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Vaginal anti-infectives


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.

Vaginal anti-infectives are available as creams, pessaries (tablets), gels or solutions to treat either bacterial or fungal vaginal infections. Vaginal antifungal products are used to treat vaginal thrush. Antibacterial vaginal products are used for bacterial infections such as bacterial vaginosis. Other products are used to manage irritation or minor soreness.

See also

Medical conditions associated with vaginal anti-infectives:

AcneBacterial VaginitisCutaneous CandidiasisFungal Infection ProphylaxisOral ThrushPerioral DermatitisRosaceaTinea CorporisTinea CrurisTinea PedisTinea VersicolorVaginal Yeast Infection Drug List:/tags/gyne-lotrimin-cream/
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/tags/gynazole-1-cream/
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/tags/clindamax-cream/
/tags/derma-gran-af-topical/
/tags/aloe-vesta/
/tags/avc/
/tags/betadine-cream/
/tags/canesten-topical/
/tags/clindacin-p/
/tags/clotrimazole-7/
/tags/desenex-spray/
/tags/fungicure-pump-spray/
/tags/fungoid-kit/
/tags/gyne-sulf/
/tags/micatin-cream/
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/tags/micatin-jock-itch/
/tags/micon-7/
/tags/minidyne-solution/
/tags/mitrazol/
/tags/monistat-1-combo-pack-cream/
/tags/mycelex-cream/
/tags/ony-clear/
/tags/polydine-solution/
/tags/secura-antifungal-topical/
/tags/terazol-3-suppositories/
/tags/tetterine-cream/
/tags/trysul/
/tags/v-v-s/

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Vandazole


Generic Name: metronidazole (Vaginal route)

met-roe-NYE-da-zole

Commonly used brand name(s)

In the U.S.

Metrogel-Vaginal Vandazole

In Canada

Flagyl Neo-Metric Nidagel

Available Dosage Forms:

Suppository Gel/Jelly Cream

Therapeutic Class: Antibacterial

Chemical Class: Nitroimidazole

Uses For Vandazole

Metronidazole vaginal is used to treat women with vaginal infections (e.g., bacterial vaginosis).

Metronidazole belongs to the class of medicines known as antibiotics. It works by killing the bacteria or preventing their growth. However, this medicine will not work for vaginal fungus or yeast infections.

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

Before Using Vandazole

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

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

Allergies

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

Pediatric

Appropriate studies on the relationship of age to the effects of metronidazole vaginal gel have not been performed in the pediatric population. However, pediatric-specific problems that would limit the usefulness of this medication in teenagers are not expected. This medicine may be used for bacterial vaginosis in teenage females but should not be used before the start of menstruation.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of metronidazole vaginal gel in the elderly.

Pregnancy Pregnancy Category Explanation All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus. Breast Feeding

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

Interactions with Medicines

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

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

Amprenavir Disulfiram

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

Amiodarone Busulfan Fluorouracil Mycophenolate Mofetil Warfarin

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

Carbamazepine Cholestyramine Cyclosporine Lithium Milk Thistle Tacrolimus Interactions with Food/Tobacco/Alcohol

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

Using this medicine with any of the following is not recommended. Your doctor may decide not to treat you with this medication, change some of the other medicines you take, or give you special instructions about the use of food, alcohol, or tobacco.

Ethanol Other Medical Problems

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

Aseptic meningitis, history of or Encephalopathy (brain disorder), history of or Leukopenia (low white blood cells), history of or Optic neuropathy (eye disease with vision changes), history of or Peripheral neuropathy (nerve disease with pain, numbness, or tingling), history of or Seizures or epilepsy, history of—Use with caution. May make these conditions worse. Liver disease, severe—Patients with severe liver disease may have an increase in side effects. Proper Use of metronidazole

This section provides information on the proper use of a number of products that contain metronidazole. It may not be specific to Vandazole. Please read with care.

Use this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

This medicine is to be used only in the vagina. Use it at bedtime, unless your doctor tells you otherwise.

Do not get it in your eyes, nose, mouth, or skin. If this medicine does get into your eyes, wash them out right away with large amounts of cool tap water. If your eyes still burn or are painful, check with your doctor.

This medicine usually come with patient directions. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Wash your hands with soap and water before and after using this medicine.

Metronidazole vaginal gel is in a tube. You will use an applicator to put the gel into your vagina. The applicator has a plastic tube called a barrel that is open at one end and has a plunger (another piece of plastic that can move inside the barrel) at the other end.

To fill the applicator: For cream or gel dosage forms: Break the metal seal at the opening of the tube by using the point on the top of the cap. Screw the applicator onto the tube. Squeeze the medicine into the applicator slowly until it is full. Remove the applicator from the tube. Replace the cap on the tube. For vaginal tablet dosage form: Place the vaginal tablet into the applicator. Wet the vaginal tablet with water for a few seconds. To insert vaginal metronidazole using the applicator For all dosage forms: Relax while lying on your back with your knees bent (or in any position that you feel comfortable). Hold the full applicator in one hand. Insert it slowly into the vagina. Stop before it becomes uncomfortable. Slowly press the plunger until it stops. Withdraw the applicator. The medicine will be left behind in the vagina. Remove the applicator from your vagina. Use each applicator only once, and then throw it away.

To help clear up your infection completely, it is very important that you keep using this medicine for the full time of treatment, even if your symptoms begin to clear up after a few days. If you stop using this medicine too soon, your symptoms may return. Do not miss any doses. Also, continue using this medicine even if your menstrual period starts during the time of treatment.

Dosing

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

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

For bacterial vaginal infections: For vaginal dosage form (cream): Adults and teenagers—One applicatorful (500 milligrams [mg]), inserted into the vagina. Use the medicine one or two times a day for 10 or 20 days. Children—Use and dose must be determined by your doctor. For vaginal dosage form (gel): Adults and teenagers—One applicatorful (5000 milligrams [mg]) inserted into the vagina once a day (at bedtime) for 5 days. Each applicatorful contains 37.5 mg of metronidazole. Children—Use and dose must be determined by your doctor. For vaginal dosage form (tablets): Adults and teenagers—One 500 milligram (mg) tablet, inserted high into the vagina. Use the medicine once a day in the evening for 10 or 20 days. Children—Use and dose must be determined by your doctor. Missed Dose

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

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

Precautions While Using Vandazole

It is important that your doctor check your progress after you finish using this medicine. This is to make sure that the infection is cleared up.

If your symptoms do not improve within a few days after you start this medicine or if they become worse, check with your doctor.

You should not use this medicine if you have taken disulfiram (Antabuse®) within the last 2 weeks. Disulfiram is used to help people who have a drinking problem. If these 2 medicines are taken close together, serious unwanted effects may occur.

Drinking alcoholic beverages while using this medicine may cause stomach pain, nausea, vomiting, headache, or flushing or redness of the face. Alcohol-containing medicines (e.g., elixirs, cough syrups, tonics) may also cause problems. The chance of these problems occurring may continue for at least a day after you stop using metronidazole. You should not drink alcoholic beverages or take other alcohol-containing medicines while you are using this medicine and for at least 3 days after stopping it.

Stop using this medicine and check with your doctor right away if you have dizziness, problems with muscle control or coordination, shakiness or an unsteady walk, slurred speech, or trouble with speaking. These may be symptoms of a serious brain condition called encephalopathy.

Stop using this medicine and call your doctor right away if you have confusion, drowsiness, fever, a general feeling of illness, a headache, loss of appetite, nausea, a stiff neck or back, or vomiting. These could be symptoms of a serious condition called aseptic meningitis.

Stop using this medicine and check with your doctor right away if you are having burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet. These could be symptoms of a condition called peripheral neuropathy.

This medicine may cause some people to become dizzy or lightheaded. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert. If these reactions are especially bothersome, check with your doctor.

Vaginal medicines usually leak out of the vagina during treatment. To keep the medicine from getting on your clothing, wear a mini-pad or sanitary napkin. Do not use tampons (like those used for menstrual periods) since they may soak up the medicine.

To help clear up your infection completely and to help make sure it does not return, good health habits are also required.

Wear cotton panties (or panties or pantyhose with cotton crotches) instead of synthetic (e.g., nylon or rayon) panties. Wear only freshly washed panties daily.

Do not have sexual intercourse while you are using this medicine. Having sexual intercourse may reduce the strength of the medicine. This may keep the medicine from working properly. Also, oils in the cream and vaginal tablets (but not the vaginal gel) may damage latex (rubber) contraceptive devices (e.g., cervical caps, condoms, or diaphragms), causing them to leak, wear out sooner, or not work properly.

Avoid using douches or other vaginal products unless your doctor tells you to.

Many vaginal infections (e.g., trichomoniasis) are spread by having sexual intercourse. You can give the infection to your sexual partner, and the infection could be given back to you. Your partner may also need to be treated for some infections. Until you are sure that the infection is completely cleared up after your treatment with this medicine, your partner should wear a condom during sexual intercourse . If you have any questions about this, check with your doctor.

Before you have any medical tests, tell the medical doctor in charge that you are using this medicine. The results of some tests may be affected by this medicine.

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

Vandazole Side Effects

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

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

More common Itching in the vagina pain during sexual intercourse thick, white vaginal discharge with no odor or with a mild odor Less common Abdominal or stomach cramping or pain burning on urination or need to urinate more often burning or irritation of penis of sexual partner itching, stinging, or redness of the genital area

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

Less common Diarrhea dizziness or lightheadedness dryness of the mouth feeling of a furry tongue headache loss of appetite metallic taste or other change in taste sensation nausea vomiting

Metronidazole may cause your urine to become dark. This is harmless and will go away when you stop using this medicine.

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

Any vaginal or genital irritation or itching pain during sexual intercourse thick, white vaginal discharge not present before treatment, with no odor or with a mild odor

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

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

See also: Vandazole side effects (in more detail)

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

More Vandazole resources Vandazole Side Effects (in more detail) Vandazole Use in Pregnancy & Breastfeeding Vandazole Drug Interactions Vandazole Support Group 2 Reviews for Vandazole - Add your own review/rating Vandazole Prescribing Information (FDA) Vandazole Concise Consumer Information (Cerner Multum) MetroCream Cream MedFacts Consumer Leaflet (Wolters Kluwer) MetroCream Concise Consumer Information (Cerner Multum) MetroCream Prescribing Information (FDA) MetroGel Prescribing Information (FDA) Metrocream Metrolotion Noritate Prescribing Information (FDA) Rozex Emulsion MedFacts Consumer Leaflet (Wolters Kluwer) Vitazol Prescribing Information (FDA) Compare Vandazole with other medications Bacterial Vaginitis
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terconazole vaginal


Generic Name: terconazole vaginal (ter KON a zole VAJ in al)
Brand Names: Terazol 3, Terazol 7, Zazole

What is terconazole vaginal?

Terconazole is an antifungal antibiotic that fights infections caused by fungus.

Terconazole vaginal is used to treat candida (yeast) infections of the vagina.

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

What is the most important information I should know about terconazole vaginal?

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Terconazole vaginal will not treat a viral infection such as the common cold or flu.

Avoid wearing tight-fitting, synthetic clothing (e.g., panty hose) that does not allow air circulation. Wear loose-fitting clothing made of cotton and other natural fibers until the infection is healed.

Avoid getting this medication in your eyes, nose, or mouth. If this does happen, rinse with water. What should I discuss with my healthcare provider before using terconazole vaginal? You should not use terconazole vaginal if you are allergic to it, or if you have:

a fever;

stomach pain; or

foul-smelling vaginal discharge.

To make sure you can safely use terconazole vaginal, tell your doctor if you have any of these other conditions:

diabetes;

HIV or AIDS.; or

if you have ever had an allergic reaction to similar medications such as butoconazole (Femstat, Mycelex), clotrimazole (Lotrimin, Femcare), econazole (Spectazole), fluconazole (Diflucan), ketoconazole (Nizoral), itraconazole (Sporanox), miconazole (Monistat), and others.

FDA pregnancy category C. It is not known whether terconazole vaginal 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 terconazole passes into breast milk. Do not use terconazole vaginal without first talking to your doctor if you are breast-feeding a baby. How should I use terconazole vaginal?

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.

Terconazole vaginal is usually applied once daily at bedtime for 3 days in a row. Follow your doctor's instructions.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Wash your hands before and after using this medication.

Insert the suppository or cream into the vagina using the applicator as directed.

You can use a sanitary napkin to prevent the medication from staining clothing but do not use a tampon.

Use this medication for the full prescribed length of time, even during your menstrual period. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Terconazole vaginal will not treat a viral infection such as the common cold or flu.

Call your doctor if your symptoms do not improve, or if they get worse while using terconazole vaginal. Do not use terconazole vaginal to treat any vaginal condition that has not been checked by your doctor. Store at room temperature away from moisture and heat. What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use 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. What should I avoid while using terconazole vaginal? Avoid getting this medication in your eyes, nose, or mouth. If this does happen, rinse with water.

Avoid using other vaginal medications or douches during your treatment with terconazole vaginal, unless you doctor tells you to.

Avoid wearing tight-fitting, synthetic clothing (e.g., panty hose) that does not allow air circulation. Wear loose-fitting clothing made of cotton and other natural fibers until the infection is healed.

Avoid sexual intercourse or use a condom to prevent the infection from spreading to a sexual partner.

Avoid exposure to sunlight or tanning beds. Terconazole can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors. Terconazole vaginal side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using terconazole vaginal and call your doctor at once if you have a serious side effect such as:

severe vaginal burning or irritation; or

fever, chills, flu symptoms.

Less serious side effects may include:

headache; or

menstrual cramps.

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.

Terconazole vaginal Dosing Information

Usual Adult Dose for Vaginal Candidiasis:

Vaginal suppositories: 1 suppository intravaginally once a day at bedtime for 3 consecutive days
0.8% vaginal cream: 1 applicatorful intravaginally once a day at bedtime for 3 consecutive days
0.4% vaginal cream: 1 applicatorful intravaginally once a day at bedtime for 7 consecutive days

What other drugs will affect terconazole vaginal?

It is not likely that other drugs you take orally or inject will have an effect on vaginally applied terconazole. But many drugs can interact with each other. 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 terconazole vaginal resources Terconazole vaginal Side Effects (in more detail) Terconazole vaginal Dosage Terconazole vaginal Use in Pregnancy & Breastfeeding Terconazole vaginal Support Group 6 Reviews for Terconazole - Add your own review/rating Compare terconazole vaginal with other medications Vaginal Yeast Infection Where can I get more information? Your pharmacist can provide more information about terconazole vaginal.

See also: terconazole side effects (in more detail)


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MetroGel-Vaginal


Generic Name: metronidazole vaginal (MET roe NYE da zole)
Brand Names: MetroGel-Vaginal, Vandazole

What is MetroGel-Vaginal (metronidazole vaginal)?

Metronidazole is an antibiotic that fights bacteria in the body.

Metronidazole vaginal is used to treat vaginal infections caused by bacteria.

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

What is the most important information I should know about MetroGel-Vaginal (metronidazole vaginal)?

Do not use metronidazole vaginal if you have ever had an allergic reaction to it.

Before using metronidazole vaginal, tell your doctor if you have liver disease, a seizure disorder, problems with circulation (such as Raynaud's syndrome), or if you have taken disulfiram (Antabuse) within the past 14 days.

Avoid having sex until your vaginal infection has been completely treated and you have finished using the medication.

Avoid using other vaginal creams or douches at the same time as metronidazole vaginal unless your doctor approves.

Use metronidazole vaginal for the entire length of time prescribed by your doctor, even during your menstrual period. Your symptoms may get better before the infection is completely treated. If the infection does not clear up after you have finished one course of therapy, or if your symptoms get worse, see your doctor. You may have another type of infection that metronidazole will not treat. What should I discuss with my doctor before using MetroGel-Vaginal (metronidazole vaginal)?

Do not use metronidazole vaginal if you have ever had an allergic reaction to it.

Before using metronidazole vaginal, tell your doctor if you are allergic to any drugs, or if you have:

liver disease;

a seizure disorder; or

problems with circulation (such as Raynaud's syndrome).

If you have any of these conditions, you may need a dose adjustment or special tests to safely use metronidazole vaginal.

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. Metronidazole vaginal may 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 use MetroGel-Vaginal (metronidazole vaginal)?

Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor.

Wash your hands before and after using this medication.

Insert the cream into your vagina using the applicator as directed.

Your medication may come with disposable applicators. Use each applicator for only 1 day and then throw it away. If you use the medication twice daily, wash and rinse the applicator after your morning dose and use it again for your evening dose. Then throw it away and use a new applicator the next day.

Use metronidazole vaginal for the entire length of time prescribed by your doctor, even during your menstrual period. Your symptoms may get better before the infection is completely treated.

If the infection does not clear up after you have finished one course of therapy, or if your symptoms get worse, see your doctor. You may have another type of infection that metronidazole will not treat.

You may need to use a sanitary napkin during treatment, but do not use a tampon.

Metronidazole vaginal can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using this medication.

Store metronidazole vaginal at room temperature away from moisture or heat. Do not allow it to freeze. What happens if I miss a dose?

Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and use the medicine at the next regularly scheduled time. Do not use 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.

An overdose of metronidazole applied in the vagina is not expected to produce life-threatening symptoms.

What should I avoid while using MetroGel-Vaginal (metronidazole vaginal)? Avoid getting this medication in your eyes, nose, or mouth. If it does get into any of these areas, rinse with plenty of cool water.

Avoid wearing tight-fitting, synthetic clothing such as nylon underwear or panty hose that does not allow air circulation. Wear loose-fitting clothing made of cotton and other natural fibers until your infection is healed.

Avoid having sex until your vaginal infection has been completely treated and you have finished using the medication.

Avoid using other vaginal creams or douches at the same time as metronidazole vaginal unless your doctor approves.

Avoid drinking alcohol while you are using metronidazole vaginal. MetroGel-Vaginal (metronidazole vaginal) 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.

Rare but serious side effects may include:

seizure (convulsions); or

numbness, burning, pain, or tingly feeling in your hands or feet.

Less serious side effects may include:

mild burning or stinging when the medication is applied;

pelvic pain or cramps;

loss of appetite, constipation, upset stomach, vomiting;

dizziness, sleep problems (insomnia);

runny nose;

urinating more than usual;

acne, increased sweating; or

breast discharge or enlargement.

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 MetroGel-Vaginal (metronidazole vaginal)?

Tell your doctor if you have taken disulfiram (Antabuse) within the past 14 days. Also tell your doctor if you are using:

cimetidine (Tagamet);

lithium (Eskalith, Lithobid, Lithonate); or

a blood thinner such as warfarin (Coumadin).

There may be other drugs that can interact with metronidazole vaginal. 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 MetroGel-Vaginal resources MetroGel-Vaginal Side Effects (in more detail) MetroGel-Vaginal Use in Pregnancy & Breastfeeding MetroGel-Vaginal Drug Interactions MetroGel-Vaginal Support Group 3 Reviews for MetroGel-Vaginal - Add your own review/rating MetroCream Cream MedFacts Consumer Leaflet (Wolters Kluwer) MetroCream Prescribing Information (FDA) MetroGel Prescribing Information (FDA) Metrocream Metrocream Topical Advanced Consumer (Micromedex) - Includes Dosage Information Metrogel-Vaginal Advanced Consumer (Micromedex) - Includes Dosage Information Metrolotion Noritate Prescribing Information (FDA) Rozex Emulsion MedFacts Consumer Leaflet (Wolters Kluwer) Vandazole Prescribing Information (FDA) Vitazol Prescribing Information (FDA) Compare MetroGel-Vaginal with other medications Bacterial Vaginitis Where can I get more information? Your pharmacist can provide more information about metronidazole vaginal.

See also: MetroGel-Vaginal side effects (in more detail)


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Metronidazole topical


Class: Antibacterials
VA Class: DE101
Chemical Name: 2-Methyl-5-nitro-1H-imidazole-1-ethanol
Molecular Formula: C6H9N3O3
CAS Number: 443-48-1
Brands: MetroCream, MetroGel, MetroGel-Vaginal, MetroLotion, Noritate, Vandazole

Introduction

Antibacterial and antiprotozoal;1 2 27 29 47 183 also has anti-inflammatory and immunosuppressive effects;1 2 14 17 21 28 180 nitroimidazole derivative.3

Uses for Metronidazole Rosacea

Treatment of inflammatory lesions (papules and pustules) associated with rosacea (acne rosacea);1 2 8 9 10 16 17 18 19 20 21 47 180 184 207 topical gel designated an orphan drug by FDA for use in this condition.23

Has no beneficial effects on telangiectasia,2 9 10 17 19 21 47 rhinophyma,47 or ocular manifestations of rosacea.47 83

Optimal treatment not determined; inflammatory lesions may respond to long-term treatment with topical anti-infectives (e.g., metronidazole) or oral anti-infectives (e.g., doxycycline, tetracycline, erythromycin, ampicillin, metronidazole).10 11 12 13 15 16 17 20 21 47 80 82 2 8 9 10 16 17 18 19 20 21 47 80 81 82 Topical metronidazole may be preferred to oral metronidazole;17 147 has been effective in patients with inadequate response or relapse with other therapies (e.g., oral tetracycline).2 10 17 21 62

Effects appear palliative;17 18 19 47 81 61 99 manifestations recur commonly following discontinuance of therapy.17 18 19 47 61 99

Adjunctive measures recommended to decrease exposure to factors that exacerbate rosacea (e.g., excessive sunlight, wind, hot liquids, spicy food, alcohol, extremes of heat and cold).2 12 80

Bacterial Vaginosis

Treatment of bacterial vaginosis (formerly called Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, anaerobic vaginosis)109 111 112 114 115 119 120 122 123 139 153 183 214 in nonpregnant women.214

CDC recommends treatment of bacterial vaginosis in all symptomatic women (including pregnant women).109 In addition, asymptomatic pregnant women at high risk for complications of pregnancy should be screened (preferably at the first prenatal visit) and treatment initiated if needed.109

Treatment recommendations for bacterial vaginosis in HIV-infected women are the same as those for women without HIV infection.109

Regimens of choice in nonpregnant women are a 7-day regimen of oral metronidazole, a 5-day regimen of intravaginal metronidazole gel, or a 7-day regimen of intravaginal clindamycin cream;109 114 alternative regimens are a 7-day regimen of oral clindamycin or 3-day regimen of intravaginal clindamycin suppositories.109 114 The preferred regimens for pregnant women are a 7-day regimen of oral metronidazole or a 7-day regimen of oral clindamycin.109

Regardless of regimen used, relapse or recurrence is common;109 110 120 122 138 153 162 an alternative regimen (e.g., oral therapy when topical was used initially) may be used in such situations.109 122

Routine treatment of asymptomatic male sexual contacts of women who have relapsing or recurrent bacterial vaginosis not recommended.109 113 201 202 203

Decubitus and Other Ulcers

Treatment of infected decubitus ulcers†;27 39 40 41 42 212 topical metronidazole designated an orphan drug by FDA for use in treatment of grade III or IV, anaerobically infected, decubitus ulcers.23

Perioral Dermatitis

Treatment of perioral dermatitis†;210 211 topical gel designated an orphan drug by FDA for treatment of this condition.23

Trichomoniasis

Has been used intravaginally as an adjunct to oral metronidazole for treatment of trichomoniasis caused by Trichomonas vaginalis† in selected cases (e.g., refractory infections),156 205 but not included in CDC recommendations for treatment of trichomoniasis.109 Intravaginal metronidazole not effective used alone.114

Drug of choice for treatment of trichomoniasis is oral metronidazole or oral tinidazole.109 114 123 215 216

Metronidazole Dosage and Administration Administration

Administer topically to the skin2 180 184 207 or intravaginally183 214 in appropriate formulations.

