vandazole 0.75% vaginal gel anyone take it and been ok while pregnant
 

Pills
 

ED Pills

ED Drugs
 

Vaginal Dryness Medications


There are currently no drugs listed for "Vaginal Dryness".

Definition of Vaginal Dryness: There are many causes of vaginal dryness. A very common cause of vaginal dryness is lack of the hormone estrogen in postmenopausal women. Other causes can include an infection, foreign body, or a tumor (a rare cause of vaginal dryness).

Learn more about Vaginal Dryness

Medical Encyclopedia:

Vaginal dryness
Drug List:
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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/
/tags/vandazole/
/tags/monistat-7-cream/
/tags/gynazole-1-cream/
/tags/metrogel-vaginal-gel/
/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/
/tags/micatin-foot-powder/
/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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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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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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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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Micon 7


Generic Name: miconazole vaginal (my CAW nah zole)
Brand Names: M-Zole Dual Pack, Micon 7, Monistat 3, Monistat 5, Monistat 7

What is Micon 7 (miconazole vaginal)?

Miconazole is an antifungal medication. It prevents fungus from growing.

Miconazole vaginal is used to treat vaginal candida (yeast) infections.

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

What is the most important information I should know about Micon 7 (miconazole vaginal)?

Use this medication for the full amount of time prescribed by your doctor or recommended in the package even if you begin to feel better. The symptoms may improve before the infection is completely healed.

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 the eyes, nose, or mouth. What should I discuss with my healthcare provider before using Micon 7 (miconazole vaginal)?

If this is the first time that you have ever had symptoms of a vaginal yeast infection, consult your doctor before using this medication.

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

Before using miconazole vaginal, talk to your doctor if you have

a fever,

abdominal pain,

foul-smelling discharge,

diabetes, or

HIV or AIDS.

You may not be able to use miconazole vaginal, or you may require special monitoring during treatment if you have any of the conditions listed above.

Do not use miconazole vaginal without first talking to your doctor if you are pregnant. Do not use miconazole vaginal without first talking to your doctor if you are breast-feeding a baby. How should I use Micon 7 (miconazole vaginal)? Use miconazole vaginal exactly as directed by your doctor or follow the directions that accompany the package. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

Wash your hands before and after using the medication.

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

Use this medication for the full amount of time prescribed by your doctor or recommended in the package even if you begin to feel better. The symptoms may improve before the infection is completely healed.

Use this medication continuously, even during your menstrual period.

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

If the infection does not clear up after you have finished one course of therapy, or if it appears to get worse, see your doctor. You may have another type of infection.

Avoid getting this medication in the eyes, nose, or mouth. Store miconazole vaginal at room temperature away from moisture and heat. What happens if I miss a dose?

Apply the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the dose you missed and apply only the next regularly scheduled dose. Do not use a double dose of this medication.

What happens if I overdose?

An overdose of miconazole vaginal is unlikely. If you do suspect that a much larger than normal dose has been used or that miconazole vaginal has been ingested, contact an emergency room or a poison control center.

What should I avoid while using Micon 7 (miconazole vaginal)?

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.

Miconazole may damage a condom or diaphragm. Use another form of birth control while using miconazole vaginal.

Micon 7 (miconazole vaginal) side effects Stop using miconazole vaginal and seek emergency medical attention if you experience an allergic reaction (shortness of breath; closing of your throat; swelling of your lips, face, or tongue; or hives).

Other, less serious side effects may be more likely to occur. These include burning, itching, irritation of the skin, and an increased need to urinate.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Micon 7 (miconazole vaginal)? Do not use miconazole vaginal without first talking to your doctor if you are taking warfarin (Coumadin). Special monitoring or a dosage adjustment may be necessary.

Avoid using other vaginal creams or douches at the same time as miconazole vaginal unless otherwise directed by your doctor.

Drugs other than those listed here may also interact with miconazole vaginal. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.

More Micon 7 resources Micon 7 Side Effects (in more detail) Micon 7 Use in Pregnancy & Breastfeeding Micon 7 Drug Interactions Micon 7 Support Group 0 Reviews for Micon 7 - Add your own review/rating Baza Antifungal Topical Advanced Consumer (Micromedex) - Includes Dosage Information Cruex Prescription Strength Topical Advanced Consumer (Micromedex) - Includes Dosage Information Lotrimin AF Lotion MedFacts Consumer Leaflet (Wolters Kluwer) Micatin Cream MedFacts Consumer Leaflet (Wolters Kluwer) Monistat 3 Cream MedFacts Consumer Leaflet (Wolters Kluwer) Monistat 3 Prescribing Information (FDA) Monistat 7 Cream MedFacts Consumer Leaflet (Wolters Kluwer) Zeasorb-AF Gel MedFacts Consumer Leaflet (Wolters Kluwer) Compare Micon 7 with other medications Vaginal Yeast Infection Where can I get more information? Your pharmacist has additional information about miconazole vaginal written for health professionals that you may read.

See also: Micon 7 side effects (in more detail)


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Monistat 7 Cream



Dosage Form: vaginal cream
Monistat 7 Cream

Drug Facts

Active ingredient

Miconazole nitrate 2% (100 mg in each applicatorful)

Purpose

Vaginal antifungal

Uses treats vaginal yeast infections relieves external itching and irritation due to a vaginal yeast infection Warnings

For vaginal use only

Do not use if you have never had a vaginal yeast infection diagnosed by a doctor

Ask a doctor before use if you have

vaginal itching and discomfort for the first time lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. You may have a more serious condition. vaginal yeast infections often (such as once a month or 3 in 6 months). You could be pregnant or have a serious underlying medical cause for your symptoms, including diabetes or a weakened immune system. been exposed to the human immunodeficiency virus (HIV) that causes AIDS

Ask a doctor or pharmacist before use if you are taking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur

When using this product

do not use tampons, douches, spermicides or other vaginal products. Condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted diseases (STDs). do not have vaginal intercourse mild increase in vaginal burning, itching or irritation may occur if you do not get complete relief ask a doctor before using another product

Stop use and ask a doctor if

symptoms do not get better in 3 days symptoms last more than 7 days you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions before using this product, read the enclosed consumer information leaflet for complete directions and information adults and children 12 years of age and over: applicator: insert 1 applicatorful into the vagina at bedtime for 7 nights in a row. Throw away applicator after use. use the same tube of cream if you have itching and irritation on the skin outside the vagina. Squeeze a small amount of cream onto your fingertip. Apply to itchy, irritate skin outside the vagina (vulva). Use 2 times daily for up to 7 days as needed. children under 12 years of age: ask a doctor Other information

do not use if seal over tube opening has been punctured or embossed design

do not purchase if carton is open store at 20°-25°C (68°-77°F) Inactive ingredients benzoic acid, cetyl alcohol, isopropyl myristate, polysorbate 60, potassium hydroxide, propylene glycol, purified water, stearyl alcohol Questions?

