (Capoten), fosinopril (Monopril), enalapril (Vasotec), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), or ramipril (Altace).

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

kidney disease (or if you are on dialysis);

liver disease;

congestive heart failure;

diabetes;

a nerve-muscle disease such as muscular dystrophy; or

a connective tissue disease such as Marfan syndrome, Sjogren's syndrome, lupus, scleroderma, or rheumatoid arthritis.

FDA pregnancy category D. Do not use trandolapril and verapamil if you are pregnant. Stop using this medication and tell your doctor right away if you become pregnant. Trandolapril and verapamil 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 trandolapril and verapamil. Trandolapril and verapamil can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using trandolapril and verapamil. How should I take Tarka (trandolapril and verapamil)?

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 doctor may occasionally change your dose to make sure you get the best results.

Trandolapril and verapamil works best if you take it with food.

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). Follow your doctor's instructions about the type and amount of liquids you should drink while taking trandolapril and verapamil. Tell your doctor if you have a prolonged illness that causes diarrhea or vomiting. If you need surgery, tell the surgeon ahead of time that you are using trandolapril and verapamil.

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. 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 slow heart rate, weak pulse, muscle weakness, tingly feeling, seizure (convulsions), feeling light-headed, or fainting.

What should I avoid while taking Tarka (trandolapril and verapamil)?

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Do not use salt substitutes or potassium supplements while taking trandolapril and verapamil, unless your doctor has told you to. Tarka (trandolapril and verapamil) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; severe stomach pain; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

urinating less than usual or not at all;

swelling, weight gain, feeling short of breath;

feeling like you might pass out;

anxiety, sweating, pale skin, severe shortness of breath, wheezing, gasping for breath, cough with foamy mucus;

chest pain, fast, slow, or uneven heart rate; or

fever, upper stomach pain, and jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

cough;

headache;

runny or stuffy nose, sore throat;

constipation, diarrhea;

dizziness;

back pain;

joint pain; or

nausea.

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.

What other drugs will affect Tarka (trandolapril and verapamil)?

Many drugs can interact with trandolapril and verapamil. Below is just a partial list. Tell your doctor if you are using:

buspirone (BuSpar);

colchicine (Colcrys);

cyclosporine (Neoral, Sandimmune, Gengraf);

dexamethasone (Cortastat, Dexasone, Solurex, DexPak);

digoxin (digitalis, Lanoxin);

gold injections (to treat arthritis);

lithium (Lithobid, Eskalith);

phenobarbital (Solfoton) or other barbiturates;

insulin or oral diabetes medication;

sirolimus (Rapamune) or tacrolimus (Prograf);

St. John's wort;

theophylline (Elixophyllin, Respbid, Theo-Dur, and others);

an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), rifampin (Rifadin, Rifater, Rifamate) and others;

antifungal medication such as itraconazole (Sporanox), ketoconazole (Nizoral), miconazole (Oravig), or voriconazole (Vfend);

aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Arthrotec, Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze), indomethacin (Indocin), meloxicam (Mobic), and others;

a beta-blocker such as atenolol (Tenormin), carvedilol (Coreg), metoprolol (Lopressor, Toprol), propranolol (Inderal, InnoPran), and others;

a diuretic (water pill);

drugs to treat high blood pressure or a prostate disorder, such as alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), terazosin (Hytrin), tamsulosin (Flomax);

cholesterol-lowering drugs such as atorvastatin (Lipitor, Caduet), lovastatin (Mevacor, Altoprev, Advicor), or simvastatin (Zocor, Simcor, Vytorin, Juvisync);

heart rhythm or blood pressure medication such as disopyramide (Norpace), flecainide (Tambocor), nicardipine (Cardene) or quinidine (Quin-G);

HIV or AIDS medication; or

seizure medication such as carbamazepine (Carbatrol, Equetro, Tegretol), phenytoin (Dilantin), and others.

This list is not complete and there are many other drugs that can interact with trandolapril and verapamil. 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. Keep a list of all your medicines and show it to any healthcare provider who treats you.

More Tarka resources Tarka Side Effects (in more detail) Tarka Use in Pregnancy & Breastfeeding Drug Images Tarka Drug Interactions Tarka Support Group 4 Reviews for Tarka - Add your own review/rating Tarka Prescribing Information (FDA) Tarka Advanced Consumer (Micromedex) - Includes Dosage Information Tarka MedFacts Consumer Leaflet (Wolters Kluwer) Compare Tarka with other medications High Blood Pressure Where can I get more information? Your pharmacist can provide more information about trandolapril and verapamil.

See also: Tarka side effects (in more detail)


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Minipress


Generic Name: Prazosin Hydrochloride
Class: alpha-Adrenergic Blocking Agents
VA Class: CV150
CAS Number: 19237-84-4

Introduction

Postsynaptic ?1-adrenergic blocking agent; quinazoline derivative.101 b

Uses for Minipress Hypertension

Management of hypertension (alone or in combination with other classes of antihypertensive agents).101 153 161

Current antihypertensive and urology guidelines (e.g., JNC 7) no longer recommend ?1-blockers as preferred first-line therapy for patients with hypertension.b

Acute management of severe hypertension in patients with increased concentrations of circulating catecholamines.b

Benign Prostatic Hyperplasia (BPH)

Has been used to reduce urinary obstruction and relieve associated manifestations in patients with symptomatic BPH†; efficacy relative to other ?1-adrenergic blockers remains to be established.112 113 114 115 116 117 118 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133

Posttraumatic Stress Disorder (PTSD)

Has been used in the management of PTSD†, particularly in combat veterans and in patients experiencing nighttime PTSD symptoms (e.g., nightmares, sleep disturbances).200 201 202 203 204 205 206 207 208 209 210 211 212 215 216 217 221 222 225

Some clinicians currently recommend prazosin as first-line or alternative therapy when treating PTSD patients with prominent nighttime symptoms, particularly in combat veterans.201 204 212 215 217 222 225 Further studies necessary in civilians with noncombat trauma-related PTSD and in treatment of daytime PTSD symptoms.200 201 203 204 208 216

Minipress Dosage and Administration Administration Oral Administration

Administer orally in divided doses 2 or 3 times daily.101

Manufacturers make no specific recommendations regarding administration with meals.101 221

Dosage

Available as prazosin hydrochloride; dosage expressed in terms of prazosin.101 b

Individualize dosage according to patient response and tolerance.101 b Initiate at low dosage to minimize frequency of postural hypotension and syncope.101 b

Postural effects are most likely to occur 2–6 hours after a dose; monitor BP during this period after first dose and with any dosage increases.161 179

If therapy is interrupted for a few days, restart using initial dosage regimen.

Pediatric Patients Hypertension† Oral

Initially, 0.05–0.1 mg/kg daily given in 3 divided doses.195 Increase dosage as necessary up to a maximum of 0.5 mg/kg daily given in 3 divided doses.195

Adults Hypertension Monotherapy Oral

Initially, 1 mg 2 or 3 times daily.101 b Do not initiate with higher dosages.101 b May increase dosage gradually to 20 mg daily given in divided doses.101 b

Usual maintenance dosage: 6–15 mg daily given in divided doses.101 b

Careful monitoring of BP is recommended during initial titration or subsequent upward dosage adjustment;161 avoid large or abrupt reductions in BP.161 179

For the acute management of severe hypertension, initially, 1–2 mg; dosage may be repeated after 1 hour, if necessary.b

Combination Therapy Oral

When other hypotensive agents or diuretics are added to existing prazosin therapy, reduce dosage to 1 or 2 mg 3 times daily; gradually increase according to patient's response and tolerance.101 b

Posttraumatic Stress Disorder†

Optimum dosage not established.200 201 212 In clinical studies, usual initial dosage was 1 mg at bedtime; dosage was then gradually increased based on patient's response and tolerance.200 201 202 203 204 205 206 207 208 209 210 211 212 217 220 Maintenance dosages ranging from 1 to 25 mg daily (given once daily at bedtime or in 2 divided doses) have been use.200 203 206 210 212 217 220 225 Some experts recommend a target maintenance dosage of 1–10 mg daily; others recommend a higher target dosage of 2–20 mg daily.224 225

Prescribing Limits Pediatric Patients Hypertension† Oral

Maximum 0.5 mg/kg daily.195

Adults Hypertension Oral

Maximum 20 mg daily.101 b Although higher dosages usually do not increase efficacy, a few patients may benefit from ?40 mg daily.101 b

Special Populations Hepatic Impairment

No specific dosage recommendations at this time.b

Renal Impairment

Initially, 1 mg twice daily.b Patients with chronic renal failure may require only small dosages.b

Geriatric Patients

No specific dosage recommendations at this time;b generally increase dosage more slowly in geriatric hypertensive patients than in younger adults.

Cautions for Minipress Contraindications

Known hypersensitivity to prazosin, quinazolines (e.g., alfuzosin, doxazosin, terazosin), or any ingredient in the formulation.101

Warnings/Precautions Warnings Postural Hypotension

Like other ?-adrenergic blocking agents, marked hypotension, especially in the upright position, can occur; may be accompanied by syncope, palpitations, and other postural effects (e.g., dizziness, lightheadedness, vertigo).101

Postural effects are most common after an initial dose, shortly after dosing (e.g., within 90 minutes), when dosage is rapidly increased, or when other antihypertensive agents are added to therapy.101 b

To decrease risk of excessive hypotension and syncope, initiate therapy at a low dosage (i.e., 1 mg) and titrate slowly; initiate concomitant antihypertensive agents with caution.101 b

If syncope or hypotension occurs, place patient in a recumbent position and institute supportive therapy as necessary.101 b

General Precautions Intraoperative Floppy Iris Syndrome (IFIS)

IFIS observed during cataract surgery in some patients currently receiving or previously treated with ?1-adrenergic blocking agents.101 218

If patient has received ?1-blockers, ophthalmologist should be prepared to modify the surgical technique (e.g., through use of iris hooks, iris dilator rings, viscoelastic substances) to minimize complications of IFIS.101 218

Benefit of discontinuing ?1-blockers, including prazosin, prior to cataract surgery not established.101 218

Prostate Cancer

Exclude possibility of prostate cancer before initiation of therapy for BPH.155 156

Specific Populations Pregnancy

Category C.101

Lactation

Distributed into milk in small amounts.101 Caution if used in nursing women.101 b