Topical skin preparations (cream, gel, lotion) are for external use only and should not be used orally, intravaginally, or near or in eyes.1 177 180 184 207

Intravaginal preparations are for intravaginal administration only and should not be used orally, topically on the skin, or near or in eyes.183 214

Topical Administration

Apply topically to the skin as a 0.75 or 1% cream, 1% gel, or 0.75% lotion.1 19 180 184 207

Prior to topical application, wash affected area with mild, nonirritating cleanser.1 2 180 184 207 To minimize risk of local irritation, some clinicians suggest application be delayed until about 15–20 minutes after skin cleansing.99

Rub cream, gel, or lotion into affected area.1 19 180 184 207 Avoid contact with eyes.1 19 180 184 207

If irritation occurs at application site, reduce application frequency or discontinue.1 19 180 184 207

Cosmetics may be applied to skin after application of cream, gel, or lotion;1 47 180 184 207 allow lotion to dry ?5 minutes before applying cosmetics.207

Intravaginal Topical Administration

Administer intravaginally as a 0.75% gel using vaginal applicators provided by the manufacturers.183 214

If once-daily regimen used, administer dose at bedtime.183 214

If once-daily regimen used, use new vaginal applicator for each dose.214 If twice-daily regimen used, use new applicator each day; wash, rinse, and dry applicator after morning dose and discard after evening dose.214

Dosage Pediatric Patients Bacterial Vaginosis Treatment in Nonpregnant Postmenarchal Females Intravaginal

0.75% gel: One applicatorful (approximately 37.5 g of metronidazole) once daily (at bedtime) or twice daily (in morning and evening) given for 5 consecutive days.214

Adults Rosacea Topical

0.75% cream or lotion: Apply thin film to cleansed, affected area twice daily (morning and evening)180 207 or as directed by clinician.207

1% cream or gel: Apply thin film to cleansed, affected area once daily.1 184

Optimum treatment duration not established;10 17 18 19 21 47 81 has been continued for ?21 weeks in clinical studies.2 9 10 16 17 18 19 20 21 29

Chronic therapy (usually intermittent) may be necessary, particularly for moderate to severe disease.61 99

Clinical improvement usually occurs within 3 weeks.17 21 Once adequate response occurs, adjust frequency and duration of treatment according to disease course.47

Although disease may remit during treatment,17 18 19 relapse occurs commonly following discontinuance.17 18 19 47 61 99

Bacterial Vaginosis Treatment in Nonpregnant Women Intravaginal

0.75% gel: One applicatorful (approximately 37.5 g of metronidazole) once daily (at bedtime) or twice daily (in morning and evening) given for 5 consecutive days.109 111 112 114 115 183 214

Cautions for Metronidazole Contraindications

Known hypersensitivity to metronidazole, other nitroimidazole derivatives, or any ingredient in the formulation.1 180 183 184 207 214

Warnings/Precautions Warnings Seizures and Peripheral Neuropathy

Convulsive seizures and peripheral neuropathy (characterized by numbness or paresthesia of an extremity) reported with oral or IV nitroimidazoles (e.g., metronidazole, tinidazole).183 217 214

If abnormal neurologic signs develop with vaginal gel, promptly discontinue drug.183 214

Use vaginal gel with caution in patients with history of CNS disease.183 214

Interactions

Psychotic reactions reported in alcoholic patients receiving oral metronidazole and disulfiram concurrently;183 214 disulfiram-like reactions to alcohol reported in patients receiving oral metronidazole.106 183 214 Similar reactions could occur with intravaginal metronidazole.183 214

Avoid intravaginal metronidazole in patients who have received disulfiram within the last 2 weeks.183 214 Caution patients to avoid drinking alcohol while being treated with intravaginal metronidazole.183 214 (See Specific Drugs under Interactions.)

General Precautions Administration Precautions

Avoid contact with the eyes.1 180 183 184 207 214

Topical cream, gel, or lotion may cause tearing.1 180 184 207

Vaginal gel may cause ocular burning and irritation.183 214

Iirrigate eyes with copious amounts of cool water if contact occurs.183 214

Local Irritation

If reaction suggesting local irritation occurs, advise patient to use the topical preparation less frequently or discontinue use.1 180 184 207

History of Blood Dyscrasia

Use with caution in patients with evidence or history of blood dyscrasia.1 180 184 207

Transient leukopenia and neutropenia reported with systemic metronidazole;30 adverse hematologic abnormalities not reported to date with topical metronidazole.2 21 47

Vaginal Intercourse and Use of Vaginal Products

Patients treated with vaginal gel should not engage in vaginal intercourse111 112 113 183 214 and should not use other vaginal products (tampons, douches) during entire treatment course.111 112 113 214

Vaginal intercourse or other vaginal products could reduce efficacy of intravaginal metronidazole (e.g., by dislodgment and/or dilution, by increased vaginal pH secondary to deposition of semen).111 112 113 214

Superinfection

Symptoms of known or previously unrecognized vaginal candidiasis may become more prominent during intravaginal metronidazole therapy.183 214 Symptomatic Candida vaginitis reported during or immediately after therapy.183 214

Systemic Adverse Effects

Although topical application to skin results in lower systemic absorption than oral or IV administration, adverse systemic effects (e.g., metallic taste,1 180 207 nausea,1 180 207 paresthesia,184 tingling or numbness of extremities1 180 207 ) have been reported with topical metronidazole.1 180

Although intravaginal administration results in lower systemic absorption than oral or IV administration, consider possibility that adverse effects reported with systemic metronidazole could occur when drug is given intravaginally.115 119 183 214

Specific Populations Pregnancy

Category B.1 180 183 184 207 214

Safety and efficacy of intravaginal metronidazole for treatment of bacterial vaginosis in pregnant women not established.109 119 183 214 Existing data do not support use of intravaginal agents during pregnancy and intravaginal metronidazole not included in current CDC recommendations for treatment of bacterial vaginosis in pregnant women.109

Lactation

Distributed into milk following oral or IV administration;1 30 45 131 180 183 184 207 214 not known whether distributed into milk following topical or intravaginal administration.183 f 214

Discontinue nursing or the drug.1 180 183 184 207 214

Pediatric Use

Safety and efficacy of topical1 180 184 207 or intravaginal183 metronidazole not established in pediatric patients.

One manufacturer states safety and efficacy of vaginal gel established in postmenarchal females based on extrapolation of data from adult women; safety and efficacy of vaginal gel not established in premenarchal females.214

Geriatric Use

Safety and efficacy of topical gel in geriatric patients ?65 years of age appear similar to those in younger adults.1

Insufficient experience with vaginal gel in patients ?65 years of age to determine whether geriatric patients respond differently than younger adults.214

Hepatic Impairment

Use vaginal gel with caution in severe hepatic impairment.183 214

Reduced elimination and increased plasma concentrations may occur in severe hepatic dysfunction.183 214

Common Adverse Effects

Topical application to skin: Local effects such as erythema, irritation, stinging/burning, local allergic reactions, contact dermatitis, drying, pruritus, aggravated rosacea.1 47 180 184 207

Intravaginal administration: Vaginal discharge,183 symptomatic Candida cervicitis/vaginitis,183 fungal infection,214 vulvovaginal irritation,183 dysmenorrhea,214 GI effects (abdominal pain, GI discomfort, nausea, vomiting, diarrhea),183 214 headache,183 214 pruritus.214

Interactions for Metronidazole

Because metronidazole can be absorbed systemically following topical application to skin1 2 9 10 21 47 207 or following intravaginal administration,119 131 132 183 214 the possibility that drug and laboratory test interactions could occur with these routes should be considered.106 183 f

Specific Drugs and Laboratory Tests

Drug

Interaction

Comments

Alcohol

Disulfiram-like reactions reported rarely when alcohol ingested during intravaginal metronidazole treatment;106 183 214 such reactions not reported to date with topical application of metronidazole to skin21 47 61 99

Caution patients to avoid alcohol ingestion during intravaginal metronidazole treatment183 214

Anticoagulants, oral (warfarin)

Prolonged PT reported with systemic metronidazole 1 30 45 92 93 94 95 96 183 214

Consider possibility of potentiated anticoagulant effect if topical or intravaginal metronidazole used with oral anticoagulant therapy180 183 214

Cimetidine

Possible prolonged half-life and decreased clearance of metronidazole with concomitant cimetidine and oral or IV metronidazole182 183 214

Consider possibility of increased metronidazole adverse effects182

Disulfiram

Psychotic reactions reported in alcoholic patients receiving oral metronidazole and disulfiram concurrently92 97 168 169 183 214

Avoid concomitant use;92 97 214 do not initiate intravaginal metronidazole until 2 weeks after discontinuance of disulfiram183 214

Lithium

Increased lithium concentrations resulting in lithium toxicity reported after initiation of short-term oral metronidazole therapy in patients stabilized on relatively high lithium dosages181 183 214

Tests based on ultraviolet (UV) absorbance

Falsely decreased serum concentrations (including undetectable concentrations) of AST, ALT, LDH, triglycerides, or hexokinase glucose may be reported during metronidazole therapy if results are based on decreases in UV absorbance that occur during oxidation-reduction of NADH/NAD30 183 214

UV absorbance peaks of NADH and metronidazole are similar30 183 214

Use caution when interpreting test results based on UV absorbance during metronidazole therapy30 183 214

Metronidazole Pharmacokinetics Absorption Bioavailability

Absorbed systemically following topical application to skin; extent of absorption depends on formulation used (cream, gel, lotion).1 2 9 10 21 47 207

Absorbed systemically following intravaginal administration;119 131 132 183 214 systemic bioavailability of vaginal gel averages 50–56%.119 131 132 183 186

Following repeated topical application to the face of 1% cream (approximately 3.75 mg per dose) in adults with rosacea, serum concentrations were minimal or undetectable.9 Following topical application to the face of 1 g of 1% cream in healthy individuals, serum concentrations were minimal or undetectable and peak serum concentrations were attained within 8–12 hours after the dose.184

Following topical application to the face of 1 g of 1% topical gel in adults with rosacea, peak serum concentrations of metronidazole were attained 6–10 hours after the dose and were <1% of concentrations reported with a single 250-mg oral dose.1

Following topical application to the face of 1 g of 0.75% topical lotion (approximately 7.5 mg of metronidazole) twice daily for 4 days, drug was detectable in plasma of all patients and peak plasma concentrations were approximately 80 times lower than peak concentrations attained with a single 250-mg oral dose.207

Following intravaginal administration of 5 g of 0.75% vaginal gel (approximately 37.5 mg of metronidazole) in healthy women, peak serum concentrations were attained 4–17 hours after the dose and were approximately 2% of that attained after a single 500-mg oral dose.119 132 183 186 214

Distribution Extent

Not fully characterized following topical application to skin10 or intravaginal administration.176 177

Crosses placenta following oral or IV administration;1 30 45 56 131 180 183 184 207 not known whether crosses placenta following topical application to skin1 or intravaginal administration.183

Distributed into milk following oral or IV administration;1 30 45 56 131 180 183 184 207 214 not known whether distributed into milk following topical application to skin1 or intravaginal administration.183

Elimination Metabolism

Not fully characterized following topical application to skin10 or intravaginal administration.176 177

Elimination Route

Any systemically absorbed drug probably metabolized in liver and excreted in urine.10 61

Stability Storage Topical Cream

20–25°C.180 184

Gel

20–25°C (may be exposed to 15–30°C).1

Lotion

20–25°C; do not freeze.207

Intravaginal Gel

MetroGel-Vaginal: 15–30°C; do not freeze.183

Vandazole: 20–25°C; do not freeze.214

ActionsActions

Bactericidal, amebicidal, and trichomonacidal in action.2 30 48 52 56

Un-ionized at physiologic pH49 and readily taken up by anaerobic organisms or cells.48 49 50 56 72 In susceptible organisms or cells, metronidazole reduced by low-redox-potential electron transport proteins (e.g., nitroreductases such as ferredoxin);48 49 50 56 64 65 66 68 69 70 71 72 the reduction product(s) apparently are responsible for cytotoxic and antimicrobial effects of the drug (e.g., disruption of DNA, inhibition of nucleic acid synthesis).48 56 63 64 65 66 67 68 70 71 72

Has direct anti-inflammatory effects2 14 17 21 28 180 and effects on neutrophil motility, lymphocyte transformation, and some aspects of cell-mediated immunity.2 10 32 33 34 35

Mechanism of reducing inflammatory lesions (papules and pustules) and erythema in patients with rosacea not elucidated to date;1 2 6 10 11 17 19 21 28 29 184 207 these effects may result from anti-inflammatory or immunosuppressive actions of the drug.1 2 3 10 17 28 29 207

Suppression of skin bacteria does not appear to play a major role in the mechanism of action of the drug in treatment of inflammatory lesions of rosacea;2 10 11 29 inactive in vitro against Propionibacterium acnes,2 4 5 48 staphylococci, and streptococci,2 48 and has no appreciable effects on the aerobic or anaerobic microflora of the skin of patients with rosacea.2 10 29

Spectrum of activity includes most obligately anaerobic bacteria2 7 29 30 45 48 53 56 64 and many protozoa.2 29 30 48 52 64 Inactive against fungi2 3 48 and viruses48 and most aerobic or facultatively anaerobic bacteria.2 7 30 45 48 73 74

Gram-positive anaerobes: Active against Clostridium,2 30 45 48 53 55 C. difficile,54 55 C. perfringens,48 55 Eubacterium,2 30 45 48 53 54 Peptococcus,2 30 45 48 53 54 55 and Peptostreptococcus.2 7 30 45 48 53 55 124 128 Actinomyces, Lactobacillus,48 Propionibacterium acnes,2 4 5 48 P. avidum,5 and P. granulosum5 generally are resistant.

Gram-negative anaerobes: Active against Bacteroides fragilis,2 3 30 45 48 53 54 55 124 126 130 B. distasonis,30 45 54 55 124 B. ovatus,30 45 55 124 B. thetaiotaomicron,30 45 54 55 124 B. vulgatus,30 45 54 55 124 B. ureolyticus,124 126 Fusobacterium,2 7 30 45 48 53 55 Prevotella bivia,53 124 126 128 129 P. disiens,54 128 P. intermedia,7 124 P. melaninogenica,48 54 124 126 128 129 P. oralis,54 124 126 129 Porphyromonas,124 129 and Veillonella.7 54 55

Other organisms: Active against Campylobacter fetus.48 Most strains of Gardnerella vaginalis (formerly Haemophilus vaginalis) are susceptible only to relatively high concentrations in vitro.119 126 129 135 140 141 142 Concentrations readily achievable locally (750 mcg/mL) following intravaginal application of 0.75% vaginal gel have inhibited approximately 90% of strains tested in vitro.119 177

Natural and acquired resistance has been reported in some T. vaginalis.48 52 75 76 77 78 79 Resistance also reported rarely in B. fragilis and other anaerobic bacteria following long-term therapy.44 48 215

Advice to Patients

Importance of using topical or intravaginal metronidazole only as directed and only for the disorder for which drug was prescribed.1 180 183 184 207 f

Advise patients that topical cream, gel, and lotion are for external use only and to avoid contact with eyes.1 180 184 207 (See Administration under Dosage and Administration.)

Advise patients that vaginal gel is for intravaginal administration only and to avoid contact with eyes.183 214 (See Administration under Dosage and Administration.) If such contact occurs, importance of irrigating eyes with copious amounts of cool water.177 183

Instruct patients receiving vaginal gel regarding appropriate use of vaginal applicator.f

Advise women using vaginal gel not to engage in vaginal intercourse111


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urofollitropin


Generic Name: urofollitropin (UE roe FOL i TROE pin)
Brand names: Bravelle, Metrodin, Fertinex

What is urofollitropin?

Urofollitropin is a purified form of a hormone called follicle-stimulating hormone (FSH). FSH is important in the development of follicles (eggs) that are produced by the ovaries in women.

Urofollitropin is used to treat infertility in women whose own natural FSH is not sufficient in stimulating follicles to mature. Urofollitropin also is used to help the ovaries produce multiple eggs for use in "in vitro" fertilization.

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

What is the most important information I should know about urofollitropin? Some women using this medicine have developed a condition called ovarian hyperstimulation syndrome (OHSS). This syndrome may be more likely to occur within the first 10 days after receiving the last dose in a treatment cycle. OHSS can be a life-threatening condition. Call your doctor right away if you have any symptoms of OHSS: severe pelvic pain, swelling of the hands or legs, stomach pain and swelling, shortness of breath, weight gain, diarrhea, nausea or vomiting, and urinating less than usual.

Using this medicine can increase your chances of having a multiple pregnancy (twins, triplets, quadruplets, etc). A multiple pregnancy is a high-risk pregnancy for the mother and for the babies. Follow your doctor's instructions about any special care you may need during your pregnancy.

Although urofollitropin can help you become pregnant, this medication is in the FDA pregnancy category X. This means that using the medication once you are pregnant can cause birth defects in the baby. Do not use this medication if you are pregnant. Tell your doctor right away if you become pregnant during treatment. What should I discuss with my healthcare provider before using urofollitropin?

Urofollitropin will not cause ovulation (production of an egg by the ovaries). You may need to receive other medications to stimulate ovulation.

You should not use this medication if you are allergic to urofollitropin medications, or if you have:

infertility that is not caused by lack of ovulation;

a condition called primary ovarian failure;

unusual vaginal bleeding;

an ovarian cyst;

a tumor of your pituitary gland;

an untreated or uncontrolled disorder of your thyroid or adrenal gland; or

if you are pregnant.

Using this medicine can increase your chances of having a multiple pregnancy (twins, triplets, quadruplets, etc). A multiple pregnancy is a high-risk pregnancy for the mother and for the babies. Follow your doctor's instructions about any special care you may need during your pregnancy.

Although urofollitropin can help you become pregnant, this medication is in the FDA pregnancy category X. This means that using the medication once you are pregnant can cause birth defects in the baby. Do not use this medication if you are pregnant. Tell your doctor right away if you become pregnant during treatment. It is not known whether urofollitropin passes into breast milk. Do not use urofollitropin without telling your doctor if you are breast-feeding a baby. How should I use urofollitropin?

Use this medication exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Urofollitropin is given as an injection under the skin or into a muscle. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to inject your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

Urofollitropin comes as a powder and liquid (diluent) that must be mixed together before you draw your dose into a syringe.

Do not shake the mixture. Vigorous shaking can ruin the medicine. Do not draw your urofollitropin dose into a syringe until you are ready to give yourself an injection. Do not use the medication if it does not clear after mixing, or if it has any particles in it. Call your doctor for a new prescription.

After giving the injection, throw away any portion of the mixed medicine that is not used right away. Do not save it for later use.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

To be sure this medication is helping your condition, your doctor will need to check you on a regular basis. Do not miss any scheduled appointments.

Infertility is often treated with a combination of different drugs. For best results, use all of your medications as directed by your doctor. Be sure to read the medication guide or patient instructions provided with each of your medications. Do not change your doses or medication schedule without advice from your doctor.

If you store urofollitropin at home, keep it at room temperature away from light, moisture, and heat. What happens if I miss a dose?

Call your doctor if you miss a dose of urofollitropin.

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

Symptoms of a urofollitropin overdose are not known.

What should I avoid while using urofollitropin?

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using urofollitropin.

Urofollitropin 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. Some women using this medicine have developed a condition called ovarian hyperstimulation syndrome (OHSS). This syndrome may be more likely to occur within the first 10 days after receiving the last dose in a treatment cycle. OHSS can be a life-threatening condition. Stop using urofollitropin and call your doctor at once if you have any symptoms of OHSS:

severe pelvic pain;

swelling of your hands or legs;

stomach pain and swelling;

shortness of breath;

weight gain;

nausea, vomiting, diarrhea; or

urinating less than usual.

Less serious side effects may include:

mild stomach upset, constipation;

mild pelvic pain, cramps;

breast tenderness;

skin rash;

hot flashes;

acne; or

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

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.

Urofollitropin Dosing Information

Usual Adult Dose for Follicle Stimulation:

Fertinex in Assisted Reproductive Technologies:
150 international units subcutaneously per day until sufficient follicular development is obtained. In most case, therapy should not exceed 10 days.
Fertinex in polycystic Ovary Syndrome:
75 to 300 international units subcutaneously per day depending on patient response. A response in generally evident after 5 to 7 days.
Bravelle:
150 international units subcutaneously daily for first 5 days. Depending on patient response, dose may be adjusted once every 2 days by 75 to 150 international units per adjustment. The maximum daily dose should not exceed 450 international units and in most cases dosing beyond 12 days is not recommended.

What other drugs will affect urofollitropin?

There may be other drugs that can interact with urofollitropin. 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 urofollitropin resources Urofollitropin Side Effects (in more detail) Urofollitropin Use in Pregnancy & Breastfeeding Urofollitropin Drug Interactions Urofollitropin Support Group 0 Reviews for Urofollitropin - Add your own review/rating urofollitropin Intramuscular, Subcutaneous, Injection Advanced Consumer (Micromedex) - Includes Dosage Information Urofollitropin Professional Patient Advice (Wolters Kluwer) Bravelle Prescribing Information (FDA) Bravelle MedFacts Consumer Leaflet (Wolters Kluwer) Fertinex MedFacts Consumer Leaflet (Wolters Kluwer) Compare urofollitropin with other medications Female Infertility Follicle Stimulation Where can I get more information? Your pharmacist can provide more information about urofollitropin.

