what is miconazole shelf life
 

Pills
 

ED Pills

ED Drugs
 

Iflerit


Iflerit may be available in the countries listed below.

Ingredient matches for Iflerit Fluprednidene

Fluprednidene 21-acetate (a derivative of Fluprednidene) is reported as an ingredient of Iflerit in the following countries:

Greece Miconazole

Miconazole nitrate (a derivative of Miconazole) is reported as an ingredient of Iflerit in the following countries:

Greece

International Drug Name Search


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Miconazole Powder


Pronunciation: mi-KON-a-zole
Generic Name: Miconazole
Brand Name: Examples include Lotrimin AF and Zeasorb-AF
Miconazole Powder is used for:

Treating athlete's foot, jock itch, or ringworm and relieving the itching, scaling, burning, and discomfort due to those conditions. It may also be used for other conditions as determined by your doctor.

Miconazole Powder is an antifungal. It works by weakening the fungal cell membrane, which kills the fungus.

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

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

Before using Miconazole Powder:

Some medical conditions may interact with Miconazole Powder. 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

Some MEDICINES MAY INTERACT with Miconazole Powder. Because little, if any, of Miconazole Powder is absorbed into the blood, the risk of it interacting with another medicine is low.

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

How to use Miconazole Powder:

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

Clean the affected area and dry it thoroughly. Sprinkle a thin layer of medicine over the entire affected area in the morning and evening unless otherwise directed by your doctor. Wash hands immediately after using Miconazole Powder unless your hands are part of the treated area. For athlete's foot, pay special attention to the area between the toes. Wear well-fitting, ventilated shoes, and change your shoes and socks at least once daily. To clear up your infection completely, continue using Miconazole Powder for the full course of treatment even if you feel better in a few days. Supervise children in the use of this product. If you miss a dose of Miconazole Powder, 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 Miconazole Powder.

Important safety information: Miconazole Powder is for external use only. Avoid contact with the eyes. If you get Miconazole Powder in your eyes, rinse them immediately with a generous amount of cool water. If Miconazole Powder is swallowed, contact a doctor or poison control center immediately. Do not cover the treated area with a bandage or dressing unless directed otherwise by your doctor. If there is no improvement of athlete's foot or ringworm within 4 weeks or jock itch within 2 weeks, or if your condition persists, contact your health care provider. Miconazole Powder is not effective on the scalp or nails. Do not use on CHILDREN younger than 2 years of age unless directed by a doctor. PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Miconazole Powder, discuss with your doctor the benefits and risks of using Miconazole Powder during pregnancy. It is unknown if Miconazole Powder is excreted in breast milk. If you are or will be breast-feeding while you are using Miconazole Powder, check with your doctor or pharmacist to discuss the risks to your baby. Possible side effects of Miconazole Powder:

All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with this product. 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); irritation.

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

If OVERDOSE is suspected:

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

Proper storage of Miconazole Powder:

Store Miconazole Powder 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. Keep Miconazole Powder out of the reach of children and away from pets.

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

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

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Miconazole resources Miconazole Use in Pregnancy & BreastfeedingMiconazole Drug InteractionsMiconazole Support Group8 Reviews for Miconazole - Add your own review/rating Compare Miconazole with other medications Cutaneous CandidiasisOral ThrushTinea CorporisTinea CrurisTinea PedisTinea VersicolorVaginal Yeast Infection
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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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Zeasorb-AF


Generic Name: miconazole topical (my CON a zole)
Brand Names: Aloe Vesta, Aloe Vesta 2 in 1 Antifungal, Baza, Cruex Prescription Strength, Desenex Prescription Strength, Fungoid, Fungoid Kit, Micatin, Micatin Cooling Action, Micatin Foot Powder, Micatin Foot Powder Deodorant, Micatin Jock Itch, Micatin Liquid Foot, Mitrazol, Monistat Derm, Ony-Clear, Zeasorb-AF

What is Zeasorb-AF (miconazole topical)?

Miconazole topical is an antifungal medication. Miconazole topical prevents fungus from growing on your skin.

Miconazole topical is used to treat skin infections such as athlete's foot, jock itch, ringworm, tinea versicolor (a fungus that discolors the skin), and yeast infections.

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

What is the most important information I should know about Zeasorb-AF (miconazole topical)? Use this medication for the full amount of time prescribed by your doctor or as recommended in the package even if you begin to feel better. Your symptoms may improve before the infection is completely healed.

Do not use bandages or dressings that do not allow air to circulate to the affected area (occlusive dressings) unless otherwise directed by your doctor. Wear loose-fitting clothing (preferably cotton).

Avoid getting this medication in your eyes, nose, or mouth. Who should not use Zeasorb-AF (miconazole topical)?

Do not use miconazole topical if you have had an allergic reaction to it in the past.

It is not known whether miconazole topical will harm an unborn baby. Do not use miconazole topical without first talking to your doctor if you are pregnant. It is not known whether miconazole passes into breast milk. Do not use miconazole topical without first talking to your doctor if you are breast-feeding a baby. How should I use Zeasorb-AF (miconazole topical)? Use miconazole topical 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 this medication.

Clean and dry the affected area. Apply the cream, lotion, spray, or powder once or twice daily as directed for 2 to 4 weeks.

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

If the infection does not clear up in 2 weeks (or 4 weeks for athlete's foot), or if it appears to get worse, see your doctor.

Do not use bandages or dressings that do not allow air circulation over the affected area (occlusive dressings) unless otherwise directed by your doctor. A light cotton-gauze dressing may be used to protect clothing.

Avoid getting this medication in your eyes, nose, or mouth. Store miconazole topical 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 your next regularly scheduled dose, skip the dose you missed and apply only the regular amount of miconazole topical. Do not use a double dose unless otherwise directed by your doctor.

What happens if I overdose?

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

What should I avoid while using Zeasorb-AF (miconazole topical)?

Avoid wearing tight-fitting, synthetic clothing that doesn't allow air circulation. Wear loose-fitting clothing made of cotton and other natural fibers until the infection is healed.

Zeasorb-AF (miconazole topical) side effects

Serious side effects of miconazole topical use are not expected. Stop using miconazole topical and see your doctor if you experience unusual or severe blistering, itching, redness, peeling, dryness, or irritation of the skin.

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 Zeasorb-AF (miconazole topical)?

Avoid using other topicals at the same time unless your doctor approves. Other skin medications may affect the absorption or effectiveness of miconazole topical.

More Zeasorb-AF resources Zeasorb-AF Side Effects (in more detail) Zeasorb-AF Use in Pregnancy & Breastfeeding Zeasorb-AF Drug Interactions Zeasorb-AF Support Group 1 Review for Zeasorb-AF - Add your own review/rating Zeasorb-AF Gel MedFacts Consumer Leaflet (Wolters Kluwer) Zeasorb-AF 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) Compare Zeasorb-AF with other medications Cutaneous Candidiasis Tinea Corporis Tinea Cruris Tinea Pedis Tinea Versicolor Where can I get more information? Your pharmacist has additional information about miconazole topical written for health professionals that you may read.

See also: Zeasorb-AF side effects (in more detail)


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Monistat Derm


Generic Name: miconazole topical (my CON a zole)
Brand Names: Aloe Vesta, Aloe Vesta 2 in 1 Antifungal, Baza, Cruex Prescription Strength, Desenex Prescription Strength, Fungoid, Fungoid Kit, Micatin, Micatin Cooling Action, Micatin Foot Powder, Micatin Foot Powder Deodorant, Micatin Jock Itch, Micatin Liquid Foot, Mitrazol, Monistat Derm, Ony-Clear, Zeasorb-AF

What is Monistat Derm (miconazole topical)?