Pediatric Use

Safety and efficacy not established in children <18 years of age.101 b

Geriatric Use

Geriatric patients may be particularly susceptible to postural effects and other adverse effects.153 161

Common Adverse Effects

Dizziness, lightheadedness, headache, drowsiness, lack of energy, weakness, palpitation, nausea.101 b

Interactions for Minipress Protein-bound Drugs

Potential pharmacokinetic interaction (displacement of prazosin or other protein-bound drug).b

Specific Drugs and Laboratory Tests

Drug

Interaction

Comments

Analgesic agents (aspirin, indomethacin, phenylbutazone [no longer commercially available in the US], propoxyphene)

No interaction observed101

Antiarrhythmic agents (procainamide, quinidine)

No interaction observed101

Antigout agents (allopurinol, colchicine, probenecid)

No interaction observed101

Antihypertensive agents (e.g., propranolol)

Possible additive hypotensive effects and symptomatic hypotension101

Initiate additional antihypertensive agents with caution; may reduce prazosin dosage and gradually increase dosage based on clinical response101

Benzodiazepines (chlordiazepoxide, diazepam)

No interaction observed101

Digoxin

No interaction observed101

Diuretics

Possible additive hypotensive effects and symptomatic hypotension101 b

Effect usually used to therapeutic advantageb

Initiate diuretics with caution; may reduce prazosin dosage and gradually increase dosage based on clinical response101

Hypoglycemic agents (insulin, chlorpropramide, phenformin [no longer commercially available in the US], tolazamide, tolbutamide)

No interaction observed101

Phenobarbital

No interaction observed101

Phosphodiesterase (PDE) type 5 inhibitors (e.g., sildenafil, tadalafil, vardenafil)

Possible additive hypotensive effects and symptomatic hypotension101

Initiate PDE type 5 inhibitor at lowest possible dosage101

Test for pheochromocytoma

Possible increase in urinary metabolite of norepinephrine and VMA; false positive results may occur in pheochromocytoma screening tests101

If elevated VMA is observed, discontinue prazosin and repeat test after 1 month101

Minipress Pharmacokinetics Absorption Bioavailability

Peak plasma concentrations attained within about 2–3 hours.b

Bioavailability is approximately 60%.b

Onset

In patients with hypertension, maximum reduction in BP usually occurs 2–4 hours after administration.b

Food

Food does not affect the extent of absorption; however, absorption may be delayed.b

Distribution Extent

Not known whether prazosin crosses the placenta;b distributed into milk in small amounts.b Crosses the blood-brain barrier.200 204 205 206 208 210

Plasma Protein Binding

Approximately 97%.b

Elimination Metabolism

Extensively metabolized, principally in the liver by demethylation and conjugation.101 b

Elimination Route

Excreted principally in feces via biliary excretion and to a lesser extent in urine (6–10%).101 b

Half-life

2–4 hours.b

Stability Storage Oral Capsules

20-25°C; protect from moisture and light.221

ActionsActions

Reduces peripheral vascular resistance and BP as a result of vasodilating effects;101 b produces both arterial and venous dilation.101

Effects appear to result from selective, competitive inhibition of ?1-adrenergic receptors.b

Generally causes no change in heart rate, cardiac output, renal blood flow, and GFR.101 b

Binds to ?-adrenergic receptors on the prostate capsule, prostate adenoma, and bladder trigone, resulting in decreased urinary outflow resistance in men.

May improve to limited extent the serum lipid profile (e.g., small increases in HDL and HDL/total cholesterol ratio; small decreases in LDL, total cholesterol, and triglyceride concentrations).153 161 c

Precise mechanism of action in PTSD not fully elucidated; however, norepinephrine and ?1-adrenergic receptors play an important role in the pathophysiology of PTSD-associated nightmares, arousal, selective attention and vigilance.200 201 203 204 205 206 207 208 209 210 216 217 220 Prazosin is believed to help correct the effects of ?1-adrenergic receptor hyperstimulation in PTSD and has also been shown to normalize the sleep cycle.200 203 205 206 211 220

Advice to Patients

Possible dizziness, lightheadedness or fainting, especially at initiation of therapy;101 b importance of avoiding driving or other hazardous tasks where injury could occur for 24 hours after the first dose or when dosage is increased.101

Importance of advising patient that alcohol use, hot weather, exercise, and standing for long periods of time may precipitate or exacerbate symptoms of dizziness, lightheadedness, or fainting, and to use caution during these situations.101

Importance of sitting or lying down when symptoms of lowered BP occur, and of rising carefully from a sitting or lying position.101 b

Possible drowsiness or somnolence; use caution when operating machinery or driving a motor vehicle until effects on individual are known.b

Importance of advising patients being considered for cataract surgery that they should inform their ophthalmologist of current or prior ?1-blocker therapy, including prazosin.101 218

Importance of advising patients receiving prazosin for PTSD† that the drug may help reduce nightmares and improve sleep and other symptoms; however, it does not cure PTSD and their nightmares, anxiety, and other PTSD-related symptoms may return if therapy is stopped.201 203 219

Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.101

Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as concomitant illnesses.101

Importance of informing patients of other important precautionary information.101 (See Cautions.)

Preparations

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

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Prazosin Hydrochloride

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Capsules

1 mg (of prazosin)*

Minipress

Pfizer

Prazosin Hydrochloride Capsules

2 mg (of prazosin)*

Minipress

Pfizer

Prazosin Hydrochloride Capsules

5 mg (of prazosin)*

Minipress

Pfizer

Prazosin Hydrochloride Capsules

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Minipress 1MG Capsules (PFIZER U.S.): 60/$51.99 or 180/$149.97

Minipress 2MG Capsules (PFIZER U.S.): 60/$69.99 or 180/$199.98

Minipress 5MG Capsules (PFIZER U.S.): 60/$123.99 or 180/$347.96

Prazosin HCl 1MG Capsules (MYLAN): 60/$17.99 or 180/$37.97

Prazosin HCl 2MG Capsules (TEVA PHARMACEUTICALS USA): 60/$22.99 or 180/$49.97

Prazosin HCl 5MG Capsules (TEVA PHARMACEUTICALS USA): 60/$33.99 or 180/$93.97

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, 1959-2011, Selected Revisions February 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

Only references cited for selected revisions after 1984 are available electronically.

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179. 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.

180. Thomas E. Kottke, MD, MSPH; Robert J. Stroebel, MD; Rebecca S. Hoffman, BA JNC 7—It’s More Than High Blood Pressure. JAMA. 2003;289.

181. Neal B, MacMahon S, Chapman N. Effects of ACE inhibitors, calcium antagonists, and other blood-pressure-lowering drugs. Lancet. 2000;356:1955-64.

182. Cushman WC, Ford CE, Cutler JA, et al. Success and predictors of blood pressure control in diverse North American settings: The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). J Clin Hypertens (Greenwich). 2002;4:393-404.

183. Black HR, Elliott WJ, Neaton JD et al. Baseline characteristics and elderly blood pressure control in the CONVINCE trial. Hypertension. 2001; 37:12-18. [PubMed 11208750]

184. Black HR, Elliott WJ, Grandits G, et al. Principal results of the Controlled Onset Verapamil Investigation of Cardiovascular End Points (CONVINCE) trial. JAMA. 2003;289:2073-2082.

185. Dahlof B, Devereux RB, Kjeldsen SE, et al. Cardiovascular morbidity and mortality in the Losartan Intervention For Endpoint Reduction in Hypertension Study (LIFE). Lancet. 2002;359:995-1003.

186. The Heart Outcomes Prevention Evaluation Study Investigators. Effects of an angiotensin-converting-enzyme inhibitor, ramipril, on cardiovascular events in high-risk patients. N Engl J Med. 2000;342:145-153.

187. PROGRESS Collaborative Group. Randomised trial of a perindopril-based blood-pressure-lowering regimen among 6105 individuals with previous stroke or transient ischaemic attack. Lancet. 2001;358:1033-41.

188. Wing LMH, Reid CM, Ryan P, et al, for Second Australian National Blood Pressure Study Group. A comparison of outcomes with angiotensin-converting-enzyme inhibitors and diuretics for hypertension in the elderly. N Engl J Med. 2003;348:583-92.

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208. T


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Slo-Niacin nicotinic acid


Generic Name: niacin (nicotinic acid) (NYE a sin (NIK oh TIN ik AS id))
Brand Names: B-3-50, B3-500-Gr, Niacin SR, Niacor, Niaspan ER, Slo-Niacin

What is niacin?

Niacin, also called nicotinic acid, is a B vitamin (vitamin B3). It occurs naturally in plants and animals, and is also added to many foods as a vitamin supplement. Niacin is also present in many multiple vitamins and nutritional supplements.

Niacin is used to treat and prevent a lack of natural niacin in the body, and to lower cholesterol and triglycerides (types of fat) in the blood. It is also used to lower the risk of heart attack in people with high cholesterol who have already had a heart attack. Niacin is sometimes used to treat coronary artery disease (also called atherosclerosis).

Niacin may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about niacin? Do not take this medication if you are allergic to niacin, or if you have severe liver disease, a stomach ulcer, or active bleeding.

Niacin can cause certain side effects, such as flushing (warmth, itching, redness, or tingly feeling under your skin). These effects can be made worse if you drink alcohol or hot beverages shortly after you take niacin. These effects should disappear over time as you keep taking the medication.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Avoid taking colestipol (Colestid) or cholestyramine (Locholest, Prevalite, Questran) at the same time you take niacin. If you take either of these other medications, take them at least 4 to 6 hours before or after you take niacin.

Niacin is only part of a complete program of treatment that may also include diet, exercise, weight control, and other medications. Follow your diet, medication, and exercise routines very closely.

What should I discuss with my healthcare provider before taking niacin ? Do not take this medication if you are allergic to niacin, or if you have severe liver disease, a stomach ulcer, or active bleeding.

Before taking niacin, tell your doctor if you are allergic to any drugs, or if you have:

liver or kidney disease;

heart disease or uncontrolled angina (chest pain);

a stomach ulcer;

diabetes;

gout; or

a muscle disorder such as myasthenia gravis.

If you have any of these conditions, you may not be able to use niacin, or you may need dosage adjustments or special tests during treatment.

FDA pregnancy category C. Niacin may be harmful to an unborn baby when the medication is taken at doses to treat high cholesterol or other conditions. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Niacin can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I take niacin ?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Niacin is sometimes taken at bedtime with a low-fat snack. Follow your doctor's instructions.