If you have any questions or comments, please call 1-877-666-4782

PRINCIPAL DISPLAY PANEL - 45g Tube Carton

NDC 30014-024-15

MONISTAT® 7
Miconazole Nitrate Vaginal Cream (2%)
Vaginal Antifungal

(Miconazole Nitrate 100 mg per application)

CURES MOST VAGINAL YEAST INFECTIONS
AND RELIEVES ASSOCIATED EXTERNAL ITCHING AND IRRITATION

ORTHO

7 Day Vaginal Cream
with Disposable Applicators

Net Wt.
1.59 oz. (45g) tube


MONISTAT 7   7-DAY DISPOSABLE APPLICATORS
miconazole nitrate  cream Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 30014-024 Route of Administration VAGINAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Miconazole Nitrate (Miconazole) Miconazole Nitrate 20 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 30014-024-15 7 TUBE In 1 CARTON contains a TUBE, WITH APPLICATOR 1 45 g In 1 TUBE, WITH APPLICATOR This package is contained within the CARTON (30014-024-15)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA017450 04/15/2010
Labeler - McNeil-PPC, Inc. (801375143) Revised: 04/2010McNeil-PPC, Inc.
More Monistat 7 Cream resources Monistat 7 Cream Use in Pregnancy & Breastfeeding Monistat 7 Cream Drug Interactions Monistat 7 Cream Support Group 8 Reviews for Monistat 7 - Add your own review/rating Compare Monistat 7 Cream with other medications Cutaneous Candidiasis Oral Thrush Tinea Corporis Tinea Cruris Tinea Pedis Tinea Versicolor Vaginal Yeast Infection
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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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Topcare Tioconazole 1



Dosage Form: ointment
Topco Tioconazole 1 Drug Facts Active ingredient (in each applicator)

Tioconazole 300 mg (6.5%)

Purpose

Vaginal antifungal

Uses treats vaginal yeast infections Warnings

For vaginal use only

Do not use

if you have never had a vaginal yeast infection diagnosed by a doctor

Ask a doctor before use if you have vaginal itching and discomfort for the first time lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. You may have a more serious condition. vaginal yeast infections often (such as once a month or 3 in 6 months). You could be pregnant or have a serious underlying medical cause for your symptoms, including diabetes or a weakened immune system. been exposed to human immunodeficiency virus (HIV) that causes AIDS When using this product do not use tampons, douches, spermicides, or other vaginal products. Condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted disease (STDs). do not have vaginal intercourse mild increase in vaginal burning, itching or irritation may occur Stop use and ask a doctor if symptoms do not get better after 3 days symptoms last more than 7 days you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions before using this product read the enclosed brochure and instructions on foil packet for complete directions and information adults and children 12 years and over: open the foil packet just before use and remove purple cap insert entire contents of applicator into the vagina at bedtime. Throw applicator away after use. children under 12 years of age: ask a doctor Other information this product is a 1-dose treatment, most women do not experience complete relief of their symptoms in just one day. Most women experience some relief within one day and complete relief of symptoms within 7 days. if you have questions about vaginal yeast infections, consult your doctor store at 20° - 25°C (68° - 77°F) see end flap of carton for lot number and expiration date Inactive ingredients

butylated hydroxyanisole, magnesium aluminum silicate, white petrolatum

Questions or comments?

1-888-423-0139

Principal Display Panel

1-Dose Vaginal Treatment

Tioconazole 1

Tioconazole Ointment 6.5%

Vaginal Antifungal

Cures Most Vaginal Yeast Infections

1 Ready-to-Use Convenient Prefilled Applicator

Compare to 1-Day™ active ingredient

Tioconazole 1 Carton


Topcare Tioconazole 1 
tioconazole  ointment Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 36800-426 Route of Administration VAGINAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TIOCONAZOLE (TIOCONAZOLE) TIOCONAZOLE 6.5 g  in 100 g Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color BROWN (light to dark tan) Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 36800-426-54 1 APPLICATOR In 1 CARTON contains a APPLICATOR 1 4.6 g In 1 APPLICATOR This package is contained within the CARTON (36800-426-54)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075915 03/03/2008
Labeler - Topco Associates LLC (006935977) Revised: 11/2009Topco Associates LLC
More Topcare Tioconazole 1 resources Topcare Tioconazole 1 Side Effects (in more detail) Topcare Tioconazole 1 Use in Pregnancy & Breastfeeding Topcare Tioconazole 1 Support Group 7 Reviews for Topcare Tioconazole - Add your own review/rating Compare Topcare Tioconazole 1 with other medications Vaginal Yeast Infection
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Up and Up Tioconazole 1



Dosage Form: vaginal ointment
Target Corp. Tioconazole 1 Drug Facts Active ingredient (in each applicator)

Tioconazole 300 mg (6.5%)

Purpose

Vaginal antifungal

Uses treats vaginal yeast infections Warnings

For vaginal use only

Do not use

if you have never had a vaginal yeast infection diagnosed by a doctor

Ask a doctor before use if you have vaginal itching and discomfort for the first time lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. You may have a more serious condition. vaginal yeast infections often (such as once a month or 3 in 6 months). You could be pregnant or have a serious underlying medical cause for your symptoms, including diabetes or a weakened immune system. been exposed to human immunodeficiency virus (HIV) that causes AIDS When using this product do not use tampons, douches, spermicides, or other vaginal products. Condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted disease (STDs). do not have vaginal intercourse mild increase in vaginal burning, itching or irritation may occur Stop use and ask a doctor if symptoms do not get better after 3 days symptoms last more than 7 days you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions before using this product read the enclosed brochure and instructions on foil packet for complete directions and information adults and children 12 years and over: open the foil packet just before use and remove purple cap insert entire contents of applicator into the vagina at bedtime. Throw applicator away after use. children under 12 years of age: ask a doctor Other information this product is a 1-dose treatment, most women do not experience complete relief of their symptoms in just one day. Most women experience some relief within one day and complete relief of symptoms within 7 days. if you have questions about vaginal yeast infections, consult your doctor store at 20° - 25°C (68° - 77°F) see end flap of carton for lot number and expiration date Inactive ingredients

butylated hydroxyanisole, magnesium aluminum silicate, white petrolatum

Questions or comments?

1-800-910-6874

Principal Display Panel

1-Dose Treatment

Tioconazole 1

Tioconazole Ointment 6.5%

Vaginal Antifungal

Compare to active ingredient in 1-Day™

Cures Most Vaginal Yeast Infections

1 Ready-to-Use Prefilled Applicator

Educational Brochure Enclosed

1 Dose

Tioconazole 1 Carton


Up and Up Tioconazole 1 
tioconazole  ointment Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 11673-426 Route of Administration VAGINAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TIOCONAZOLE (TIOCONAZOLE) TIOCONAZOLE 6.5 g  in 100 g Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color BROWN (light to dark tan) Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 11673-426-54 1 POUCH In 1 CARTON contains a POUCH 1 1 APPLICATOR In 1 POUCH This package is contained within the CARTON (11673-426-54) and contains a APPLICATOR 1 4.6 g In 1 APPLICATOR This package is contained within a POUCH and a CARTON (11673-426-54)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075915 07/08/2009
Labeler - Target Corporation (006961700) Revised: 11/2009Target Corporation
More Up and Up Tioconazole 1 resources Up and Up Tioconazole 1 Side Effects (in more detail) Up and Up Tioconazole 1 Use in Pregnancy & Breastfeeding Up and Up Tioconazole 1 Support Group 7 Reviews for Up and Up Tioconazole - Add your own review/rating Compare Up and Up Tioconazole 1 with other medications Vaginal Yeast Infection
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Monistat 7 Combination Pack


miconazole nitrate
Dosage Form: cream
Monistat 7 Combination Pack Triple Action

Drug Facts

Active ingredients Purpose Miconazole nitrate 2% (100 mg in each applicatorful) Vaginal antifungal Miconazole nitrate 2% (external cream) Vaginal antifungal Uses treats vaginal yeast infections relieves external itching and irritation due to a vaginal yeast infection Warnings

For vaginal use only

Do not use if you have never had a vaginal yeast infection diagnosed by a doctor

Ask a doctor before use if you have

vaginal itching and discomfort for the first time lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. You may have a more serious condition. vaginal yeast infections often (such as once a month or 3 in 6 months). You could be pregnant or have a serious underlying medical cause for your symptoms, including diabetes or a weakened immune system. been exposed to the human immunodeficiency virus (HIV) that causes AIDS

Ask a doctor or pharmacist before use if you are taking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur

When using this product

do not use tampons, douches, spermicides or other vaginal products. Condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted diseases (STDs). do not have vaginal intercourse mild increase in vaginal burning, itching or irritation may occur if you do not get complete relief ask a doctor before using another product

Stop use and ask a doctor if

symptoms do not get better in 3 days symptoms last more than 7 days you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions before using this product, read the enclosed consumer information leaflet for complete directions and information adults and children 12 years of age and over: applicators: insert 1 applicatorful into the vagina at bedtime for 7 nights in a row. Throw away applicator after use. external cream: squeeze a small amount of cream onto your fingertip. Apply the cream onto the itchy, irritated skin outside the vagina (vulva). Use 2 times daily for up to 7 days, as needed. children under 12 years of age: ask a doctor Other information

do not use if seal over tube opening has been punctured or embossed design

do not purchase if carton is open store at 20°-25°C (68°-77°F) Inactive ingredients benzoic acid, cetyl alcohol, isopropyl myristate, polysorbate 60, potassium hydroxide, propylene glycol, purified water, stearyl alcohol Questions?