Miconazole topical is an antifungal medication. Miconazole topical prevents fungus from growing on your skin.

Miconazole topical is used to treat skin infections such as athlete's foot, jock itch, ringworm, tinea versicolor (a fungus that discolors the skin), and yeast infections.

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

What is the most important information I should know about Monistat Derm (miconazole topical)? Use this medication for the full amount of time prescribed by your doctor or as recommended in the package even if you begin to feel better. Your symptoms may improve before the infection is completely healed.

Do not use bandages or dressings that do not allow air to circulate to the affected area (occlusive dressings) unless otherwise directed by your doctor. Wear loose-fitting clothing (preferably cotton).

Avoid getting this medication in your eyes, nose, or mouth. Who should not use Monistat Derm (miconazole topical)?

Do not use miconazole topical if you have had an allergic reaction to it in the past.

It is not known whether miconazole topical will harm an unborn baby. Do not use miconazole topical without first talking to your doctor if you are pregnant. It is not known whether miconazole passes into breast milk. Do not use miconazole topical without first talking to your doctor if you are breast-feeding a baby. How should I use Monistat Derm (miconazole topical)? Use miconazole topical 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 this medication.

Clean and dry the affected area. Apply the cream, lotion, spray, or powder once or twice daily as directed for 2 to 4 weeks.

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

If the infection does not clear up in 2 weeks (or 4 weeks for athlete's foot), or if it appears to get worse, see your doctor.

Do not use bandages or dressings that do not allow air circulation over the affected area (occlusive dressings) unless otherwise directed by your doctor. A light cotton-gauze dressing may be used to protect clothing.

Avoid getting this medication in your eyes, nose, or mouth. Store miconazole topical 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 your next regularly scheduled dose, skip the dose you missed and apply only the regular amount of miconazole topical. Do not use a double dose unless otherwise directed by your doctor.

What happens if I overdose?

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

What should I avoid while using Monistat Derm (miconazole topical)?

Avoid wearing tight-fitting, synthetic clothing that doesn't allow air circulation. Wear loose-fitting clothing made of cotton and other natural fibers until the infection is healed.

Monistat Derm (miconazole topical) side effects

Serious side effects of miconazole topical use are not expected. Stop using miconazole topical and see your doctor if you experience unusual or severe blistering, itching, redness, peeling, dryness, or irritation of the skin.

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 Monistat Derm (miconazole topical)?

Avoid using other topicals at the same time unless your doctor approves. Other skin medications may affect the absorption or effectiveness of miconazole topical.

More Monistat Derm resources Monistat Derm Side Effects (in more detail) Monistat Derm Use in Pregnancy & Breastfeeding Monistat Derm Drug Interactions Monistat Derm Support Group 0 Reviews for Monistat Derm - Add your own review/rating Monistat Derm 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 Monistat Derm with other medications Cutaneous Candidiasis Tinea Corporis Tinea Cruris Tinea Pedis Tinea Versicolor Where can I get more information? Your pharmacist has additional information about miconazole topical written for health professionals that you may read.

See also: Monistat Derm side effects (in more detail)


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Micatin Foot Powder Deodorant


Generic Name: miconazole topical (my CON a zole)
Brand Names: Aloe Vesta, Aloe Vesta 2 in 1 Antifungal, Baza, Cruex Prescription Strength, Desenex Prescription Strength, Fungoid, Fungoid Kit, Micatin, Micatin Cooling Action, Micatin Foot Powder, Micatin Foot Powder Deodorant, Micatin Jock Itch, Micatin Liquid Foot, Mitrazol, Monistat Derm, Ony-Clear, Zeasorb-AF

What is Micatin Foot Powder Deodorant (miconazole topical)?

Miconazole topical is an antifungal medication. Miconazole topical prevents fungus from growing on your skin.

Miconazole topical is used to treat skin infections such as athlete's foot, jock itch, ringworm, tinea versicolor (a fungus that discolors the skin), and yeast infections.

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

What is the most important information I should know about Micatin Foot Powder Deodorant (miconazole topical)? Use this medication for the full amount of time prescribed by your doctor or as recommended in the package even if you begin to feel better. Your symptoms may improve before the infection is completely healed.

Do not use bandages or dressings that do not allow air to circulate to the affected area (occlusive dressings) unless otherwise directed by your doctor. Wear loose-fitting clothing (preferably cotton).

Avoid getting this medication in your eyes, nose, or mouth. Who should not use Micatin Foot Powder Deodorant (miconazole topical)?

Do not use miconazole topical if you have had an allergic reaction to it in the past.

It is not known whether miconazole topical will harm an unborn baby. Do not use miconazole topical without first talking to your doctor if you are pregnant. It is not known whether miconazole passes into breast milk. Do not use miconazole topical without first talking to your doctor if you are breast-feeding a baby. How should I use Micatin Foot Powder Deodorant (miconazole topical)? Use miconazole topical 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 this medication.

Clean and dry the affected area. Apply the cream, lotion, spray, or powder once or twice daily as directed for 2 to 4 weeks.

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

If the infection does not clear up in 2 weeks (or 4 weeks for athlete's foot), or if it appears to get worse, see your doctor.

Do not use bandages or dressings that do not allow air circulation over the affected area (occlusive dressings) unless otherwise directed by your doctor. A light cotton-gauze dressing may be used to protect clothing.

Avoid getting this medication in your eyes, nose, or mouth. Store miconazole topical 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 your next regularly scheduled dose, skip the dose you missed and apply only the regular amount of miconazole topical. Do not use a double dose unless otherwise directed by your doctor.

What happens if I overdose?

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

What should I avoid while using Micatin Foot Powder Deodorant (miconazole topical)?

Avoid wearing tight-fitting, synthetic clothing that doesn't allow air circulation. Wear loose-fitting clothing made of cotton and other natural fibers until the infection is healed.

Micatin Foot Powder Deodorant (miconazole topical) side effects

Serious side effects of miconazole topical use are not expected. Stop using miconazole topical and see your doctor if you experience unusual or severe blistering, itching, redness, peeling, dryness, or irritation of the skin.

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 Micatin Foot Powder Deodorant (miconazole topical)?

Avoid using other topicals at the same time unless your doctor approves. Other skin medications may affect the absorption or effectiveness of miconazole topical.

More Micatin Foot Powder Deodorant resources Micatin Foot Powder Deodorant Side Effects (in more detail)Micatin Foot Powder Deodorant Use in Pregnancy & BreastfeedingMicatin Foot Powder Deodorant Drug Interactions0 Reviews for Micatin Foot Deodorant - 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 Micatin Foot Powder Deodorant with other medications Cutaneous CandidiasisTinea CorporisTinea CrurisTinea PedisTinea Versicolor Where can I get more information? Your pharmacist has additional information about miconazole topical written for health professionals that you may read.

See also: Micatin Foot Deodorant side effects (in more detail)


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Daktarin Aktiv Cream (McNeil Products Ltd)


1. Name Of The Medicinal Product

Daktarin Aktiv Cream

2. Qualitative And Quantitative Composition

Miconazole nitrate 2.0% w/w

(Each gram of cream contains 20mg of miconazole nitrate)

For excipients, see Section 6.1

3. Pharmaceutical Form

Cream

White homogeneous cream

4. Clinical Particulars 4.1 Therapeutic Indications

For the treatment of athlete's foot.

4.2 Posology And Method Of Administration

For all ages.

Apply the cream twice daily to the lesions. Treatment should be prolonged for 10 days after all lesions have disappeared to prevent relapse.

Method of administration: Cutaneous application.