Niacin can cause certain side effects, such as flushing (warmth, itching, redness, or tingly feeling under your skin). These effects can be made worse if you drink alcohol or hot beverages shortly after you take niacin. These effects should disappear over time as you keep taking the medication.

Take niacin with a full glass of cold or cool water. Taking the medication with a hot drink may increase your risk of side effects such as flushing. Do not crush, chew, break, or open an extended-release tablet or capsule. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking or opening the pill would cause too much of the drug to be released at one time. Niacin extended-release tablets and capsules contain higher strengths of the medicine than the regular niacin tablets. Take only the dose that is correct for the type of niacin tablet or capsule you are using.

Niacin can cause you to have unusual results with certain medical tests (urine tests). Tell any doctor who treats you that you are using niacin.

If you stop taking niacin for any length of time, talk with your doctor before starting the medication again. You may need to restart the medication at a lower dose.

Niacin is only part of a complete program of treatment that may also include diet, exercise, weight control, and other medications. Follow your diet, medication, and exercise routines very closely.

To be sure this medication is not causing harmful effects, your blood will need to be tested on a regular basis. Your kidney or liver function may also need to be tested. Do not miss any scheduled appointments.

Store niacin at room temperature away from moisture and heat. What happens if I miss a dose?

Take the missed dose as soon as you remember. Be sure to take the missed dose with food if you normally take your niacin dose with a meal or snack.

If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include nausea, dizziness, itching, vomiting, upset stomach, and flushing.

What should I avoid while taking niacin ?

Avoid drinking hot beverages shortly after taking niacin. Hot drinks can worsen niacin's flushing effect (warmth, itching, redness, or tingly feeling under your skin).

Avoid drinking alcohol while taking niacin. Alcohol may increase your risk of liver damage, and can also worsen the flushing effects of niacin.

Avoid taking colestipol (Colestid) or cholestyramine (Locholest, Prevalite, Questran) at the same time you take niacin. If you take either of these other medications, take them at least 4 to 6 hours before or after you take niacin.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Niacin 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 any of these serious side effects:

feeling light-headed, fainting;

fast, pounding, or uneven heart beats;

feeling short of breath;

swelling;

jaundice (yellowing of your skin or eyes); or

muscle pain, tenderness, or weakness with fever or flu symptoms and dark colored urine.

If you are diabetic, tell your doctor about any changes in your blood sugar levels.

Less serious side effects of niacin include:

mild dizziness;

warmth, redness, or tingly feeling under your skin;

itching, dry skin;

sweating or chills;

nausea, diarrhea, belching, gas;

muscle pain, leg cramps; or

sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect niacin ?

Tell your doctor about all other cholesterol-lowering drugs you are taking with niacin, especially atorvastatin (Lipitor), fluvastatin (Lescol), lovastatin (Mevacor), pravastatin (Pravachol), or simvastatin (Zocor).

Before taking niacin, tell your doctor if you are also using any of the following drugs:

a blood thinner such as warfarin (Coumadin);

multivitamins or mineral supplements that contain niacin;

blood pressure or heart medications such as amlodipine (Norvasc), diltiazem (Tiazac, Cartia, Cardizem), felodipine (Plendil), nicardipine (Cardene), nifedipine (Procardia, Adalat), nimodipine (Nimotop), nisoldipine (Sular), or verapamil (Calan, Covera, Isoptin, Verelan); or

heart medications such as doxazosin (Cardura), isosorbide (Dilatrate, Imdur, Isordil, Monoket, Sorbitrate), nitroglycerin (Nitro-Bid, Nitro-Dur, Nitrostat), prazosin (Minipress), or terazosin (Hytrin).

This list is not complete and there may be other drugs that can interact with niacin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More Slo-Niacin resources Slo-Niacin Side Effects (in more detail) Slo-Niacin Use in Pregnancy & Breastfeeding Drug Images Slo-Niacin Drug Interactions Slo-Niacin Support Group 1 Review for Slo-Niacin - Add your own review/rating Compare Slo-Niacin with other medications High Cholesterol Hyperlipoproteinemia Hyperlipoproteinemia Type IV, Elevated VLDL Hyperlipoproteinemia Type V, Elevated Chylomicrons VLDL Niacin Deficiency Pellagra Where can I get more information? Your pharmacist can provide more information about niacin.

See also: Slo-Niacin side effects (in more detail)


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Infasurf


Generic Name: calfactant (kal FAK tant)
Brand Names: Infasurf

What is Infasurf (calfactant)?

Calfactant is a lung surface acting agent, or "surfactant." It helps the lungs function normally. Calfactant is similar to the natural fluid in the lungs that helps maintain effective breathing.

Calfactant is used to treat or prevent respiratory distress syndrome (RDS) in a premature baby whose lungs have not fully developed.

Calfactant may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Infasurf (calfactant)?

Your baby will receive this medication in a neonatal intensive care unit (NICU) or similar hospital setting.

Calfactant is given directly into the baby's lungs through a breathing tube that is also connected to a ventilator (a machine that moves air in and out of the lungs to help your baby breathe easier and get enough oxygen).

Calfactant is similar to the natural fluid in the lungs that helps maintain effective breathing.

Your baby will remain under constant supervision during treatment with calfactant. What should I discuss with my health care provider before receiving Infasurf (calfactant)? To best participate in the care of your baby while he or she is in the NICU, carefully follow all instructions provided by your baby's caregivers. How is calfactant given?

Calfactant is given directly into the baby's lungs through a breathing tube. Your baby will receive this medication in a neonatal intensive care unit (NICU) or similar hospital setting.

The breathing tube is connected to a ventilator (a machine that moves air in and out of the lungs to help your baby breathe easier and get enough oxygen).

Calfactant is given as soon as possible after the baby's birth, usually within 30 minutes.

Calfactant is usually given every 12 hours for up to 3 doses.

Your baby's breathing, blood pressure, oxygen levels, and other vital signs will be watched closely during treatment with calfactant. What happens if a dose is missed?

Since calfactant is given as needed by a healthcare professional, it is not likely that your baby will miss a dose.

What happens if an overdose is given?

Since calfactant is given in a controlled medical setting by a healthcare professional, an overdose is not likely to occur. However, an overdose of calfactant is not expected to produce life-threatening symptoms.

What should be avoided after receiving Infasurf (calfactant)?

Follow your doctor's instructions about any restrictions in feeding, medications, or activity after your baby has been treated with calfactant.

Infasurf (calfactant) side effects Calfactant causes few side effects. There is a possibility that the baby will have breathing difficulties during the calfactant treatment, and these problems may require further treatment by health care professionals. Your baby will remain under constant supervision during treatment with calfactant.

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.

What other drugs will affect Infasurf (calfactant)?

Your baby's caregivers will manage and monitor all medications given to your baby during treatment in the NICU. A drug interaction between calfactant and other medications is not expected to occur.

Do not give any medications to your baby that have not been prescribed by the baby's doctor. This includes vitamins, minerals, or herbal products. More Infasurf resources Infasurf Side Effects (in more detail) Infasurf Use in Pregnancy & Breastfeeding Infasurf Support Group 0 Reviews for Infasurf - Add your own review/rating Infasurf Prescribing Information (FDA) Calfactant Professional Patient Advice (Wolters Kluwer) Calfactant Compare Infasurf with other medications Respiratory Distress Syndrome Where can I get more information? Your doctor or pharmacist can provide more information about calfactant.

See also: Infasurf side effects (in more detail)


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calfactant


Generic Name: calfactant (kal FAK tant)
Brand Names: Infasurf

What is calfactant?

Calfactant is a lung surface acting agent, or "surfactant." It helps the lungs function normally. Calfactant is similar to the natural fluid in the lungs that helps maintain effective breathing.

Calfactant is used to treat or prevent respiratory distress syndrome (RDS) in a premature baby whose lungs have not fully developed.

Calfactant may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about calfactant?

Your baby will receive this medication in a neonatal intensive care unit (NICU) or similar hospital setting.

Calfactant is given directly into the baby's lungs through a breathing tube that is also connected to a ventilator (a machine that moves air in and out of the lungs to help your baby breathe easier and get enough oxygen).

Calfactant is similar to the natural fluid in the lungs that helps maintain effective breathing.

Your baby will remain under constant supervision during treatment with calfactant. What should I discuss with my health care provider before receiving calfactant? To best participate in the care of your baby while he or she is in the NICU, carefully follow all instructions provided by your baby's caregivers. How is calfactant given?

Calfactant is given directly into the baby's lungs through a breathing tube. Your baby will receive this medication in a neonatal intensive care unit (NICU) or similar hospital setting.

The breathing tube is connected to a ventilator (a machine that moves air in and out of the lungs to help your baby breathe easier and get enough oxygen).

Calfactant is given as soon as possible after the baby's birth, usually within 30 minutes.

Calfactant is usually given every 12 hours for up to 3 doses.

Your baby's breathing, blood pressure, oxygen levels, and other vital signs will be watched closely during treatment with calfactant. What happens if a dose is missed?

Since calfactant is given as needed by a healthcare professional, it is not likely that your baby will miss a dose.

What happens if an overdose is given?

Since calfactant is given in a controlled medical setting by a healthcare professional, an overdose is not likely to occur. However, an overdose of calfactant is not expected to produce life-threatening symptoms.

What should be avoided after receiving calfactant?

Follow your doctor's instructions about any restrictions in feeding, medications, or activity after your baby has been treated with calfactant.

Calfactant side effects Calfactant causes few side effects. There is a possibility that the baby will have breathing difficulties during the calfactant treatment, and these problems may require further treatment by health care professionals. Your baby will remain under constant supervision during treatment with calfactant.

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.

Calfactant Dosing Information

Usual Pediatric Dose for Respiratory Distress Syndrome:

>72 hours of life: Safety and efficacy have not been established.

What other drugs will affect calfactant?

Your baby's caregivers will manage and monitor all medications given to your baby during treatment in the NICU. A drug interaction between calfactant and other medications is not expected to occur.

Do not give any medications to your baby that have not been prescribed by the baby's doctor. This includes vitamins, minerals, or herbal products. More calfactant resources Calfactant Side Effects (in more detail) Calfactant Use in Pregnancy & Breastfeeding Calfactant Support Group 0 Reviews for Calfactant - Add your own review/rating Calfactant Calfactant Professional Patient Advice (Wolters Kluwer) Infasurf Prescribing Information (FDA) Compare calfactant with other medications Respiratory Distress Syndrome Where can I get more information? Your doctor or pharmacist can provide more information about calfactant.