See also: urofollitropin side effects (in more detail)


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Premarin Cream


Pronunciation: KON-joo-GAY-ted ES-troe-jenz
Generic Name: Conjugated Estrogens
Brand Name: Premarin

Premarin Cream increases the chances of getting cancer of the uterus. Report any unusual vaginal bleeding right away while you are using Premarin Cream. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your health care provider should check any unusual vaginal bleeding to find out the cause.

Do not use Premarin Cream with or without progestins (eg, medroxyprogesterone) to prevent heart disease, heart attacks, strokes, or dementia. Using estrogens with or without progestins may increase your chances of getting heart attacks, strokes, breast cancer, and blood clots. Using estrogens with or without progestins may increase your risk of dementia, based on a study of women 65 years old or older. You and your health care provider should talk regularly about whether you still need treatment with Premarin Cream.


Premarin Cream is used for:

Treating certain menopausal changes of the vagina (eg, vaginal dryness) and other vaginal conditions. It is also used to treat painful intercourse caused by those vaginal changes. It may also be used for certain conditions as determined by your doctor.

Premarin Cream is a mixture of female estrogen hormones. It works by replacing natural estrogens in a woman who can no longer produce enough estrogen.

Do NOT use Premarin Cream if: you are allergic to any ingredient in Premarin Cream you are pregnant or suspect you may be pregnant you have a history of known or suspected breast cancer or other cancers that are estrogen-dependent you have abnormal vaginal bleeding of unknown cause you have liver problems or liver disease you have recently (within the last year) had a stroke or a heart attack you have blood clots (eg, in the legs or lungs) or a history of blood clots

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

Before using Premarin Cream:

Some medical conditions may interact with Premarin Cream. 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 an abnormal mammogram if you have asthma (wheezing), a benign breast nodule, the blood disease porphyria, bone cancer, depression, diabetes, endometriosis or endometrial (uterine) cancer, epilepsy (seizures), gallbladder disease, heart problems, high blood pressure, kidney problems, liver problems or a history of yellowing of the skin or eyes, low blood levels of parathyroid hormone, lupus, migraines, pancreatitis, uterine fibroids, thyroid problems, or high calcium levels in your blood if you use tobacco, are overweight, are going to have surgery, or will be on bed rest if you have a personal or family history of high cholesterol, lipid, calcium, or triglyceride levels, or breast cancer

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

Clarithromycin, erythromycin, itraconazole, ketoconazole, or ritonavir because they may increase the risk of Premarin Cream's side effects. Carbamazepine, hydantoins (eg, phenytoin), phenobarbital, rifamycins (eg, rifampin), or St. John's wort because they may decrease Premarin Cream's effectiveness

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

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

An extra patient leaflet is available with Premarin Cream. Talk to your pharmacist if you have questions about this information. Closely follow the dosing schedule provided by your doctor. On days that you are using Premarin Cream, use it at the same time each day. Wash your hands before and after using Premarin Cream. Fill the applicator with Premarin Cream according to the directions provided. Lie on your back with your knees drawn up, insert the applicator high into the vagina, and press the plunger to release the medicine. To clean the applicator, pull the plunger to remove it from the barrel. Wash with mild soap and warm water and rinse well. Do not boil or use hot water. Talk with your doctor about stopping Premarin Cream 4 to 6 weeks before surgery. Eating grapefruit or drinking grapefruit juice may increase the risk of side effects. Check with your doctor before including grapefruit or grapefruit juice in your diet. If you miss a dose of Premarin Cream, take it as soon as possible. If it is almost time for the 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 Premarin Cream.

Important safety information: Premarin Cream may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Premarin Cream with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Premarin Cream may increase the risk of a stroke, blood clots, high blood pressure, or similar problems. The risk may be greater if you smoke (especially women older than 35 years). Before using Premarin Cream, you will need to have a complete medical and family history exam, which will include blood pressure, breast, stomach, and pelvic organ exams, and a Pap smear. You should have periodic mammograms as determined by your doctor. Follow your doctor's instructions for examining your own breasts, and report any lumps immediately. Your doctor should reevaluate you every 3 to 6 months to determine whether you need to continue using Premarin Cream. If you are only being treated for vaginal menopause symptoms, products applied locally, such as vaginal creams, tablets, or rings, should be considered before products taken by mouth or absorbed through the skin. If you have other medical conditions and are prescribed estrogens for more than one condition, consult your doctor about your treatment plan and its options. Premarin Cream may weaken and increase the failure of condoms, diaphragms, or cervical caps made of latex or rubber. If you may become pregnant, use another form of birth control. Diabetes patients - Premarin Cream may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine. Premarin Cream may cause dark skin patches on your face (melasma). Exposure to the sun may make these patches darker, and you may need to avoid prolonged sun exposure and sunlamps. Consult your doctor regarding the use of sunscreens and protective clothing. If you wear contact lenses and you develop problems with them, contact your doctor. If you will be having surgery or will be on bedrest, notify your doctor beforehand. Special precautions may need to be taken in these circumstances while you are using Premarin Cream. Premarin Cream may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using Premarin Cream. Lab tests, including a lipid profile or thyroid function, may be performed while you use Premarin Cream. Breast and pelvic exams should be performed every year unless your doctor tells you otherwise. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. Use Premarin Cream with caution in ELDERLY women; they may be more sensitive to its effects. Premarin Cream should not be used in CHILDREN; safety and effectiveness in children have not been confirmed. PREGNANCY and BREAST-FEEDING: Do not use Premarin Cream if you are pregnant. Avoid becoming pregnant while you are using it. If you think you may be pregnant, contact your doctor right away. Premarin Cream is found in breast milk. If you are or will be breast-feeding while you use Premarin Cream, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Premarin Cream:

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:

Back pain; bloating; breast pain or tenderness; diarrhea; dizziness; headache; increased cough; increased or decreased interest in sex; irregular vaginal bleeding or spotting; light-headedness; mild fluid retention; mild hair loss; mild vaginal burning, itching, or irritation; muscle aches or cramps; nausea; sore throat; stomach pain or cramping; trouble sleeping; vomiting; weakness; weight changes.

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); breast lumps; calf pain or tenderness; changes in vision or speech; chest pain; confusion; dark urine; depression; fainting; fever, chills, or persistent sore throat; mental or mood changes; one-sided weakness; persistent pain or tenderness in the upper abdomen; severe or persistent dizziness or headache; severe or persistent stomach or back pain with nausea or vomiting; shortness of breath; swelling of the hands or feet; unusual vaginal bleeding or discharge, itching, or odor; weakness or numbness of an arm or leg; yellowing of the skin or eyes.

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.

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 excessive vaginal bleeding 2 to 7 days following overdose; severe nausea and vomiting.

Proper storage of Premarin Cream:

Store Premarin Cream at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Premarin Cream out of the reach of children and away from pets.

General information: If you have any questions about Premarin Cream, please talk with your doctor, pharmacist, or other health care provider. Premarin Cream 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 Premarin Cream. Additionally, your doctor may have prescribed Premarin Cream for a use not mentioned above. 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 Premarin resources Premarin Use in Pregnancy & Breastfeeding Premarin Drug Interactions Premarin Support Group 0 Reviews for Premarin - Add your own review/rating Compare Premarin with other medications Atrophic Urethritis Atrophic Vaginitis Postmenopausal Symptoms
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Omacor


OMACOR

1000 mg soft capsules

Omega-3-acid ethyl esters 90

Read all of this leaflet carefully before you start taking this medicine.

Keep this leaflet. You may want to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

If any of the side-effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1. What Omacor is and what it is used for
2. Before you take Omacor
3. How to take Omacor
4. Possible side effects
5. How to store Omacor
6. Further information

What Omacor Is And What It Is Used For

Omacor contains highly purified omega-3 polyunsaturated fatty acids.

Omacor belongs to a group of so called reducers of cholesterol and triglycerides.

Omacor is used:

together with other medicines for treatment after a heart attack. to treat certain forms of increased triglycerides (fats) in the blood after changes to the diet have not worked. Before You Take Omacor Do not take Omacor, if you are allergic (hypersensitive) to the main ingredient or any of the other ingredients of Omacor (see Section: Important information about some of the ingredients, and Section 6: Further Information).

If any of the above applies to you, do not take this medicine, and talk to your doctor.

Take special care with Omacor if: you are due to have or have had surgery recently you have had a trauma recently you have a kidney problem you have diabetes which is not controlled you have problems with your liver. Your doctor will monitor any effects Omacor may have on your liver with blood tests.

If any of the above applies to you, talk to your doctor or pharmacist before taking this medicine.

Using other medicines

If you are using a medicine to stop blood clotting in your arteries, such as warfarin, you may need extra blood tests and your usual dose of your blood thinning medicine may have to be changed.

Please tell your doctor or pharmacist if you are using or have recently used other medicines including medicines obtained without prescription.

Taking Omacor with food or drink

You should take the capsules at meal times. This is to help lower the chances of side effects that affect the area in and around the stomach (the gastro-intestinal area).

Use in elderly

Use Omacor with care if you are over 70 years.

Use in children

Children should not take this medicine.

Pregnancy and breast-feeding

You should not take this medicine if you are pregnant or breast-feeding, unless your doctor decides it is absolutely necessary.

Ask your doctor or pharmacist for advice before using any medicine.

Driving and using machines

This medicine is not likely to affect you being able to drive or use any tools or machines.

Important Information about some of the ingredients

Omacor may contain soya-bean oil. If you are allergic to peanut or soya, do not use this medicinal product.

How To Take Omacor

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

Swallow the capsules with a drink of water. You may take the capsules at meal times to help reduce gastro-intestinal side effects. Your doctor will decide how long you should take this medicine. Dose after a heart attack

The usual dose is one capsule a day.

Dose to treat high blood triglyceride levels (high levels of fat in the blood or hypertriglyceridaemia)

The usual dose is 2 capsules a day, as recommended by a doctor.

If the medicine is not working well enough at this dose, your doctor may increase this to 4 capsules a day.

If you take more of Omacor than you should

If you accidentally take more of this medicine than you should, do not worry, as this is unlikely to need special treatment.

If you forget to take Omacor

If you miss a dose, take it when you remember unless it is almost time for your next dose, in which case take the next dose as usual. Do not take a double dose (twice the dose recommended by your doctor) to make up for a forgotten dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Omacor Side Effects

Like all medicines, Omacor can cause side effects, although not everybody gets them. The following are side effects that may happen with this medicine:

Common side effects (occur in 1 to 10 users in 100):

stomach problems and indigestion (dyspepsia) feeling sick (nausea)

Uncommon side effects (occur in 1 to 10 users in 1,000):

abdominal and stomach pain allergic reactions dizziness problems with taste diarrhoea being sick (vomiting)

Rare side effects (occur in 1 to 10 users in 10,000):

headache acne itchy rash (pruritus) high blood sugar levels liver problems

Very rare side effects (occur in less than 1 in 10,000 users):

blood in your stools low blood pressure dry nose raised red skin rash (hives or urticaria) changes in the results of certain blood tests

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

How To Store Omacor Keep out of the reach and sight of children. Do not use Omacor after the expiry date which is printed on the carton and the label. The expiry date refers to the last day of the month. Do not store Omacor above 25°C. Do not freeze.

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

Further Information What Omacor contains

The active substances are omega-3-acid ethyl esters, 1000 mg of omega-3-acid ethyl esters 90 comprising 460 mg eicosapentaenoic acid (EPA) and 380 mg docosahexaenoic acid (DHA) ethyl esters (these substances are called omega-3 polyunsaturated fatty acids) including as antioxidant 4 mg d-alpha- tocopherol (mixed with a vegetable oil e.g. soya-bean oil).

The soft capsule shell is made up of gelatin, glycerol and purified water.

What Omacor looks like and contents of the pack

Omacor capsules are transparent soft gelatin capsules containing pale yellow oil.

Omacor is available in the following pack sizes:

1 x 20 capsules 1 x 28 capsules 1 x 60 capsules 1 x 100 capsules 10 x 28 capsules

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

The marketing authorisation holder and manufacturer of Omacor is:

Pronova BioPharma Norge AS 1327 Lysaker Norway

This leaflet was last updated: April 2010

Omacor is supplied in the United Kingdom by

Abbott Healthcare Products Limited Mansbridge Road Southampton SO18 3JD

1070990 Laetus 35


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Aczone topical


Generic Name: Dapsone topical
Class: Skin and Mucous Membrane Agents, Miscellaneous
ATC Class: D10AX05
Chemical Name: Diaminodiphenylsulfone
Molecular Formula: C12H12N2O2S
CAS Number: 80-08-0

Introduction

Synthetic sulfone1 2 3 5 18 with anti-infective and anti-inflammatory effects.2 3 5 18

Uses for Aczone Acne Vulgaris

Topical treatment of acne vulgaris.1 2 3 4 11

Effective against inflammatory acne lesions and, to a lesser extent, noninflammatory acne lesions.2 3

Aczone Dosage and Administration Administration Topical Administration

Administer topically to the skin as a 5% gel.1

For external use only.1 Do not use orally or intravaginally; avoid contact with the mouth and eyes.1

Gently cleanse and dry the acne-affected area prior to application.1 Apply a pea-sized amount of dapsone 5% gel in a thin layer; rub in gently and completely.1

The gel is gritty with visible drug substance particles.1 Wash hands after applying the gel.1

Dosage Pediatric Patients Acne Vulgaris Topical

Children ?12 years of age: Apply a thin layer of dapsone 5% gel to cleansed affected area twice daily.1

Reassess use of the drug if improvement does not occur after 12 weeks of treatment.1

Has been used for up to 12 months in clinical studies.3

Adults Acne Vulgaris Topical

Apply a thin layer of dapsone 5% gel to the cleansed affected area twice daily.1

Reassess use of the drug if improvement does not occur after 12 weeks of treatment.1

Has been used for up to 12 months in clinical studies.3

Cautions for Aczone Contraindications

Manufacturer states none known.1

Warnings/Precautions Sensitivity Reactions

Moderate erythema has been reported when topical dapsone 5% gel was evaluated in combined contact sensitization/irritation studies.1 Pruritus,2 3 6 rash,3 and contact dermatitis6 were reported in some patients receiving the topical gel for treatment of acne vulgaris.

Oral dapsone has been associated with hypersensitivity reactions that include severe dermatologic reactions.1 7 16 (See Dermatologic Reactions under Cautions.) Hypersensitivity reactions reported with oral dapsone have also included fever, malaise, hepatitis, and hemolysis.10

Topical dapsone did not induce phototoxicity or photoallergy in human dermal safety studies.1

Hematologic Effects

Oral dapsone has been associated with dose-related hemolysis and hemolytic anemia.1 14 Agranulocytosis also reported in patients receiving oral dapsone.1 9 Individuals with glucose-6-phosphate dehydrogenase (G6PD) deficiency are more prone to hemolysis when receiving certain drugs.1 G6PD deficiency is most prevalent in populations of African, South Asian, Middle Eastern, and Mediterranean ancestry.1

There were no reports of clinically relevant hemolysis or hemolytic anemia in clinical studies evaluating topical dapsone 5% gel in individuals with acne vulgaris, including individuals with G6PD deficiency.1 2 3 6 However, laboratory changes suggestive of hemolysis (slight decreases in hemoglobin) occurred in some individuals with G6PD deficiency using the topical gel.1 2 6

If signs and symptoms suggestive of hemolytic anemia occur, discontinue topical dapsone therapy.1

Because of the potential for hemolytic reactions, do not use topical dapsone 5% gel in individuals receiving oral dapsone or antimalarial agents.1 (See Specific Drugs under Interactions.)

Concomitant use of topical dapsone 5% gel and co-trimoxazole may increase the risk of hemolysis in patients with G6PD deficiency.1 (See Specific Drugs under Interactions.)

Peripheral Neuropathy

Oral dapsone has been associated with peripheral neuropathy (motor loss and muscle weakness).1

Peripheral neuropathy was not reported in clinical studies evaluating topical dapsone 5% gel for the treatment of acne vulgaris.1

Dermatologic Reactions

Oral dapsone has been associated with serious skin reactions, including toxic epidermal necrolysis, erythema multiforme, morbilliform and scarlatiniform reactions, bullous and exfoliative dermatitis, erythema nodosum, and urticaria.1 7

Although erythema,1 pruritus,2 3 and rash3 were reported in clinical studies evaluating topical dapsone 5% gel for the treatment of acne vulgaris, more severe dermatologic reactions were not reported.1

Specific Populations Pregnancy

Category C.1

Oral dapsone has been associated with embryocidal effects in rats and rabbits when used in dosages approximately 800 and 500 times, respectively, the systemic exposure (based on AUC) observed in human females receiving the maximum recommended dosage of topical dapsone 5% gel.1 These effects were probably secondary to maternal toxicity.1

Use during pregnancy only if potential benefits outweigh potential risks to the fetus.1

Lactation

Distributed into milk following oral administration.1 Systemic absorption is low following topical application of dapsone 5% gel; however, because of the potential to cause adverse reactions in nursing infants, discontinue nursing or discontinue topical dapsone therapy.1

Pediatric Use

Safety and efficacy not established in children <12 years of age.1

Geriatric Use

Insufficient experience with topical dapsone 5% gel in geriatric patients ?65 years of age to determine whether such individuals respond differently than younger individuals.1

Common Adverse Effects

Local reactions at the application site (oiliness/peeling, dryness, erythema).1 2

Interactions for Aczone

Although only small amounts of dapsone are absorbed systemically following topical application to skin, the possibility that drug interactions could occur should be considered.1 Concomitant use of oral dapsone and certain drugs (e.g., rifampin, anticonvulsants, St. John's wort) may increase the formation of dapsone hydroxylamine, a dapsone metabolite associated with hemolysis.1 In addition, concomitant use of oral dapsone and folic acid antagonists (e.g., pyrimethamine) may increase the likelihood of adverse hematologic effects.1

Specific Drugs

Drug

Interaction

Comments

Antimalarial agents

Increased risk of hemolytic reactions if topical dapsone used concomitantly with antimalarial agents1

Do not use topical dapsone in patients receiving antimalarial agents1

Benzoyl peroxide

In vitro, combinations of topical dapsone 5% gel and topical benzoyl peroxide resulted in an orange discoloration17

Concomitant use of topical dapsone 5% gel and topical benzoyl peroxide in individuals with acne vulgaris may result in temporary local yellow or orange discoloration of the skin and facial hair;1 usually resolves in 4–57 days1

Co-trimoxazole

Concomitant use of topical dapsone 5% gel and oral co-trimoxazole results in increased systemic exposure to dapsone and dapsone metabolites; pharmacokinetics of co-trimoxazole not affected1 5

Possible increased risk of hemolysis in patients with G6PD deficiency1

Dapsone, oral

Increased risk of hemolytic reactions if oral and topical dapsone used concomitantly1

Do not use topical dapsone in patients receiving oral dapsone1

Aczone Pharmacokinetics Absorption Bioavailability

Absorbed systemically following topical application to skin.1 5

In patients with acne vulgaris skin lesions, plasma concentrations of dapsone are detectable within 2 hours after the first dose of topical dapsone 5% gel.5

After topical application of dapsone 5% gel to acne vulgaris skin lesions on the face, upper back, shoulders, and/or upper chest (up to approximately 22.5% of total body surface area) twice daily for 14 days, mean peak plasma concentrations of the drug were 19.4 ng/mL and the median time to peak concentrations after a dose was 9 hours.5

In a long-term safety study of dapsone 5% gel, there was no evidence that systemic exposure increases over time.1

Systemic exposure (AUC) following a 14-day regimen of dapsone 5% gel is 126 times lower than systemic exposure (AUC) following a single 100-mg dose of oral dapsone.5

Special Populations

Systemic dapsone exposure following topical application of dapsone 5% gel in children 12–15 years of age is similar to that reported in those ?16 years of age.1

Stability Storage Topical Gel

20–25°C (may be exposed to 15–30°C).1 Do not freeze.1

ActionsActions

Synthetic sulfone1 2 3 5 18 with anti-infective and anti-inflammatory effects.3 5 18

For dermatologic use, dapsone is commercially available in an aqueous gel base.1

Mechanism of action in the treatment of acne vulgaris not known, but may result from a combination of both anti-inflammatory and anti-infective effects.1 2 3 18

Dapsone exerts a variety of anti-inflammatory effects.2 3 18 The drug may inhibit myeloperoxidase- and hydrogen peroxide-based cytotoxic systems in neutrophils or may act as a scavenger of reactive oxygen species, thereby minimizing inflammation associated with generation of these reactive species.18

The anti-infective effects of dapsone involve inhibition of folic acid synthesis in susceptible organisms.18

In vitro, dapsone has some antibacterial activity against Propionibacterium acnes.18 It is not known whether topical dapsone therapy results in decreased susceptibility of P. acnes to other drugs used to treat acne.1

Advice to Patients

Importance of using as directed by the clinician and only for condition prescribed.1

Advise patient that topical dapsone is for external use only and should not be used orally or intravaginally; importance of avoiding contact with the mouth and eyes.1

Importance of storing at room temperature and protecting the drug from freezing.1

Importance of informing clinician of glucose-6-phosphate dehydrogenase (G6PD) deficiency.1

Importance of reporting any signs of adverse reactions to a clinician.1

Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs, especially topical agents applied to the skin (e.g., preparations containing benzoyl peroxide).1

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

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

Preparations

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

Dapsone

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Topical

Gel

5%

Aczone

Allergan

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 July 2010. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Allergan. Aczone (dapsone) gel 5% prescribing information. Irvine, CA. 2009 Mar.

2. Draelos ZD, Carter E, Maloney JM et al. Two randomized studies demonstrate the efficacy and safety of dapsone gel, 5% for the treatment of acne vulgaris. J Am Acad Dermatol. 2007; 56:439.e1-10.