If you have any questions or comments, please call 1-877-666-4782

PRINCIPAL DISPLAY PANEL - Kit Carton

NDC-30014-003-07

MONISTAT®7
COMBINATION PACK
Miconazole Nitrate Cream (2%) and Miconazole Nitrate Cream (2%)

(Miconazole Nitrate 100 mg per applicator)

ORTHO
CLINICALLY PROVEN
Multi-Symptom Relief

VAGINAL ANTIFUNGAL

CURES MOST VAGINAL YEAST INFECTIONS AND
RELIEVES ASSOCIATED EXTERNAL ITCHING AND IRRITATION

7-Day Vaginal Cream with Disposable Applicators
PLUS External Cream

Net Wt. 1.59 oz. (45g)
+ 0.32 oz. (9g) Tube


Monistat 7 Combination Pack  TRIPLE ACTION
miconazole nitrate  kit Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 30014-003 Packaging # NDC Package Description Multilevel Packaging 1 30014-003-07 1 KIT In 1 PACKAGE, COMBINATION None QUANTITY OF PARTS Part # Package Quantity Total Product Quantity Part 1 1 TUBE, WITH APPLICATOR   0.1 g Part 2 1 TUBE   0.009 g Part 1 of 2 MICONAZOLE NITRATE 
miconazole nitrate  cream Product Information       Route of Administration VAGINAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Miconazole Nitrate (Miconazole) Miconazole Nitrate 20 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 0.1 g In 1 TUBE, WITH APPLICATOR None Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA017450 04/10/2010
Part 2 of 2 MICONASOLE NITRATE 
miconazole nitrate  cream Product Information       Route of Administration VAGINAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Miconazole Nitrate (Miconazole) Miconazole Nitrate 20 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 0.009 g In 1 TUBE None Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA017450 04/10/2010
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA017450 04/10/2010
Labeler - McNeil, PPC, Inc. (801375143) Revised: 04/2010McNeil, PPC, Inc.
More Monistat 7 Combination Pack resources Monistat 7 Combination Pack Side Effects (in more detail) Monistat 7 Combination Pack Use in Pregnancy & Breastfeeding Monistat 7 Combination Pack Drug Interactions Monistat 7 Combination Pack Support Group 0 Reviews for Monistat 7 Combination Pack - Add your own review/rating Compare Monistat 7 Combination Pack with other medications Vaginal Yeast Infection
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Mycostatin Vaginal Cream


Generic Name: nystatin (Vaginal route)

nye-STAT-in

Commonly used brand name(s)

In Canada

Mycostatin Mycostatin Vaginal Cream Nadostine Nilstat Vaginal Cream Nilstat Vaginal Tablet Nyaderm Vaginal Cream

Available Dosage Forms:

Cream Tablet

Therapeutic Class: Antifungal

Chemical Class: Polyene

Uses For Mycostatin Vaginal Cream

Nystatin belongs to the group of medicines called antifungals. Vaginal nystatin is used to treat fungus infections of the vagina. Nystatin vaginal cream or tablets may also be used for other problems as determined by your doctor.

Nystatin is available only with your doctor's prescription.

Before Using Mycostatin Vaginal Cream

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

Allergies

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

Pediatric

Studies on this medicine have been done only in adults, and there is no specific information comparing use of vaginal nystatin in children with use in other age groups.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing the use of vaginal nystatin in the elderly with use in other age groups.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

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

Proper Use of nystatin

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

Nystatin usually comes with patient directions. Read them carefully before using this medicine.

This medicine is usually inserted into the vagina with an applicator. However, if you are pregnant, check with your doctor before using the applicator to insert the vaginal tablet.

To help clear up your infection completely, keep using this medicine for the full time of treatment, even if your condition has improved. Also, keep using this medicine even if you begin to menstruate during the time of treatment. Do not miss any doses.

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 treating fungus (yeast) infections: For vaginal cream dosage form: Adults and teenagers—One 100,000-unit applicatorful inserted into the vagina one or two times a day for two weeks. Or, your doctor may want you to insert one 500,000-unit applicatorful into the vagina once a day. Children—Dose must be determined by your doctor. For vaginal tablet dosage form: Adults and teenagers—One 100,000-unit tablet inserted into the vagina one or two times a day for two weeks. Children—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.

Precautions While Using Mycostatin Vaginal Cream

To help cure the infection and to help prevent reinfection, good health habits are required.

Wear cotton panties (or panties or pantyhose with cotton crotches) instead of synthetic (for example, nylon, rayon) underclothes. Wear freshly laundered underclothes.

If you have any questions about this, check with your health care professional.

If you have any questions about douching or intercourse during the time of treatment with nystatin, check with your doctor.

Since there may be some vaginal drainage while you are using this medicine, a sanitary napkin may be worn to protect your clothing.

Mycostatin Vaginal Cream 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 as soon as possible if any of the following side effects occur:

Rare Vaginal burning or itching not present before use of this medicine

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

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

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

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

More Mycostatin Vaginal Cream resources Mycostatin Vaginal Cream Use in Pregnancy & BreastfeedingMycostatin Vaginal Cream Support Group6 Reviews for Mycostatin Vaginal - Add your own review/rating Compare Mycostatin Vaginal Cream with other medications Cutaneous CandidiasisVaginal Yeast Infection
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Monistat 3


miconazole nitrate
Dosage Form: vaginal cream, vaginal suppositories
MONISTAT® 3
COMBINATION PACK

Miconazole Nitrate Vaginal Suppositories (200 mg) and Miconazole Nitrate Vaginal Cream
(2%)
Vaginal Antifungal

DRUG FACTS

Active ingredients Purpose Miconazole nitrate (200 mg in each suppository) Vaginal antifungal Miconazole nitrate 2% (external cream) Vaginal antifungal Uses treats vaginal yeast infections relieves external itching and irritation due to a vaginal yeast infection Warnings

For vaginal use only

Do not use if you have never had a vaginal yeast infection diagnosed by a doctor

Ask a doctor before use if you have

vaginal itching and discomfort for the first time lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. You may have a more serious condition. vaginal yeast infections often (such as once a month or 3 in 6 months). You could be pregnant or have a serious underlying medical cause for your symptoms, including diabetes or a weakened immune system. been exposed to the human immunodeficiency virus (HIV) that causes AIDS

Ask a doctor or pharmacist before use if you are taking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur

When using this product

do not use tampons, douches, spermicides or other vaginal products. Condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted diseases (STDs). do not have vaginal intercourse mild increase in vaginal burning, itching or irritation may occur if you do not get complete relief ask a doctor before using another product.