See also: calfactant side effects (in more detail)


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tadalafil


Generic Name: tadalafil (ta DAL a fil)
Brand Names: Adcirca, Cialis

What is tadalafil?

Tadalafil relaxes muscles and increases blood flow to particular areas of the body.

Tadalafil under the name of Cialis is used to treat erectile dysfunction (impotence) and symptoms of benign prostatic hypertrophy (enlarged prostate). Another brand of sildenafil is Adcirca, which is used to treat pulmonary arterial hypertension and improve exercise capacity in men and women.

Tadalafil may also be used for purposes not listed in this medication guide.

What is the most important information I should know about tadalafil? Do not take tadalafil if you are allergic to it, or if you are also using a nitrate drug for chest pain or heart problems, including nitroglycerin (Nitro Dur, Nitrolingual, Nitrostat, Transderm Nitro, and others), isosorbide dinitrate (Dilatrate, Isordil, Isochron), isosorbide mononitrate (Imdur, ISMO, Monoket), or recreational drugs such as amyl nitrate or nitrite ("poppers"). Taking tadalafil with a nitrate medicine can cause a sudden and serious decrease in blood pressure. If you become dizzy or nauseated during sexual activity, or if you have pain, numbness, or tingling in your chest, arms, neck, or jaw, stop and call your doctor right away. You could be having a serious side effect of tadalafil. Do not take tadalafil more than once a day. Allow 24 hours to pass between doses. Contact your doctor or seek emergency medical attention if your erection is painful or lasts longer than 4 hours. A prolonged erection (priapism) can damage the penis.

Tadalafil can decrease blood flow to the optic nerve of the eye, causing sudden vision loss. This has occurred in a small number of people taking tadalafil, most of whom also had heart disease, diabetes, high blood pressure, high cholesterol, or certain pre-existing eye problems, and in those who smoke or are over 50 years old. It is not clear whether tadalafil is the actual cause of vision loss.

Stop using tadalafil and get emergency medical help if you have sudden vision loss. What should I discuss with my healthcare provider before taking tadalafil? You should not take tadalafil if you are allergic to it.

Tadalafil should not be used together with nitrate medication, such as nitroglycerin (Nitro Dur, Nitrolingual, Nitrostat, Transderm Nitro, and others), isosorbide dinitrate (Dilatrate, Isordil, Isochron), isosorbide mononitrate (Imdur, ISMO, Monoket), or recreational drugs such as amyl nitrate or nitrite ("poppers"). Taking tadalafil with a nitrate medicine for chest pain or heart problems can cause a sudden and serious decrease in blood pressure.

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

heart disease or heart rhythm problems;

a recent heart attack (within the past 90 days);

a recent history (in the past 6 months) of a stroke, or congestive heart failure;

angina (chest pain), high or low blood pressure;

liver disease;

kidney disease (or if you are on dialysis);

a blood cell disorder such as sickle cell anemia, multiple myeloma, or leukemia;

a bleeding disorder such as hemophilia;

a stomach ulcer;

retinitis pigmentosa (an inherited condition of the eye);

a physical deformity of the penis (such as Peyronie's disease); or

if you have been told you should not have sexual intercourse for health reasons.

Tadalafil can decrease blood flow to the optic nerve of the eye, causing sudden vision loss. This has occurred in a small number of people taking tadalafil, most of whom also had heart disease, diabetes, high blood pressure, high cholesterol, or certain pre-existing eye problems, and in those who smoke or are over 50 years old.

It is not clear whether tadalafil is the actual cause of vision loss. Stop using tadalafil and get emergency medical help if you have sudden vision loss. FDA pregnancy category B. Tadalafil is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment with Adcirca. It is not known whether tadalafil passes into breast milk or if it could harm a nursing baby. Do not use Adcirca without telling your doctor if you are breast-feeding a baby. How should I take tadalafil?

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.

Tadalafil can be taken with or without food.

Do not break or split a Cialis tablet. Swallow it whole.

Cialis is usually taken only once per day. Follow your doctor's instructions. For erectile dysfunction, take the medicine just before sexual activity but not more than once per day.

Cialis can help achieve an erection when sexual stimulation occurs. An erection will not occur just by taking a pill. Follow your doctor's instructions.

Adcirca is usually taken once per day. Follow your doctor's instructions. Do not take Cialis for erectile dysfunction if you are taking Adcirca for pulmonary arterial hypertension.

Do not take tadalafil more than once a day. Allow 24 hours to pass between doses. If you take the medication daily, take it at the same time each day. Contact your doctor or seek emergency medical attention if your erection is painful or lasts longer than 4 hours. A prolonged erection (priapism) can damage the penis. Store at room temperature away from moisture and heat.

See also: Tadalafil dosage (in more detail)

What happens if I miss a dose?

If tadalafil is used as needed, you are not likely to be on a dosing schedule.

If you take tadalafil every day and you 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 chest pain, nausea, irregular heartbeat, and feeling light-headed or fainting.

What should I avoid while taking tadalafil? Drinking alcohol can increase certain side effects of tadalafil.

Grapefruit and grapefruit juice may interact with tadalafil and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Avoid using other medicines to treat erectile dysfunction, such as sildenafil (Viagra) or vardenafil (Levitra) while you are taking tadalafil. Tadalafil 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. If you become dizzy or nauseated during sexual activity, or if you have pain, numbness, or tingling in your chest, arms, neck, or jaw, stop and call your doctor right away. You could be having a serious side effect of tadalafil. Stop using tadalafil and call your doctor at once if you have any of these serious side effects:

changes in vision or sudden vision loss;

ringing in your ears, or sudden hearing loss;

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

irregular heartbeat;

shortness of breath, swelling in your hands or feet;

seizure (convulsions);

feeling light-headed, fainting; or

penis erection that is painful or lasts 4 hours or longer.

Less serious side effects may include:

redness or warmth in your face, neck, or chest;

cold symptoms such as stuffy nose, sneezing, or sore throat;

headache;

memory problems;

diarrhea, upset stomach; or

muscle pain, back pain.

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.

Tadalafil Dosing Information

Usual Adult Dose for Erectile Dysfunction:

Erectile dysfunction:
10 mg orally taken prior to anticipated sexual activity. The maximum recommended dosing frequency is once per day in most patients.
Alternatively, 2.5 mg orally once daily, without regard to timing of sexual activity. May increase to 5 mg orally once daily based on efficacy and tolerability.
Erectile dysfunction and benign prostatic hyperplasia together:
5 mg orally taken at approximately the same time every day.

Usual Adult Dose for Pulmonary Hypertension:

40 mg orally once daily, with or without food. Dividing the dose (40 mg) over the course of the day is not recommended.

Usual Adult Dose for Benign Prostatic Hyperplasia:

Benign prostatic hyperplasia and benign prostatic hyperplasia with erectile dysfunction:
5 mg orally taken at approximately the same time every day.

What other drugs will affect tadalafil?

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

rifabutin (Mycobutin), rifampin (Rifadin, Rimactane, Rifater, Rifamate), or rifapentine (Priftin);

an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), or telithromycin (Ketek);

antifungal medication such as itraconazole (Sporanox), ketoconazole (Nizoral), miconazole (Oravig), or voriconazole (Vfend);

an antidepressant such as nefazodone;

a barbiturate such as phenobarbital (Solfoton);

drugs to treat high blood pressure or a prostate disorder, such as alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), terazosin (Hytrin), tamsulosin (Flomax);

heart or blood pressure medication such as diltiazem (Cardizem, Dilacor, Tiazac), nicardipine (Cardene), quinidine (Quin-G), or verapamil (Calan, Covera, Isoptin, Verelan); or

HIV or AIDS medications such as darunavir (Prezista), efavirenz (Sustiva), etravirine (Intelence), nevirapine (Viramune), fosamprenavir (Lexiva), indinavir (Crixivan), ritonavir (Norvir, Kaletra), and others; or

seizure medications such as carbamazepine (Carbatrol, Equetro, Tegretol), phenytoin (Dilantin), and others.

This list is not complete and other drugs may interact with tadalafil. 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 tadalafil resources Tadalafil Side Effects (in more detail) Tadalafil Dosage Tadalafil Use in Pregnancy & Breastfeeding Tadalafil Drug Interactions Tadalafil Support Group 103 Reviews for Tadalafil - Add your own review/rating tadalafil Advanced Consumer (Micromedex) - Includes Dosage Information Tadalafil MedFacts Consumer Leaflet (Wolters Kluwer) Tadalafil Monograph (AHFS DI) Tadalafil Professional Patient Advice (Wolters Kluwer) Adcirca Prescribing Information (FDA) Adcirca Consumer Overview Adcirca MedFacts Consumer Leaflet (Wolters Kluwer) Cialis Prescribing Information (FDA) Cialis Consumer Overview Compare tadalafil with other medications Benign Prostatic Hyperplasia Erectile Dysfunction Pulmonary Arterial Hypertension Where can I get more information? Your pharmacist can provide more information about tadalafil.

See also: tadalafil side effects (in more detail)


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Synthetic ovulation stimulants


A drug may be classified by the chemical type of the active ingredient or by the way it is used to treat a particular condition. Each drug can be classified into one or more drug classes.

Synthetic ovulation stimulants are drugs that stimulate ovulation or release of ovum from the ovaries.

The drug in this category has a similar structure to estrogen. It binds to the estrogen receptors so the brain thinks there is a low level of estrogen in the body. Therefore estrogen cannot provide accurate negative feedback to the hypothalamus and gonadotropin releasing hormone (GnRH) is released. GnRH activates the pituitary gland to release follicle stimulating hormone (FSH) and luteinizing hormone (LH). FSH and LH secretion stimulates growth of ovarian follicles and subsequent release of the egg.

Synthetic ovulation stimulants are used in treating infertility in anovulatory women.

See also

Medical conditions associated with synthetic ovulation stimulants:

Female Infertility Lactation Suppression Oligospermia Ovulation Induction Drug List: Clomid Serophene
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Exterol 5% w / w Ear Drops, Solution


1. Name Of The Medicinal Product

EXTEROL™ 5% w/w EAR DROPS, SOLUTION

2. Qualitative And Quantitative Composition

Urea Hydrogen Peroxide 5.0% w/w.

3. Pharmaceutical Form

Ear drops, solution.