3. Lucky AW, Maloney JM, Roberts J et al. Dapsone gel 5% for the treatment of acne vulgaris: safety and efficacy of long-term (1 year) treatment. J Drugs Dermatol. 2007; 6:981-7. [PubMed 17966175]

4. Raimer S, Maloney JM, Bourcier M et al. Efficacy and safety of dapsone gel 5% for the treatment of acne vulgaris in adolescents. Cutis. 2008; 81:171-8. [PubMed 18441772]

5. Thiboutot DM, Willmer J, Sharata H et al. Pharmacokinetics of dapsone gel, 5% for the treatment of acne vulgaris. Clin Pharmacokinet. 2007; 46:697-712. [PubMed 17655376]

6. Piette WW, Taylor S, Pariser D et al. Hematologic safety of dapsone gel, 5%, for topical treatment of acne vulgaris. Arch Dermatol. 2008; 144:1564-70. [PubMed 19075138]

7. Agrawal S, Agarwalla A. Dapsone hypersensitivity syndrome: a clinico-epidemiological review. J Dermatol. 2005; 32:883-9. [PubMed 16361748]

9. Coleman MD. Dapsone-mediated agranulocytosis: risks, possible mechanisms and prevention. Toxicology. 2001; 162:53-60. [PubMed 11311458]

10. Corp CC, Ghishan FK. The sulfone syndrome complicated by pancreatitis and pleural effusion in an adolescent receiving dapsone for treatment of acne vulgaris. J Pediatr Gastroenterol Nutr. 1998; 26:103-5. [PubMed 9443128]

11. Del Rosso JQ. Newer topical therapies for the treatment of acne vulgaris. Cutis. 2007; 80:400-10. [PubMed 18189027]

14. Ismail R. Acne fulminans with dapsone induced haemolysis: a case report. Med J Malaysia. 1987; 42:124-6. [PubMed 2971861]

16. Tomecki KJ, Catalano CJ. Dapsone hypersensitivity. The sulfone syndrome revisited. Arch Dermatol. 1981; 117:38-9. [PubMed 6450569]

17. Dubina MI, Fleischer AB. Interaction of topical sulfacetamide and topical dapsone with benzoyl peroxide. Arch Dermatol. 2009; 145:1027-9. [PubMed 19770443]

18. Center for Drug Evaluation and Research. Microbiology review of NDA application 21-794. 2005 Jun 20.

More Aczone topical resources Aczone topical Side Effects (in more detail) Aczone topical Use in Pregnancy & Breastfeeding Aczone topical Drug Interactions Aczone topical Support Group 33 Reviews for Aczone - Add your own review/rating Compare Aczone topical with other medications Acne
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Equell



Dosage Form: FOR ANIMAL USE ONLY
Equell®
(ivermectin)
Paste 1.87%
Anthelmintic and Boticide

FOR ORAL USE IN HORSES ONLY

Removes worms and bots with a single dose.

Contents will treat up to 1320 lb body weight.

Net Weight: 0.225 oz (6.42 g)

INDICATIONS

Consult your veterinarian for assistance in the diagnosis, treatment and control of parasitism. Equell (ivermectin) Paste provides effective control of the following parasites in horses:

Large Strongyles (adults)
  Strongylus vulgaris (also early forms in blood vessels)
  S. edentatus (also tissue stages)
  S. equinus
  Triodontophorus spp. including T. brevicauda, T. serratus
  Craterostomum acuticaudatum

Small Strongyles (adults, including those resistant to some benzimidazole class compounds)
  Coronocyclus spp. including C. coronatus, C. labiatus and C. labratus
  Cyathostomum spp. including C. catinatum, C. pateratum
  Cylicocyclus spp. including C. insigne, C. leptostomum, C. nassatus, C. brevicapsulatus
  Cylicostephanus spp. including C. calicatus, C. goldi, C. longibursatus, C. minutus
  Cylicodontophorus spp.
  Petrovinema poculatum

Small Strongyles (fourth-stage larvae)

Pinworms (adults and fourth-stage larvae)
  Oxyuris equi

Ascarids (adults and third- and fourth-stage larvae)
  Parascaris equorum

Hairworms (adults)
  Trichostrongylus axei

Large-mouth Stomach Worms (adults)
  Habronema muscae

Bots (oral and gastric stages)
  Gasterophilus spp. including G. intestinalis and G. nasalis

Lungworms (adults and fourth-stage larvae)
  Dictyocaulus arnfieldi

Intestinal Threadworms (adults)
  Strongyloides westeri

Summer Sores caused by Habronema and Draschia spp. cutaneous third-stage larvae

Dermatitis caused by Neck Threadworm microfilariae, Onchocerca sp.

Equell Dosage and Administration

This syringe contains sufficient paste to treat one 1320-lb horse at the recommended dose rate of 91 mcg ivermectin per lb (200 mcg/kg) of body weight. Each weight marking on the syringe plunger delivers enough paste to treat 250 lb (114 kg) of body weight.

While holding plunger, turn the knurled ring on the plunger 1/4 turn to the left and slide it so the side nearest the barrel is at the prescribed weight marking. Lock the ring in place by making a 1/4 turn to the right. Make sure that the horse’s mouth contains no feed. Remove the cover from the tip of the syringe. Insert the syringe tip into the horse’s mouth at the space between the teeth. Depress the plunger as far as it will go, depositing paste on the back of the tongue. Immediately raise the horse's head for a few seconds after dosing. Parasite Control Program

All horses should be included in a regular parasite control program with particular attention being paid to mares, foals, and yearlings. Foals should be treated initially at 6 to 8 weeks of age, and routine treatment repeated as appropriate. Consult your veterinarian for a control program to meet your specific needs. Equell Paste effectively controls gastrointestinal nematodes and bots of horses. Regular treatment will reduce the chances of verminous arteritis caused by Strongylus vulgaris.

Product Advantages Broad-spectrum Control

Equell Paste kills important internal parasites, including bots and the arterial stages of S. vulgaris, with a single dose. Equell Paste is a potent antiparasitic agent that is neither a benzimidazole nor an organophosphate.

ANIMAL SAFETY

Equell Paste may be used in horses of all ages, including mares at any stage of pregnancy. Stallions may be treated without adversely affecting their fertility.

Warnings

Do not use in horses intended for human consumption.

Not for use in humans. Keep this and all drugs out of reach of children. Refrain from smoking and eating when handling. Wash hands after use. Avoid contact with eyes.

The Material Safety Data Sheet (MSDS) contains more detailed occupational safety information. To report adverse reactions in users, to obtain more information, or to obtain a MSDS, contact Bimeda, Inc. at 1-888-524-6332.

Precautions

Equell Paste has been formulated specifically for use in horses only. This product should not be used in other animal species as severe adverse reactions, including fatalities in dogs, may result.

Environmental Safety

Ivermectin and excreted ivermectin residues may adversely affect aquatic organisms. Do not contaminate ground or surface water. Dispose of the syringe in an approved landfill or by incineration.

Store at room temperature (25°C/77°F), with excursions permitted between 15°- 30°C (59°- 86°F).

INFORMATION FOR HORSE OWNERS

Swelling and itching reactions after treatment with ivermectin paste have occurred in horses carrying heavy infections of neck threadworm (Onchocerca sp. microfilariae). These reactions were most likely the result of microfilariae dying in large numbers. Symptomatic treatment may be advisable. Consult your veterinarian should any such reactions occur. Healing of summer sores involving extensive tissue changes may require other appropriate therapy in conjunction with treatment with Equell Paste. Reinfection, and measures for its prevention, should also be considered. Consult your veterinarian if the condition does not improve.

ANADA 200-320, Approved by FDA

Manufactured by:
Virbac AH Inc.
3200 Meacham Blvd
Fort Worth, Texas 76137

Distributed by:
Bimeda, Inc.
Le Sueur, MN 56058

Equell is a Registered Trademark of Virbac SA.

November 2009

301981-01

PRINCIPAL DISPLAY PANEL - 6.42 g Syringe Carton

Equell®
(ivermectin)

Paste 1.87%

Anthelmintic and Boticide

Removes worms and bots with a single dose.

Contents will treat up to 1320 lb. body weight.

FOR ORAL USE IN HORSES ONLY

Net Weight: 0.225 oz (6.42 g)

ANADA 200-320, Approved by FDA

Bimeda


Equell 
ivermectin  paste Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 61133-7010 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Ivermectin (Ivermectin) Ivermectin 200 ug Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color WHITE Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 61133-7010-1 1 SYRINGE In 1 CARTON None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANADA ANADA200320 01/14/2010
Labeler - Bimeda Inc (043653216) Registrant - Virbac AH Inc (131568396) Establishment Name Address ID/FEI Operations Virbac Bridgeton 808558100 MANUFACTURE Revised: 01/2010Bimeda Inc

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Follitropin Alfa Solution


Pronunciation: FALL-lee-tro-pin
Generic Name: Follitropin Alfa
Brand Name: Gonal-f RFF Pen
Follitropin Alfa Solution is used for:

Treating infertility in certain women. It may also be used for other conditions as determined by your doctor.

This is a fertility medicine that helps develop eggs in the ovaries in women trying to become pregnant. Follitropin Alfa Solution is usually used with fertility programs and other fertility medicines.

Do NOT use Follitropin Alfa Solution if: you are allergic to any ingredient in Follitropin Alfa Solution you have primary ovarian failure (eg, your ovaries do not make eggs) you have uncontrolled thyroid or adrenal problems you have hormone-sensitive tumors you have pituitary tumor or other brain lesion or tumor you are pregnant or think you may be pregnant you have cancer in your female organs (eg, ovaries, breast, uterus) you have heavy or irregular bleeding from your uterus or vagina you have ovarian cysts or enlargement, not due to polycystic ovary syndrome (PCOS)

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

Before using Follitropin Alfa Solution:

Some medical conditions may interact with Follitropin Alfa Solution. Tell your health care provider 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 urinary tract bleeding if you have an adrenal gland or thyroid problem if you have blood clotting or breathing problems (eg, asthma)

Some MEDICINES MAY INTERACT with Follitropin Alfa Solution. Tell your health care provider if you are taking any other medicines.

Ask your health care provider if Follitropin Alfa Solution 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 Follitropin Alfa Solution:

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

An extra patient leaflet is available with Follitropin Alfa Solution. Talk to your pharmacist if you have questions about this information. Follitropin Alfa Solution is sometimes used at home as an injection. Use Follitropin Alfa Solution exactly as prescribed. Do not change the dose unless your doctor tells you to. Your doctor will tell you the number of units of the pen to use each day and the number of days to use the same pen. Follitropin Alfa Solution is an injection given under the skin. Your doctor or health care provider will instruct you as to how to inject yourself. Do not use Follitropin Alfa Solution at home until your health care provider has shown you the correct way. Make sure that you understand how to properly prepare and measure your dose. If you have any questions about preparing or measuring the dose, contact your health care provider. Prime the pen before the first use. You only need to prime the first time you use a new pen. Do not touch the needle or allow it to touch any surface. Allow the liquid solution to come to room temperature before you inject. Check that the liquid is clear before you inject. Do not use the injection if it contains any particles. Report this to your health care provider immediately. It is normal for a small amount of drug to be left over in the medicine pen. Discard any remaining medicine in the pen after your injection. If you are traveling, keep the pen away from light and extreme temperatures. If you use too much medicine in the pen, call your health care provider at once. If you miss a dose of Follitropin Alfa Solution, do not double the dose. Contact your doctor if to find out when you should take your next dose.

Ask your health care provider any questions you may have about how to use Follitropin Alfa Solution.

Important safety information: Follitropin Alfa Solution may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Follitropin Alfa Solution with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. You will need to have a complete gynecological and hormone evaluation prior to starting therapy with Follitropin Alfa Solution. Your partner should be evaluated for fertility problems. Ovarian hyperstimulation syndrome (OHSS) is a severe side effect that may occur in some patients who use Follitropin Alfa Solution. Contact your doctor right away if you develop severe stomach pain or bloating; nausea, vomiting, or diarrhea; sudden unexplained weight gain; shortness of breath; or decreased urination. Follitropin Alfa Solution may cause multiple births (eg, twins). Talk with your doctor to discuss your chances of multiple births. Lab tests, including ultrasound or drawing an estradiol level, may be performed while you use Follitropin Alfa Solution. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. Follitropin Alfa Solution should not be used in CHILDREN; safety and effectiveness in children have not been confirmed. PREGNANCY and BREAST-FEEDING: Do not use Follitropin Alfa Solution if you are pregnant. If you think you may be pregnant, contact your doctor right away. If you are or will be breast-feeding while you use Follitropin Alfa Solution, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Follitropin Alfa Solution:

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:

Breast pain; discomfort, pain, or mild bruising at the injection site; headache; mild stomach pain or nausea; sinus inflammation; sore throat; stuffy nose.

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); abnormal vaginal bleeding; calf pain or tenderness; chest pain; confusion; decreased urination; diarrhea; fever; one-sided weakness; severe or persistent stomach pain, upset, or bloating; severe or persistent nausea; severe pelvic or back pain; shortness of breath; slurred speech; sudden, unexplained weight gain; unusual vaginal itching, discharge, or odor; vision changes; vomiting.

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: Follitropin Alfa 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 of overdose may include nausea; severe headache; severe stomach pain or swelling; vomiting; weakness; weight gain.

Proper storage of Follitropin Alfa Solution:

Store Follitropin Alfa Solution in the refrigerator (36 to 46 degrees F; 2 to 8 degrees C) until the expiration date. It can be kept at room temperature (68 to 77 degrees F; 20 to 25 degrees C) for up to 1 month or until the expiration date, whichever comes first. Protect from light. Do not freeze. Keep Follitropin Alfa Solution out of the reach of children and away from pets.

General information: If you have any questions about Follitropin Alfa Solution, please talk with your doctor, pharmacist, or other health care provider. Follitropin Alfa Solution 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 Follitropin Alfa Solution. 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 Follitropin Alfa resources Follitropin Alfa Side Effects (in more detail) Follitropin Alfa Use in Pregnancy & Breastfeeding Follitropin Alfa Drug Interactions Follitropin Alfa Support Group 2 Reviews for Follitropin Alfa - Add your own review/rating Compare Follitropin Alfa with other medications Follicle Stimulation Hypogonadism, Male Ovulation Induction
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Gonal-f Powder


Pronunciation: FALL-lee-tro-pin
Generic Name: Follitropin Alfa
Brand Name: Gonal-f
Gonal-f Powder is used for:

Treating infertility in certain patients. It may also be used for other conditions as determined by your doctor.

Gonal-f Powder is a human follicle-stimulating hormone. It is used to treat infertility in women by stimulating the ovaries to produce eggs.It is used to treat male infertility by increasing sperm count. Gonal-f Powder is usually given with other medicines.

Do NOT use Gonal-f Powder if: you are allergic to any ingredient in Gonal-f Powder you are allergic to sucrose, sodium phosphate, or benzyl alcohol you have uncontrolled thyroid or adrenal problems you have pituitary tumor or other brain lesion or tumor you have hormone-sensitive tumors you have primary ovarian failure (eg, your ovaries do not make eggs) you are pregnant or think you may be pregnant you have cancer in your female organs (eg, ovaries, breast, uterus) you have heavy or irregular bleeding from your uterus or vagina you have ovarian cysts or enlargement, not due to polycystic ovary syndrome (PCOS)

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

Before using Gonal-f Powder:

Some medical conditions may interact with Gonal-f Powder. Tell your health care provider 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 or other substances if you have urinary tract bleeding if you have an adrenal gland or thyroid problem if you have permanent damage to the testes if you have swollen, enlarged, or painful ovaries if you have blood-clotting problems or breathing problems (eg, asthma)

Some MEDICINES MAY INTERACT with Gonal-f Powder. Tell your health care provider if you are taking any other medicines.

Ask your health care provider if Gonal-f Powder 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 Gonal-f Powder:

Use Gonal-f Powder as directed by your doctor. Check the label on the medicine for exact dosing instructions.

An extra patient leaflet is available with Gonal-f Powder. Talk to your pharmacist if you have questions about this information. Gonal-f Powder is usually administered as an injection at your doctor's office, hospital, or clinic. If you will be using Gonal-f Powder at home, a health care provider will teach you how to use it. Be sure you understand how to use Gonal-f Powder. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions. Do not use Gonal-f Powder if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged. Do not touch the needle or allow it to touch any surface. The duration of treatment will be determined by your health care provider. It is recommended that a couple using Gonal-f Powder has intercourse daily, starting on the day before the injection of Gonal-f Powder. If you miss a dose of Gonal-f Powder, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Gonal-f Powder.

Important safety information: Gonal-f Powder may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Gonal-f Powder with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Women will need to have a complete gynecological and hormone evaluation prior to starting therapy with Gonal-f Powder. Your partner should be evaluated for fertility problems. Men will need to have a complete medical and hormone evaluation before starting therapy with Gonal-f Powder. Ovarian hyperstimulation syndrome (OHSS) is a severe side effect that may occur in some women who use Gonal-f Powder. Contact your doctor right away if you develop severe stomach pain or bloating; nausea, vomiting, or diarrhea; sudden unexplained weight gain; shortness of breath; or decreased urination. Gonal-f Powder may cause multiple births (eg, twins). Talk with your doctor to discuss your chances of multiple births. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Lab tests, such as ultrasound or drawing an estradiol level, may be performed while you use Gonal-f Powder. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. Gonal-f Powder is not for use in the ELDERLY; safety and effectiveness in the elderly have not been confirmed. Gonal-f Powder should not be used in CHILDREN; safety and effectiveness in children have not been confirmed. PREGNANCY and BREAST-FEEDING: Do not use Gonal-f Powder if you are pregnant. If you think you may be pregnant, contact your doctor right away. If you are or will be breast-feeding while you use Gonal-f Powder, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Gonal-f Powder:

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:

Acne; breast pain or growth; discomfort at the injection site; headache; sinus infection; stomach upset; tiredness.

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); abnormal vaginal bleeding; calf pain or tenderness; chest pain; confusion; fever; one-sided weakness; severe or persistent shortness of breath; severe pelvic or back pain; signs of OHSS (eg, decreased urination; diarrhea; severe or persistent stomach pain, upset or bloating; nausea; sudden unexplained weight gain; vomiting); slurred speech; unusual vaginal itching, discharge, or odor; vision changes.

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: Gonal-f 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 of overdose may include nausea; severe headache; severe stomach pain or swelling; vomiting; weakness; weight gain.

Proper storage of Gonal-f Powder:

Store Gonal-f Powder in the refrigerator (36 to 46 degrees F; 2 to 8 degrees C) until the expiration date. It can be kept at room temperature (68 to 77 degrees F; 20 to 25 degrees C) for up to 1 month or until the expiration date, whichever comes first. Once Gonal-f Powder is mixed, it should be used immediately. Do not store medicine that has been mixed. Protect from light. Do not freeze. Keep Gonal-f Powder out of the reach of children and away from pets.

General information: If you have any questions about Gonal-f Powder, please talk with your doctor, pharmacist, or other health care provider. Gonal-f Powder 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 Gonal-f Powder. 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 Gonal-f resources Gonal-f Side Effects (in more detail) Gonal-f Use in Pregnancy & Breastfeeding Gonal-f Drug Interactions Gonal-f Support Group 2 Reviews for Gonal-f - Add your own review/rating Compare Gonal-f with other medications Follicle Stimulation Hypogonadism, Male Ovulation Induction
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Zimecterin



Dosage Form: FOR ANIMAL USE ONLY
Zimecterin®
(ivermectin) 1.87% Paste INDICATIONS

Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. Zimecterin® (ivermectin) Paste provides effective treatment and control of the following parasites in horses.

Large Strongyles (adults) – Strongylus vulgaris (also early forms in blood vessels), S. edentatus (also tissue stages), S. equinus, Triodontophorus spp. including T. brevicauda and T. serratus and Craterostomum acuticaudatum;
Small Strongyles (adults, including those resistant to some benzimidazole class compounds) – Coronocyclus spp. including C. coronatus, C. labiatus and C. labratus, Cyathostomum spp. including C. catinatum and C. pateratum, Cylicocyclus spp. including C. insigne, C. leptostomum, C. nassatus and C. brevicapsulatus, Cylicodontophorus spp., Cylicostephanus spp. including C. calicatus, C. goldi, C. longibursatus and C. minutus, and Petrovinema poculatum;
Small Strongyles – Fourth-stage larvae;
Pinworms (adults and fourth-stage larvae) – Oxyuris equi;
Ascarids (adults and third- and fourth-stage larvae) – Parascaris equorum;
Hairworms (adults) – Trichostrongylus axei;
Large-mouth Stomach Worms (adults) – Habronema muscae;
Bots (oral and gastric stages) – Gasterophilus spp. including G. intestinalis and G. nasalis;
Lungworms (adults and fourth-stage larvae) – Dictyocaulus arnfieldi;
Intestinal Threadworms (adults) – Strongyloides westeri;
Summer Sores caused by Habronema and Draschia spp. cutaneous third-stage larvae;
Dermatitis caused by neck threadworm microfilariae, Onchocerca sp.

Zimecterin Dosage and Administration

This syringe contains sufficient paste to treat one 1250 lb horse at the recommended dose rate of 91 mcg ivermectin per lb (200 mcg/kg) body weight. Each weight marking on the syringe plunger delivers enough paste to treat 250 lb body weight. (1) While holding plunger, turn the knurled ring on the plunger 1/4 turn to the left and slide it so the side nearest the barrel is at the prescribed weight marking. (2) Lock the ring in place by making a 1/4 turn to the right. (3) Make sure that the horse's mouth contains no feed. (4) Remove the cover from the tip of the syringe. (5) Insert the syringe tip into the horse's mouth at the space between the teeth. (6) Depress the plunger as far as it will go, depositing paste on the back of the tongue. (7) Immediately raise the horse's head for a few seconds after dosing.

PARASITE CONTROL PROGRAM

All horses should be included in a regular parasite control program with particular attention being paid to mares, foals and yearlings. Foals should be treated initially at 6 to 8 weeks of age, and routine treatment repeated as appropriate. Consult your veterinarian for a control program to meet your specific needs. Zimecterin® (ivermectin) Paste effectively controls gastrointestinal nematodes and bots of horses. Regular treatment will reduce the chances of verminous arteritis caused by Strongylus vulgaris.

PRODUCT ADVANTAGES Broad-spectrum Control

Zimecterin® Paste kills important internal parasites, including bots and the arterial stages of S. vulgaris, with a single dose. Zimecterin® Paste is a potent antiparasitic agent that is neither a benzimidazole nor an organophosphate.

ANIMAL SAFETY

Zimecterin® (ivermectin) Paste may be used in horses of all ages, including mares at any stage of pregnancy. Stallions may be treated without adversely affecting their fertility.

STORAGE INFORMATION

Store at 68° F - 77° F (20-25° C). Excursions between 59° F - 86° F (15-30° C) are permitted.

Warning

Do not use in horses intended for human consumption.