Stop use and ask a doctor if

symptoms do not get better in 3 days symptoms last more than 7 days you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions before using this product read the enclosed consumer information leaflet for complete directions and information adults and children 12 years of age and over: suppositories: insert 1 suppository into the vagina at bedtime for 3 nights in a row. Throw away applicator after use. external cream: squeeze a small amount of cream onto your fingertip. Apply the cream onto the itchy, irritated skin outside the vagina. Use 2 times daily for up to 7 days, as needed. children under 12 years of age: ask a doctor Other information do not use if printed suppository blister is torn, open or incompletely sealed

do not use if seal over tube opening has been punctured or embossed design

do not purchase if carton is open store at 20°-25°C (68°-77°F) Inactive ingredients

suppository: hydrogenated vegetable oil base

external cream: benzoic acid, cetyl alcohol, isopropyl myristate, polysorbate 60, potassium hydroxide, propylene glycol, purified water, stearyl alcohol

Questions? If you have any questions or comments, please call 1-877-666-4782
Visit our website @ www.monistat.com

PRINCIPAL DISPLAY PANEL

30014-018-03

MONISTAT® 3
COMBINATION PACK

Miconazole Nitrate Vaginal uppositories (200mg) and Miconazole Nitrate Vaginal Cream (2%)
Vaginal Antifungal

(Miconazole Nitrate 200 mg per suppository plus 2% external vulvar cream)

CURES MOST VAGINAL YEAST INFECTIONS

AND RELIEVES ASSOCIATED EXTERNAL ITCHING AND IRRITATION

ORTHO

3 Vaginal Suppositories with Reusable
Applicator plus External Cream

Net Wt. 3 Suppositories
0.32 oz (9g) tube


Monistat 3 COMBINATION PACK 
miconazole nitrate  kit Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 30014-018 Packaging # NDC Package Description Multilevel Packaging 1 30014-018-03 1 KIT In 1 PACKAGE, COMBINATION None QUANTITY OF PARTS Part # Package Quantity Total Product Quantity Part 1 1 BLISTER PACK   3  Part 2 1 TUBE   9 g Part 1 of 2 Monistat 3 
miconazole nitrate  suppository Product Information       Route of Administration VAGINAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Miconazole Nitrate (Miconazole) Miconazole Nitrate 200 mg 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 3 SUPPOSITORY In 1 BLISTER PACK None Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020670 12/10/2009
Part 2 of 2 Monistat 3 
miconazole nitrate  cream Product Information       Route of Administration VAGINAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Miconazole Nitrate (Miconazole) Miconazole Nitrate 10 mg  in 0.5 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 9 g In 1 TUBE None Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020670 12/10/2009
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020670 12/10/2009
Labeler - McNeil-PPC, Inc. (801375143) Establishment Name Address ID/FEI Operations Draxis Specialty Pharmaceuticals Inc., Canada 243604761 Analysis, Manufacture Revised: 12/2009McNeil-PPC, Inc.
More Monistat 3 resources Monistat 3 Side Effects (in more detail) Monistat 3 Use in Pregnancy & Breastfeeding Monistat 3 Drug Interactions Monistat 3 Support Group 0 Reviews for Monistat 3 - Add your own review/rating Monistat 3 Cream MedFacts Consumer Leaflet (Wolters Kluwer) Monistat 3 Concise Consumer Information (Cerner Multum) Aloe Vesta Concise Consumer Information (Cerner Multum) Baza Antifungal Topical Advanced Consumer (Micromedex) - Includes Dosage Information Cruex Prescription Strength Topical Advanced Consumer (Micromedex) - Includes Dosage Information Lotrimin AF Lotion MedFacts Consumer Leaflet (Wolters Kluwer) Micatin Cream MedFacts Consumer Leaflet (Wolters Kluwer) Monistat 7 Cream MedFacts Consumer Leaflet (Wolters Kluwer) Zeasorb-AF Gel MedFacts Consumer Leaflet (Wolters Kluwer) Compare Monistat 3 with other medications Vaginal Yeast Infection
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Estrace Vaginal Cream local


Generic Name: estradiol vaginal (local) (ess tra DYE ole VAJ in ul (LO kul))
Brand Names: Estrace Vaginal, Estring, Vagifem

What is estradiol vaginal (local)?

Estradiol is a form of estrogen, a female sex hormone the regulates many processes in the body.

Estradiol vaginal (local) is used to treat certain symptoms of menopause such as dryness, burning, and itching of the vaginal area. Estradiol vaginal also reduces urgency or irritation of urination.

Estradiol vaginal (local) may also be used for purposes not listed in this medication guide.

What is the most important information I should know about estradiol vaginal (local)?

Some estradiol products placed directly into the vagina are used for "local" treatment of vaginal menopause symptoms involving the secretions and surrounding tissues of the vagina. Other vaginal estradiol products are used for treating menopause symptoms affecting the vagina as well as other parts of the body (such as hot flashes). This type of vaginal estradiol has "systemic" effects, meaning that it can affect parts of the body other than where the medicine is placed or applied.

The information in this leaflet is specific to estradiol vaginal products that are used for local treatment of symptoms.

Do not use this medication if you have any of the following conditions: a history of stroke or blood clot, circulation problems, a hormone-related cancer such as breast or uterine cancer, or abnormal vaginal bleeding. This medication can cause birth defects in an unborn baby. Do not use if you are pregnant. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

Estradiol increases your risk of developing endometrial hyperplasia, a condition that may lead to cancer of the uterus. Taking progestins while using estradiol may lower this risk. If your uterus has not been removed, your doctor may prescribe a progestin for you to take while you are using estradiol vaginal.

Long-term estradiol treatment may increase your risk of breast cancer, heart attack, or stroke. Talk with your doctor about your individual risks before using estradiol long-term. Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment.

Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using estradiol.

What should I discuss with my healthcare provider before using estradiol vaginal (local)? You should not use estradiol vaginal if you have:

a bleeding or blood-clotting disorder;

a history of stroke or circulation problems;

abnormal vaginal bleeding that a doctor has not checked; or

any type of breast, uterine, or hormone-dependent cancer.

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

high blood pressure, angina, or heart disease;

high cholesterol or triglycerides;

liver disease; kidney disease;

asthma;

epilepsy or other seizure disorder;

migraines;

diabetes;

depression;

gallbladder disease; or

if you have had your uterus removed (hysterectomy).

Estradiol increases your risk of developing endometrial hyperplasia, a condition that may lead to cancer of the uterus. Taking progestins while using estradiol may lower this risk. If your uterus has not been removed, your doctor may prescribe a progestin for you to take while you are using estradiol vaginal.

FDA pregnancy category X. This medication can harm an unborn baby or cause birth defects. Do not use estradiol vaginal if you are pregnant. Tell your doctor right away if you become pregnant during treatment.

Long-term estradiol treatment may increase your risk of stroke. Talk with your doctor about your individual risks before using estradiol long-term. Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment.

Estradiol may decrease breast milk flow and have other effects on milk composition. Do not use estradiol without first talking to your doctor if you are breast-feeding a baby. How should I use estradiol vaginal (local)?

Some estradiol products placed directly into the vagina are used for "local" treatment of vaginal menopause symptoms involving the secretions and surrounding tissues of the vagina. Other vaginal estradiol products are used for treating menopause symptoms affecting the vagina as well as other parts of the body (such as hot flashes). This type of vaginal estradiol has "systemic" effects, meaning that it can affect parts of the body other than where the medicine is placed or applied.

The information in this leaflet is specific to estradiol vaginal products that are used for local treatment of symptoms.

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

To use the estradiol vaginal ring:

Squeeze the sides of the ring together and insert it into the vagina as far as possible. You should not be able to feel the ring once it is in place. If you can feel it, use a finger to push it in farther. It is not possible for the ring to go too far in or become lost.

Leave the ring in place for 90 days. If the ring ever falls out, rinse it with warm water and reinsert it. If it slides down into the lower part of the vagina, use a finger to push it in farther. After 90 days, remove the ring. Your doctor may want you to replace it with a new ring.

The ring does not need to be removed during sexual intercourse. Neither partner should be able to feel the ring when it is in place. If the ring is bothersome, you may remove it, rinse it with warm water, and reinsert it after intercourse.

To remove the ring, loop a finger through the ring and gently pull it from the vagina.

To use the estradiol vaginal cream:

Using the marked applicator provided, measure the prescribed dose of cream.

Lie on your back with your knees drawn up, sit, or stand in a position that allows you comfortable access to the vaginal area. Gently insert the applicator deep into your vagina and press in the plunger to empty the cream from the applicator into the vagina.

Take apart the applicator and wash it with mild soap and warm water. Allow the applicator to dry completely before using it again.

To use the estradiol vaginal tablets:

Each vaginal tablet is supplied in a disposable applicator.

Lie on your back with your knees drawn up, sit, or stand in a position that allows you comfortable access to the vaginal area. Gently insert the applicator deep into your vagina and press in the plunger to empty the tablet into the vagina.

Throw the applicator away.

Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using estradiol vaginal.

Store this medication 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.

If a vaginal ring falls out, rinse it with warm water and reinsert it. If it slides down into the lower part of the vagina, use a finger to push it in farther.

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

Overdose symptoms may include nausea, vomiting, and vaginal bleeding.

What should I avoid while using estradiol vaginal (local)?

Avoid using other vaginal products without your doctor's advice.

Estradiol vaginal (local) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

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

sudden numbness or weakness, especially on one side of the body;

sudden headache, confusion, problems with vision, speech, or balance;

pain, swelling, warmth, or redness in one or both legs;

abnormal vaginal bleeding;

pain, swelling, or tenderness in your stomach;

jaundice (yellowing of the skin or eyes); or

a lump in your breast.

Less serious side effects may include:

nausea, vomiting, loss of appetite;

swollen breasts;

acne or skin color changes;

decreased sex drive, impotence, or difficulty having an orgasm;

migraine headaches or dizziness;

vaginal pain, dryness, or discomfort;

swelling of your ankles or feet;

depression; or

changes in your menstrual periods, break-through bleeding.

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

What other drugs will affect estradiol vaginal (local)?

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

St. John's wort;

phenobarbital (Solfoton);

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

ritonavir (Norvir, Kaletra);

carbamazepine (Carbatrol, Tegretol);

rifampin (Rifadin, Rifater, Rifamate, Rimactane);

antibiotics such as clarithromycin (Biaxin) or erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole); or

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

This list is not complete and other drugs may interact with estradiol vaginal. 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 Estrace Vaginal Cream resources Estrace Vaginal Cream Side Effects (in more detail) Estrace Vaginal Cream Use in Pregnancy & Breastfeeding Estrace Vaginal Cream Drug Interactions Estrace Vaginal Cream Support Group 12 Reviews for Estrace Vaginal - Add your own review/rating Compare Estrace Vaginal Cream with other medications Atrophic Urethritis Atrophic Vaginitis Hypoestrogenism Where can I get more information? Your pharmacist can provide more information about estradiol vaginal (local).

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Synthetic Conjugated Estrogens, A vaginal


Generic Name: conjugated estrogens (vaginal) (KON joo gay ted ES troe jenz)
Brand Names: Premarin Vaginal, Synthetic Conjugated Estrogens, A

What are vaginal conjugated estrogens?

Estrogen is a female sex hormone produced by the ovaries. Estrogen is necessary for many processes in the body.

Vaginal conjugated estrogens are a mixture of estrogen hormones used to treat the vaginal symptoms of menopause such as dryness, burning, irritation, and painful sexual intercourse.

Vaginal conjugated estrogens should not be used to prevent heart disease or dementia, because this medication may actually increase your risk of developing these conditions.

Vaginal conjugated estrogens may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about vaginal conjugated estrogens? This medication can cause birth defects in an unborn baby. Do not use vaginal conjugated estrogens if you are pregnant. Do not use this medication if you have any of the following conditions: a history of heart attack, stroke, or blood clot (especially in your lung or your lower body), liver disease, abnormal vaginal bleeding, or a hormone-related cancer such as breast or uterine cancer.

Long-term treatment with conjugated estrogens may increase your risk of breast cancer, heart attack, or stroke. Talk with your doctor about your individual risks before using vaginal conjugated estrogens long term, especially if you smoke or are overweight. Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment.

Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using vaginal conjugated estrogens.

Vaginal conjugated estrogens should not be used to prevent heart disease or dementia, because this medication may actually increase your risk of developing these conditions. What should I discuss with my healthcare provider before using vaginal conjugated estrogens? Do not use vaginal conjugated estrogens if you are pregnant, or if you have:

a history of heart attack, stroke, or blood clot (especially in your lung or your lower body);

abnormal vaginal bleeding that a doctor has not checked;

liver disease; or

any type of breast, uterine, or hormone-dependent cancer.

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

high blood pressure, heart disease, or circulation problems;

a personal or family history of stroke;

endometriosis;

liver or kidney disease;

asthma;

epilepsy or other seizure disorder;

migraines;

diabetes;

underactive thyroid;

high cholesterol or triglycerides;

high or low levels of calcium in your blood;

porphyria;

systemic lupus erythematosus (SLE);

gallbladder disease; or

if you have had your uterus removed (hysterectomy).

Vaginal conjugated estrogens increase your risk of developing endometrial hyperplasia, a condition that may lead to cancer of the uterus. Taking progestins while using conjugated estrogens may lower this risk. If your uterus has not been removed, your doctor may prescribe a progestin for you to take while you are using vaginal conjugated estrogens.

Long-term conjugated estrogens treatment may increase your risk of stroke or blood clots. Talk with your doctor about your individual risks before using vaginal conjugated estrogens long term, especially if you smoke or are overweight. Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment.

FDA pregnancy category X. This medication can cause birth defects. Do not use vaginal conjugated estrogens if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use an effective form of birth control while you are using this medication. You should know that conjugated estrogens vaginal cream can weaken the latex of a condom, diaphragm, or cervical cap. Talk to your doctor about the best contraceptive methods to use. Conjugated estrogens can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. Do not use if you are breast-feeding a baby. Do not use this medication in anyone under 18 years old without the advice of a doctor. How should I use vaginal conjugated estrogens?

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. Follow the directions on your prescription label.

Vaginal conjugated estrogens are usually prescribed for only a short time and are most often used in a cycle, such as 3 weeks on followed by 1 week off. Some conditions require daily use and others require use only twice a week during the treatment period. Follow the directions on your prescription label.

To apply this medication, use only the vaginal applicator provided. After each use, take the applicator apart and clean it with mild soap and warm water. Do not use hot or boiling water.

Have regular physical exams and self-examine your breasts for lumps on a monthly basis if you are using vaginal conjugated estrogens long term.

If you need to have any type of surgery, tell the surgeon ahead of time that you are using conjugated estrogens. You may need to stop using the medicine for a short time.

This medication can affect the results of certain medical tests. Tell any doctor who treats you that you are using conjugated estrogens.

Store this medication at room temperature away from moisture and heat. 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 your 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. Overdose symptoms may include nausea, vomiting, or vaginal bleeding. What should I avoid while using vaginal conjugated estrogens?

Do not smoke while using this medication. Smoking can increase your risk of blood clots, stroke, or heart attack caused by vaginal conjugated estrogens.

Vaginal conjugated estrogens side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:

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

sudden numbness or weakness, especially on one side of the body;

sudden headache, confusion, problems with vision, speech, or balance;

pain or swelling in your lower leg;

abnormal vaginal bleeding;

migraine headache;

pain, swelling, or tenderness in your stomach;

confusion, problems with memory or concentration;

jaundice (yellowing of the skin or eyes);

swelling in your hands, ankles, or feet; or

a breast lump.

Less serious side effects may include:

mild nausea, vomiting, bloating, stomach cramps;

breast pain, tenderness, or swelling;

freckles or darkening of facial skin;

increased hair growth, loss of scalp hair;

changes in weight or appetite;

problems with contact lenses;

vaginal itching or discharge;

changes in your menstrual periods, decreased sex drive; or

headache, nervousness, dizziness, tired feeling.

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

What other drugs will affect vaginal conjugated estrogens?

Before using conjugated estrogens, tell your doctor if you are using any of the following medicines:

a blood thinner such as warfarin (Coumadin);

a thyroid medication such as levothyroxine (Synthroid);

insulin or diabetes medicine taken by mouth;

rifampin (Rifadin, Rifater, Rifamate, Rimactane);

ketoconazole (Nizoral) or itraconazole (Sporanox);

seizure medicines such as phenytoin (Dilantin), carbamazepine (Tegretol), felbamate (Felbatol), oxcarbazepine (Trileptal), or primidone (Mysoline);

a barbiturate such as amobarbital (Amytal), butabarbital (Butisol), mephobarbital (Mebaral), secobarbital (Seconal), or phenobarbital (Luminal, Solfoton); or

antidepressants such as amitriptyline (Elavil, Etrafon), amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Sinequan), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), or trimipramine (Surmontil).