Clear, straw-coloured, viscous ear drops.

4. Clinical Particulars 4.1 Therapeutic Indications

As an aid in the removal of hardened ear wax.

4.2 Posology And Method Of Administration

For adults, children and the elderly: Instil up to 5 drops into the ear. Retain drops in ear for several minutes by keeping the head tilted and then wipe away any surplus. Repeat once or twice daily for at least 3 to 4 days, or as required.

4.3 Contraindications

Do not use if the eardrum is known or suspected to be damaged, in cases of dizziness, or if there is any other ear disorder (such as pain, discharge, inflammation, infection or tinnitus). Do not use after ill-advised attempts to dislodge wax using fingernails, cotton buds or similar implements, as such mechanical efforts can cause the ear's delicate inner lining to become damaged, inflamed or infected, whereupon the use of ear drops can be painful. For similar reasons, it is inadvisable to use Exterol within 2 to 3 days of syringing. Do not use where there is a history of ear problems, unless under close medical supervision. Do not use if sensitive to any of the ingredients.

4.4 Special Warnings And Precautions For Use

Keep Exterol away from the eyes. For external use only. Replace cap after use, and return bottle to carton.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Exterol should not be used at the same time as anything else in the ear.

4.6 Pregnancy And Lactation

No known side-effects.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Due to the release of oxygen, patients may experience a mild, temporary effervescence in the ear. Stop usage if irritation or pain occurs. Instillation of ear drops can aggravate the painful symptoms of excessive ear wax, including some loss of hearing, dizziness and tinnitus. Very rarely, unpleasant taste has been reported. If patients encounter any of these problems, or if their symptoms persist or worsen, they should discontinue treatment and consult a doctor.

4.9 Overdose

No adverse effects.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

After insertion of the drops into the ear, the urea hydrogen peroxide complex liberates oxygen which acts to break up the hardened wax. The hydrogen peroxide component is also an antiseptic, especially in sites with relative anaerobiosis. The glycerol assists in softening the wax, so that it may more easily be removed from the ear, either with or without syringing. The urea acts as a mild keratolytic, helping to reduce the keratin-load in the wax debris, thereby assisting penetration of the other components.

5.2 Pharmacokinetic Properties

Exterol is intended only for the treatment of impacted wax in the external auditory canal. The ingredients of the formulation are therefore readily available for intimate contact with the affected area, as the drops are instilled into the ear and retained therein for several minutes by tilting the head.

5.3 Preclinical Safety Data

No special information.

6. Pharmaceutical Particulars 6.1 List Of Excipients

8-Hydroxyquinoline; Glycerol.

6.2 Incompatibilities

None known.

6.3 Shelf Life

24 months. Discard 4 weeks after first opening.

6.4 Special Precautions For Storage

Store upright. Do not store above 25°C. Replace cap after use.

6.5 Nature And Contents Of Container

8 ml easy squeeze plastic dropper bottle with screw cap. This is supplied as an original pack (OP).

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Dermal Laboratories

Tatmore Place, Gosmore

Hitchin, Herts SG4 7QR, UK.

8. Marketing Authorisation Number(S)

00173/0037.

9. Date Of First Authorisation/Renewal Of The Authorisation

28 January 2007.

10. Date Of Revision Of The Text

July 2010.


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Centrine



Dosage Form: FOR ANIMAL USE ONLY
Centrine®
AMINOPENTAMIDE
HYDROGEN SULFATE
Veterinary Injection and Tablets
Centrine Description

Centrine (aminopentamide hydrogen sulfate) is a potent antispasmodic agent. As a cholinergic blocking agent for smooth muscle, its action is similar to atropine.

ACTION

Centrine effectively reduces the tone and amplitude of colonic contractions to a greater degree and for a more extended period than does atropine.

Centrine effects a reduction in gastric secretion, a decrease in gastric acidity and a marked decrease in gastric motility.

The mydriatic and salivary effects of Centrine are less than those produced by atropine at similar dosage, permitting the control of vomiting and diarrhea with less distress to the animal due to dryness of the mouth and blurred vision.

INDICATIONS

Centrine is indicated in the treatment of acute abdominal visceral spasm, pylorospasm or hypertrophic gastritis and associated nausea, vomiting and/or diarrhea.

Contraindications

Centrine should not be used in animals with glaucoma because of the occurrence of mydriasis.

Warning

FOR USE IN DOGS AND CATS ONLY.

Precautions

Dryness of the mouth is the most commonly reported side effect. Blurring of vision may occur and dryness of the eyes may occur if larger (greater than therapeutic) doses are used. Centrine should be used cautiously, if at all, in pyloric obstruction because of its action in delaying gastric emptying. These effects frequently decrease with continued administration of the drug. Disturbances in urination are relatively infrequent. They vary from slightly hesitancy in initiating urination to complete inability to urinate; the latter is an indication for discontinuing the drug. After a day or two, it may be resumed at a lower dosage level.

DOSAGE

Centrine (aminopentamide hydrogen sulfate) may be administered by subcutaneous or intramuscular injection or by oral tablets according to the following schedule. If the desired effect is not obtained, the dosage may be gradually increased up to a maximum of 5 times the doses listed. When the condition has been brought under control by parenteral medication, treatment can be continued, if desired, with 0.2 mg scored tablets according to the dosage schedule.

Weight of Animal Amount to be Administered Every 8 to 12 hours Dosage Injectable Volume Oral Tablets 10 lbs or less 0.1 mg 0.2 mL 1/2 Tab 11 lbs to 20 lbs 0.2 mg 0.4 mL 1 Tab 21 lbs to 50 lbs 0.3 mg 0.6 mL 1 1/2 Tabs 51 lbs to 100 lbs 0.4 mg 0.8 mL 2 Tabs Over 100 lbs 0.5 mg 1.0 mL 2 1/2 Tabs CAUTION

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

How is Centrine Supplied

0.5 mg/mL Centrine (aminopentamide hydrogen sulfate) VETERINARY INJECTION, 10 mL vials.

0.2 mg Centrine (aminopentamide hydrogen sulfate) VETERINARY TABLETS, bottles of 100.

NDC 0856-2401-10 – 0.5 mg/mL – 10 mL vials.
NDC 0856-2400-60 – 0.2 mg – bottles of 100.

Store at controlled room temperature 15° to 30°C (59° to 86°F).

Fort Dodge Animal Health
Fort Dodge, Iowa 50501 USA

92686
Rev. September 1996
4260F

NADA 43-079, Approved by FDA
NADA 43-078, Approved by FDA

PRINCIPAL DISPLAY PANEL - 10 mL Vial Label

NDC 0856-2401-10

Centrine®
AMINOPENTAMIDE
HYDROGEN SULFATE
Veterinary Injection

FORT DODGE®

contains 0.5 mg/mL
aminopentamide hydrogen sulfate

10 mL

CAUTION: Federal law restricts this
drug to use by or on the order of a
licensed veterinarian.

NADA 43-079, Approved by FDA


Centrine 
aminopentamide sulfate  injection, solution Product Information Product Type PRESCRIPTION ANIMAL DRUG NDC Product Code (Source) 0856-2401 Route of Administration SUBCUTANEOUS, INTRAMUSCULAR DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength aminopentamide sulfate (aminopentamide) aminopentamide sulfate 0.5 mg  in 1 mL Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 0856-2401-10 10 mL In 1 BOTTLE None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA043079 09/05/1970
Labeler - FDAH, Division of Wyeth (149957656) Revised: 07/2010FDAH, Division of Wyeth

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vitamin A


Generic Name: vitamin A (VYE ta min A)
Brand Names: A-25, A/Fish Oil, Aquasol A

What is vitamin A?

Vitamin A is found in foods such as liver, milk, cheese, eggs, carrots, squash, dark green and yellow vegetables, and fruits such as cantaloupe or apricots. Vitamin A is important for the eyes and skin, and for normal growth.

Vitamin A is used to treat vitamin A deficiency.

Vitamin A may also be used for purposes not listed in this medication guide.

What is the most important information I should know about vitamin A? Never take more than the recommended dose of vitamin A. Avoid taking more than one vitamin product at the same time unless your doctor tells you to. Taking similar vitamin products together can result in a vitamin overdose or serious side effects. An overdose of vitamin A can cause serious or life-threatening side effects. Do not take vitamin A without medical advice if you are pregnant. Vitamin A can cause birth defects if taken in large doses.

Before taking vitamin A, tell your doctor about all other medicines you use.

What should I discuss with my healthcare provider before taking vitamin A?

Before using vitamin A, talk to your doctor, pharmacist, herbalist, or other healthcare provider. You may not be able to use vitamin A if you have certain medical conditions.

Do not take vitamin A without medical advice if you are pregnant. Although some vitamin A is needed for the normal development of a baby, vitamin A can cause birth defects if taken in large doses. You may need to use a prenatal vitamin specially formulated for pregnant women. Ask your doctor about taking vitamin A if you are breast-feeding a baby. Your dose needs may be different while you are nursing. How should I take vitamin A?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Swallow the tablet or capsule whole.

Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Never take more than the recommended dose of vitamin A. Avoid taking more than one vitamin product at the same time unless your doctor tells you to. Taking similar vitamin products together can result in a vitamin overdose or serious side effects.

Your healthcare provider may occasionally change your dose to make sure you get the best results from vitamin A. The recommended dietary allowance of vitamin A increases with age. Follow your healthcare provider's instructions. You may also consult the National Academy of Sciences "Dietary Reference Intake" or the U.S. Department of Agriculture's "Dietary Reference Intake" (formerly "Recommended Daily Allowances" or RDA) listings for more information.

Store at room temperature away from light, moisture, and heat. 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. An overdose of vitamin A can cause serious or life-threatening side effects.

Overdose symptoms may include nausea, vomiting, loss of appetite, vision changes, hair loss, peeling skin, cracked skin around your mouth, changes in menstrual periods, dizziness, drowsiness, tired feeling, bone or joint pain, severe headache, pain behind your eyes, severe stomach pain, dark urine, or jaundice (yellowing of the skin or eyes).

What should I avoid while taking vitamin A? Avoid taking orlistat (alli, Xenical) or mineral oil while you are taking vitamin A. Vitamin A 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.

Less serious side effects are more likely to occur, and you may have none at all.

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.