4.3 Contraindications

Daktarin Aktiv Cream is contraindicated in individuals with a known hypersensitivity to miconazole or another ingredient in this product.

4.4 Special Warnings And Precautions For Use

Daktarin Aktiv Cream must not come into contact with the eyes.

If a reaction suggesting sensitivity or irritation should occur, the treatment should be discontinued.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Miconazole administered systemically is known to inhibit CYP3A4/2C9. Due to the limited systemic availability after topical application, clinically relevant interactions are rare. However, in patients on oral anticoagulants, such as warfarin, caution should be exercised and anticoagulant effect should be monitored.

4.6 Pregnancy And Lactation

Pregnancy

In animals, miconazole nitrate has shown no teratogenic effects but is foetotoxic at high oral doses. Only small amounts of miconazole nitrate are absorbed following topical administration. However, as with other imidazoles, miconazole nitrate should be used with caution during pregnancy.

Lactation

Topically applied miconazole is minimally absorbed into the systemic circulation, and it is not known whether miconazole is excreted in human breast milk. Caution should be exercised when using topically applied miconazole products during lactation.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

Adverse drug reactions from spontaneous reports during the worldwide postmarketing experience with Daktarin that meet threshold criteria are included. The adverse drug reactions are ranked by frequency, using the following convention:

Very common > 1/10

Common > 1/100 and < 1/10

Uncommon > 1/1,000 and < 1/100

Rare > 1/10,000, < 1/1,000

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

The frequencies provided below reflect reporting rates for adverse drug reactions from spontaneous reports, and do not represent more precise estimates of incidence that might be obtained in clinical or epidemiological studies.

Immune system disorders

Very rare: anaphylactic reaction, hypersensitivity, angioneurotic edema.

Skin and subcutaneous tissue disorders

Very rare: urticaria, contact dermatitis, rash, erythema, pruritus, skin burning sensation.

General disorders and administration site conditions

Rare: application site reactions, including application site irritation.

4.9 Overdose

Symptoms

Cutaneous use: Excessive use can result in skin irritation, which usually disappears after discontinuation of therapy.

Treatment

Daktarin Aktiv Cream is intended for cutaneous use, not for oral use. If accidental ingestion of large quantities of the product occurs, an appropriate method of gastric emptying may be used if considered necessary.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic classification: (Antifungals for dermatological/topical use; imidazole derivative) ATC code: D01A C02.

Miconazole is an imidazole antifungal agent and may act by interfering with the permeability of the fungal cell membrane. It possesses a wide antifungal spectrum and has some antibacterial activity.

5.2 Pharmacokinetic Properties

Absorption: There is little absorption through skin or mucous membranes when miconazole nitrate is applied topically.

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

Metabolism and Excretion: The small amount of miconazole that is absorbed is eliminated predominantly in faeces as both unchanged drug and metabolites.

5.3 Preclinical Safety Data

Preclinical data reveal no special hazard for humans based on conventional studies of local irritation, single and repeated dose toxicity, genotoxicity, and toxicity to reproduction.

6. Pharmaceutical Particulars 6.1 List Of Excipients

PEG-6, PEG 32 and glycol stearate

Oleoyl macroglycerides

Liquid paraffin

Benzoic acid (E210)

Butylated hydroxyanisole (E320)

Purified water

6.2 Incompatibilities

None known.

6.3 Shelf Life

24 months.

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

Aluminium tube lined with epoxyphenol resin. Cap made of white polypropylene for the 15, 30 and 70g sizes. Cap for 5g size made of high density polyethylene.

Daktarin Aktiv Cream may be supplied in packs of 5, 15, 30 and 70g.

*Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

McNeil Products Limited

Foundation Park

Roxborough Way

Maidenhead

Berkshire

SL6 3UG

United Kingdom

8. Marketing Authorisation Number(S)

PL 15513/0304

9. Date Of First Authorisation/Renewal Of The Authorisation

01 July 2008

10. Date Of Revision Of The Text

10 July 2008


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Daktarin Cream (Janssen-Cilag Ltd)


1. Name Of The Medicinal Product

Daktarin Cream.

2. Qualitative And Quantitative Composition

Miconazole nitrate 2% w/w.

(Each gram of cream contains 20mg of miconazole nitrate)

For excipients, see Section 6.1

3. Pharmaceutical Form

Cream

White homogeneous cream.

4. Clinical Particulars 4.1 Therapeutic Indications

For the treatment of mycotic infections of the skin and nails and superinfections due to Gram-positive bacteria.

4.2 Posology And Method Of Administration

Route of administration:

Cutaneous use.

Recommended dosage:

For all ages:

Skin infections: Apply the cream twice daily to the lesions. Treatment should be prolonged for 10 days after all lesions have disappeared to prevent relapse.

Nail infections: Apply the cream once or twice daily to the lesions. Treatment should be prolonged for 10 days after all lesions have disappeared to prevent relapse.

4.3 Contraindications

Daktarin Cream is contraindicated in individuals with a known hypersensitivity to miconazole or another ingredient in this product.

4.4 Special Warnings And Precautions For Use

Daktarin Cream must not come into contact with the eyes.

If a reaction suggesting sensitivity or irritation should occur, the treatment should be discontinued.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Miconazole administered systemically is known to inhibit CYP3A4/2C9. Due to the limited systemic availability after topical application, clinically relevant interactions are rare. However, in patients on oral anticoagulants, such as warfarin, caution should be exercised and anticoagulant effect should be monitored.

4.6 Pregnancy And Lactation

Pregnancy

In animals miconazole nitrate has shown no teratogenic effects but is foetotoxic at high oral doses. Only small amounts of miconazole nitrate are absorbed following topical administration. However, as with other imidazoles, miconazole nitrate should be used with caution during pregnancy.

Lactation

Topically applied miconazole is minimally absorbed into the systemic circulation, and it is not known whether miconazole is excreted in human breast milk. Caution should be exercised when using topically applied miconazole products during lactation.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

Adverse drug reactions from spontaneous reports during the worldwide postmarketing experience with Daktarin that meet threshold criteria are included. The adverse drug reactions are ranked by frequency, using the following convention:

Very common

Common

Uncommon

Rare

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

The frequencies provided below reflect reporting rates for adverse drug reactions from spontaneous reports, and do not represent more precise estimates of incidence that might be obtained in clinical or epidemiological studies.

Immune system disorders

Very rare: anaphylactic reaction, hypersensitivity, angioneurotic edema

Skin and subcutaneous tissue disorders

Very rare: urticaria, contact dermatitis, rash, erythema, pruritus, skin burning sensation

General disorders and administration site conditions

Rare: application site reactions, including application site irritation

4.9 Overdose

Symptoms

Cutaneous use: Excessive use can result in skin irritation, which usually disappears after discontinuation of therapy.

Treatment

Daktarin Cream is intended for cutaneous use, not for oral use. If accidental ingestion of large quantities of the product occurs, an appropriate method of gastric emptying may be used if considered necessary.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic classification: (Antifungals for dermatological/topical use; imidazole derivative) ATC code: D01A C02.

Miconazole nitrate is an imidazole antifungal agent and may act by interfering with the permeability of the fungal cell membrane. It possesses a wide antifungal spectrum and has some antibacterial activity.

5.2 Pharmacokinetic Properties

Absorption: There is little absorption through skin or mucous membranes when miconazole nitrate is applied topically.

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

Metabolism and Excretion: The small amount of miconazole that is absorbed is eliminated predominantly in faeces as both unchanged drug and metabolites.

5.3 Preclinical Safety Data

Preclinical data reveal no special hazard for humans based on conventional studies of local irritation, single and repeated dose toxicity, genotoxicity, and toxicity to reproduction.