This list is not complete and there may be other drugs that can interact with vaginal conjugated estrogens. 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 Synthetic Conjugated Estrogens, A resources Synthetic Conjugated Estrogens, A Side Effects (in more detail) Synthetic Conjugated Estrogens, A Use in Pregnancy & Breastfeeding Synthetic Conjugated Estrogens, A Drug Interactions 0 Reviews for Synthetic Conjugated Estrogens, A - Add your own review/rating Compare Synthetic Conjugated Estrogens, A with other medications Atrophic Urethritis Atrophic Vaginitis Postmenopausal Symptoms Where can I get more information? Your pharmacist can provide more information about vaginal conjugated estrogens.

See also: Synthetic Conjugated Estrogens, A side effects (in more detail)


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Topcare Miconazole 3



Dosage Form: vaginal suppositories, external cream
Topco Miconazole 3 Drug Facts Active ingredient

Miconazole nitrate (200 mg in each suppository)

Miconazole nitrate 2% (external cream)

Purpose

Vaginal antifungal

Uses treats vaginal yeast infections relieves external itching and irritation due to a vaginal yeast infection Warnings

For vaginal use only

Do not use

if you have never had a vaginal yeast infection diagnosed by a doctor

Ask a doctor before use if you have vaginal itching and discomfort for the first time lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. You may have a more serious condition. vaginal yeast infections often (such as once a month or 3 in 6 months). You could be pregnant or have a serious underlying medical cause for your symptoms, including diabetes or a weakened immune system. been exposed to the human immunodeficiency virus (HIV) that causes AIDS Ask a doctor or pharmacist before use if you are

taking a prescription blood thinning medicine, such as warfarin, because bleeding or bruising may occur

When using this product do not use tampons, douches, spermicides or other vaginal products. Condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted diseases (STDs). do not have vaginal intercourse mild increase in vaginal burning, itching or irritation may occur Stop use and ask a doctor if symptoms do not get better in 3 days symptoms last more than 7 days you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions before using this product read the enclosed consumer information leaflet for complete instructions and information adults and children 12 years of age and over: suppositories: insert 1 suppository into the vagina at bedtime for 3 nights in a row. Throw applicator away after use. external cream: squeeze a small amount of cream onto your fingertip. Apply the cream onto the itchy, irritated skin outside the vagina. Use 2 times daily for up to 7 days, as needed. children under 12 years of age: ask a doctor Other information do not use if printed suppository wrapper is missing or damaged (each suppository is individually wrapped) do not use if seal over tube opening has been punctured or cannot be seen do not purchase if carton is open store at 20°-25°C (68°-77°F) Inactive ingredients

suppository: hydrogenated vegetable oil

external cream: benzoic acid, butylated hydroxyanisole, glyceryl stearate, mineral oil, peglicol 5 oleate, pegoxol 7 stearate, purified water

Questions or comments?

1-888-423-0139

Principal Display Panel

3-Day Treatment

Vaginal Suppositories

Miconazole 3

Miconazole Nitrate Vaginal Suppositories (200 mg) and Miconazole Nitrate Cream (2%)

Vaginal Antifungal

Combination Pack

(Miconazole Nitrate 200 mg per Suppository Plus 2% External Vulvar Cream)

Cures Most Vaginal Yeast Infections

Relieves Associated External Itching and Irritation

3 Vaginal Suppositories with 3 Disposable Applicators plus External Vulvar Cream

Compare to Monistat® 3 active ingredients

Miconazole 3 Carton


Topcare Miconazole 3  COMBINATION PACK
miconazole nitrate  kit Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 36800-081 Packaging # NDC Package Description Multilevel Packaging 1 36800-081-00 1 KIT In 1 CARTON None QUANTITY OF PARTS Part # Package Quantity Total Product Quantity Part 1 1 BLISTER PACK   3  Part 2 1 TUBE   9 g Part 1 of 2 MICONAZOLE 
miconazole nitrate  suppository Product Information       Route of Administration VAGINAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MICONAZOLE NITRATE (MICONAZOLE) MICONAZOLE NITRATE 200 mg Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color WHITE (to off white, opaque) Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 1 BLISTER PACK In 1 KIT contains a BLISTER PACK 1 3 SUPPOSITORY In 1 BLISTER PACK This package is contained within the KIT Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075329 05/10/2000
Part 2 of 2 MICONAZOLE 
miconazole nitrate  cream Product Information       Route of Administration TOPICAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MICONAZOLE NITRATE (MICONAZOLE) MICONAZOLE NITRATE 2 g  in 100 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 1 TUBE In 1 KIT contains a TUBE 1 9 g In 1 TUBE This package is contained within the KIT Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075329 05/10/2000
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075329 05/10/2000
Labeler - Topco Associates LLC (006935977) Revised: 09/2009Topco Associates LLC
More Topcare Miconazole 3 resources Topcare Miconazole 3 Use in Pregnancy & BreastfeedingTopcare Miconazole 3 Drug InteractionsTopcare Miconazole 3 Support Group8 Reviews for Topcare Miconazole 3 - Add your own review/rating Compare Topcare Miconazole 3 with other medications Cutaneous CandidiasisOral ThrushTinea CorporisTinea CrurisTinea PedisTinea VersicolorVaginal Yeast Infection
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gentian violet Vaginal


JEN-shun VYE-oh-let

Uses For gentian violet

Vaginal gentian violet is used to treat fungus (yeast) infections.

Vaginal gentian violet was available only with your doctor's prescription.

Key Pharmaceuticals discontinued Genapax® on October 3, 1990 .

Before Using gentian violet

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 gentian violet, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to gentian violet 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

Studies on gentian violet have been done only in adult patients, and there is no specific information comparing use of vaginal gentian violet in children with use in other age groups.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of vaginal gentian violet in the elderly with use in other age groups, gentian violet is not expected to cause different side effects or problems in older people than it does in younger adults.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

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

Proper Use of gentian violet

Gentian violet usually comes with patient directions. Read them carefully before using gentian violet.

After insertion, remove the tampon from the vagina after 3 to 4 hours unless otherwise directed by your doctor.

To help clear up your infection completely, keep using gentian violet for the full time of treatment, even though your condition may have improved. Do not miss any doses.

While you are using gentian violet tampons, the use of regular (non-medicated) tampons is not recommended. They will soak up the medicine that stays in the vagina after the gentian violet tampon is taken out. During your menstrual period you should wear a minipad or sanitary napkin instead.

Dosing

The dose of gentian violet 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 gentian violet. 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 vaginal dosage form (tampons): For treating a vaginal fungus (yeast) infection: Adults and teenagers—5 milligrams (one tampon) inserted into your vagina one or two times a day for twelve days in a row. The tampon should be left in your vagina for three to four hours. Missed Dose

If you miss a dose of gentian violet, 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.

Precautions While Using gentian violet

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

Gentian violet will stain the skin and clothing. Vaginal medicines usually will come out of the vagina during treatment. To keep the medicine from getting on your clothing, wear a minipad or sanitary napkin.

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

Wear cotton panties (or panties or pantyhose with cotton crotches) instead of synthetic (for example, nylon or rayon) panties. Wear only clean panties.

If you have any questions about this, check with your health care professional.

Many vaginal infections are spread by having sex. A male sexual partner may carry the germs on or in his penis. While you are using gentian violet, it may be a good idea for your partner to wear a condom during sex to avoid re-infection. Also, your partner may need to be treated. Do not stop using gentian violet if you have sex during treatment.