What other drugs will affect vitamin A? Do not take vitamin A without your doctor's advice if you are also taking:

birth control pills;

a blood thinner such as warfarin (Coumadin, Jantoven);

bexarotene (Targretin);

cholestyramine (Questran, Prevalite);

acitretin (Soriatane);

tretinoin (Vesanoid); or

isotretinoin (Accutane, Sotret, Claravis, Amnesteem).

This list is not complete and other drugs may interact with vitamin A. Tell your healthcare provider 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 vitamin A resources Vitamin A Drug Interactions Vitamin A Support Group 0 Reviews for Vitamin A - Add your own review/rating Aquasol A Prescribing Information (FDA) Vitamin A Monograph (AHFS DI) vitamin a Oral, Intramuscular Advanced Consumer (Micromedex) - Includes Dosage Information Compare vitamin A with other medications Vitamin A Deficiency Where can I get more information? Your pharmacist can provide more information about vitamin A.
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Granisol


Generic Name: granisetron (oral) (gra NIS e tron)
Brand Names: Granisol, Kytril

What is granisetron?

Granisetron blocks the actions of chemicals in the body that can trigger nausea and vomiting.

Granisetron is used to prevent nausea and vomiting that may be caused by medicine to treat cancer (chemotherapy or radiation).

Granisetron may be used for other purposes not listed in this medication guide.

What is the most important information I should know about granisetron? You should not use this medication if you are allergic to granisetron or to similar medicines such as dolasetron (Anzemet), ondansetron (Zofran), or palonosetron (Aloxi).

Before taking granisetron, tell your doctor if you have liver disease, a heart rhythm disorder, an electrolyte imbalance (such as low levels of potassium or magnesium in your blood), or a personal or family history of Long QT syndrome.

Granisetron is usually started up to 1 hour before chemotherapy. Tell your doctor if you forget to take the medication within the specified amount of time before your procedure.

What should I discuss with my health care provider before taking granisetron? You should not use this medication if you are allergic to granisetron, to similar medicines such as dolasetron (Anzemet), ondansetron (Zofran), or palonosetron (Aloxi).

If you have any of these other conditions, you may need a dose adjustment or special tests to safely take granisetron:

liver disease;

a heart rhythm disorder;

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

a personal or family history of Long QT syndrome.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether granisetron passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I take granisetron?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Granisetron is usually started up to 1 hour before chemotherapy. Follow your doctor's instructions.

Measure the liquid form of granisetron with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Store granisetron at room temperature away from moisture and heat. What happens if I miss a dose?

Tell your doctor if you forget to take your dose within 1 hour before chemotherapy. Do not take extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention if you think you have received too much of this medicine.

Overdose symptoms may include headache.

What should I avoid while taking granisetron?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Granisetron 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:

fast or pounding heartbeats;

fever, body aches, flu symptoms; or

easy bruising or bleeding; unusual weakness.

Less serious side effects may include:

headache;

stomach pain or upset, loss of appetite;

diarrhea or constipation;

dizziness; or

sleep problems (insomnia);

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.

What other drugs will affect granisetron?

There may be other drugs that can interact with granisetron. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More Granisol resources Granisol Side Effects (in more detail) Granisol Use in Pregnancy & Breastfeeding Granisol Drug Interactions Granisol Support Group 0 Reviews for Granisol - Add your own review/rating Granisol Advanced Consumer (Micromedex) - Includes Dosage Information Granisol Prescribing Information (FDA) Granisetron MedFacts Consumer Leaflet (Wolters Kluwer) Granisetron Prescribing Information (FDA) Granisetron Hydrochloride Monograph (AHFS DI) Kytril Prescribing Information (FDA) Kytril Consumer Overview Sancuso Prescribing Information (FDA) Sancuso Advanced Consumer (Micromedex) - Includes Dosage Information Sancuso Consumer Overview Sancuso MedFacts Consumer Leaflet (Wolters Kluwer) Compare Granisol with other medications Nausea/Vomiting, Chemotherapy Induced Nausea/Vomiting, Postoperative Nausea/Vomiting, Radiation Induced Where can I get more information? Your pharmacist can provide more information about granisetron.

See also: Granisol side effects (in more detail)


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palonosetron


Generic Name: palonosetron (PAL oh NOE se tron)
Brand Names: Aloxi

What is palonosetron?

Palonosetron blocks the actions of chemicals in the body that can trigger nausea and vomiting.

Palonosetron is used to prevent nausea and vomiting that may be caused by medicine to treat cancer (chemotherapy).

Palonosetron may be used for other purposes not listed in this medication guide.

What is the most important information I should know about palonosetron? You should not use this medication if you are allergic to palonosetron or to similar medicines such as dolasetron (Anzemet), granisetron (Kytril), or ondansetron (Zofran).

Tell your doctor if you forget to take your dose within 1 hour before chemotherapy. Do not take extra medicine to make up the missed dose.

What should I discuss with my health care provider before taking palonosetron? You should not use this medication if you are allergic to palonosetron or to similar medicines such as dolasetron (Anzemet), granisetron (Kytril), or ondansetron (Zofran). FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether palonosetron passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I take palonosetron?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Palonosetron is usually taken 1 hour before chemotherapy. Follow your doctor's instructions.

Store palonosetron at room temperature away from moisture and heat.

See also: Palonosetron dosage (in more detail)

What happens if I miss a dose?

Tell your doctor if you forget to take your dose within 1 hour before chemotherapy. Do not take extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention if you think you have received too much of this medicine.

An overdose of palonosetron is not expected to produce life-threatening symptoms.

What should I avoid while taking palonosetron?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Palonosetron 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.

Less serious side effects may include:

headache;

constipation; or

tired feeling.

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.

Palonosetron Dosing Information

Usual Adult Dose for Nausea/Vomiting -- Chemotherapy Induced:

Parenteral: 0.25 mg IV as a single dose 30 minutes before the start of chemotherapy.
Oral: 0.5 mg orally administered approximately 1 hour prior to the start of chemotherapy.

Usual Adult Dose for Nausea/Vomiting -- Postoperative:

0.075 mg IV as a single dose immediately before induction of anesthesia.

Usual Pediatric Dose for Nausea/Vomiting -- Chemotherapy Induced:

The dosing information for children and adolescents for prevention of acute chemotherapy-induced nausea and vomiting is based on clinical trials:
Kadota (2007): A randomized trial of 60 pediatric patients greater than 2 years of age [12 patients (1 month to 2 years) treated in an open-label fashion] showed 3 mcg/kg (maximum dose: 0.25 mg) and 10 mcg/kg (maximum dose: 0.75 mg) were well-tolerated and effective (no emesis, no rescue first 0 to 24 hours).
Sepulveda-Vildosola (2008): A randomized comparison of palonosetron (0.25 mg single dose 30 minutes before chemotherapy) and ondansetron (8 mg/m2 every 8 hours beginning 30 minutes before chemotherapy) in children 2 to 15 years, evaluated 100 chemotherapy courses in each arm and showed a statistically significant reduction in emetic events on days 2 to 3 in the palonosetron group and clinically significant reduction in emetic events on days 4 to 7 (up to 6 emetic events in the ondansetron group versus none with palonosetron).

What other drugs will affect palonosetron?

There may be other drugs that can interact with palonosetron. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More palonosetron resources Palonosetron Side Effects (in more detail)Palonosetron DosagePalonosetron Use in Pregnancy & BreastfeedingPalonosetron Drug InteractionsPalonosetron Support Group0 Reviews for Palonosetron - Add your own review/rating palonosetron Advanced Consumer (Micromedex) - Includes Dosage Information Palonosetron MedFacts Consumer Leaflet (Wolters Kluwer) Aloxi Monograph (AHFS DI) Aloxi Prescribing Information (FDA) Aloxi Advanced Consumer (Micromedex) - Includes Dosage Information Aloxi Consumer Overview Compare palonosetron with other medications Nausea/Vomiting, Chemotherapy InducedNausea/Vomiting, Postoperative Where can I get more information? Your pharmacist can provide more information about palonosetron.

See also: palonosetron side effects (in more detail)


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Nabilone 1mg Capsules


Nabilone 1 mg Capsules

(nabilone)

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 you experience any side effect and this becomes serious, tell your doctor or pharmacist. In this leaflet: 1. What Nabilone is and what it is used for 2. Before you take Nabilone Capsules 3. How to take Nabilone Capsules 4. Possible side effects 5. How to store Nabilone Capsules 6. Further information What Nabilone Is And What It Is Used For

Nabilone is a medicine that helps to reduce nausea and vomiting caused by many anticancer medicines.

Nabilone is often used when other medicines have not helped your nausea or vomiting.

Nabilone is a man-made chemical known as a cannabinoid. It is not made from the Cannabis plant but it is similar to some marijuana extracts and can cause similar effects.

Before You Take Nabilone Capsules Do not take Nabilone If you are allergic (hypersensitive) to any of the other ingredients of Nabilone Capsules (these are listed in section 6, "Further Information"). If your nausea / vomiting is not due to anticancer treatment. If you are under 18 years. Nabilone is not meant for children. Take special care with Nabilone

It is best if you take Nabilone Capsules in hospital, as you may experience side effects.

Tell your doctor before you start treatment if you have any of the following problems or if you develop any of these during treatment:

Any liver problems. High blood pressure or any other heart problem. Any mental illness, for example depression or schizophrenia. Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

In particular, tell your doctor if you are taking any sleeping pills, pain killers or tranquillisers.

Taking Nabilone with alcohol

Do not drink alcohol while you are taking Nabilone.

Pregnancy and breast-feeding

Tell your doctor before you start treatment

If you are pregnant, if you think that you are pregnant, or if you intend to become pregnant. If you are breast-feeding or planning to breast-feed.

Your doctor will then decide if you can take this medicine.

Driving and using machines

Nabilone Capsules may cause side effects such as sleepiness, confusion, hallucinations, a feeling of dizziness or spinning, poor muscle co-ordination, problems with your sight and problems with concentration. These side effects may occur up to 3 days after taking Nabilone. This may affect your ability to drive and operate machinery. Do not drive or operate machinery if you experience any of these side effects.

How To Take Nabilone Capsules

Always take Nabilone exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure how to take it. Your doctor will usually start you on the lowest possible dose.

It is best if you take Nabilone Capsules in hospital, especially the first time that you take Nabilone. This is because you may experience side effects.

The hospital doctor or nurse may give you your first dose the night before you start chemotherapy and the second dose one to three hours before it begins.

Swallow the capsules with water.