6. Pharmaceutical Particulars 6.1 List Of Excipients

PEG-6, PEG-32 and glycol stearate

Oleoyl macroglycerides

Liquid paraffin

Benzoic acid (E210)

Butylated hydroxyanisole (E320)

Purified water

6.2 Incompatibilities

None known.

6.3 Shelf Life

24 months.

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

Aluminium tube inner lined with heat polymerised epoxy-phenol resin with a white polypropylene cap containing 15 g, 30 g or 70 g* of cream, or aluminium tube inner lined with heat polymerised epoxy-phenol resin with a high density polyethylene cap containing 5 g of cream.

*Not all pack sizes may be marketed

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Janssen-Cilag Ltd,

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

UK

8. Marketing Authorisation Number(S)

PL 00242/0016

9. Date Of First Authorisation/Renewal Of The Authorisation

13 May 1974 / 08 December 2008

10. Date Of Revision Of The Text

08 December 2008


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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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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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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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Daktacort Ointment


1. Name Of The Medicinal Product

Daktacort™ Ointment.

2. Qualitative And Quantitative Composition

Miconazole nitrate 2% w/w and hydrocortisone 1% w/w.

3. Pharmaceutical Form

White, odourless, fatty ointment.

4. Clinical Particulars 4.1 Therapeutic Indications

For the topical treatment of inflamed dermatoses where infection by susceptible organisms and inflammation co-exist, eg intertrigo and infected eczema.

Moist or dry eczema or dermatitis including atopic eczema, primary irritant or contact allergic eczema or seborrhoeic eczema including that associated with acne.

Intertriginous eczema including inframammary intertrigo, perianal and genital dermatitis.

Organisms which are susceptible to miconazole are dermatophytes and pathogenic yeasts (eg Candida spp.). Also many Gram-positive bacteria including most strains of Streptococcus and Staphylococcus.

The properties of Daktacort indicate it particularly for the initial stages of treatment. Once the inflammatory symptoms have disappeared (after about 7 days), treatment can be continued where necessary with Daktarin™ Cream or Daktarin™ Powder.

4.2 Posology And Method Of Administration

For topical administration.

Daktacort Ointment should be applied topically two or three times daily.

The same dosage applies to both adults and children.

Use in elderly:

Natural thinning of the skin occurs in the elderly, hence corticosteroids should be used sparingly and for short periods of time.

In infants, long term continuous topical corticosteroid therapy should be avoided.

If after about 7 days' application, no improvement has occurred, cultural isolation of the offending organism should be followed by appropriate local or systemic antimicrobial therapy.

4.3 Contraindications

True hypersensitivity to any of the ingredients. Tubercular or viral infections of the skin or those caused by Gram-negative bacteria.

4.4 Special Warnings And Precautions For Use

When Daktacort is used by patients taking oral anticoagulants, the anticoagulant effect should be carefully monitored.

As with any topical corticosteroid, care is advised with infants and children when Daktacort is to be applied to extensive surface areas or under occlusive dressings including baby napkins; similarly, application to the face should be avoided.

In infants, long term continuous topical corticosteroid therapy should be avoided. Adrenal suppression can occur even without occlusion.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Miconazole administered systemically is known to inhibit CYP3A4/2C9. Due to the limited systemic availability after topical application (see Section 5.2 Pharmacokinetic properties), clinically relevant interactions are rare. However, in patients on oral anticoagulants, such as warfarin, caution should be exercised and anticoagulant effect should be monitored.

Miconazole is a CYP3A4 inhibitor that can decrease the rate of metabolism of hydrocortisone. Serum concentrations of hydrocortisone may be higher with the use of Daktacort compared with topical preparations containing hydrocortisone alone.

4.6 Pregnancy And Lactation

In animals, miconazole nitrate has shown no teratogenic effects but is foetotoxic at high oral doses and administration of corticosteroids to pregnant animals can cause abnormalities of foetal development. The relevance of these findings to humans has not been established. However, combinations of topical steroids with imidazoles should be used in pregnant women only if the practitioner considers it to be necessary.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Rarely, local sensitivity may occur requiring discontinuation of treatment.

Additional adverse drug reactions reported in postmarketing reports with DAKTACORT CREAM but not with DAKTACORT OINTMENT are included in Table 1. The frequencies are based on spontaneous reporting rates, according to the following convention:

Very common Common Uncommon Rare Very rare <1/10,000, including isolated reports

Table 1. Adverse Drug Reactions Identified During Postmarketing Experience with Daktacort Cream by Frequency Category Estimated from Spontaneous Reporting Rates

     

Immune system disorders

 

Very rare

Anaphylactic reaction

   

Skin and Subcutaneous Tissue Disorders

 

Very rare

Contact dermatitis, Erythema, Rash

Review of adverse events reported with Daktacort Ointment did not find sufficient evidence to assess any of the events as adverse drug reactions associated with the use of Daktacort Ointment.

4.9 Overdose

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects. If accidental ingestion of large quantities of the product occurs, an appropriate method of gastric emptying may be used if considered necessary.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Miconazole nitrate is a potent broad-spectrum antifungal and antibacterial agent with marked activity against dermatophytes, pathogenic yeasts (eg Candida spp) and many Gram-positive bacteria including most strains of Streptococcus and Staphylococcus.

Hydrocortisone is a widely used topical anti-inflammatory of value in the treatment of inflammatory skin conditions including atrophic and infantile eczema, contact sensitivity reactions and intertrigo.

5.2 Pharmacokinetic Properties

Absorption

Miconazole remains in the skin after topical application for up to 4 days. Systemic absorption of miconazole is limited, with a bioavailability of less than 1% following topical application of miconazole. Plasma concentrations of miconazole and/or its metabolites were measurable 24 and 48 hours after application. Approximately 3% of the dose of hydrocortisone is absorbed after application on the skin.

Distribution

Absorbed miconazole is bound to plasma proteins (88.2%) and red blood cells (10.6%). More than 90% of hydrocortisone is bound to plasma proteins.

Metabolism and elimination

The small amount of miconazole that is absorbed is eliminated predominantly in faeces as both unchanged drug and metabolites over a four-day post-administration period. Smaller amounts of unchanged drug and metabolites also appear in urine.

The half-life of hydrocortisone is about 100 minutes. Metabolism takes place in the liver and tissues and the metabolites are excreted with the urine, mostly as glucuronides, together with a very small fraction of unchanged hydrocortisone.

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Polyethylene 5.5% liquid paraffin gel.

6.2 Incompatibilities

None known.

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

Store at or below 25°C.

6.5 Nature And Contents Of Container

Aluminium tube with polypropylene cap.

Each tube contains 5 g, 30 g or 75 g ointment.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Janssen-Cilag Ltd

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

UK

8. Marketing Authorisation Number(S)

PL 00242/0130

9. Date Of First Authorisation/Renewal Of The Authorisation Date of First Authorisation: 05/03/87 Renewal of Authorisation: 28/03/03 10. Date Of Revision Of The Text

2nd March 2009

LEGAL CATEGORY

POM.


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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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Gyno-Daktarin 20mg / g Cream


1. Name Of The Medicinal Product

Gyno-Daktarin 20mg/g cream

2. Qualitative And Quantitative Composition

Miconazole nitrate 2% w/w.

(Each gram of cream contains 20mg miconazole nitrate)

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Vaginal cream.

The cream is white and homogeneous.

4. Clinical Particulars 4.1 Therapeutic Indications

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

4.2 Posology And Method Of Administration

Gyno-Daktarin cream is for vaginal administration.