Some women may want to use a douche before putting each dose in the vagina. Some doctors will allow the use of a vinegar and water douche or other douche. However, others do not allow any douching. If you do use a douche, do not overfill the vagina. To do so may push the douche up into the uterus and possibly cause inflammation or infection. Also, do not douche if you are pregnant since this may harm the fetus. If you have any questions about this, check with your health care professional.

gentian violet 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 as soon as possible if any of the following side effects occur:

Vaginal burning, itching, pain, or other sign of irritation not present before use of gentian violet

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

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

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

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

More gentian violet Vaginal resources Gentian violet Vaginal Support Group 0 Reviews for Gentian violet Vaginal - Add your own review/rating Compare gentian violet Vaginal with other medications Fungal Infection Prophylaxis Oral Thrush
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Mycelex-7 Inserts


Pronunciation: kloe-TRIM-a-zole
Generic Name: Clotrimazole
Brand Name: Gyne-Lotrimin and Mycelex-7
Mycelex-7 Inserts are used for:

Treating vaginal yeast infections.

Mycelex-7 Inserts are an antifungal agent. It works by weakening the cell membrane of the fungus, resulting in the death of the fungus.

Do NOT use Mycelex-7 Inserts if: you are allergic to any ingredient in Mycelex-7 Inserts you have never had a vaginal yeast infection diagnosed by a doctor you have itching caused by a condition other than a yeast infection you have stomach, shoulder, or lower back pain; fever; chills; nausea; foul-smelling vaginal discharge; or vomiting

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

Before using Mycelex-7 Inserts:

Some medical conditions may interact with Mycelex-7 Inserts. 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 the blood disease porphyria or a history of liver disease or diabetes, or you have been exposed to HIV if this is the first time you have had vaginal itching and discomfort if you have vaginal yeast infections often (eg, your symptoms return within 2 months) or your symptoms do not clear up with treatment if you are taking antibiotics

Some MEDICINES MAY INTERACT with Mycelex-7 Inserts. However, no specific interactions with Mycelex-7 Inserts are known at this time.

Ask your health care provider if Mycelex-7 Inserts 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 Mycelex-7 Inserts:

Use Mycelex-7 Inserts as directed by your doctor. Check the label on the medicine for exact dosing instructions.

An extra patient leaflet is available with Mycelex-7 Inserts. Talk to your pharmacist if you have questions about this information. Mycelex-7 Inserts are for vaginal use only. Do not use it rectally or take by mouth. Using the applicator provided, insert 1 suppository high into the vagina at bedtime for 7 days. Some forms of this product come with 7 disposable applicators. If this product contains disposable applicators, throw away each applicator after use. Some forms of this product come with one applicator to be used for all 7 days of treatment. If this product contains only one applicator, do not throw it away after use. Separate the pieces of the applicator and wash with warm, soapy water immediately after use. Rinse thoroughly. Make sure the applicator is completely dry before the next use. Wash your hands immediately after using Mycelex-7 Inserts. To clear up your infection completely, use Mycelex-7 Inserts for the full course of treatment. Keep using it even if you feel better in a few days. If you miss a dose of Mycelex-7 Inserts, use 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 use 2 doses at once.

Ask your health care provider any questions you may have about how to use Mycelex-7 Inserts.

Important safety information: Mycelex-7 Inserts are for vaginal use only. Avoid contact with the eyes, nose, or mouth. If you get Mycelex-7 Inserts in your eyes, flush with a generous amount of cool water. Be sure to use Mycelex-7 Inserts for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future. If your symptoms do not improve within 3 days, if they last more than 7 days, or if they get worse, check with your doctor. Do not use Mycelex-7 Inserts for itching caused by other conditions. Dry the outside vaginal area completely after showering, bathing, or swimming. Do not go swimming for at least 9 to 12 hours after applying Mycelex-7 Inserts. Change out of wet bathing suits or damp workout clothes as soon as possible. Continue using Mycelex-7 Inserts even during your menstrual period. Do not use tampons while you are using Mycelex-7 Inserts or until all of your symptoms go away. Use unscented pads or pantiliners. Do not have vaginal sexual intercourse while you are using Mycelex-7 Inserts. Mycelex-7 Inserts may decrease the effectiveness of condoms and diaphragms, increasing the chance of pregnancy or risk of sexually transmitted disease. Do not use tampons, douches, spermicides, or other vaginal products while using Mycelex-7 Inserts. If you use topical products too often, your condition may become worse. Mycelex-7 Inserts should not be used in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Mycelex-7 Inserts while you are pregnant. It is not known if Mycelex-7 Inserts are found in breast milk. If you are or will be breast-feeding while you use Mycelex-7 Inserts, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Mycelex-7 Inserts:

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:

Mild vaginal burning, irritation, or itching.

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); fever or chills; foul-smelling vaginal discharge; nausea; severe or prolonged vaginal burning, irritation, or itching; stomach pain; swelling; 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: Mycelex-7 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 Mycelex-7 Inserts:

Store Mycelex-7 Inserts at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Avoid temperatures above 86 degrees F (30 degrees C). Avoid freezing. Do not store in the bathroom. Do not use if the wrapper on the applicator or suppository is torn or damaged. Keep Mycelex-7 Inserts out of the reach of children and away from pets.

General information: If you have any questions about Mycelex-7 Inserts, please talk with your doctor, pharmacist, or other health care provider. Mycelex-7 Inserts are 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 Mycelex-7 Inserts. 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 Mycelex-7 resources Mycelex-7 Side Effects (in more detail) Mycelex-7 Use in Pregnancy & Breastfeeding Mycelex-7 Support Group 0 Reviews for Mycelex-7 - Add your own review/rating Compare Mycelex-7 with other medications Cutaneous Candidiasis Tinea Corporis Tinea Cruris Tinea Pedis Tinea Versicolor Vaginal Yeast Infection
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Monistat 1 Combo Pack Cream


Pronunciation: mi-KON-a-zole
Generic Name: Miconazole
Brand Name: Monistat 1 Combo Pack
Monistat 1 Combo Pack Cream is used for:

Treating vaginal yeast infections and relieving external vulvar itching and irritation associated with yeast infection.

Monistat 1 Combo Pack Cream is an antifungal agent. It works by weakening the cell membrane of the fungus, resulting in the death of the fungus.

Do NOT use Monistat 1 Combo Pack Cream if: you are allergic to any ingredient in Monistat 1 Combo Pack Cream you have never had a vaginal yeast infection diagnosed by a doctor

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

Before using Monistat 1 Combo Pack Cream:

Some medical conditions may interact with Monistat 1 Combo Pack 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 the blood disease porphyria or a history of liver disease, or you have been exposed to HIV if you have stomach, shoulder, or lower back pain; fever; chills; nausea; foul-smelling vaginal discharge; or vomiting if this is the first time you have had vaginal itching and discomfort if you have vaginal yeast infections often (eg, once a month or 3 in 6 months) if you are taking antibiotics

Some MEDICINES MAY INTERACT with Monistat 1 Combo Pack Cream. Tell your health care provider if you are taking any other medicines, especially any of the following:

Anticoagulants (eg, warfarin) because the risk of side effects such as bruising or bleeding may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Monistat 1 Combo Pack 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 Monistat 1 Combo Pack Cream:

Use Monistat 1 Combo Pack Cream as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Monistat 1 Combo Pack Cream comes with an additional patient leaflet. Read it carefully and reread it each time you get Monistat 1 Combo Pack Cream refilled. Monistat 1 Combo Pack Cream is for vaginal use only. Do not use in the eyes or take by mouth. Suppositories - Using the applicator provided, insert the suppository high into the vagina at bedtime. External cream - Squeeze a small amount of cream onto your finger and gently spread the cream onto the itchy, irritated skin outside the vagina as directed by your doctor or on the packaging. Wash your hands immediately after using Monistat 1 Combo Pack Cream. To clear up your infection completely, continue using Monistat 1 Combo Pack Cream for the full course of treatment. If you miss a dose of Monistat 1 Combo Pack Cream, use 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 use 2 doses at once.

Ask your health care provider any questions you may have about how to use Monistat 1 Combo Pack Cream.