Not for use in humans. Keep this and all drugs out of reach of children.
Refrain from smoking and eating when handling. Wash hands after use. Avoid contact with eyes. The Material Safety Data Sheet (MSDS) contains more detailed occupational safety information. To report adverse reactions in users, to obtain more information, or to obtain a MSDS, contact Merial at 1-888-637-4251.

Precautions

Zimecterin® (ivermectin) Paste has been formulated specifically for use in horses only. This product should not be used in other animal species as severe adverse reactions, including fatalities in dogs, may result.

Environmental Safety

Ivermectin and excreted ivermectin residues may adversely affect aquatic organisms. Do not contaminate ground or surface water. Dispose of the syringe in an approved landfill or by incineration.

INFORMATION FOR HORSE OWNERS

Swelling and itching reactions after treatment with Zimecterin® (ivermectin) Paste have occurred in horses carrying heavy infections of neck threadworm (Onchocerca sp.) microfilariae. These reactions were most likely the result of microfilariae dying in large numbers. Symptomatic treatment may be advisable. Consult your veterinarian should any such reactions occur. Healing of summer sores involving extensive tissue changes may require other appropriate therapy in conjunction with treatment with Zimecterin® Paste. Reinfection, and measures for its prevention, should also be considered. Consult your veterinarian if the condition does not improve.

Manufactured by: Merial Sa?de Animal Ltda., Paulinia, S?o Paulo, CEP 13140-970, Brazil

Manufactured for: Merial Limited, Operational Headquarters, 3239 Satellite Blvd., Duluth, GA 30096-4640, U.S.A.

PRINCIPAL DISPLAY PANEL - 6.08 g label

Product 70961
For Oral Use in Horses Only

Zimecterin®
(ivermectin) 1.87% Paste

Anthelmintic and Boticide

For Treatment of Large Strongyles, Small Strongyles,
Pinworms, Roundworms (Ascarids), Hairworms,
Neck Threadworms, Large-mouth Stomach Worms,
Bots. See carton for complete indications and use
directions. Consult your veterinarian for assistance in
the diagnosis, treatment and control of parasitism.

NADA 134-314, Approved by the FDA
U.S. Pat. 4,199,569

Net Wt. 0.21 oz (6.08 g)

MERIAL

PRINCIPAL DISPLAY PANEL - 6.08 g box

Zimecterin®
(ivermectin) 1.87% Paste
ANTHELMINTIC AND BOTICIDE

MERIAL

CONTENTS WILL TREAT UP TO 1250 lb BODY WEIGHT.

Removes worms and bots
with a single dose.
For Oral Use in Horses Only
NADA 134-314, Approved by FDA

Net Wt. 0.21 oz (6.08 g)


Zimecterin 
ivermectin  paste Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 50604-7096 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ivermectin (ivermectin) ivermectin 18.7 mg  in 1 g 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 50604-7096-1 6.08 g In 1 SYRINGE, PLASTIC None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA134314 06/15/1984
Labeler - Merial Limited (034393582) Revised: 10/2009Merial Limited

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Valacyclovir


Pronunciation: VAL-ay-SYE-kloe-vir
Generic Name: Valacyclovir
Brand Name: Valtrex
Valacyclovir is used for:

Treating shingles (herpes zoster), cold sores (fever blisters or herpes labialis), and treating, suppressing, or reducing transmission of genital herpes in patients with healthy immune systems. It is also used to treat chickenpox in children and teenagers. It is also used to suppress genital herpes in patients with HIV infection.

Valacyclovir is an antiviral. It works by stopping viral replication. However, Valacyclovir does not eliminate the virus; it is not a cure. When used as a suppressive therapy in patients with healthy immune systems with genital herpes using safer sex practices, the risk of spreading the infections to others is reduced.

Do NOT use Valacyclovir if: you are allergic to any ingredient in Valacyclovir or to acyclovir

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

Before using Valacyclovir:

Some medical conditions may interact with Valacyclovir. 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 had a bone marrow or kidney transplant if you have HIV or AIDS if you have kidney problems or you are dehydrated

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

Medicines that may harm the kidney (eg, aminoglycoside antibiotics [eg, gentamicin], amphotericin B, cyclosporine, nonsteroidal anti-inflammatory drugs [NSAIDS] [eg, ibuprofen], tacrolimus, vancomycin) because the risk of kidney side effects may be increased. Ask your doctor if you are unsure if any of your medicines might harm the kidney

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

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

Take Valacyclovir by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation. Drinking extra fluids while you are taking Valacyclovir is recommended. Check with your doctor for instructions. To treat cold sores, chickenpox, shingles, or genital herpes, start treatment as soon as possible after your symptoms start. If treating an acute outbreak, use Valacyclovir for the full course of treatment. Keep using it even if you feel better in a few days. For suppressive therapy, Valacyclovir works best if it is taken at the same time each day. If you miss a dose of Valacyclovir, 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 Valacyclovir.

Important safety information: Valacyclovir may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Valacyclovir with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Valacyclovir is not a cure for herpes. Remain under the care of your doctor. Safer sex practices can lower the chances of passing genital herpes to your partner. Do not have sexual contact with your partner when you have any symptoms or outbreak of genital herpes. Use a condom made of latex or polyurethane whenever you have sexual contact. Valacyclovir has not been shown to decrease the risk of passing other sexually transmitted infections to your partner. Lab tests, including complete blood cell counts, kidney function, and liver function, may be performed while you use Valacyclovir. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. Use Valacyclovir with caution in the ELDERLY; they may be more sensitive to its effects, especially kidney and nervous system problems. Valacyclovir should be used with extreme caution in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed. PREGNANCY and BREAST-FEEDING: If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Valacyclovir while you are pregnant. Valacyclovir is found in breast milk. If you are or will be breast-feeding while you use Valacyclovir, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Valacyclovir:

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

Dizziness; headache; nausea; stomach pain; vomiting.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); agitation; aggressive behavior; bloody or dark urine; change in the amount of urine produced; confusion; depression; fatigue; fever; hallucinations; joint pain; lower back pain; painful menstrual periods; pale skin; pinpoint bruises; seizures; severe abdominal pain; severe or persistent headache; shaky movements; speech problems; swelling of the face, hands, feet, or entire body; unsteady movement; unusual bruising or bleeding; weakness; yellowing of the skin or eyes.

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: Valacyclovir side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org ), or emergency room immediately.

Proper storage of Valacyclovir:

Store Valacyclovir at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Valacyclovir out of the reach of children and away from pets.

General information: If you have any questions about Valacyclovir, please talk with your doctor, pharmacist, or other health care provider. Valacyclovir 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 Valacyclovir. 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 Valacyclovir resources Valacyclovir Side Effects (in more detail)Valacyclovir DosageValacyclovir Use in Pregnancy & BreastfeedingDrug ImagesValacyclovir Drug InteractionsValacyclovir Support Group62 Reviews for Valacyclovir - Add your own review/rating Valacyclovir Prescribing Information (FDA) Valacyclovir Hydrochloride Monograph (AHFS DI) Valtrex Consumer Overview Valtrex Prescribing Information (FDA) valacyclovir Advanced Consumer (Micromedex) - Includes Dosage Information Compare Valacyclovir with other medications Cold SoresCytomegalovirus InfectionHerpes Simplex, Mucocutaneous/Immunocompetent HostHerpes Simplex, Mucocutaneous/Immunocompromised HostHerpes Simplex, SuppressionHerpes ZosterMultiple SclerosisVaricella-Zoster
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Gyno-Daktarin 20mg / g Cream


1. Name Of The Medicinal Product

Gyno-Daktarin 20mg/g cream

2. Qualitative And Quantitative Composition

Miconazole nitrate 2% w/w.

(Each gram of cream contains 20mg miconazole nitrate)

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Vaginal cream.

The cream is white and homogeneous.

4. Clinical Particulars 4.1 Therapeutic Indications

For the treatment of mycotic vulvovaginitis and superinfections due to gram-positive bacteria.

4.2 Posology And Method Of Administration

Gyno-Daktarin cream is for vaginal administration.

Recommended dosage

Administer the contents of one applicator (about 5g of cream) once daily deeply into vagina for 10 – 14 days or twice daily for 7 days. For vulvitis the cream should be applied topically twice daily. Continue the course of treatment even after pruritus and leukorrhoea have disappeared or menstruation begins.

4.3 Contraindications

Gyno-Daktarin cream is contraindicated in individuals with a known hypersensitivity to miconazole or another ingredient of the cream.

4.4 Special Warnings And Precautions For Use

Should local sensitisation or an allergic reaction occur, treatment should be discontinued.

Appropriate therapy is indicated when the sexual partner is also infected.

Gyno-Daktarin cream does not stain skin or clothes.

The concurrent use of latex condoms or diaphragms with vaginal anti-infective preparations may decrease the effectiveness of latex contraceptive agents. Therefore Gyno-Daktarin cream should not be used concurrently with a latex condom or latex diaphragm.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Miconazole administered systemically is known to inhibit CYP3A4/2C9. Due to the limited systemic availability after vaginal application, clinically relevant interactions occur very rarely. In patients on oral anticoagulants, such as warfarin, caution should be exercised and anticoagulant effect should be monitored. The effects and side effects of other drugs metabolized by CYP2C9 (e.g.,oral hypoglycemics and phenytoin) and also CYP3A4 (e.g., HMG-CoA reductase inhibitors such as simvastatin and lovastatin and calcium channel blockers such as dihydropyridines and verapamil), when co-administered with miconazole, can be increased and caution should be exercised.

Contact should be avoided between certain latex products such as contraceptive diaphragms or condoms and Gyno-Daktarin cream since the constituents of the cream may damage the latex. (see section 4.4).

4.6 Pregnancy And Lactation

Pregnancy

Although intravaginal absorption is limited, Gyno-Daktarin cream should only be used in the first trimester of pregnancy only if, in the judgement of the physician, the potential benefits outweigh the possible risks.

Lactation

It is not known whether miconazole nitrate is excreted in human milk. Caution should be exercised when using Gyno-Daktarin cream during lactation.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

The safety of GYNO-DAKTARIN was evaluated in a total of 537 women with microbiologically confirmed candidiasis and symptoms (e.g., vulvovaginal itching, burning/irritation), or signs of vulvar erythema, edema, excoriation, or vaginal erythema or edema who participated in 2 single-blind clinical trials. Subjects were treated with miconazole intravaginally, randomly assigned to either a single 1,200 mg capsule, or a 7-day application of 2% vaginal cream. Adverse Drug Reactions (ADRs) reported by

In the table, the frequencies are provided according to the following convention:

Very common

Common

Uncommon

Rare

Very rare <1/10,000, including isolated reports

Table 1. Adverse Drug Reactions Reported by Gyno-Daktarin-treated Subjects in 2 Single Blind Clinical Trials

 

Body System/Organ Class

Frequency Category

Undesirable effects

 

Skin and subcutaneous tissue disorders

 

 

Common

Rash

Uncommon

Rash pruritic, urticaria

Reproductive System and Breast Disorders

 

 

Very common

Genital pruritus female, vaginal burning sensation, vulvovaginal discomfort

 

Common

Dysmenorrhoea

 

A range of additional reactions were reported during the clinical trials, such as: vaginal discharge, vaginal haemorrhage, vaginal pain, headache, dysuria, urinary tract infection, abdominal pain, rosacea, swelling face and nausea. However due to the design of these studies, a definitive causal relationship could not be established.

Table 2.Adverse Drug Reactions Identified During Postmarketing Experience with Gyno-Daktarin by Frequency Category Estimated from Spontaneous Reporting Rates

 

Immune System Disorders

 

Not known

Hypersensitivity including Anaphylactic and Anaphylactoid reactions, Angioedema

Skin and Subcutaneous Tissue Disorders

 

Not known

Pruritis

Reproductive System and Breast Disorders

 

Not known

Vaginal irritation, pelvic cramps

4.9 Overdose

Symptoms

In case of accidental ingestion, no problems are expected.

Treatment

In the event of accidental ingestion of large quantities, an appropriate method of gastric emptying may be used if considered appropriate.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic classification:

(Anti-infectives and antiseptics, excl. combinations with corticosteroids, imidazole derivatives)

ATC code: G01A F04

Miconazole combines a potent antifungal activity against common dermatophytes and yeasts with an antibacterial activity against certain gram-positive bacilli and cocci.

Miconazole inhibits the biosynsthesis of ergosterol in fungi and changes the composition of other lipid components in the membrane, resulting in fungal cell necrosis.

In general, miconazole exerts a very rapid effect on pruritus, a symptom that frequently accompanies dermatophyte and yeast infections.

5.2 Pharmacokinetic Properties

Absorption: Miconazole persists in the vagina for up to 72 hours after a single dose. Systemic absorption of miconazole after intravaginal administration is limited, with a bioavailability of 1 to 2% following intravaginal administration of a 1200 mg dose. Plasma concentrations of miconazole are measurable within 2 hours of administration in some subjects, with maximal levels seen 12 to 24 hours after administration. Plasma concentrations decline slowly thereafter and were still measurable in most subjects 96 hours post-dose. A second dose administered 48 hours later resulted in a plasma profile similar to that of the first dose.

Distribution: Absorbed miconazole is bound to plasma proteins (88.2%) and red blood cells (10.6%).

Metabolism and Excretion: The small amount of miconazole that is absorbed is eliminated predominantly in faeces as both unchanged drug and metabolites over a four-day post-administration period. Smaller amounts of unchanged drug and metabolites also appear in urine. The mean apparent elimination half-life is 57 hours.

5.3 Preclinical Safety Data

No relevant information additional to that contained elsewhere in the Summary of Product Characteristics.

6. Pharmaceutical Particulars 6.1 List Of Excipients

PEG-6, PEG-32 and glycol stearate

Oleoyl macroglycerides

Liquid paraffin

Benzoic acid (E210)

Butylated hydroxyanisole (E320)

Purified water

6.2 Incompatibilities

None known.

6.3 Shelf Life

24 months.

6.4 Special Precautions For Storage

Do not store above 25?C.

6.5 Nature And Contents Of Container

Tube containing 15 g, 40 g or 78 g of cream.

The aluminium tube inner is lined with heat polymerised epoxy-phenol resin with a white polypropylene cap.

The cream is supplied with disposable cardboard vaginal applicators.

*Not all pack sizes are marketed.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

Janssen-Cilag Ltd

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

UK

8. Marketing Authorisation Number(S)

PL 0242/0015

9. Date Of First Authorisation/Renewal Of The Authorisation

12 December 2008

10. Date Of Revision Of The Text

23rd July 09


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MetroGel Vaginal



Dosage Form: vaginal gel
MetroGel-Vaginal®
(metronidazole vaginal gel)
0.75% Vaginal Gel

FOR INTRAVAGINAL USE ONLY
NOT FOR OPHTHALMIC, DERMAL, OR ORAL USE

MetroGel Vaginal Description

METROGEL-VAGINAL is the intravaginal dosage form of the synthetic antibacterial agent, metronidazole, USP at a concentration of 0.75%. Metronidazole is a member of the imidazole class of antibacterial agents and is classified therapeutically as an antiprotozoal and antibacterial agent. Chemically, metronidazole is a 2-methyl-5-nitroimidazole-1-ethanol. It has a chemical formula of C6H9N3O3, a molecular weight of 171.16, and has the following structure:

METROGEL-VAGINAL is a gelled, purified water solution, containing metronidazole at a concentration of 7.5 mg/g (0.75%). The gel is formulated at pH 4.0. The gel also contains carbomer 934P, edetate disodium, methylparaben, propylparaben, propylene glycol, and sodium hydroxide.

Each applicator full of 5 grams of vaginal gel contains approximately 37.5 mg of metronidazole.

MetroGel Vaginal - Clinical Pharmacology Normal Subjects

Following a single, intravaginal 5 gram dose of metronidazole vaginal gel (equivalent to 37.5 mg of metronidazole) to 12 normal subjects, a mean maximum serum metronidazole concentration of 237 ng/mL was reported (range: 152 to 368 ng/mL). This is approximately 2% of the mean maximum serum metronidazole concentration reported in the same subjects administered a single, oral 500 mg dose of metronidazole (mean Cmax = 12,785 ng/mL, range: 10,013 to 17,400 ng/mL). These peak concentrations were obtained in 6 to 12 hours after dosing with metronidazole vaginal gel and 1 to 3 hours after dosing with oral metronidazole.

The extent of exposure [area under the curve (AUC)] of metronidazole, when administered as a single intravaginal 5 gram dose of metronidazole vaginal gel (equivalent to 37.5 mg of metronidazole), was approximately 4% of the AUC of a single oral 500 mg dose of metronidazole (4977 ng-hr/mL and approximately 125,000 ng-hr/mL, respectively).

Dose-adjusted comparisons of AUCs demonstrated that, on a mg to mg comparison basis, the absorption of metronidazole, when administered vaginally, was approximately half that of an equivalent oral dosage.

Patients with Bacterial Vaginosis

Following single and multiple 5 gram doses of metronidazole vaginal gel to 4 patients with bacterial vaginosis, a mean maximum serum metronidazole concentration of 214 ng/mL on day 1 and 294 ng/mL (range: 228 to 349 ng/mL) on day five were reported. Steady state metronidazole serum concentrations following oral dosages of 400 to 500 mg BID have been reported to range from 6,000 to 20,000 ng/mL.

Microbiology

The intracellular targets of action of metronidazole on anaerobes are largely unknown. The 5-nitro group of metronidazole is reduced by metabolically active anaerobes, and studies have demonstrated that the reduced form of the drug interacts with bacterial DNA. However, it is not clear whether interaction with DNA alone is an important component in the bactericidal action of metronidazole on anaerobic organisms.

Culture and sensitivity testing of bacteria are not routinely performed to establish the diagnosis of bacterial vaginosis. (See INDICATIONS AND USAGE.)

Standard methodology for the susceptibility testing of the potential bacterial vaginosis pathogens, Gardnerella vaginalis, Mobiluncus spp., and Mycoplasma hominis, has not been defined. Nonetheless, metronidazole is an antimicrobial agent active in vitro against most strains of the following organisms that have been reported to be associated with bacterial vaginosis:

  Bacteroides spp.   Gardnerella vaginalis   Mobiluncus spp.   Peptostreptococcus spp. Indications and Usage for MetroGel Vaginal

METROGEL-VAGINAL is indicated in the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis).

NOTE: For purposes of this indication, a clinical diagnosis of bacterial vaginosis is usually defined by the presence of a homogeneous vaginal discharge that (a) has a pH of greater than 4.5, (b) emits a "fishy" amine odor when mixed with a 10% KOH solution, and (c) contains clue cells on microscopic examination. Gram's stain results consistent with a diagnosis of bacterial vaginosis include (a) markedly reduced or absent Lactobacillus morphology, (b) predominance of Gardnerella morphotype, and (c) absent or few white blood cells.

Other pathogens commonly associated with vulvovaginitis, e.g., Trichomonas vaginalis, Chlamydia trachomatis, N. gonorrhoeae, Candida albicans, and Herpes simplex virus should be ruled out.

Contraindications

METROGEL-VAGINAL is contraindicated in patients with a prior history of hypersensitivity to metronidazole, parabens, other ingredients of the formulation, or other nitroimidazole derivatives.

Warnings Convulsive Seizures and Peripheral Neuropathy

Convulsive seizures and peripheral neuropathy, the latter characterized mainly by numbness or paresthesia of an extremity, have been reported in patients treated with oral or intravenous metronidazole. The appearance of abnormal neurologic signs demands the prompt discontinuation of metronidazole vaginal gel therapy. Metronidazole vaginal gel should be administered with caution to patients with central nervous system diseases.

Psychotic Reactions

Psychotic reactions have been reported in alcoholic patients who were using oral metronidazole and disulfiram concurrently. Metronidazole vaginal gel should not be administered to patients who have taken disulfiram within the last two weeks.

Precautions

METROGEL-VAGINAL affords minimal peak serum levels and systemic exposure (AUCs) of metronidazole compared to 500 mg oral metronidazole dosing. Although these lower levels of exposure are less likely to produce the common reactions seen with oral metronidazole, the possibility of these and other reactions cannot be excluded presently. Data from well-controlled trials directly comparing metronidazole administered orally to metronidazole administered vaginally are not available.

General

Patients with severe hepatic disease metabolize metronidazole slowly. This results in the accumulation of metronidazole and its metabolites in the plasma. Accordingly, for such patients, metronidazole vaginal gel should be administered cautiously.

Known or previously unrecognized vaginal candidiasis may present more prominent symptoms during therapy with metronidazole vaginal gel. Approximately 6–10% of patients treated with METROGEL-VAGINAL developed symptomatic Candida vaginitis during or immediately after therapy.

Disulfiram-like reaction to alcohol has been reported with oral metronidazole, thus the possibility of such a reaction occurring while on metronidazole vaginal gel therapy cannot be excluded.

METROGEL-VAGINAL contains ingredients that may cause burning and irritation of the eye. In the event of accidental contact with the eye, rinse the eye with copious amounts of cool tap water.

Information for the Patient

The patient should be cautioned about drinking alcohol while being treated with metronidazole vaginal gel. While blood levels are significantly lower with METROGEL-VAGINAL than with usual doses of oral metronidazole, a possible interaction with alcohol cannot be excluded.

The patient should be instructed not to engage in vaginal intercourse during treatment with this product.

Drug Interactions

Oral metronidazole has been reported to potentiate the anticoagulant effect of warfarin and other coumarin anticoagulants, resulting in a prolongation of prothrombin time. This possible drug interaction should be considered when metronidazole vaginal gel is prescribed for patients on this type of anticoagulant therapy.

In patients stabilized on relatively high doses of lithium, short-term oral metronidazole therapy has been associated with elevation of serum lithium levels and, in a few cases, signs of lithium toxicity.

Use of cimetidine with oral metronidazole may prolong the half-life and decrease plasma clearance of metronidazole.