Recommended dosage

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

4.3 Contraindications

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

4.4 Special Warnings And Precautions For Use

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

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

Gyno-Daktarin cream does not stain skin or clothes.

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

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

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

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

4.6 Pregnancy And Lactation

Pregnancy

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

Lactation

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

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

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

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

Very common

Common

Uncommon

Rare

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

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

 

Body System/Organ Class

Frequency Category

Undesirable effects

 

Skin and subcutaneous tissue disorders

 

 

Common

Rash

Uncommon

Rash pruritic, urticaria

Reproductive System and Breast Disorders

 

 

Very common

Genital pruritus female, vaginal burning sensation, vulvovaginal discomfort

 

Common

Dysmenorrhoea

 

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

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

 

Immune System Disorders

 

Not known

Hypersensitivity including Anaphylactic and Anaphylactoid reactions, Angioedema

Skin and Subcutaneous Tissue Disorders

 

Not known

Pruritis

Reproductive System and Breast Disorders

 

Not known

Vaginal irritation, pelvic cramps

4.9 Overdose

Symptoms

In case of accidental ingestion, no problems are expected.

Treatment

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

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic classification:

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

ATC code: G01A F04

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

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

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

5.2 Pharmacokinetic Properties

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

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

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

5.3 Preclinical Safety Data

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

6. Pharmaceutical Particulars 6.1 List Of Excipients

PEG-6, PEG-32 and glycol stearate

Oleoyl macroglycerides

Liquid paraffin

Benzoic acid (E210)

Butylated hydroxyanisole (E320)

Purified water

6.2 Incompatibilities

None known.

6.3 Shelf Life

24 months.

6.4 Special Precautions For Storage

Do not store above 25?C.

6.5 Nature And Contents Of Container

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

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

The cream is supplied with disposable cardboard vaginal applicators.

*Not all pack sizes are marketed.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

Janssen-Cilag Ltd

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

UK

8. Marketing Authorisation Number(S)

PL 0242/0015

9. Date Of First Authorisation/Renewal Of The Authorisation

12 December 2008

10. Date Of Revision Of The Text

23rd July 09


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Triple Care Antifungal Topical


Generic Name: miconazole (Topical route)

mye-KON-a-zole

Commonly used brand name(s)

In the U.S.

Aloe Vesta 2-N-1 Antifungal Aloe Vesta Antifungal Baza Antifungal Carrington Antifungal Derma Gran AF DiabetAid Antifungal Foot Bath Fungoid Lotrimin AF Micatin Micro-Guard Mitrazol Monistat 1 Monistat Derm Neosporin AF QC Miconazole Nitrate Secura Antifungal Soothe & Cool Inzo Antifungal Tetterine Therasoft Antifungal Triple Care Antifungal Triple Care EPC Zeasorb-AF

Available Dosage Forms:

Lotion Tablet, Effervescent Cream Ointment Powder Kit Gel/Jelly Tincture Spray

Therapeutic Class: Antifungal

Chemical Class: Imidazole

Uses For Triple Care Antifungal

Miconazole belongs to the group of medicines called antifungals. Topical miconazole is used to treat some types of fungus infections.

Some of these preparations may be available without a prescription.

Before Using Triple Care Antifungal

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

Although there is no specific information comparing use of topical miconazole in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children than it does in adults.

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 topical miconazole in the elderly with use in other age groups, this medicine 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 miconazole

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

Keep this medicine away from the eyes.

Apply enough miconazole to cover the affected area, and rub in gently.

To use the aerosol powder form of miconazole:

Shake well before using. From a distance of 6 to 10 inches, spray the powder on the affected areas. If it is used on the feet, spray it between the toes, on the feet, and in the socks and shoes. Do not inhale the powder. Do not use near heat, near open flame, or while smoking.

To use the aerosol solution form of miconazole:

Shake well before using. From a distance of 4 to 6 inches, spray the solution on the affected areas. If it is used on the feet, spray it between the toes and on the feet. Do not inhale the vapors from the spray. Do not use near heat, near open flame, or while smoking.

To use the powder form of miconazole:

If the powder is used on the feet, sprinkle it between the toes, on the feet, and in the socks and shoes.

When miconazole is used to treat certain types of fungus infections of the skin, an occlusive dressing (airtight covering, such as kitchen plastic wrap) should not be applied over this medicine. To do so may cause irritation of the skin. Do not apply an occlusive dressing over this medicine unless you have been directed to do so by your doctor.

To help clear up your infection completely, keep using this medicine for the full time of treatment, even if your condition has improved. 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 aerosol powder, aerosol solution, cream , and powder dosage forms: For fungus infections: Adults and children—Apply to the affected area(s) of the skin two times a day, morning and evening. For cream and lotion dosage forms: For sun fungus: Adults and children—Apply to the affected area(s) of the skin once a day. Missed Dose

If you miss a dose of this medicine, apply 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.

Storage

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

Store the canister at room temperature, away from heat and direct light. Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Triple Care Antifungal

If your skin problem does not improve within 4 weeks, or if it becomes worse, check with your health care professional.

Triple Care Antifungal 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:

Blistering, burning, redness, skin rash, or other sign of skin irritation 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 Triple Care Antifungal Topical resources Triple Care Antifungal Topical Use in Pregnancy & BreastfeedingTriple Care Antifungal Topical Drug InteractionsTriple Care Antifungal Topical Support Group8 Reviews for Triple Care Antifungal Topical - Add your own review/rating Compare Triple Care Antifungal Topical with other medications Cutaneous CandidiasisOral ThrushTinea CorporisTinea CrurisTinea PedisTinea VersicolorVaginal Yeast Infection
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Monistat Derm Topical


Generic Name: miconazole (Topical route)

mye-KON-a-zole

Commonly used brand name(s)

In the U.S.

Aloe Vesta 2-N-1 Antifungal Aloe Vesta Antifungal Baza Antifungal Carrington Antifungal Derma Gran AF DiabetAid Antifungal Foot Bath Fungoid Lotrimin AF Micatin Micro-Guard Mitrazol Monistat 1 Monistat Derm Neosporin AF QC Miconazole Nitrate Secura Antifungal Soothe & Cool Inzo Antifungal Tetterine Therasoft Antifungal Triple Care Antifungal Triple Care EPC Zeasorb-AF

Available Dosage Forms:

Lotion Tablet, Effervescent Cream Ointment Powder Kit Gel/Jelly Tincture Spray

Therapeutic Class: Antifungal

Chemical Class: Imidazole

Uses For Monistat Derm

Miconazole belongs to the group of medicines called antifungals. Topical miconazole is used to treat some types of fungus infections.

Some of these preparations may be available without a prescription.

Before Using Monistat Derm

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

Although there is no specific information comparing use of topical miconazole in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children than it does in adults.

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 topical miconazole in the elderly with use in other age groups, this medicine 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 miconazole

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

Keep this medicine away from the eyes.

Apply enough miconazole to cover the affected area, and rub in gently.

To use the aerosol powder form of miconazole:

Shake well before using. From a distance of 6 to 10 inches, spray the powder on the affected areas. If it is used on the feet, spray it between the toes, on the feet, and in the socks and shoes. Do not inhale the powder. Do not use near heat, near open flame, or while smoking.

To use the aerosol solution form of miconazole:

Shake well before using. From a distance of 4 to 6 inches, spray the solution on the affected areas. If it is used on the feet, spray it between the toes and on the feet. Do not inhale the vapors from the spray. Do not use near heat, near open flame, or while smoking.

To use the powder form of miconazole:

If the powder is used on the feet, sprinkle it between the toes, on the feet, and in the socks and shoes.