Important safety information: Monistat 1 Combo Pack Cream is for vaginal use only. Avoid contact with the eyes, nose, or mouth. If you get Monistat 1 Combo Pack Cream in your eyes, flush with a generous amount of cool water. It is important to use Monistat 1 Combo Pack Cream for the full course of treatment. Failure to do so may decrease the effectiveness of Monistat 1 Combo Pack Cream and increase the risk that the fungus will no longer be sensitive to Monistat 1 Combo Pack Cream and will not be able to be treated by this or certain other antibiotics in the future. If your symptoms do not improve within 3 days, if they last more than 7 days, or if they become worse, stop using Monistat 1 Combo Pack Cream and contact your health care provider at once. You may have a more serious illness. Do not use Monistat 1 Combo Pack Cream for itching caused by other conditions. Dry the outside vaginal area completely after showering, bathing, or swimming. Do not go swimming for at least 9 to 12 hours after applying Monistat 1 Combo Pack Cream. Change out of wet bathing suits or damp workout clothes as soon as possible. Continue using Monistat 1 Combo Pack Cream even during your menstrual period. Do not use tampons while you are using Monistat 1 Combo Pack Cream or until all of your symptoms go away. Use unscented pads or pantiliners. Do not have vaginal sexual intercourse while you are using Monistat 1 Combo Pack Cream. Monistat 1 Combo Pack Cream may decrease the effectiveness of condoms and diaphragms, increasing the chance of pregnancy or risk of sexually transmitted disease. Do not use these products for at least 1 day after treatment with Monistat 1 Combo Pack Cream. Do not use tampons, douches, spermicides, or other vaginal products while using Monistat 1 Combo Pack Cream. Overuse of topical products may worsen your condition. Do not use Monistat 1 Combo Pack Cream in CHILDREN younger than 12 years of age unless advised to do so by your health care provider. PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Monistat 1 Combo Pack Cream, discuss with your doctor the benefits and risks of using Monistat 1 Combo Pack Cream during pregnancy. It is unknown if Monistat 1 Combo Pack Cream is excreted in breast milk. If you are or will be breast-feeding while you are using Monistat 1 Combo Pack Cream, check with your doctor or pharmacist. Possible side effects of Monistat 1 Combo Pack 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:

Headache; mild vaginal burning, irritation, or itching; stomach cramps.

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fever or chills; foul-smelling vaginal discharge; nausea; severe or prolonged vaginal burning, irritation, or itching; stomach pain; swelling; 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: Monistat Combo Pack 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 Monistat 1 Combo Pack Cream:

Store Monistat 1 Combo Pack Cream at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Do not use if the wrapper on the applicator or suppository is torn or damaged. Keep Monistat 1 Combo Pack Cream out of the reach of children and away from pets.

General information: If you have any questions about Monistat 1 Combo Pack Cream, please talk with your doctor, pharmacist, or other health care provider. Monistat 1 Combo Pack 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 Monistat 1 Combo Pack Cream. 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 Monistat 1 Combo Pack resources Monistat 1 Combo Pack Side Effects (in more detail) Monistat 1 Combo Pack Use in Pregnancy & Breastfeeding Monistat 1 Combo Pack Drug Interactions 0 Reviews for Monistat Combo Pack - Add your own review/rating Compare Monistat 1 Combo Pack with other medications Vaginal Yeast Infection
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Gynoxin 200 mg vaginal capsules


1. Name Of The Medicinal Product

Gynoxin 200 mg Vaginal Capsules

2. Qualitative And Quantitative Composition

Each vaginal capsule contains 200 mg of the active ingredient fenticonazole nitrate.

For excipients, see 6.1

3. Pharmaceutical Form

Vaginal capsule, soft

Ivory white, opaque, soft gelatin capsules

4. Clinical Particulars 4.1 Therapeutic Indications

Treatment of vulvovaginal candidiasis.

4.2 Posology And Method Of Administration

Route of Administration:

Intravaginal

Adults:

One 200 mg vaginal capsule at bedtime for 3 days

The capsule must be introduced deeply into the vagina.

Gynoxin is not greasy, does not soil and can easily be removed with water.

Children:

The use of Gynoxin in children is not recommended.

4.3 Contraindications

Ascertained hypersensitive to the product and to other imidazole derivatives.

4.4 Special Warnings And Precautions For Use

The product should not be used in conjunction with barrier contraceptives.

In the event of a hypersensitivity reaction or development of resistant organisms, treatment should be discontinued and the physician consulted.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Not investigated. Since systemic absorption of fenticonazole after application is low, interactions with other drugs are unlikely.

4.6 Pregnancy And Lactation

Oral administration of fenticonazole in rats has been reported to produce prolonged gestation and embryotoxic effects after doses above 40mg/kg/day. Fenticonazole does not interfere with the function of male and female gonads and does not modify the first phases of reproduction.

Fenticonazole has shown no teratogenic effects in rats and rabbits. Fenticonazole or its metabolites cross the placental barrier in pregnant rats and rabbits after vaginal application and are excreted in milk of lactating rats.

Since there is no experience of use during pregnancy or lactation, Gynoxin should not be used unless the physician considers it essential to the welfare of the patient.

4.7 Effects On Ability To Drive And Use Machines

None.

4.8 Undesirable Effects

After intravaginal administration slight transient burning, which usually disappears rapidly, may occasionally occur.

Prolonged topical application may cause sensitisation reactions.

4.9 Overdose

Because of the low systemic absorption after vaginal application, overdosage is unlikely. In case of a suspected accidental oral ingestion emesis should be induced or gastric lavage may be attempted. Irrespective of success in inducing emesis the patient should be made to drink water or lemonade with active charcoal and a laxative. Symptomatic therapy may be administered if indicated.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

ATC code: G01A F12

Fenticonazole is a broad-spectrum antimycotic agent.

• In vitro: high fungistatic and fungicidal activity against Candida albicans

• In vivo: healing of vaginal mycoses due to Candida within 5 days in mice.

5.2 Pharmacokinetic Properties

Pharmacokinetic studies in humans have shown that systemic absorption of fenticonazole nitrate after vaginal administration is minimal.

5.3 Preclinical Safety Data

LD50 mice: oral>3000mg/kg; i.p 1276mg/kg (M), 1265mg/kg (F)

LD50 rats: oral>3000mg/kg; s.c>750mg/kg; i.p. 440mg/kg (M), 309mg/kg (F)

Chronic toxicity: following oral administration of 40-80-160mg/kg/day for 6 months in rats and dogs, fenticonazole was well tolerated, although some evidence of light and moderate general toxicity occurred (increase in liver weight at 160mg/kg without histopathological alterations in rats, and a transient increase in serum SGPT at 80 and 160mg/kg, together with an increase in liver weight in dogs).

Fenticonazole does not interfere with the function of male and female gonads, and does not modify the first phases of reproduction. Studies in reproductive toxicology revealed, as for other imidazole derivatives, an embryolethal effect at high dosages (>20mg/kg). Fenticonazole has shown no teratogenic effects in rats and rabbits and has revealed no mutagenic potential in six mutagenicity tests.

Satisfactory results were obtained in tolerability tests performed in guinea pigs, rabbits as well as in mini-pigs, the skin of which is similar to that of humans, as far as morphology, functionality and sensitivity to irritating agents are concerned.

Fenticonazole has shown no evidence of sensitisation, phototoxicity and photoallergy.

Pharmacokinetic studies have revealed no transcutaneous absorption either in man or in animals and a very low vaginal absorption.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Medium chain triglycerides

Colloidal anhydrous silica

Shell constituents:

Gelatin

Glycerol

Titanium dioxide

Ethyl parahydroxybenzoate sodium (E215)

Sodium propyl parahydroxybenzoate (E217)

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

3 years

6.4 Special Precautions For Storage

Do not store above 30°C. Do not refrigerate or freeze. Store in the original package.

6.5 Nature And Contents Of Container

Blister pack of PVC/PVdC + aluminium foil, in packs of 3.

6.6 Special Precautions For Disposal And Other Handling

None

Administrative Data 7. Marketing Authorisation Holder

Recordati Industria Chimica e Farmaceutica SpA

Via Matteo Civitali

1-20148 Milano

Italy

8. Marketing Authorisation Number(S)

PL 04595/0007

9. Date Of First Authorisation/Renewal Of The Authorisation

22/09/99

10. Date Of Revision Of The Text

14/12/2009

POM


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