Dose The usual dose is 1 or 2 capsules twice a day. You should never take more than 2 capsules three times a day. You can take Nabilone while you are having chemotherapy treatment and for up to 2 days after your last dose of chemotherapy.

The dosing recommendations for elderly patients are the same as for other adults.

If you take more Nabilone than you should

If you ever take too many capsules, tell your doctor or get someone to take you to the nearest hospital casualty department immediately together with your medicine to show to the doctor.

If you forget to take Nabilone

If you miss a dose, wait until it is time for the next dose, and then continue as before.

Do not take a double dose to make up for a forgotten dose.

Possible Side Effects

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

Side effects that you may experience are: Feeling sleepy, relaxed, or "high". A few patients have had hallucinations, felt confused, depressed, anxious or had other changes in their mood or mental state. A feeling of dizziness or spinning, especially when you stand up. Poor muscle co-ordination. Dry mouth, problems with your sight or concentration, difficulty sleeping, or headaches. Shaking, a faster heart beat than normal, low blood pressure, losing your appetite and stomach pains.

Any changes in your mood, such as feeling depressed, relaxed or "high", may last for 2 or 3 days after you stop taking Nabilone. You may find that you get used to these feelings.

If you have any of these side effects, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How To Store Nabilone Capsules Keep Nabilone Capsules out of the reach and sight of children. Do not use Nabilone after the expiry date which is stated on the bottle and carton after "EXP". The expiry date refers to the last day of that month. Keep the container tightly closed. Store your capsules at room temperature (15-25°C) in a dry place. If your doctor tells you to stop taking the capsules, please take them back to the pharmacist. Medicines should not be disposed of via wastewater or household waste. Only keep the capsules if your doctor tells you to. Further Information What Nabilone contains

Active substance: Nabilone. Each capsule contains 1 mg of nabilone.
Other ingredients: Povidone, starch, gelatin and the colourants E132, E172 and E171.

What Nabilone looks like and contents of the pack Nabilone capsules are blue and white and have CL 3101 printed on them. Each bottle or blister pack of Nabilone contains 20 capsules. Marketing Authorisation Holder Meda Pharmaceuticals Ltd. Skyway House Parsonage Road Takeley Bishop's Stortford CM22 6PU UK Manufacturer Dales Pharmaceuticals Limited Snaygill Industrial Estate Keighley Road Skipton North Yorkshire BD23 2RW UK

For any information about this medicine, please contact the Marketing Authorisation Holder.

This leaflet was last approved in July 2009.

F687


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Liposic


1. Name Of The Medicinal Product

Liposic®, eye gel

2. Qualitative And Quantitative Composition

Each 1g of gel contains 2mg of carbomer

For excipients see 6.1

3. Pharmaceutical Form

Eye gel; white, turbid, highly viscous, dripable

4. Clinical Particulars 4.1 Therapeutic Indications

Symptomatic treatment of dry eye syndrome

4.2 Posology And Method Of Administration

Therapy of dry eye conditions requires an individual dosage regimen.

According to the severity and intensity of the symptoms, instill one drop into the conjunctival sac 3

Generally, an ophthalmologist should be consulted when treating keratoconjunctivitis sicca, which normally turns out to be long-term or permanent therapy.

An appropriate drop size is obtained when the tube is held in a vertical position above the eye during instillation.

4.3 Contraindications

Hypersensitivity to any component of this product

4.4 Special Warnings And Precautions For Use

Contact lenses should be removed prior to administration, and may be inserted again 30 minutes after Liposic has been instilled. Concomitant ocular medication should be administered 15 minutes prior to instillation of Liposic (see 4.5).

No specific studies with Liposic have been performed in children.

If the symptoms of the dry eye continue or worsen, treatment should be stopped and an ophthalmologist should be consulted.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known

Please note:

Liposic may prolong the contact-time of topically applied drugs in ophthalmology. Concomitant ocular medication should be administered 15 minutes prior to instillation of Liposic.

4.6 Pregnancy And Lactation

Clinical data regarding the safety of Liposic in human pregnancy or lactation are not available. Preclinical data predict that the risk of Liposic use in human pregnancy or lactation is very low. But due to the lack of clinical data the use of Liposic during pregnancy or lactation can not be recommended.

4.7 Effects On Ability To Drive And Use Machines

Even when used as indicated, this medicinal product may impair visual acuity for about five minutes due to the formation of streaks after gel application, and patients should exercise caution when driving vehicles or operating machinery.

4.8 Undesirable Effects

Ocular irritation may occur in rare cases due to the preservative contained. Intolerance reactions to one of the ingredients may be seen in isolated cases. Observed undesirable effects include burning, reddening of the eyes, sticky eyelids, palpebral giant papillary conjunctivitis, corneal stipples, episcleritis, blurred vision, itching, discomfort

4.9 Overdose

Any ocular overdosage or oral intake which might occur is of no clinical relevance. However, care should be taken to administer small drops to the eye to avoid sticky eyelids.

5. Pharmacological Properties

ATC code S01XA20

5.1 Pharmacodynamic Properties

Liposic eye gel is based on a high molecular weight hydrophilic polymer. Its pH and osmolality are similar to those of the normal tear film. Due to its physical properties, the eye gel binds water and forms a translucent lubricating and wetting film on the surface of the eye. The gel structure is destroyed by the salts contained in the lacrimal fluid and releases moisture. A study in 54 patients with keratoconjunctivitis sicca found that Liposic therapy prolonged tear break-up time from a mean of 5.3 seconds to 11.2 seconds after 6 weeks. Schirmer I-test values were increased from a mean of 4.8 mm to 10.7 mm after 6 weeks.

5.2 Pharmacokinetic Properties

No controlled animal nor human pharmacokinetic studies with this product are available. However, absorption or accumulation in eye tissues can presumably be excluded due to the high molecular weight of carbomer. Clinical studies performed with an essentially similar product have shown that ocular residence time can be assumed to be approximately up to 90 minutes.

5.3 Preclinical Safety Data

Preclinical data reveal no special hazard for humans based on studies of repeated dose toxicity, genotoxicity, carcinogenic potential, reproductive toxicity and pharmacological safety.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Cetrimide, sorbitol, medium-chain triglycerides, sodium hydroxide (for pH adjustment), purified water

6.2 Incompatibilities

None known so far.

6.3 Shelf Life

3 years

28 days after opening of the container

6.4 Special Precautions For Storage

Do not store above 25?C

6.5 Nature And Contents Of Container

Tubes of 5 g eye gel. Packs with one or three tubes of 5 g eye gel.

Tubes of 10 g eye gel. Packs with one or three tubes of 10 g eye gel.

6.6 Special Precautions For Disposal And Other Handling

No special requirements

7. Marketing Authorisation Holder

Dr. Gerhard Mann

Chem.-Pharm. Fabrik GmbH

Brunsbuetteler Damm 165-173

13581 Berlin (Germany)

8. Marketing Authorisation Number(S)

PL 13757/0001

9. Date Of First Authorisation/Renewal Of The Authorisation

21 March 2000

10. Date Of Revision Of The Text

26 October 2001

11. Legal Category

P


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Flumadine


Generic Name: rimantadine (ri MAN ta deen)
Brand Names: Flumadine

What is Flumadine (rimantadine)?

Rimantadine is an antiviral medication. It blocks the actions of viruses in your body.

Rimantadine is used to treat and prevent influenza A (a viral infection) in adults. It is also used to prevent influenza A in children.

There may be some flu seasons during which rimantadine is not recommended because certain flu strains may be resistant to this drug.

Rimantadine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Flumadine (rimantadine)? Do not use this medicine if you are allergic to rimantadine or a similar medicine called amantadine (Symmetrel).

Before taking rimantadine, tell your doctor if you are allergic to any drugs, or if you have a seizure disorder, kidney disease, or liver disease.

Take this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Do not use FluMist nasal influenza "live vaccine" while you are being treated with rimantadine and for at least 48 hours after you stop taking rimantadine. The nasal vaccine may not be as effective if you receive it while you are taking rimantadine. Before taking rimantadine, tell your doctor if you have received a nasal flu vaccine within the past 14 days.

Avoid coming into close contact with someone who has a weak immune system, such as a person who is taking steroids, being treated for cancer, or has a bone marrow disorder or an illness such as HIV or AIDS. If you have a type of influenza that is resistant to rimantadine, your body may actually shed that virus and a person with a weak immune system could easily become ill from being near you.

What should I discuss with my healthcare provider before taking Flumadine (rimantadine)? Do not use this medicine if you are allergic to rimantadine or a similar medicine called amantadine (Symmetrel).

Before taking rimantadine, tell your doctor if you are allergic to any drugs, or if you have:

epilepsy or other seizure disorder;

kidney disease; or liver disease.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take this medication.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether rimantadine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I take Flumadine (rimantadine)?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

If you are taking rimantadine to treat influenza A, take it within 48 hours of when you notice your first flu symptoms.

Take this medication with a full glass of water.

Measure the liquid form of rimantadine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Take this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Store rimantadine at room temperature away from moisture and heat. What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include agitation, confusion, hallucinations, or uneven heart rate.

What should I avoid while taking Flumadine (rimantadine)? Do not use FluMist nasal influenza "live vaccine" while you are being treated with rimantadine and for at least 48 hours after you stop taking rimantadine. The nasal vaccine may not be as effective if you receive it while you are taking rimantadine. Before taking rimantadine, tell your doctor if you have received a nasal flu vaccine within the past 14 days.

Avoid coming into close contact with someone who has a weak immune system, such as a person who is taking steroids, being treated for cancer, or has a bone marrow disorder or an illness such as HIV or AIDS. If you have a type of influenza that is resistant to rimantadine, your body may actually shed that virus and a person with a weak immune system could easily become ill from being near you.

Flumadine (rimantadine) 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. Stop using rimantadine and call your doctor at once if you have a seizure (black-out or convulsions).

Less serious side effects may include:

nausea, vomiting, diarrhea, loss of appetite, stomach pain;

dry mouth;

sleep problems (insomnia);

dizziness;

headache; or

anxiety, trouble concentrating.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Flumadine (rimantadine)?

Before taking rimantadine, tell your doctor if you are using any of the following drugs:

cimetidine (Tagamet);

aspirin or acetaminophen (Tylenol); or

nasal flu vaccine (FluMist).