Drug/Laboratory Test Interactions

Metronidazole may interfere with certain types of determinations of serum chemistry values, such as aspartate aminotransferase (AST, SGOT), alanine aminotransferase (ALT, SGPT), lactate dehydrogenase (LDH), triglycerides, and glucose hexokinase. Values of zero may be observed. All of the assays in which interference has been reported involve enzymatic coupling of the assay to oxidation-reduction of nicotinamide-adenine dinucleotides (NAD + NADH). Interference is due to the similarity in absorbance peaks of NADH (340 nm) and metronidazole (322 nm) at pH 7.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Metronidazole has shown evidence of carcinogenic activity in a number of studies involving chronic oral administration in mice and rats. Prominent among the effects in the mouse was the promotion of pulmonary tumorigenesis. This has been observed in all six reported studies in that species, including one study in which the animals were dosed on an intermittent schedule (administration during every fourth week only). At very high dose levels (approximately 500 mg/kg/day), there was a statistically significant increase in the incidence of malignant liver tumors in males. Also, the published results of one of the mouse studies indicate an increase in the incidence of malignant lymphomas as well as pulmonary neoplasms associated with lifetime feeding of the drug. All these effects are statistically significant. Several long-term oral dosing studies in the rat have been completed. There were statistically significant increases in the incidence of various neoplasms, particularly in mammary and hepatic tumors, among female rats administered metronidazole over those noted in the concurrent female control groups. Two lifetime tumorigenicity studies in hamsters have been performed and reported to be negative.

These studies have not been conducted with 0.75% metronidazole vaginal gel, which would result in significantly lower systemic blood levels than those obtained with oral formulations.

Although metronidazole has shown mutagenic activity in a number of in vitro assay systems, studies in mammals (in vivo) have failed to demonstrate a potential for genetic damage.

Fertility studies have been performed in mice up to six times the recommended human oral dose (based on mg/m2) and have revealed no evidence of impaired fertility.

Pregnancy Teratogenic Effects Pregnancy Category B

There has been no experience to date with the use of METROGEL-VAGINAL in pregnant patients. Metronidazole crosses the placental barrier and enters the fetal circulation rapidly. No fetotoxicity or teratogenicity was observed when metronidazole was administered orally to pregnant mice at six times the recommended human dose (based on mg/m2); however, in a single small study where the drug was administered intraperitoneally, some intrauterine deaths were observed. The relationship of these findings to the drug is unknown.

There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, and because metronidazole is a carcinogen in rodents, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers

Specific studies of metronidazole levels in human milk following intravaginally administered metronidazole have not been performed. However, metronidazole is secreted in human milk in concentrations similar to those found in plasma following oral administration of metronidazole.

Because of the potential for tumorigenicity shown for metronidazole in mouse and rat studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in children have not been established.

ADVERSE EVENTS Clinical Trials

There were no deaths or serious adverse events related to drug therapy in clinical trials involving 800 non-pregnant women who received METROGEL-VAGINAL.

In a randomized, single-blind clinical trial of 505 non-pregnant women who received METROGEL-VAGINAL once or twice a day, 2 patients (one from each regimen) discontinued therapy early due to drug-related adverse events. One patient discontinued drug because of moderate abdominal cramping and loose stools, while the other patient discontinued drug because of mild vaginal burning. These symptoms resolved after discontinuation of drug.

Medical events judged to be related, probably related, or possibly related to administration of METROGEL-VAGINAL once or twice a day were reported for 195/505 (39%) patients. The incidence of individual adverse reactions were not significantly different between the two regimens. Unless percentages are otherwise stipulated, the incidence of individual adverse reactions listed below was less than 1%:

   Reproductive:    Vaginal discharge (12%),    Symptomatic Candida cervicitis/vaginitis (10%),    Vulva/vaginal irritative symptoms (9%),    Pelvic discomfort (3%).    Gastrointestinal:    Gastrointestinal discomfort (7%),    Nausea and/or vomiting (4%),    Unusual taste (2%),    Diarrhea/loose stools (1%),    Decreased appetite (1%),    Abdominal bloating/gas; thirsty, dry mouth.    Neurologic:    Headache (5%),    Dizziness (2%),    Depression.    Dermatologic:    Generalized itching or rash.    Other:    Unspecified cramping (1%),    Fatigue,    Darkened urine.

In previous clinical trials submitted for approved labeling of METROGEL-VAGINAL the following was also reported:

  Laboratory:   Increased/decreased white blood cell counts (1.7%). Other Metronidazole Formulations

Other effects that have been reported in association with the use of topical (dermal) formulations of metronidazole include skin irritation, transient skin erythema, and mild skin dryness and burning. None of these adverse events exceeded an incidence of 2% of patients.

METROGEL-VAGINAL affords minimal peak serum levels and systemic exposure (AUC) of metronidazole compared to 500 mg oral metronidazole dosing. Although these lower levels of exposure are less likely to produce the common reactions seen with oral metronidazole, the possibility of these and other reactions cannot be excluded presently.

The following adverse reactions and altered laboratory tests have been reported with the oral or parenteral use of metronidazole:

   Cardiovascular: Flattening of the T-wave may be seen in electrocardiographic tracings.    Central Nervous System: (See WARNINGS.) Headache, dizziness, syncope, ataxia, confusion, convulsive seizures, peripheral neuropathy, vertigo, incoordination, irritability, depression, weakness, insomnia.    Gastrointestinal: Abdominal discomfort, nausea, vomiting, diarrhea, an unpleasant metallic taste, anorexia, epigastric distress, abdominal cramping, constipation, "furry" tongue, glossitis, stomatitis, pancreatitis, and modification of taste of alcoholic beverages.    Genitourinary: Overgrowth of Candida in the vagina, dyspareunia, decreased libido, proctitis.    Hematopoietic: Reversible neutropenia, reversible thrombocytopenia.    Hypersensitivity Reactions: Urticaria; erythematous rash; flushing; nasal congestion; dryness of the mouth, vagina, or vulva; fever; pruritus; fleeting joint pains.    Renal: Dysuria, cystitis, polyuria, incontinence, a sense of pelvic pressure, darkened urine. Overdosage

There is no human experience with overdosage of metronidazole vaginal gel. Vaginally applied metronidazole gel, 0.75% could be absorbed in sufficient amounts to produce systemic effects. (See WARNINGS.)

MetroGel Vaginal Dosage and Administration

The recommended dose is one applicator full of METROGEL-VAGINAL (approximately 5 grams containing approximately 37.5 mg of metronidazole) intravaginally once or twice a day for 5 days. For once a day dosing, METROGEL-VAGINAL should be administered at bedtime.

How is MetroGel Vaginal Supplied

METROGEL-VAGINAL (metronidazole vaginal gel) 0.75% Vaginal Gel is supplied in a 70 gram tube and packaged with 5 vaginal applicators.

The NDC number for the 70 gram tube is 99207-130-70.

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

Clinical Studies

In a randomized, single-blind clinical trial of non-pregnant women with bacterial vaginosis who received METROGEL-VAGINAL daily for 5 days, the clinical cure rates for evaluable patients determined at 4 weeks after completion of therapy for the QD and BID regimens were 98/185 (53%) and 109/190 (57%), respectively.

Rx only

Manufactured for:
Medicis, The Dermatology Company
Scottsdale, AZ 85256

by:
DPT Laboratories, Inc.
San Antonio, TX 78215

129800
Rev 12/11

DIRECTIONS FOR USE 1. Filling the applicator Remove cap and puncture metal seal on tube with the pointed tip of cap. (See Figure 1) Screw end of applicator onto tube. (See Figure 2) Gently squeeze the tube from the bottom to fill applicator. Plunger will stop when the applicator is full. (See Figure 3) Unscrew applicator and replace cap on tube. 2. Inserting the applicator The applicator may be inserted while lying on your back with your knees bent or in any comfortable position. Hold filled applicator by barrel, and gently insert into vagina as far as it will comfortably go. (See Figure 4) Slowly press the plunger until it stops to deposit gel into vagina and then withdraw the applicator. 3. Care of the applicator
If physician prescribes twice-a-day dosing: After use, pull the plunger out of the barrel. (See Figure 5) Wash both plunger and barrel in warm soapy water and rinse thoroughly. To reassemble applicator, gently push plunger back into barrel.

IMPORTANT:

For once-a-day dosing, apply one applicator full at bedtime. For twice-a-day dosing, apply one applicator full each morning and evening for five days, or as directed by physician.

WARNINGS:

If significant irritation develops from the use of this medication, discontinue use and consult your physician. Do not use during pregnancy except under the supervision of a physician. Keep this and all medications out of reach of children. For vaginal use only. Not for use in the eyes, on the skin or in the mouth.

Store at room temperature. Avoid exposure to extreme heat or cold.

See end of carton and bottom of tube for lot number and expiration date.

Scottsdale, AZ 85256

129800
Rev 12/11

PRINCIPAL DISPLAY PANEL - 70 g Carton

NDC 99207-130-70

MetroGel-Vaginal®

(metronidazole vaginal gel)
0.75% Vaginal Gel
with 5 applicators

FOR INTRAVAGINAL USE ONLY.
(NOT FOR OPHTHALMIC, DERMAL, OR ORAL USE.)

Rx only

MEDICIS®

Net Wt. 70g


METROGEL-VAGINAL 
metronidazole  gel Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 99207-130 Route of Administration VAGINAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength metronidazole (metronidazole) metronidazole 7.5 mg  in 1 g Inactive Ingredients Ingredient Name Strength CARBOMER 934P   EDETATE DISODIUM   METHYLPARABEN   PROPYLPARABEN   PROPYLENE GLYCOL   SODIUM HYDROXIDE   Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 99207-130-70 1 TUBE In 1 CARTON contains a TUBE, WITH APPLICATOR 1 70 g In 1 TUBE, WITH APPLICATOR This package is contained within the CARTON (99207-130-70)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020014 11/28/2011
Labeler - Medicis Pharmaceutical Corp (182837492) Establishment Name Address ID/FEI Operations DPT Laboratories Inc. 832224526 MANUFACTURE Revised: 01/2012Medicis Pharmaceutical Corp

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Estrogens, Conjugated


Class: Estrogens
VA Class: GU500
Brands: Cenestin, Enjuvia, Premarin, Premphase, Prempro

Estrogens increase the risk of endometrial cancer in postmenopausal women.101 104 105 106 107 121 (See Endometrial Cancer under Cautions.)

Do not use estrogens with or without progestins for prevention of cardiovascular disease101 104 105 106 107 121 (see Cardiovascular Risk Reduction under Uses and Cardiovascular Disorders under Cautions) or dementia (see Alzheimer’s Disease under Uses).101 104 105 107

The Women’s Health Initiative (WHI) study of estrogen alone reported increased risks of stroke and DVT in postmenopausal women receiving approximately 7 years of therapy with conjugated estrogens 0.625 mg daily.101 104 105 107

The WHI study of estrogen plus progestin reported increased risks of MI, stroke, invasive breast cancer, pulmonary embolism, and DVT in postmenopausal women receiving ?5 years of therapy with conjugated estrogens 0.625 mg in conjunction with medroxyprogesterone acetate 2.5 mg daily.101 104 105 106 107

The WHI Memory Study (WHIMS) reported increased risk of developing probable dementia in postmenopausal women ?65 years of age receiving long-term therapy (4–5 years) with conjugated estrogens in conjunction with medroxyprogesterone acetate or conjugated estrogens alone.101 104 105 107 Not known whether this finding also applies to younger postmenopausal women.101 104 105 107

Other dosages of conjugated estrogens with medroxyprogesterone and other combinations or dosage forms of estrogens with progestin not studied in WHI trials; in the absence of comparable data, assume risks are similar.101 104 105 107

Prescribe estrogens (with or without progestins) at the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman.101 104 105 106 107

Introduction

Mixture of estrogens available either as preparations that meet current official USP standards (i.e., conjugated estrogens USP)101 105 107 108 109 or as nonofficial preparations (i.e., synthetic conjugated estrogens A and synthetic conjugated estrogens B, which are prepared synthetically from plant sources).106 108 109 121 122

Uses for Estrogens, Conjugated

Use of estrogens alone in postmenopausal women generally is referred to as estrogen replacement therapy (ERT); use of estrogens in combination with progestins usually is referred to as hormone replacement therapy (HRT) or postmenopausal hormone therapy.b

ERT

Management of moderate to severe vasomotor symptoms associated with menopause.101 106 107 121

Management of vulvar and vaginal atrophy associated with menopause.101 105 106 107 If used solely for this indication, consider use of topical vaginal preparations.101 105 106 107

Osteoporosis

Prevention of postmenopausal osteoporosis.100 101 107 Used adjunctively with other measures (e.g., diet, calcium, vitamin D, weight-bearing exercise, physical therapy) to retard further bone loss and progression of osteoporosis in postmenopausal women.100 101 107

Estrogens are effective for prevention of osteoporosis but are associated with a number of adverse effects.100 101 107 If prevention of postmenopausal osteoporosis is the sole indication for therapy, consider alternative therapy (e.g., alendronate, raloxifene, risedronate).101 107 112

Has been effective in the treatment of osteoporosis in postmenopausal women. Formerly recommended as first-line therapy; however, recommendations on appropriate use of HRT have been revised based on WHI study findings. (See Boxed Warning.) Evaluate risks and benefits of long-term HRT use in the management of osteoporosis, taking into account the increased risk of breast cancer and cardiovascular disease, availability of other pharmacologic modalities (e.g., alendronate, calcitonin, calcium, raloxifene, risedronate, vitamin D), and life-style factors that can be modified.101 107

Has been used in a limited number of anorexic women with chronic amenorrhea to reduce calcium loss† and, thereby, reduce risk of osteoporosis.

Corticosteroid-induced Osteoporosis

Has been used to prevent bone loss in postmenopausal women receiving low- to moderate-dose corticosteroid therapy†.

Hypoestrogenism

Treatment of hypoestrogenism secondary to hypogonadism, castration, or primary ovarian failure.101 Used for induction of puberty in adolescents with pubertal delay due to hypogonadism.101

Metastatic Breast Carcinoma

Palliative treatment of metastatic breast cancer in selected women and men.101 One of several second-line agents.a

Prostate Carcinoma

Palliative treatment of advanced androgen-dependent prostate carcinoma.101

Abnormal Uterine Bleeding

Treatment of abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology.104

Cardiovascular Risk Reduction†

ERT or HRT does not decrease the incidence of cardiovascular disease.101 105 106 107 AHA, American College of Obstetricians and Gynecologists, FDA, and manufacturers recommend that hormone therapy not be used to prevent heart disease in healthy women (primary prevention) or to protect women with preexisting heart disease (secondary prevention).

Alzheimer’s Disease

Prior use of HRT, but not current HRT unless such use exceeds 10 years, associated with reduced risk of Alzheimer’s disease†. Estrogens have not been shown to prevent progression of Alzheimer’s disease; American Academy of Neurology recommends that estrogens not be used for treatment of Alzheimer’s disease.

Initiation of ERT or HRT in women ?65 years of age not associated with an improvement in cognitive function. Some women receiving ERT or HRT experience detrimental effects. Incidence of probable dementia in women receiving ERT or HRT was higher than that in women receiving placebo. (See Boxed Warning.) Use of ERT or HRT to prevent dementia or cognitive decline in women ?65 years of age is not recommended.

Postpartum Breast Engorgement

Used in the past for prevention of postpartum breast engorgement†; FDA has withdrawn approval of estrogen-containing drugs for this indication, since estrogens have not been shown to be safe for this use.110 (See Lactation under Cautions.)

Pregnancy

Not effective for any purpose during pregnancy; use contraindicated in pregnant women.101 104 105 106 107 121 (See Pregnancy under Cautions.)

Estrogens, Conjugated Dosage and Administration General

A progestin generally is added to estrogen therapy (HRT) in women with an intact uterus.101 104 105 107 121 Addition of a progestin for ?10 days per cycle of estrogen or daily with estrogen reduces incidence of endometrial hyperplasia and attendant risk of endometrial carcinoma in women with an intact uterus.101 104 105 107 121

ERT is appropriate in women who have undergone a hysterectomy (to avoid unnecessary exposure to progestins).101 104 105 107 121

Administration

Conjugated estrogens USP usually administered orally; may also administer intravaginally or by deep IM or slow IV injection.101 104 105 107

Administer synthetic conjugated estrogens A and synthetic conjugated estrogens B orally.106 121

Estrogen therapy generally is administered in a continuous daily dosage regimen or, alternatively, in a cyclic regimen.101 105 107 When administered cyclically, estrogen usually is given once daily for 3 weeks followed by 1 week without the drug or once daily for 25 days followed by 5 days off; regimen is repeated as necessary.101 105

When parenteral administration of conjugated estrogens USP is required, IV injection is preferred because of the more rapid response compared with IM injection.104

Oral Administration

Oral preparations containing medroxyprogesterone acetate in combination with conjugated estrogens USP as monophasic or biphasic regimens are commercially available in a mnemonic dispensing package to aid user in complying with the prescribed dosage schedule.107

IV Administration

For solution and drug compatibility information, see Compatibility under Stability.

Administer by direct IV injection.104

Reconstitution

Reconstitute vial containing 25 mg of conjugated estrogens USP with 5 mL of sterile water for injection.104 Do not shake vigorously.104 Administer immediately after reconstitution.104

Rate of Administration

Administer slowly (to avoid flushing reaction).104

IM Administration

Administer by deep IM injection.104

Reconstitution

Reconstitute vial containing 25 mg of conjugated estrogens USP with 5 mL of sterile water for injection.104 Do not shake vigorously.104 Administer immediately after reconstitution.104

Vaginal Administration

Administer intravaginally as a vaginal cream.105

Dosage

Individualize dosage according to the condition being treated and the tolerance and therapeutic response of the patient.101 104 105 106 107 121

To minimize risk of adverse effects, use the lowest possible effective dosage.101 104 105 106 107 121 Because of the potential increased risk of cardiovascular events, breast cancer, and venous thromboembolic events, limit estrogen and estrogen/progestin therapy to the lowest effective doses and shortest duration of therapy consistent with treatment goals and risks for the individual woman.101 104 105 107 121

Periodically reevaluate estrogen and estrogen/progestin therapy (i.e., at 3- to 6-month intervals).101 104 105 107 121

Pediatric Patients Hypoestrogenism Oral

Conjugated estrogens USP: 0.15 mg daily may induce breast development.101 Increase dosage at 6- to 12-month intervals to achieve appropriate bone age advancement and epiphyseal closure.101

Conjugated estrogens USP: 0.625 mg daily (with progestins) sufficient to induce artificial cyclic menses and to maintain bone mineral density (BMD) after skeletal maturity.101

Adults Estrogen Replacement Therapy Vasomotor Symptoms Oral

Conjugated estrogens USP: Initially, 0.3 mg daily continuously or in cyclic regimen (25 days on, 5 days off).101 Adjust dosage based on patient response.101

Synthetic conjugated estrogens A: Initially, 0.45 mg daily.106 May increase dosage up to 1.25 mg daily.106

Synthetic conjugated estrogens B: Initially, 0.3 mg daily.121 Adjust dosage based on patient response.121

Conjugated estrogens USP in fixed combination with medroxyprogesterone acetate (Prempro), monophasic regimen: Initially, conjugated estrogens USP 0.3 mg with medroxyprogesterone acetate 1.5 mg daily.107 Alternatively, conjugated estrogens USP 0.45 mg with medroxyprogesterone acetate 1.5 mg daily, conjugated estrogens USP 0.625 mg with medroxyprogesterone acetate 2.5 mg daily, or conjugated estrogens USP 0.625 mg with medroxyprogesterone acetate 5 mg daily.107

Conjugated estrogens USP with medroxyprogesterone acetate (Premphase), biphasic regimen: Conjugated estrogens USP 0.625 mg daily; medroxyprogesterone acetate 5 mg daily on days 15–28 of the cycle.107

Vulvar and Vaginal Atrophy Oral

Conjugated estrogens USP: Initially, 0.3 mg daily continuously or in cyclic regimen (25 days on, 5 days off).101 Adjust dosage based on patient response.101

Synthetic conjugated estrogens A: 0.3 mg daily.106

Conjugated estrogens USP in fixed combination with medroxyprogesterone acetate (Prempro), monophasic regimen: Initially, conjugated estrogens USP 0.3 mg with medroxyprogesterone acetate 1.5 mg daily.107 Alternatively, conjugated estrogens USP 0.45 mg with medroxyprogesterone acetate 1.5 mg daily, conjugated estrogens USP 0.625 mg with medroxyprogesterone acetate 2.5 mg daily, or conjugated estrogens USP 0.625 mg with medroxyprogesterone acetate 5 mg daily.107

Conjugated estrogens USP with medroxyprogesterone acetate (Premphase), biphasic regimen: Conjugated estrogens USP 0.625 mg daily; medroxyprogesterone acetate 5 mg daily on days 15–28 of the cycle.107

Vaginal

Conjugated estrogens USP: 0.5–2 g daily in cyclic regimen (3 weeks on, 1 week off).105

Osteoporosis Prevention in Postmenopausal Women Oral

Conjugated estrogens USP: Initially, 0.3 mg daily continuously or in cyclic regimen (25 days on, 5 days off).101 Adjust dosage based on clinical and BMD response.101

Conjugated estrogens USP in fixed combination with medroxyprogesterone acetate (Prempro), monophasic regimen: Initially, conjugated estrogens USP 0.3 mg with medroxyprogesterone acetate 1.5 mg daily.107 Alternatively, conjugated estrogens USP 0.45 mg with medroxyprogesterone acetate 1.5 mg daily, conjugated estrogens USP 0.625 mg with medroxyprogesterone acetate 2.5 mg daily, or conjugated estrogens USP 0.625 mg with medroxyprogesterone acetate 5 mg daily.107 Adjust dosage based on clinical and BMD response.107

Conjugated estrogens USP with medroxyprogesterone acetate (Premphase), biphasic regimen: Conjugated estrogens USP 0.625 mg daily; medroxyprogesterone acetate 5 mg daily on days 15–28 of the cycle.107

Hypoestrogenism Female Hypogonadism Oral

Conjugated estrogens USP: 0.3–0.625 mg daily in a cyclic regimen (3 weeks on, 1 week off).101 Adjust dosage based on symptom severity and endometrial responsiveness.101

Female Castration or Primary Ovarian Failure Oral

Conjugated estrogens USP: 1.25 mg daily in a cyclic regimen.101 Adjust dosage based on symptom severity and clinical response.101

Metastatic Breast Carcinoma Oral

Conjugated estrogens USP: 10 mg 3 times daily for ?3 months.101

Prostate Carcinoma Oral

Conjugated estrogens USP: 1.25–2.5 mg 3 times daily.101

Abnormal Uterine Bleeding IV or IM

Conjugated estrogens USP: 25 mg; can repeat dose in 6–12 hours.104

Cautions for Estrogens, Conjugated Contraindications

Undiagnosed abnormal genital bleeding.101 104 105 106 107 121

Known or suspected breast cancer or history of breast cancer (except when used for palliative treatment of metastatic disease in appropriately selected individuals).101 104 105 106 107 121

Known or suspected estrogen-dependent neoplasia.101 104 105 106 107 121

Active DVT or pulmonary embolism; history of DVT or pulmonary embolism.101 104 105 106 107 121

Active or recent (within past year) arterial thromboembolic disease (e.g., stroke, MI).101 104 105 106 107 121

Liver disease or impairment.101 104 105 107 121

Known or suspected pregnancy.101 104 105 106 107 121

Known hypersensitivity to estrogen or any ingredient in the formulation.101 104 105 106 107 121

Warnings/Precautions Warnings Cardiovascular Disorders

Estrogen/progestin therapy associated with increased risk of MI, stroke, DVT, and pulmonary embolism.101 104 105 106 107 112 113 114 121 Estrogen therapy associated with increased risk of stroke and DVT.101 104 105 107 (See Boxed Warning.) Discontinue estrogens immediately if any of these events occur or are suspected.101 104 105 106 107 121 Use of ERT or HRT is not advised in women with a history of stroke or transient ischemic attacks. (See Contraindications under Cautions.)