When miconazole is used to treat certain types of fungus infections of the skin, an occlusive dressing (airtight covering, such as kitchen plastic wrap) should not be applied over this medicine. To do so may cause irritation of the skin. Do not apply an occlusive dressing over this medicine unless you have been directed to do so by your doctor.

To help clear up your infection completely, keep using this medicine for the full time of treatment, even if your condition has improved. 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 aerosol powder, aerosol solution, cream , and powder dosage forms: For fungus infections: Adults and children—Apply to the affected area(s) of the skin two times a day, morning and evening. For cream and lotion dosage forms: For sun fungus: Adults and children—Apply to the affected area(s) of the skin once a day. Missed Dose

If you miss a dose of this medicine, apply 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.

Storage

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

Store the canister at room temperature, away from heat and direct light. Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Monistat Derm

If your skin problem does not improve within 4 weeks, or if it becomes worse, check with your health care professional.

Monistat Derm 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:

Blistering, burning, redness, skin rash, or other sign of skin irritation 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.

See also: Monistat Derm Topical side effects (in more detail)

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

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

More Monistat Derm Topical resources Monistat Derm Topical Side Effects (in more detail) Monistat Derm Topical Use in Pregnancy & Breastfeeding Monistat Derm Topical Drug Interactions Monistat Derm Topical Support Group 0 Reviews for Monistat Derm Topical - Add your own review/rating Compare Monistat Derm Topical with other medications Cutaneous Candidiasis Tinea Corporis Tinea Cruris Tinea Pedis Tinea Versicolor
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Therasoft Antifungal Topical


Generic Name: miconazole (Topical route)

mye-KON-a-zole

Commonly used brand name(s)

In the U.S.

Aloe Vesta 2-N-1 Antifungal Aloe Vesta Antifungal Baza Antifungal Carrington Antifungal Derma Gran AF DiabetAid Antifungal Foot Bath Fungoid Lotrimin AF Micatin Micro-Guard Mitrazol Monistat 1 Monistat Derm Neosporin AF QC Miconazole Nitrate Secura Antifungal Soothe & Cool Inzo Antifungal Tetterine Therasoft Antifungal Triple Care Antifungal Triple Care EPC Zeasorb-AF

Available Dosage Forms:

Lotion Tablet, Effervescent Cream Ointment Powder Kit Gel/Jelly Tincture Spray

Therapeutic Class: Antifungal

Chemical Class: Imidazole

Uses For Therasoft Antifungal

Miconazole belongs to the group of medicines called antifungals. Topical miconazole is used to treat some types of fungus infections.

Some of these preparations may be available without a prescription.

Before Using Therasoft Antifungal

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

Although there is no specific information comparing use of topical miconazole in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children than it does in adults.

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 topical miconazole in the elderly with use in other age groups, this medicine 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 miconazole

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

Keep this medicine away from the eyes.

Apply enough miconazole to cover the affected area, and rub in gently.

To use the aerosol powder form of miconazole:

Shake well before using. From a distance of 6 to 10 inches, spray the powder on the affected areas. If it is used on the feet, spray it between the toes, on the feet, and in the socks and shoes. Do not inhale the powder. Do not use near heat, near open flame, or while smoking.

To use the aerosol solution form of miconazole:

Shake well before using. From a distance of 4 to 6 inches, spray the solution on the affected areas. If it is used on the feet, spray it between the toes and on the feet. Do not inhale the vapors from the spray. Do not use near heat, near open flame, or while smoking.

To use the powder form of miconazole:

If the powder is used on the feet, sprinkle it between the toes, on the feet, and in the socks and shoes.

When miconazole is used to treat certain types of fungus infections of the skin, an occlusive dressing (airtight covering, such as kitchen plastic wrap) should not be applied over this medicine. To do so may cause irritation of the skin. Do not apply an occlusive dressing over this medicine unless you have been directed to do so by your doctor.

To help clear up your infection completely, keep using this medicine for the full time of treatment, even if your condition has improved. 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 aerosol powder, aerosol solution, cream , and powder dosage forms: For fungus infections: Adults and children—Apply to the affected area(s) of the skin two times a day, morning and evening. For cream and lotion dosage forms: For sun fungus: Adults and children—Apply to the affected area(s) of the skin once a day. Missed Dose

If you miss a dose of this medicine, apply 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.

Storage

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

Store the canister at room temperature, away from heat and direct light. Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Therasoft Antifungal

If your skin problem does not improve within 4 weeks, or if it becomes worse, check with your health care professional.

Therasoft Antifungal 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:

Blistering, burning, redness, skin rash, or other sign of skin irritation 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 Therasoft Antifungal Topical resources Therasoft Antifungal Topical Use in Pregnancy & Breastfeeding Therasoft Antifungal Topical Drug Interactions Therasoft Antifungal Topical Support Group 8 Reviews for Therasoft Antifungal Topical - Add your own review/rating Compare Therasoft Antifungal Topical with other medications Cutaneous Candidiasis Oral Thrush Tinea Corporis Tinea Cruris Tinea Pedis Tinea Versicolor Vaginal Yeast Infection
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Surolan



Dosage Form: FOR ANIMAL USE ONLY
Surolan®

otic suspension
(miconazole nitrate, polymyxin B sulfate, prednisolone acetate)

Rx

Antifungal, antibacterial and anti-inflammatory
For otic use in dogs only

CAUTION

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

Surolan Description

Surolan contains 23 mg/mL miconazole nitrate, 0.5293 mg/mL polymyxin B sulfate and 5 mg/mL prednisolone acetate. Inactive ingredients are colloidal silicon dioxide and liquid paraffin.

INDICATIONS

Surolan is indicated for the treatment of canine otitis externa associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius).

Surolan Dosage and Administration

Shake well before use.

The external ear should be thoroughly cleaned and dried before the initiation of treatment. Verify that the eardrum is intact. Instill 5 drops of Surolan in the ear canal twice daily and massage the ear. Therapy should continue for 7 consecutive days.

Contraindications

Surolan is contraindicated in dogs with suspected or known hypersensitivity to miconazole nitrate, polymyxin B sulfate, or prednisolone acetate.

Do not use in dogs with known perforated tympanum. Do not use with drugs known to induce ototoxicity.

Warnings

Not for use in humans. Keep this and all drugs out of reach of children.

ANIMAL WARNINGS

Do not administer orally.

For otic use only.

Precautions

Before instilling any medication into the ear, examine the external ear canal thoroughly to be certain the tympanic membranes are not ruptured.

If overgrowth of non-susceptible bacteria or fungi occurs, treatment should be discontinued and appropriate therapy instituted.

Long-term use of topical otic corticosteroids has been associated with adrenocortical suppression and iatrogenic hypoadrenalcorticism in dogs.

The safe use of Surolan in dogs used for breeding purposes, during pregnancy, or in lactating bitches, has not been evaluated.

Adverse Reactions

In the field study, 161 dogs treated with Surolan were included in the safety database. Two dogs experienced reduced hearing at the end of treatment; on follow-up one dog had normal hearing capacity while the other case was lost for follow-up. The owner of another dog reported that on day 4 of treatment, build-up of the medication decreased the dog's hearing. At the end of treatment, this dog had normal hearing as assessed by the investigator. Residue build-up was reported in 1 dog and pain upon drug application in another dog.

A total of 161 dogs treated with the active control was included in the safety database and adverse reactions were reported in 8 dogs treated with the active control. One dog experienced reduced hearing at the end of treatment. Residue build-up was noted in 1 dog. Four dogs vomited during treatment, 1 dog showed red pustules on the pinna and head shaking was observed in another dog.