This list is not complete and there may be other drugs that can interact with rimantadine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More Flumadine resources Flumadine Side Effects (in more detail) Flumadine Use in Pregnancy & Breastfeeding Drug Images Flumadine Drug Interactions Flumadine Support Group 0 Reviews for Flumadine - Add your own review/rating Flumadine Prescribing Information (FDA) Flumadine MedFacts Consumer Leaflet (Wolters Kluwer) Flumadine Monograph (AHFS DI) Flumadine Advanced Consumer (Micromedex) - Includes Dosage Information Rimantadine Prescribing Information (FDA) Compare Flumadine with other medications Influenza A Influenza Prophylaxis Where can I get more information? Your pharmacist can provide more information about rimantadine.

See also: Flumadine side effects (in more detail)


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Totect


Generic Name: dexrazoxane (dex ray ZOX ane)
Brand Names: Totect, Zinecard

What is dexrazoxane?

Dexrazoxane is used to protect the heart and other tissues from harmful side effects caused by certain cancer medications.

The Zinecard brand of dexrazoxane is used in women who are receiving doxorubicin for metastatic breast cancer.

The Totect brand of dexrazoxane is used in men or women to treat a condition called extravasation (es-TRA-va-ZAY-shun). Extravasation happens when an injected medicine escapes from the blood vessels and circulates into tissues in the body. Serious tissue damage can occur when extravasation happens during injection of certain cancer medications.

Dexrazoxane may also be used for purposes not listed in this medication guide.

What is the most important information I should know about dexrazoxane? You should not receive Totect if you are pregnant. It could harm the unborn baby. If possible before you receive Totect, tell your doctor if you are pregnant. It is not known whether Zinecard will harm an unborn baby. You should not receive this medication if your chemotherapy does not include doxorubicin or a similar medication such as daunorubicin (Cerubidine), epirubicin (Ellence), idarubicin (Idamycin), or mitoxantrone (Novantrone).

Before you receive dexrazoxane, tell your doctor if you have liver or kidney disease, or if you are pregnant or breast-feeding.

Tell your doctor at once if you have serious side effects such as fever, chills, body aches, flu symptoms, easy bruising or bleeding, or sores your mouth or throat.

In an emergency situation it may not be possible before you are treated to tell your caregivers about your health conditions or if you are pregnant or breast feeding. Make sure any doctor caring for you afterward knows that you have received Totect.

What should I discuss with my health care provider before receiving dexrazoxane? You should not receive Zinecard if your chemotherapy does not include doxorubicin or a similar medication such as:

daunorubicin (Cerubidine);

epirubicin (Ellence);

idarubicin (Idamycin); or

mitoxantrone (Novantrone);

If possible before you receive dexrazoxane, tell your doctor if you have:

liver disease;

kidney disease; or

if you are pregnant or breast-feeding.

Zinecard is rated as FDA pregnancy category C. It is not known whether Zinecard will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Totect is rated as FDA pregnancy category D. Do not use Totect if you are pregnant. It could harm the unborn baby. If possible before you receive Zinecard, tell your doctor if you are pregnant. It is not known whether dexrazoxane passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using dexrazoxane. In an emergency situation, it may not be possible before you are treated with Totect to tell your caregivers if you are pregnant or breast feeding. Make sure any doctor caring for your pregnancy or your baby knows you have received this medication. How is dexrazoxane given?

Dexrazoxane is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting.

Totect is usually started within 6 hours after extravasation, and continued once daily for 3 days.

Zinecard is usually started 30 minutes before you receive your doxorubicin injection.

Dexrazoxane can add to the bone marrow lowering effects of chemotherapy. This can weaken your immune system, making it easier for you to get sick from being around others who are ill.

To be sure this medication is not causing harmful effects, your blood cells and kidney function will need to be tested often. Do not miss any follow up visits to your doctor for blood or urine tests. What happens if I miss a dose?

Since dexrazoxane is given by a healthcare professional as part of your chemotherapy treatment, you are not likely to miss a dose.

Call your doctor if you miss a chemotherapy appointment.

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

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Dexrazoxane 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. Tell your doctor at once if you have any of these serious side effects:

fever, chills, body aches, flu symptoms, sores in your mouth and throat;

easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin; or

bruising, swelling, warmth, redness, oozing, or bleeding of any surgical incision.

Less serious side effects may include:

swelling in your hands or feet;

hair loss;

nausea, vomiting, diarrhea, loss of appetite;

sore throat, trouble swallowing;

dizziness, tired feeling; or

pain, swelling, or redness where the medicine was injected.

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.

What other drugs will affect dexrazoxane?

Some cancer medications may be less effective if they are used with dexrazoxane. Tell your doctor if your chemotherapy medications include:

fluorouracil (5-FU, Adrucil);

cyclophosphamide (Cytoxan, Neosar).

This list is not complete and other drugs may interact with dexrazoxane. 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 Totect resources Totect Side Effects (in more detail)Totect Use in Pregnancy & BreastfeedingTotect Support Group0 Reviews for Totect - Add your own review/rating Totect Consumer Overview Totect Prescribing Information (FDA) Totect Advanced Consumer (Micromedex) - Includes Dosage Information Dexrazoxane Prescribing Information (FDA) Dexrazoxane Professional Patient Advice (Wolters Kluwer) Dexrazoxane MedFacts Consumer Leaflet (Wolters Kluwer) Dexrazoxane Hydrochloride Monograph (AHFS DI) Zinecard Prescribing Information (FDA) Compare Totect with other medications Extravasation Where can I get more information? Your doctor or pharmacist can provide more information about dexrazoxane.

See also: Totect side effects (in more detail)


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Zinecard


Generic Name: dexrazoxane (dex ray ZOX ane)
Brand Names: Totect, Zinecard

What is Zinecard (dexrazoxane)?

Dexrazoxane is used to protect the heart and other tissues from harmful side effects caused by certain cancer medications.

The Zinecard brand of dexrazoxane is used in women who are receiving doxorubicin for metastatic breast cancer.

The Totect brand of dexrazoxane is used in men or women to treat a condition called extravasation (es-TRA-va-ZAY-shun). Extravasation happens when an injected medicine escapes from the blood vessels and circulates into tissues in the body. Serious tissue damage can occur when extravasation happens during injection of certain cancer medications.

Dexrazoxane may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Zinecard (dexrazoxane)? You should not receive Totect if you are pregnant. It could harm the unborn baby. If possible before you receive Totect, tell your doctor if you are pregnant. It is not known whether Zinecard will harm an unborn baby. You should not receive this medication if your chemotherapy does not include doxorubicin or a similar medication such as daunorubicin (Cerubidine), epirubicin (Ellence), idarubicin (Idamycin), or mitoxantrone (Novantrone).

Before you receive dexrazoxane, tell your doctor if you have liver or kidney disease, or if you are pregnant or breast-feeding.

Tell your doctor at once if you have serious side effects such as fever, chills, body aches, flu symptoms, easy bruising or bleeding, or sores your mouth or throat.

In an emergency situation it may not be possible before you are treated to tell your caregivers about your health conditions or if you are pregnant or breast feeding. Make sure any doctor caring for you afterward knows that you have received Totect.

What should I discuss with my health care provider before receiving Zinecard (dexrazoxane)? You should not receive Zinecard if your chemotherapy does not include doxorubicin or a similar medication such as:

daunorubicin (Cerubidine);

epirubicin (Ellence);

idarubicin (Idamycin); or

mitoxantrone (Novantrone);

If possible before you receive dexrazoxane, tell your doctor if you have:

liver disease;

kidney disease; or

if you are pregnant or breast-feeding.

Zinecard is rated as FDA pregnancy category C. It is not known whether Zinecard will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Totect is rated as FDA pregnancy category D. Do not use Totect if you are pregnant. It could harm the unborn baby. If possible before you receive Zinecard, tell your doctor if you are pregnant. It is not known whether dexrazoxane passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using dexrazoxane. In an emergency situation, it may not be possible before you are treated with Totect to tell your caregivers if you are pregnant or breast feeding. Make sure any doctor caring for your pregnancy or your baby knows you have received this medication. How is dexrazoxane given?

Dexrazoxane is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting.

Totect is usually started within 6 hours after extravasation, and continued once daily for 3 days.

Zinecard is usually started 30 minutes before you receive your doxorubicin injection.

Dexrazoxane can add to the bone marrow lowering effects of chemotherapy. This can weaken your immune system, making it easier for you to get sick from being around others who are ill.

To be sure this medication is not causing harmful effects, your blood cells and kidney function will need to be tested often. Do not miss any follow up visits to your doctor for blood or urine tests. What happens if I miss a dose?

Since dexrazoxane is given by a healthcare professional as part of your chemotherapy treatment, you are not likely to miss a dose.

Call your doctor if you miss a chemotherapy appointment.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. What should I avoid after receiving Zinecard (dexrazoxane)?

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Zinecard (dexrazoxane) 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. Tell your doctor at once if you have any of these serious side effects:

fever, chills, body aches, flu symptoms, sores in your mouth and throat;

easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin; or

bruising, swelling, warmth, redness, oozing, or bleeding of any surgical incision.

Less serious side effects may include:

swelling in your hands or feet;

hair loss;

nausea, vomiting, diarrhea, loss of appetite;

sore throat, trouble swallowing;

dizziness, tired feeling; or

pain, swelling, or redness where the medicine was injected.

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.

What other drugs will affect Zinecard (dexrazoxane)?

Some cancer medications may be less effective if they are used with dexrazoxane. Tell your doctor if your chemotherapy medications include:

fluorouracil (5-FU, Adrucil);

cyclophosphamide (Cytoxan, Neosar).

This list is not complete and other drugs may interact with dexrazoxane. 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 Zinecard resources Zinecard Side Effects (in more detail) Zinecard Use in Pregnancy & Breastfeeding Zinecard Support Group 0 Reviews for Zinecard - Add your own review/rating Zinecard Prescribing Information (FDA) Zinecard Advanced Consumer (Micromedex) - Includes Dosage Information Zinecard Monograph (AHFS DI) Zinecard MedFacts Consumer Leaflet (Wolters Kluwer) Dexrazoxane Prescribing Information (FDA) Dexrazoxane Professional Patient Advice (Wolters Kluwer) Totect Prescribing Information (FDA) Totect Consumer Overview Compare Zinecard with other medications Cardiomyopathy Prophylaxis Where can I get more information? Your doctor or pharmacist can provide more information about dexrazoxane.

See also: Zinecard side effects (in more detail)


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