Appropriately manage risk factors for cardiovascular disease (e.g., hypertension, diabetes mellitus, tobacco use, hypercholesterolemia, obesity) and/or venous thromboembolism (personal or family history of venous thromboembolism, obesity, systemic lupus erythematosus).101 104 105 106 107 121 (See Contraindications under Cautions.)

Discontinue estrogens, whenever feasible, at least 4–6 weeks prior to surgery that is associated with an increased risk of thromboembolism or during prolonged immobilization.101 104 105 106 107 121

Endometrial Cancer

Use of unopposed estrogen therapy in women who have a uterus is associated with increased risk of endometrial cancer.101 104 105 106 107 121 Clinical surveillance and evaluation are essential.101 104 105 106 107 121 Perform diagnostic tests to rule out malignancy in women with undiagnosed, persistent or recurring abnormal vaginal bleeding.101 104 105 106 107 121

Incidence of endometrial hyperplasia is reduced substantially when progestins are used concomitantly.101 104 105 106 107 121

Breast Cancer

HRTassociated with increased risk of breast cancer.101 104 105 106 107 112 113 114 121

All postmenopausal women should receive yearly breast examinations by a clinician and perform monthly self-examinations.101 104 105 106 107 121 Schedule periodic mammography based on patient age and risk factors.101 104 105 106 107 121

Dementia

ERT or HRT in women ?65 years of age has been associated with increased risk of developing probable dementia.101 104 105 107 121 Whether these findings apply to younger women is unknown.101 104 105 107 121 (See Alzheimer’s Disease under Uses.)

Gallbladder Disease

ERT associated with increased risk of gallbladder disease requiring surgery.101 104 105 106 107 121

Hypercalcemia

Estrogens may cause severe hypercalcemia in patients with breast cancer and bone metastases.101 104 105 106 107 121 Discontinue the drug and initiate appropriate therapy to reduce serum calcium concentrations if hypercalcemia occurs.101 104 105 106 107 121

Ocular Effects

Retinal thrombosis reported.101 104 105 106 107 121 Discontinue pending examination if sudden partial or complete loss of vision or sudden onset of proptosis, diplopia, or migraine occurs.101 104 105 107 121 Discontinue estrogens if papilledema or retinal vascular lesions noted on examination.101 104 105 106 107 104 105 121

General Precautions Elevated BP

Rarely, substantial increases in BP attributed to idiosyncratic reactions to estrogen.101 104 105 106 107 121 ERT generally is not associated with elevated BP.101 104 105 107 121 Monitor BP at regular intervals.101 104 105 106 107 121

Hypertriglyceridemia

Estrogen therapy may be associated with increases in plasma triglyceride concentrations resulting in pancreatitis in women with increased serum lipids.101 104 105 106 107 121

Fluid Retention

Estrogens may cause some degree of fluid retention; use with caution and careful monitoring in patients with conditions that might be aggravated by fluid retention (e.g., cardiac or renal impairment).101 104 105 106 107 121

Hypocalcemia

Use with caution in patients with severe hypocalcemia.101 104 105 106 107 121

Ovarian Cancer

Long-term estrogen therapy associated with increased incidence of ovarian cancer in some epidemiologic studies.101 104 105 106 107 121 Other studies did not show a clinically important association.101 104 105 106 107 121

Endometriosis

Estrogens may exacerbate endometriosis.101 104 105 106 107 121

Malignant transformation of residual endometrial implants reported rarely in women receiving unopposed estrogen following hysterectomy.101 104 105 107 Consider the addition of progestin in women with residual endometriosis following hysterectomy.101 104 105 107 121

Other Conditions

Estrogens may exacerbate asthma, diabetes mellitus, epilepsy, migraine, porphyria, systemic lupus erythematosus, and hepatic hemangiomas; use with caution in patients with these conditions.101 104 105 107 121

Precautions Specific to Vaginal Administration

Exposure to conjugated estrogens USP vaginal cream may weaken latex condoms.105 Consider the potential for the cream to weaken and contribute to protective failure of latex or rubber condoms, diaphragms, or cervical caps.105

Estrogen-Progestin Combinations

When a progestin is used in conjunction with estrogen therapy, consider the cautions, precautions, and contraindications associated with progestin therapy.107 a

Specific Populations Pregnancy

Category X.101 104 105 106 107 121 (See Contraindications under Cautions.)

In utero exposure of females to diethylstilbestrol (DES [no longer commercially available in US]) is associated with increased risk of vaginal adenosis, squamous cell dysplasia of the cervix, and clear-cell vaginal cancer in later life.b

In utero exposure of males to DES is associated with an increased risk of genital abnormalities and possibly testicular cancer later in life.b

Women who receive DES during pregnancy may be at increased risk of breast cancer; causal relationship unproven.b

Lactation

Administration of estrogens to nursing women has been associated with decreased amounts and lower quality of milk.101 104 105 106 107 121 Detectable amounts of estrogens have been identified in milk of women receiving these drugs.101 104 105 106 107 121 Caution advised.101 104 105 106 107 121

Pediatric Use

Estrogen therapy has been used for induction of puberty in adolescents with some forms of pubertal delay.101 Safety and efficacy of estrogens in children not otherwise established.101 104 105 107 121

Use estrogen therapy with caution and careful monitoring if bone growth is not yet complete, since estrogens may cause premature epiphyseal closure.101

Estrogen therapy in prepubertal girls induces premature breast development and vaginal cornification and may induce vaginal bleeding.101 Estrogen therapy in boys may modify the normal pubertal process.101

Geriatric Use

No substantial differences in safety in women ?65 years of age compared with younger women; increased incidence of stroke and invasive breast cancer reported in women?75 years of age compared with younger women.101 104 105 107

Possible increased risk of developing probable dementia in women ?65 years of age. (See Dementia under Cautions.)101 104 105 107

Clinical studies of estrogens alone or in combination with a progestin did not include sufficient numbers of patients ?65 years of age to determine whether geriatric patients respond differently than younger patients.101 104 105 107

Hepatic Impairment

Estrogens may be poorly metabolized in patients with hepatic impairment.101 104 105 106 107 121 (See Contraindications under Cautions.)

Caution advised in patients with a history of cholestatic jaundice associated with previous estrogen use or with pregnancy; discontinue if jaundice recurs.101 104 105 106 107 121

Renal Impairment

Use with caution.101 104 105 107 121 (See Fluid Retention under Cautions.)

Common Adverse Effects

Abdominal pain, asthenia, flatulence, leg cramps, pruritus, vaginal hemorrhage, vaginitis, vaginal moniliasis.101 107

Interactions for Estrogens, Conjugated

Appears to be metabolized partially by CYP3A4.101 104 105 106 107 121

Drugs Affecting Hepatic Microsomal Enzymes

CYP3A4 inhibitors: Potential pharmacokinetic interaction (increased plasma estrogen concentrations).101 104 105 106 107 121

CYP3A4 inducers: Potential pharmacokinetic interaction (decreased plasma estrogen concentrations).101 104 105 106 107 121

Specific Drugs and Foods

Drug or Food

Interaction

Comments

Anticoagulants, oral

Possible decreased anticoagulant actionb

Monitor; increase warfarin dosage if requiredb

Antifungals, azoles (itraconazole, ketoconazole)

Possible increased plasma estrogen concentrations; increased potential for adverse effects101 104 105 106 107 121

Carbamazepine

Possible decreased plasma estrogen concentrations; potential for decrease in therapeutic effects and/or changes in uterine bleeding101 104 105 106 107 121

Corticosteroids (hydrocortisone)

Enhanced anti-inflammatory effects in patients with chronic inflammatory skin diseaseb

Observe for signs of excessive corticosteroid effects; adjust corticosteroid dosage when initiating or discontinuing estrogenb

Grapefruit juice

Possible increased plasma estrogen concentrations; increased potential for adverse effects101 104 105 106 107 121

Macrolide antibiotics (clarithromycin, erythromycin)

Possible increased plasma estrogen concentrations; increased potential for adverse effects101 104 105 106 107 121

Medroxyprogesterone

Interaction unlikely101 106 107

Phenobarbital

Possible decreased plasma estrogen concentrations; potential for decrease in therapeutic effects and/or changes in uterine bleeding101 104 105 106 107 121

Rifampin

Possible decreased plasma estrogen concentrations; potential for decrease in therapeutic effects and/or changes in uterine bleeding101 104 105 106 107 121

Ritonavir

Possible increased plasma estrogen concentrations; increased potential for adverse effects101 104 105 106 107 121

St. John’s wort (Hypericum perforatum)

Possible decreased plasma estrogen concentrations; potential for decrease in therapeutic effects and/or changes in uterine bleeding101 104 105 106 107 121

Thyroid agents

Increased thyroid-binding globulin concentrations101 104 105 106 107 121

Increased dosages of thyroid replacement agents may be needed; monitor thyroid function101 104 105 106 107 121

Estrogens, Conjugated Pharmacokinetics Absorption Bioavailability

Conjugated estrogens are well absorbed through mucous membranes and from the GI tract.101 104 105 106 107 121

Food

Conjugated estrogens USP: High-fat meal does not affect extent of oral absorption.107

Synthetic conjugated estrogens A: Effect of food unknown.106

Synthetic conjugated estrogens B: Effects of food unknown.121

Distribution Extent

Widely distributed; highest concentrations found in sex hormone target organs.101 104 105 106 107 121

Plasma Protein Binding

50–80%.b

Elimination Metabolism

Metabolized in the liver; the kidney, gonads, and muscle tissue involved to some extent.b Estrogens metabolized partially by CYP3A4.101 104 105 106 107 121

Extensive metabolic conversion takes place in the liver (e.g., estradiol converted to estrone, both converted to estriol).101 104 105 106 107 121

Estrogens undergo enterohepatic recirculation via sulfate and glucuronide conjugation in the liver, biliary secretion of conjugates into the intestine, and hydrolysis in the gut followed by reabsorption.101


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Chorionic Gonadotropin


Pronunciation: KORE-ee-ON-ik goe-NAD-oh-troe-pin
Generic Name: Chorionic Gonadotropin
Brand Name: Examples include Novarel and Pregnyl
Chorionic Gonadotropin is used for:

Treating fertility problems in certain women who have not gone through menopause. Treating certain testicular development problems and stimulating the development of secondary sexual characteristics in certain patients. It is also used to treat boys 4 to 9 years old who have testicles that have not moved into the scrotum.

Chorionic Gonadotropin is a hormone. Human chorionic gonadotropin (HCG) stimulates cells in the testicles to produce androgens and in the ovaries to produce progesterone. Androgens cause the development of male secondary sexual characteristics (eg, hair growth, deepening voice) and may cause the testicles to drop. HCG acts like luteinizing hormone (LH) by stimulating ovulation (release of an egg) in women.

Do NOT use Chorionic Gonadotropin if: you are allergic to any ingredient in Chorionic Gonadotropin you have androgen (male sex hormone)-dependent tumors, prostate cancer, an active blood clot, brain lesions, unexplained uterine or genital bleeding, an enlarged ovary or ovarian cysts, or an enlargement or tumor of the pituitary gland you are experiencing abnormally early puberty you are pregnant

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

Before using Chorionic Gonadotropin:

Some medical conditions may interact with Chorionic Gonadotropin. 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 asthma, uterine fibroids, heart or kidney problems, migraine headaches, polycystic ovarian syndrome, or epilepsy

Some MEDICINES MAY INTERACT with Chorionic Gonadotropin. However, no specific interactions with Chorionic Gonadotropin are known at this time.

Ask your health care provider if Chorionic Gonadotropin 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 Chorionic Gonadotropin:

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

Chorionic Gonadotropin is usually administered as an injection at your doctor's office, hospital, or clinic. If you are using Chorionic Gonadotropin at home, carefully follow the injection procedures taught to you by your health care provider. If Chorionic Gonadotropin contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it. Using the technique described to you by your doctor, add the diluent to the vial that contains the medicine. Mix the solution by gently rotating the vial. DO NOT SHAKE. The solution should be clear and free of particles. Wipe the rubber stopper of the vial with an alcohol swab. Insert the needle straight through the center circle of the rubber stopper. Draw up the solution for injection. After drawing up the solution, switch needles. Be sure all air bubbles are tapped out of the syringe. Wipe the appropriate injection site (usually the upper thigh or buttocks) with an alcohol swab, then insert the syringe. To be sure that the needle is not in a vein, pull back on the plunger of the syringe while holding the syringe in place. If the syringe begins to fill with blood, the needle is in a vein. If this happens, remove the needle from the skin, throw the syringe away, and start the procedure again using new materials (drugs, syringes, etc.). After giving the injection, cover the injection site with a small bandage if necessary. Keep this product, as well as syringes and needles, out of the reach of children. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal. If you miss a dose of Chorionic Gonadotropin, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Chorionic Gonadotropin.

Important safety information: Women need to have a thorough gynecological exam before beginning treatment with Chorionic Gonadotropin. Men need to have a complete medical and hormone evaluation before starting therapy with Chorionic Gonadotropin. Chorionic Gonadotropin may increase your chance of multiple births (eg, twins). Talk with your doctor to discuss your chances of multiple births. Use of Chorionic Gonadotropin can increase your risk of serious blood clots and ruptured ovarian cysts. Discuss the risk of these effects with your doctor. Ovarian hyperstimulation syndrome (OHSS) is a severe side effect that may occur in some women who use Chorionic Gonadotropin. Contact your doctor right away if you develop severe stomach pain or bloating; nausea, vomiting, or diarrhea; sudden unexplained weight gain; shortness of breath; or decreased urination. Chorionic Gonadotropin may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using Chorionic Gonadotropin. Lab tests, including hormone levels, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments. Chorionic Gonadotropin is not recommended for use in CHILDREN younger than 4 years; safety and effectiveness in these children have not been confirmed. Chorionic Gonadotropin may have benzyl alcohol in it. Do not use it in NEWBORNS or INFANTS. It may cause serious and sometimes fatal nervous system problems and other side effects. PREGNANCY and BREAST-FEEDING: Do not use Chorionic Gonadotropin if you are pregnant. It may cause harm to the fetus. If you think you may be pregnant, contact your doctor right away. It is not known if Chorionic Gonadotropin is found in breast milk. If you are or will be breast-feeding while you are using Chorionic Gonadotropin, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Chorionic Gonadotropin:

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:

Fatigue; headache; irritability; nausea; pain, swelling, bruising, or redness at the injection site; restlessness; tiredness.

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; unusual hoarseness); abnormal breast development; bloating or swelling in the stomach or pelvic area; breast tenderness; depression; infrequent urination; persistent or severe nausea, vomiting, or diarrhea; stomach or pelvic pain; sudden shortness of breath; swelling of the hands, feet, or legs; symptoms of a serious blood clot (eg, calf or leg pain, swelling, redness, or tenderness; chest, jaw, or left arm pain; confusion; fainting; numbness of an arm or leg; one-sided weakness; slurred speech; sudden, severe headache; vision changes); unusual early onset of puberty; weight gain.

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: Chorionic Gonadotropin 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.

Proper storage of Chorionic Gonadotropin:

Before mixing, store Chorionic Gonadotropin at room temperature between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Different products have different storage instructions after mixing. Check with your doctor or pharmacist about how to store Chorionic Gonadotropin and how long it is good for after mixing. Keep Chorionic Gonadotropin out of the reach of children and away from pets.

General information: If you have any questions about Chorionic Gonadotropin, please talk with your doctor, pharmacist, or other health care provider. Chorionic Gonadotropin 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 Chorionic Gonadotropin. 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 Chorionic Gonadotropin resources Chorionic Gonadotropin Side Effects (in more detail) Chorionic Gonadotropin Use in Pregnancy & Breastfeeding Chorionic Gonadotropin Drug Interactions Chorionic Gonadotropin Support Group 0 Reviews for Chorionic Gonadotropin - Add your own review/rating Chorex Advanced Consumer (Micromedex) - Includes Dosage Information Hcg Consumer Overview Novarel Prescribing Information (FDA) Ovidrel Prescribing Information (FDA) Ovidrel Monograph (AHFS DI) Pregnyl Prescribing Information (FDA) Compare Chorionic Gonadotropin with other medications Female Infertility Hypogonadism, Male Ovulation Induction Prepubertal Cryptorchidism
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Econazole Nitrate


Class: Azoles
ATC Class: D01AC03
VA Class: DE102
Chemical Name: (±)-1-[2-[(4-Chlorophenyl)methoxy]-2-(2,4-dichlorophenyl)ethyl]-1H-imidazole mononitrate
Molecular Formula: C18H15Cl3N2O?HNO3
CAS Number: 68797-31-9

Introduction

Antifungal; azole (imidazole derivative).2 3

Uses for Econazole Nitrate Dermatophytoses

Treatment of tinea corporis (body ringworm) and tinea cruris (jock itch) caused by Epidermophyton floccosum, Microsporum audouinii, M. canis, M. gypseum, Trichophyton mentagrophytes, T. rubrum, or T. tonsurans.60 61

Treatment of tinea pedis (athlete’s foot) caused by E. floccosum, M. audouinii, M. canis, M. gypseum, T. mentagrophytes, T. rubrum, or T. tonsurans.60 61

Topical antifungals usually effective for treatment of uncomplicated tinea corporis or tinea cruris.46 47 50 51 52 62 An oral antifungal may be necessary when tinea corporis or tinea cruris is extensive, dermatophyte folliculitis is present, infection is chronic or does not respond to topical therapy, or patient is immunocompromised because of coexisting disease or concomitant therapy.46 47 50 51 52 62

Topical antifungals usually effective for treatment of uncomplicated tinea pedis.46 47 50 51 52 62 An oral antifungal may be necessary for treatment of hyperkeratotic areas on the palms and soles,47 52 for chronic moccasin-type (dry-type) tinea pedis,46 47 51 and for tinea unguium (fingernail or toenail dermatophyte infections, onychomycosis).46 47 50 51 52 62

Pityriasis (Tinea) Versicolor

Treatment of pityriasis (tinea) versicolor caused by Malassezia furfur (Pityrosporum orbiculare or P. ovale).60 61 62

Topical antifungals usually effective; an oral antifungal (with or without a topical antifungal) may be necessary in patients who have extensive or severe infections or have failed to respond to or have frequent relapses with topical therapy.48 49 51 62

Cutaneous Candidiasis

Treatment of cutaneous candidiasis caused by Candida albicans.60 61

Econazole Nitrate Dosage and Administration Administration Topical Administration

Apply topically to the skin as a 1% cream.60 61

Do not apply to the eye60 61 or administer intravaginally.39

Apply a sufficient amount of cream to cover affected areas.60 61

Dosage Pediatric Patients Dermatophytoses Tinea Corporis or Tinea Cruris Topical

Apply once daily for 2 weeks.60 61 62

If clinical improvement does not occur after treatment, reevaluate diagnosis.60 61 Occasionally, a treatment duration of ?6 weeks may be necessary.15 17 18 19 62

Tinea Pedis Topical

Apply once daily for 1 month.60 61 62

If clinical improvement does not occur after treatment, reevaluate diagnosis.60 61 Occasionally, a treatment duration of ?6 weeks may be necessary.15 17 18 19

Pityriasis (Tinea) Versicolor Topical

Apply once daily for 2 weeks.60 61 62

If clinical improvement does not occur after treatment, reevaluate diagnosis.60 61

Cutaneous Candidiasis Topical

Apply twice daily (morning and evening) for 2 weeks.60 61 62

If clinical improvement does not occur after treatment, reevaluate diagnosis.60 61 Occasionally, a treatment duration of ?6 weeks may be necessary.15 17 18 19

Adults Dermatophytoses Tinea Corporis or Tinea Cruris Topical

Apply once daily for 2 weeks.60 61

If clinical improvement does not occur after treatment, reevaluate diagnosis.60 61 Occasionally, a treatment duration of ?6 weeks may be necessary.15 17 18 19

Tinea Pedis Topical

Apply once daily for 1 month.60 61

If clinical improvement does not occur after treatment, reevaluate diagnosis.60 61 Occasionally, a treatment duration of ?6 weeks may be necessary.15 17 18 19

Pityriasis (Tinea) Versicolor Topical

Apply once daily for 2 weeks.60 61

If clinical improvement does not occur after treatment, reevaluate diagnosis.60 61

Cutaneous Candidiasis Topical

Apply twice daily (morning and evening) for 2 weeks.60 61

If clinical improvement does not occur after treatment, reevaluate diagnosis.60 61 Occasionally, a treatment duration of ?6 weeks may be necessary.15 17 18 19

Special Populations

No special population dosage recommendations at this time.60 61

Cautions for Econazole Nitrate Contraindications

Known hypersensitivity to econazole or any ingredient in the formulation.60 61

Warnings/Precautions Warnings Administration Precautions

For external use only.60 61 Use only for topical application to the skin; not for ophthalmic60 61 or intravaginal use.39

Fetal/Neonatal Morbidity and Mortality

Fetotoxicity and embryotoxicity demonstrated in animals receiving oral econazole.60 61 (See Pregnancy under Cautions.)