Foreign market experience: the following adverse events were reported voluntarily during post-approval use of the product in foreign markets: deafness, reduced hearing, topical hypersensitivity reactions and red blisters on pinna.

For a copy of the Material Safety Data Sheet (MSDS), for technical assistance or to report adverse reactions call V?toquinol USA Inc. at 1-800-835-9496.

PHARMACOLOGY

By virtue of its 3 active ingredients, Surolan has antibacterial, antifungal, and anti-inflammatory activity. Polymyxin B sulfate is a broad-spectrum polypeptide antibiotic with activity against both Gram-positive and Gram-negative species. Miconazole nitrate is a synthetic imidazole derivative with antifungal activity and antibacterial activity against Gram-positive bacteria. Moreover, synergistic effects between miconazole nitrate and polymyxin B sulfate have been demonstrated in an in vitro study(1). Prednisolone acetate is a glucocorticoid with anti-inflammatory activity. A study performed using an experimentally-induced model of ear inflammation in mice demonstrated the effectiveness of prednisolone acetate in treating ear inflammation either alone or in combination with the other active ingredients of Surolan(2).

MICROBIOLOGY

The compatibility and additive effect of each of the components in Surolan was demonstrated in a component effectiveness and non-interference study. An in vitro study of organisms collected from clinical cases of otitis externa at a veterinary teaching hospital and from dogs enrolled in the clinical effectiveness study for Surolan determined that polymyxin B sulfate and miconazole nitrate inhibit the growth of bacteria and yeast commonly associated with canine otitis externa. Furthermore, a synergistic effect of the two antimicrobials was demonstrated. The addition of prednisolone acetate to the combination did not impair antimicrobial activity to any clinically-significant extent.

ANIMAL SAFETY

The following adverse reactions were reported in a study when Surolan was administered at 1X, 3X and 5X for 42 consecutive days (6 times the recommended treatment duration) in laboratory Beagles: hypersensitivity reactions which included mild erythema and hyperemia, painful and sensitive ear canals on examination, changes in hematology, clinical chemistry and urinalysis values consistent with the systemic absorption of topical corticosteroids, and veterinary observations of pale ear canals.

EFFECTIVENESS

Of 337 dogs enrolled in the field study, 176 dogs were included in the effectiveness database; 91 were treated with Surolan and 85 were treated with an FDA-approved active control. Clinical evaluations of otitis externa included pain/discomfort, swelling, redness, and exudate. A non-inferiority evaluation was used to compare Surolan with the active control with respect to each clinical sign of otitis externa and overall clinical improvement. Surolan was determined to be non-inferior to treatment with the active control for otitis externa. Malassezia pachydermatis and Staphylococcus pseudintermedius were identified pre-treatment in at least 10 cases that were clinically responsive to Surolan.

Table 1. Mean Percentage of Improvement in Clinical Signs of Otitis Externa Clinical sign Surolan
N=91 Active control
N=85 Pain/discomfort 94.4% 91.7% Swelling 89.1% 90.5% Redness 91.2% 86.1% Exudate 83.1% 82.1% Overall 96.7% 95.2% How is Surolan Supplied

Surolan is available in 15 mL and 30 mL plastic dispensing bottles with applicator tip for otic use.

STORAGE AND HANDLING

Store at or below 25 °C (77 °F).

NADA 141-298, Approved by FDA.

Manufactured for V?toquinol USA Inc. by:
Janssen Pharmaceutica NV
Turnhoutseweg 30
B-2340 Beerse
Belgium

Copyright © 2009, Janssen Animal Health

Date of most recent labeling revision: 09/2009

US - 973772

REFERENCES Pietschmann S. et al. (2009)
Synergistic effects of miconazole and polymyxin B on microbial pathogens.
Veterinary Research Communications 33(6), 489-505 Bolinder A. et al. (2006)
In vivo efficacy study of the anti-inflammatory properties of Surolan
The Canadian Journal of Veterinary Research 70, 234-236 PRINCIPAL DISPLAY PANEL - 15 mL Box

NDC 17030-947-15

Surolan®

otic suspension
(miconazole nitrate,
polymyxin B sulfate,
prednisolone acetate)

15mL

For otic use in dogs only.

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

NADA 141-298
Approved by FDA

V?toquinol


Surolan 
miconazole nitrate, polymyxin b sulfate, and prednisolone acetate  suspension/ drops Product Information Product Type PRESCRIPTION ANIMAL DRUG NDC Product Code (Source) 17030-947 Route of Administration AURICULAR (OTIC) DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength miconazole nitrate (miconazole) miconazole nitrate 23 mg  in 1 mL polymyxin B sulfate (polymyxin B) polymyxin B sulfate 0.5293 mg  in 1 mL prednisolone acetate (prednisolone) prednisolone acetate 5 mg  in 1 mL Inactive Ingredients Ingredient Name Strength paraffin   Product Characteristics Color WHITE (opaque) Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 17030-947-15 1 BOTTLE In 1 BOX contains a BOTTLE, WITH APPLICATOR 1 15 mL In 1 BOTTLE, WITH APPLICATOR This package is contained within the BOX (17030-947-15) 2 17030-947-30 1 BOTTLE In 1 BOX contains a BOTTLE, WITH APPLICATOR 2 30 mL In 1 BOTTLE, WITH APPLICATOR This package is contained within the BOX (17030-947-30)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA141298 12/30/2009
Labeler - Vetoquinol USA Inc (106824209) Establishment Name Address ID/FEI Operations Jansen Pharmaceutica NV 370005019 MANUFACTURE Revised: 12/2009Vetoquinol USA Inc
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Miconazole



Dosage Form: vaginal suppositories

PHYSICIAN’S INSERT

Miconazole Nitrate Vaginal Suppositories USP, 200 mg

Rx Only

Miconazole Description

Miconazole Nitrate Vaginal Suppositories USP, 200 mg are white to off-white suppositories, each containing the antifungal agent, Miconazole nitrate, 1-[2,4-Dichloro-?-[(2,4- dichlorobenzyl)oxy] phenethyl]-imidazole mononitrate, 200 mg, in a hydrogenated vegetable oil base. The molecular formula is C18H14Cl4N2O•HNO3; the molecular weight is 479.14 and the structural formula may be represented as follows:

Miconazole - Clinical Pharmacology

Miconazole nitrate exhibits fungicidal activity in vitro against species of the genus Candida. The pharmacologic mode of action is unknown. Following intravaginal administration of Miconazole nitrate, small amounts are absorbed. Administration of a single dose of Miconazole nitrate vaginal suppositories (100 mg) to healthy subjects resulted in total recovery from the urine and feces of 0.85% (±0.43%) of the administered dose.

Animal studies indicate that the drug crossed the placenta and doses above those used in humans result in embryo and fetotoxicity (80 mg/kg, orally), although this has not been reported in human subjects (See PRECAUTIONS).

In multi-center clinical trials in 440 women with vulvovaginal candidiasis, the efficacy of treatment with the Miconazole Nitrate Vaginal Suppositories USP, 200 mg for 3 days was compared with treatment for 7 days with Miconazole Nitrate Vaginal Cream 2%. The clinical cure rates (free of microbiological evidence and clinical signs and symptoms of candidiasis at 8 - 10 days and 30 - 35 days post therapy) were numerically lower, although not statistically different, with the 3-Day Suppository when compared with the 7-Day Cream.