Sensitivity Reactions Hypersensitivity Reactions

Contact dermatitis reported following topical application of econazole or other imidazole-derivative azole antifungals.55 56 57 58 59

If irritation or sensitivity occurs, discontinue the drug.60 61

Possible cross-sensitization among the imidazoles.44 45 55 56 57 58 59

Specific Populations Pregnancy

Category C.60 61

Use during first trimester of pregnancy only when considered essential to the welfare of the patient; use during second and third trimesters only if clearly needed.60 61 (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

Lactation

Distributed into milk following oral administration in rats; not known whether distributed into human milk.60 61 Use caution.60 61

Pediatric Use

No unusual adverse effects reported when used in children ?3 months of age.16 24

Common Adverse Effects

Burning,14 60 61 stinging,15 17 60 61 pruritus,19 60 61 erythema.14 60 61

Interactions for Econazole Nitrate Specific Drugs

Drug

Interaction

Corticosteroids (hydrocortisone, triamcinolone acetonide)

Corticosteroids inhibit antifungal activity of econazole against Saccharomyces cerevisiae and Candida albicans36

Econazole does not alter activity of corticosteroid36

No effect on antibacterial activity of econazole against Staphylococcus36

Econazole Nitrate Pharmacokinetics Absorption Bioavailability

Minimal systemic absorption occurs following topical application to skin.13 60 61

Distribution Extent

About 7.6–9.6% of a topical dose found in stratum corneum;13 also found in epidermis and middle region of dermis.13 60 61

Distributed into milk following oral administration in rats; not known whether distributed into human milk.60 61

Elimination Elimination Route

Systemically absorbed drug excreted in urine and feces (<1% of topical dose).2 11 13 60 61

Stability Storage Topical Cream

20–25°C60 or <30°C.61

Actions and SpectrumActions

Imidazole-derivative azole antifungal.2 3

Usually fungistatic; may be fungicidal at high concentrations or against very susceptible organisms.2 3 4 6 40

Presumably exerts its antifungal activity by altering cellular membranes,2 4 6 40 41 resulting in increased membrane permeability,4 6 41 secondary metabolic effects,2 and growth inhibition.2 Fungistatic activity may result from interference with ergosterol synthesis.4 5

Spectrum of antifungal activity includes many fungi, including yeasts and dermatophytes.2 3 8 9 10 11 42 60 61 Also has in vitro activity against some gram-positive bacteria3 8 and Trichomonas vaginalis.11

Dermatophytes: Active in vitro against Epidermophyton floccosum,3 60 61 Microsporum audouinii,3 60 61 M. canis,3 60 61 M. gypseum,3 60 61 Trichophyton mentagrophytes,3 9 60 61 T. rubrum,3 9 60 61 T. tonsurans,3 60 61 T. verrucosum,3 60 61 and T. violaceum.3

Other fungi: Active in vitro against Malassezia furfur (Pityrosporum orbiculare)60 61 and Candida albicans,7 8 10 60 61 C. guillermondii,60 61 C. parapsilosis,60 61 and C. tropicalis.60 61 Also active in vitro against Aspergillus,3 8 9 Cladosporium,3 and Sporothrix.3

Bacteria: Active in vitro against Corynebacterium diphtheriae,8 Staphylococcus aureus,3 8 11 S. epidermidis,8 and Streptococcus pyogenes.3 8

Cross-resistance can occur among the azole antifungals.12

Advice to Patients

Importance of completing full course of treatment, even if symptoms improve.1 37 60 61

Importance of contacting clinician if skin condition worsens during treatment or if improvement does not occur after completing full course of therapy.1 37 60 61

Importance of discontinuing use and contacting clinician if signs or symptoms of irritation or sensitization occur.60 61

Importance of applying to affected areas as directed and avoiding contact with eyes60 61 and not applying intravaginally.39

Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.60 61

Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.60 61

Importance of informing patients of other important precautionary information.60 61 (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

Econazole Nitrate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Topical

Cream

1%*

Econazole Nitrate Cream (with benzoic acid)

Perrigo, Taro

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.

Econazole Nitrate 1% Cream (FOUGERA): 15/$15.99 or 45/$39.99

Econazole Nitrate 1% Cream (FOUGERA): 30/$24.05 or 90/$64.14

Econazole Nitrate 1% Cream (PERRIGO PHARMACEUTICALS): 85/$49.99 or 255/$133.98

Disclaimer

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

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

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions July 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Ortho. Spectazole (econazole nitrate 1%) cream prescribing information. Raritan, NJ; 1990 Jun.

2. Heel RC, Brogden RN, Speight TM et al. Econazole: a review of its antifungal activity and therapeutic efficacy. Drugs. 1978; 16:177-201. [IDIS 93386] [PubMed 98315]

3. Thienpont D, Van Cutsem J, Van Nueten JM et al. Biological and toxicological properties of econazole, a broad-spectrum antimycotic. (German) Arzneim-Forsch. 1975; 25:224-30.

4. Borgers M. Mechanism of action of antifungal drugs, with special reference to the imidazole derivatives. Rev Infect Dis. 1980; 2:520-34. [IDIS 124096] [PubMed 7003674]

5. Marriot MS. Inhibition of sterol biosynthesis in Candida albicans by imidazole-containing antifungals. J Gen Microbiol. 1980; 117:253-5. [PubMed 6993625]

6. Preusser HJ. Effects of in vitro treatment with econazole on the ultrastructure of Candida albicans. Mykosen. 1976; 19:304-16.

7. Haller I, Plempel M. Experimental in vitro and in vivo comparison of modern antimycotics. Curr Med Res Opin. 1978; 5:315-27.

8. Schar G, Kayser FH, Dupont MC. Antimicrobial activity of econazole and miconazole in vitro and in experimental candidiasis and aspergillosis. Chemotherapy. 1976; 22:211-20. [IDIS 69602] [PubMed 817875]

9. Odds FC. Laboratory evaluation of antifungal agents: a comparative study of five imidazole derivatives of clinical importance. J Antimicrob Chemother. 1980; 6:749-61. [PubMed 7440468]

10. Bergan T, Vangdal M. In vitro activity of antifungal agents against yeast species. Chemotherapy. 1983; 29:104-10. [IDIS 169053] [PubMed 6301773]

11. Raab W. Clinical pharmacology of modern topical broad-spectrum antimicrobials. Curr Ther Res. 1977; 22:65-82.

12. Holt RJ, Azmi A. Miconazole-resistant Candida. Lancet. 1978; 1:50-1. Letter.

13. Schaefer H, Stuttgen G. Absolute concentrations of an antimycotic agent, econazole, in the human skin after local application. (German) Arzneim-Forsch. 1976; 26:432-5.

14. Gisslen H, Hersle K, Mobacken H et al. Topical treatment of dermatomycoses and tinea versicolor with econazole cream 1% (Pevaryl). Curr Ther Res. 1977; 21:681-4.

15. Verma BS. Econazole cream in fungal infections of the skin. Curr Ther Res. 1978; 24:745-52.

16. Mackie RM. Topical econazole in cutaneous fungal infections. Practitioner. 1980; 224:1311, 1313. [IDIS 128475] [PubMed 7220455]

17. Wishart JM, Gould PW. Econazole treatment of fungal infections. N Z Med J. 1981; 94:226-7. [IDIS 141713] [PubMed 7029364]

18. Fredriksson T. Treatment of dermatomycoses with topical econazole and clotrimazole. Curr Ther Res. 1979; 25:590-4.

19. Grigoriu D, Grigoriu A. Double-blind comparison of the efficacy, toleration and safety of tioconazole base 1% and econazole nitrate 1% creams in the treatment of patients with fungal infections of the skin or erythrasma. Dermatologica. 1983; 166(Suppl. 1):8-13. [PubMed 6350072]

20. O’Neill East M, Henderson JT, Jevons S. Tioconazole in the treatment of fungal infections of the skin. An international clinical research program. Dermatologica. 1983; 166(Suppl. 1):20-33. [PubMed 6884560]

21. Anon. New topical antifungal drugs. Med Lett Drugs Ther. 1983; 25:98-100. [PubMed 6621505]

22. Anon. Drugs for athlete’s foot and tinea cruris. Med Lett Drugs Ther. 1976; 18:101-2. [PubMed 1036605]

23. Fredriksson T. Treatment of dermatomycoses with topical econazole combined with a steroid as compared with a conventional oxichinoline-steroid combination. Curr Ther Res. 1979; 26:958-61.

24. Herz G. Experiences with triamcinolone acetonide 0.1% plus econazole nitrate 1% in paediatric dermatology. J Int Med Res. 1983; 11:320-3. [PubMed 6642071]

25. Rubin A, Russell JM, Mauff A. Efficacy of econazole in the treatment of candidiasis and other vaginal discharges. S Afr Med J. 1980; 57:407-8. [IDIS 112787] [PubMed 7403993]

26. Brown D Jr, Binder GL, Gardner HL et al. Comparison of econazole and clotrimazole in the treatment of vulvovaginal candidiasis. Obstet Gynecol. 1980; 56:121-3. [IDIS 119238] [PubMed 7383476]

27. Balmer JA. Three-day therapy of vulvovaginal candidiasis with econazole: a multicentric study comprising 996 cases. Am J Obstet Gynecol. 1976; 126:436-41. [IDIS 79224] [PubMed 984105]

28. Bloch B, Kretzel A. Econazole nitrate in the treatment of candidal vaginitis. S Afr Med J. 1980; 58:314-6. [IDIS 123262] [PubMed 6157203]

29. Popkin DR. Econazole in the treatment of vaginal candidiasis. Curr Ther Res. 1982; 32:948-51.

30. Larsson B, Kjaeldgaard A. Combined vaginal and vulval treatment of vaginal candidiasis with econazole. Curr Ther Res. 1980; 27:664-9.

31. Verma BS. Econazole in vaginal candidosis. Curr Ther Res. 1979; 26:634-9.

32. Fredricsson B, Frisk A, Hagstrom B et al. Vaginal mycoses: aspects on diagnosis and their treatment with econazole nitrate. Curr Ther Res. 1980; 27:309-22.

33. Stettendorf S, Benijts G, Vignali M et al. Three-day therapy of vaginal candidiasis with clotrimazole vaginal tablets and econazole ovules: a multicenter comparative study. Chemotherapy. 1982; 28(Suppl. 1):87-91. [IDIS 168389] [PubMed 6761088]

34. Udwadia RB, Dlo MS, Rathod V et al. Econazole: a study of its role in otomycosis. Curr Ther Res. 1982; 31:954-9.

35. Momii A, Funai K, Shingu H et al. Toxicological studies on econazole nitrate. IX. Mutagenicity tests with several bacterial strains. Iyakuhin Kenkyu. 1979; 10:351-7.

36. Raab W, Gmeiner B. Interactions between econazole, a broad-spectrum antimicrobic substance, and topically active glucocorticoids. Dermatologica. 1976; 153:14-22. [PubMed 791715]

37. Scrafani JT. Superficial fungal infections and their treatment. US Pharm. 1978; 3:26-40.

38. Thorne EG (Ortho Pharmaceutical Corporation, Raritan, NJ): Personal communication; 1984 Mar 21.

39. Reviewers’ comments (personal observations); 1984 Mar 20.

40. Kern R, Zimmermann FK. Physiological effects of econazole nitrate on yeast cells. Mykosen. 1978; Suppl. 1:339-45.

41. Preusser HJ, Rostek H. Econazole effects on Trichophyton rubrum and Candida albicans—electron microscopic and cytochemical studies. Mykosen. 1978; Suppl. 1:314-21.

42. Hantschke D. In vitro sensitivity tests with antimycotic imidazole derivatives and evaluation of results. Mykosen. 1978; Suppl. 1:222-9.

43. Ryley JF, Wilson RG, Barrett-Bee KJ. Azole resistance in Candida albicans. Sabouraudia. 1984; 22:53-63.

44. Raulin C, Frosch PJ. Contact allergy to imidazole antimycotics. Contact Dermatitis. 1988; 18:76-80. [PubMed 2966706]

45. Raulin C, Frosch PJ. Contact allergy to oxiconazole. Contact Dermatitis. 1987; 16:39-40. [PubMed 3816206]

46. Gupta AK, Einarson TR, Summerbell RC et al. An overview of topical antifungal therapy in dermatomycoses: a North American perspective. Drugs. 1998; 55:645-74. [PubMed 9585862]

47. Pi?rard GE, Arrese JE, Pi?rard-Franchimont C. Treatment and prophylaxis of tinea infections. Drugs. 1996; 52:209-24. [PubMed 8841739]

48. Sunenshine PJ, Schwartz RA, Janniger CK. Tinea versicolor: an update. Cutis. 1998; 61:65-72. [PubMed 9515210]

49. Assaf RR, Weil ML. The superficial mycoses. Dermatol Clin. 1996; 14:57-67. [PubMed 8821158]

50. Lesher JL. Recent developments in antifungal therapy. Dermatol Clin. 1996; 14:163-9. [PubMed 8821170]

51. Hay RJ. Dermatophytosis and other superficial mycoses. In: Mandel GL, Douglas RG Jr, Bennett JE, eds. Principles and practices of infectious disease. 4th ed. New York: Churchill Livingston; 1995: 2375-86.

52. Drake LA, Dincehart SM, Farmer ER et al. Guidelines of care for superficial mycotic infections of the skin: tinea corporis, tinea cruris, tinea faciei, tinea manuum, and tinea pedis. J Am Acad Dermatol. 1996; 34:282-6. [IDIS 363962] [PubMed 8642094]

53. Drake LA, Dinehart SM, Farmer ER et al. Guidelines of care for superficial mycotic infections of the skin: pityriasis (tinea) versicolor. J Am Acad Dermatol. 1996; 34:287-9. [IDIS 363963] [PubMed 8642095]

54. Reviewers’ comments (personal observations) on Sulconazole 84:04.08.

55. Bigardi AS, Pigatto PD, Altomare G. Allergic contact dermatitis due to sulconazole. Contact Dermatitis. 1992; 26:281-2. [PubMed 1395584]

56. Machet L, Vaillant L, Muller C et al. Contact dermatitis and cross-sensitivity from sulconazole nitrate. Contact Dermatitis. 1992; 26:352-3. [PubMed 1395603]

57. Jones SK, Kennedy CTC. Contact dermatitis from tioconazole. Contact Dermatitis. 1990; 22:122-3. [PubMed 2138969]

58. Baes H. Contact sensitivity to miconazole with ortho-chloro cross-sensitivity to other imidazoles. Contact Dermatitis. 1991; 24:89-93. [PubMed 1828223]

59. Marren P, Powell S. Contact sensitivity to tioconazole and other imidazoles. Contact Dermatitis. 1992; 27:129-30. [PubMed 1395626]

60. Perrigo. Econazole nitrate cream, 1% prescribing information. Allegan, MI; Undated.

61. Taro Pharmaceuticals. Econazole nitrate cream 1% prescribing information. Brampton, Ontario, Canada. 2001 Sept.

62. American Academy of Pediatrics. 2006 Red Book: Report of the Committee on Infectious Diseases. 27th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2006.

More Econazole Nitrate resources Econazole Nitrate Side Effects (in more detail) Econazole Nitrate Dosage Econazole Nitrate Use in Pregnancy & Breastfeeding Econazole Nitrate Support Group 7 Reviews for Econazole Nitrate - Add your own review/rating Econazole Nitrate Professional Patient Advice (Wolters Kluwer) econazole topical Concise Consumer Information (Cerner Multum) Spectazole Prescribing Information (FDA) Spectazole Topical Advanced Consumer (Micromedex) - Includes Dosage Information Spectazole Cream MedFacts Consumer Leaflet (Wolters Kluwer) Compare Econazole Nitrate with other medications Cutaneous Candidiasis Tinea Corporis Tinea Cruris Tinea Pedis Tinea Versicolor
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Veregen


Generic Name: Sinecatechins
Class: Skin and Mucous Membrane Agents, Miscellaneous
CAS Number: 188265-33-0

Introduction

Antioxidant; a green tea extract consisting predominantly of catechins.1 2

Uses for Veregen External Genital and Perianal Human Papillomavirus Warts

Treatment of external genital and perianal warts (condylomata acuminata) caused by human papillomavirus (HPV) in immunocompetent patients.1 4

CDC recommends that external HPV genital warts be treated with a self-administered topical therapy (imiquimod, podofilox, sinecatechins), a topical therapy administered by a health-care provider (podophyllum resin, trichloroacetic acid [TCA], bichloroacetic acid [BCA]), or a surgical technique (cryotherapy, electrosurgery, surgical excision).4

Should not be used for treatment of urethral, intravaginal, cervical, rectal, or intra-anal HPV disease; safety and efficacy not established.1

Veregen Dosage and Administration Administration Topical Administration

Apply topically to the skin as a 15% ointment.1 4 For external use only.1

Avoid contact with the eyes; do not administer orally, intravaginally, or intra-anally.1 Do not apply to open wounds.1

Wash hands before and after application.1 Apply a thin layer to each wart with the finger(s), dabbing to ensure complete coverage.1 Do not use bandages, occlusive dressings, or wrappings.1

Uncircumcised males treating warts under the foreskin should retract the foreskin and clean the area daily.1

Washing ointment from the treated area prior to the next application is not necessary.1 If bathing or washing the treatment area, apply ointment afterwards.1 (See Advice to Patients.)

Dosage Adults HPV Infections External Genital and Perianal HPV Warts Topical

Apply a 0.5-cm strand of ointment to each wart 3 times daily, dabbing with fingers to ensure complete coverage and leaving a thin film on warts.1 4

Continue therapy until all warts have completely cleared or for a maximum of 16 weeks.1 4

Safety and efficacy of multiple treatment courses not established.1

Prescribing Limits Adults HPV Infections External Genital and Perianal HPV Warts Topical

Maximum of 16 weeks.1 4

Special Populations

No special population dosage recommendations.1

Cautions for Veregen Contraindications

No known contraindications.1

Warnings/Precautions Other Forms of HPV Disease

Safety and efficacy not established for treatment of urethral, intravaginal, cervical, rectal, or intra-anal HPV disease.1

Dermatologic Effects

Do not apply to open wounds.1 Local skin reactions occur frequently.1 2 (See Common Adverse Effects under Cautions.) Continue therapy when severity of the local skin reaction is acceptable.1 In case of severe local reactions (i.e., pruritus), wash area with mild soap and water to remove the ointment; withhold further doses and notify clinician.1

Avoid exposure of the genital and perianal area to sunlight or ultraviolet light; effects of such light not studied.1

Immunologic Effects

Safety and efficacy in immunosuppressed patients not established.1

Specific Populations Pregnancy

Category C.1

Lactation

Not known whether topical sinecatechins is distributed into human milk.1

Pediatric Use

Safety and efficacy not established in pediatric patients.1 Consult a clinician before using in children <12 years of age.3

Geriatric Use

Insufficient experience in patients ?65 years of age to determine whether geriatric patients respond differently than younger adults.1

Common Adverse Effects

Erythema, pruritus, burning, pain/discomfort, erosion/ulceration, edema, induration, vesicular rash.1

Interactions for Veregen

No formal drug interaction studies to date.1

Veregen Pharmacokinetics Absorption Bioavailability

Pharmacokinetics after topical application not fully characterized.1 Data suggest that systemic exposure to catechins following repeated topical application of sinecatechins ointment probably is less than that observed after single ingestion of 400 mL of green tea.1

Distribution Extent

Not known whether distributed into milk following topical application.1

Stability Storage Topical Ointment

Before dispensing to patient: 2–8°C.1 After dispensing, store refrigerated or at temperatures <25°C.1 Do not freeze.1

ActionsActions

A botanical drug product; a partially purified fraction of the water extract of green tea leaves from Camellia sinensis (L.) O Kuntze.1

Mechanism of action in treatment of external genital and perianal HPV warts is unknown.1 Antioxidant activity demonstrated in vitro; the clinical importance of this finding is unknown.1 Green tea catechins may have immunostimulant, antitumor, and potent antiviral properties that may contribute to the therapeutic effect of sinecatechins ointment.2

Consists principally of catechins (85–95% by weight), including more than 55% epigallocatechin gallate (EGCg); other catechin derivatives present include epicatechin (EC), epigallocatechin (EGC), epicatechin gallate (ECg), gallocatechin gallate (GCg), gallocatechin (GC), catechin gallate (Cg), and catechin ©).1 2 Also contains gallic acid, caffeine, and theobromine (together account for 2.5% of total drug substance) plus undefined botanical constituents.1

Advice to Patients

Importance of reading manufacturer’s patient information.1

Importance of using only as directed by clinician.1

Importance of applying externally only; importance of avoiding contact with the eyes or application into the vagina or anus.1

Importance of advising patients that sinecatechins ointment is not a cure for external genital and perianal warts.1 New warts may appear during therapy and also should be treated.1

Local skin reactions are common.1 (See Dermatologic Effects under Cautions.) If severe skin reactions occur, contact clinician, wash treatment area with mild soap and water, and withhold further application.1

Importance of advising patients to avoid sexual (genital, anal, or oral) contact while the ointment is on the skin.1 4 The ointment must be washed off carefully before having protected sexual contact, since the ointment may weaken condoms and vaginal diaphragms.1 Importance of advising patients that the effect of sinecatechins on the transmission of genital and perianal warts is unknown.1

Importance of advising female patients using tampons that a tampon should be inserted before applying the ointment; avoid accidental application of the ointment into the vagina if the tampon is changed while the ointment is on the skin.1

Importance of advising uncircumcised males to retract the foreskin and clean the area daily.1

Importance of advising patients to avoid exposure of the genital and perianal area to sunlight or ultraviolet light.1

Importance of advising patients not to bandage, cover, or wrap the treatment area.1 (See Topical Administration under Dosage and Administration.)

Importance of advising patients that the ointment may stain clothing or bedding.1

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

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

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

Preparations

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

Sinecatechins

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Topical

Ointment

15%

Veregen

PharmaDerm

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 April 04, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. PharmaDerm. Veregen (sinecatechins) ointment, 15% prescribing information. Melville, NY; 2008 Sep.

2. Tatti S, Swinehart JM, Thielert C et al. Sinecatechins, a defined green tea extract, in the treatment of external anogenital warts: a randomized controlled trial. Obstet Gynecol. 2008; 111:1371-9. [PubMed 18515521]

3. PharmaDerm, Melville, NY: Personal communication.

4. Workowski KA, Berman S, Centers for Disease Control and Prevention (CDC). Sexually transmitted diseases treatment guidelines, 2010. MMWR Recomm Rep. 2010; 59(RR-12):1-110. [PubMed 21160459]

More Veregen resources Veregen Side Effects (in more detail) Veregen Use in Pregnancy & Breastfeeding Veregen Support Group 0 Reviews for Veregen - Add your own review/rating Veregen Prescribing Information (FDA) Veregen Advanced Consumer (Micromedex) - Includes Dosage Information Veregen MedFacts Consumer Leaflet (Wolters Kluwer) Veregen Consumer Overview Compare Veregen with other medications Condylomata Acuminata
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