Indications and Usage for Miconazole

Miconazole Nitrate Vaginal Suppositories USP, 200 mg are indicated for the local treatment of vulvovaginal candidiasis (moniliasis). Effectiveness in pregnancy has not been established. As Miconazole nitrate is effective only for candidal vulvovaginitis, the diagnosis should be confirmed by KOH smear and/or cultures. Other pathogens commonly associated with vulvovaginitis (Trichomonas and Haemophilus vaginalis [Gardnerella]) should be ruled out by appropriate laboratory methods.

Contraindications

Patients known to be hypersensitive to this drug.

Precautions General

Discontinue drug if sensitization or irritation is reported during use. The base contained in the suppository formulation may interact with certain latex products, such as that used in vaginal contraceptive diaphragms. Concurrent use is not recommended. Miconazole Nitrate Vaginal Cream USP, 2% may be considered for use under these conditions.

Laboratory Tests

If there is a lack of response to Miconazole Nitrate Vaginal Suppositories, appropriate microbiological studies (standard KOH smear and/or cultures) should be repeated to confirm the diagnosis and rule out other pathogens.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal studies to determine carcinogenic potential have not been performed.

Fertility (Reproduction): Oral administration of Miconazole nitrate in rats has been reported to produce prolonged gestation. However, this effect was not observed in oral rabbit studies. In addition, signs of fetal and embryo toxicity were reported in rat and rabbit studies, and dystocia was reported in rat studies after oral doses at and above 80 mg per kg. Intravaginal administration did not produce these effects in rats.

Pregnancy

Since imidazoles are absorbed in small amounts from the human vagina, they should not be used in the first trimester of pregnancy unless the physician considers it essential to the welfare of the patient.

Clinical studies, during which Miconazole nitrate vaginal cream and suppositories were used for up to 14 days, were reported to include 541 pregnant patients. Follow-up reports available in 471 of these patients reveal no adverse effects or complications attributable to Miconazole nitrate therapy in infants born to these women.

Nursing Mothers

It is not known whether Miconazole is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Miconazole nitrate is administered to a nursing woman.

Adverse Reactions

During clinical studies with Miconazole Nitrate Vaginal Suppositories USP, 200 mg, 301 patients were treated. The incidence of vulvovaginal burning, itching or irritation was 2%. Complaints of cramping (2%) and headaches (1.3%) were also reported. Other complaints (hives, skin rash) occurred with less than a 0.5% incidence. The therapy-related dropout rate was 0.3%.

Overdosage

Overdosage of Miconazole nitrate in humans has not been reported to date. In mice, rats, guinea pigs and dogs, the oral LD 50 values were found to be 578.1, >640, 275.9 and >160 mg/kg, respectively.

Miconazole Dosage and Administration

Miconazole Nitrate Vaginal Suppositories USP, 200 mg: One suppository (Miconazole nitrate, 200 mg) is inserted intravaginally once daily at bedtime for three consecutive days. Before prescribing another course of therapy, the diagnosis should be reconfirmed by smears and/or cultures to rule out other pathogens.

How is Miconazole Supplied

Miconazole Nitrate Vaginal Suppositories USP, 200 mg are available as elliptically shaped white to off-white suppositories in packages of three with a vaginal applicator. Store at controlled room temperature 15°-30°C (59°-86°F).

Manufactured by
Alpharma USPD Inc.
Baltimore, MD 21244

FORM NO. 1738

Rev. 12/05

VC2723

PATIENT’S INSTRUCTIONS

Miconazole Nitrate Vaginal Suppositories USP, 200 mg

3-DAY THERAPY

Three oval suppositories, for use inside the vagina only.

Designed to be inserted into the vagina.

HOW TO USE:

Place one suppository into the vagina each night at bedtime for 3 nights, as directed by your doctor. The Miconazole nitrate vaginal suppository is self-lubricating and may be inserted with or without the applicator
A. Insertion with the applicator

1. Filling the applicator:

Tear off one suppository from the strip. Separate the plastic wrap at the pointed end of your thumb. With thumb and forefinger of each hand, hold the plastic tabs and pull apart. Gently remove the suppository from the plastic wrap.

Place the flat end of the suppository into the open end of the applicator as shown. You are now ready to insert the suppository into the vagina.

2. Using the applicator:

Lie on your back with your knees drawn up toward your chest.

Holding the applicator by the ribbed end of the barrel, gently insert it into the vagina as far as it will comfortably go. Press the plunger to release the suppository into the vagina.

Remove the applicator from the vagina.

3. Cleaning the applicator:

After each use, you should thoroughly clean the applicator by the following procedure:.

Pull the plunger out of the barrel. Wash both pieces with lukewarm, soapy water, and dry them thoroughly. Put the applicator back together by gently pushing the plunger into the barrel as far as it will go.

B. Insertion without the applicator

Lie on your back with your knees drawn up toward your chest. Place the suppository on the tip of your finger as shown. Insert the suppository gently into the vagina as far as it will comfortably go.

NOTE: Store at controlled room temperature 15°-30°C (59°-86°F).

See end flap for lot number and expiration date.

A WORD ABOUT YEAST INFECTIONS

Why do yeast infections occur?

Yeast infections are caused by an organism called Candida (KAN di duh). It may be present in small and harmless amounts in the mouth, digestive track, and vagina. Sometimes the natural balance of the vagina becomes upset. This may lead to rapid growth of Candida, which results in a yeast infection. Symptoms of yeast infection include itching, burning, redness, and an abnormal discharge. Your doctor can make the diagnosis of a yeast infection by evaluating your symptoms and looking at a sample of the discharge under the microscope.

How can I prevent yeast infections?

Certain factors may increase your chance of developing a yeast infection. These factors don’t actually cause the problem, but they may create a situation that allows the yeast to grow rapidly.

Clothing: Tight jeans, nylon underwear, pantyhose, and wet bathing suits can hold in heat and moisture (two conditions in which yeast organisms thrive). Looser pants or skirts, 100% cotton underwear, and stockings may help avoid this problem.

Diet: Cutting down on sweets, milk products, and artificial sweeteners reduce the risk of yeast infections.

Antibiotics: Antibiotics work by eliminating disease-causing organisms. While they are helpful in curing other problems, antibiotics may lead to an overgrowth of Candida in the vagina.

Pregnancy: Hormonal changes in the body during pregnancy encourage the growth of yeast. This is a very common time for an infection to occur. Until the baby is born, it may be hard to completely eliminate yeast infections. If you believe you are pregnant, tell your doctor.

Menstruation: Sometimes, monthly changes in hormone levels may lead to yeast infections.

Diabetes: In addition to heat and moisture, yeast thrives on sugar. Because diabetics often have sugar in their urine, their vaginas are rich in this substance. Careful control of diabetes may help prevent yeast infection.

Controlling these factors can help eliminate yeast infections and may prevent them from coming back.

Some other helpful tips:

For best results, be sure to use the medication as prescribed by your doctor, even if you feel better very quickly.

Avoid sexual intercourse, if your doctor advises you to do so. The suppository formulation (not the cream) may damage the diaphragm. Therefore, use of the diaphragm during therapy with the suppository is not recommended. Consult your physician.

If your partner has any penile itching, redness, or discomfort, he should consult his physician and mention that you are being treated for a yeast infection.

You can use the medication even if you are having your menstrual period. However, you should not use tampons because they may absorb the medication. Instead, use external sanitary pads or napkins until you have finished your medication or if the vaginal medication leaks.

Dry the genital area thoroughly after showering, bathing, or swimming. Change out of a wet bathing suit or damp exercise clothes as soon as possible. A dry environment is less likely to encourage the growth of yeast.

Wipe from front to rear (away from the vagina) after a bowel movement.

Don’t douche unless your doctor specifically tells you to do so. Douching may disturb the vaginal balance.

Don’t scratch if you can help it. Scratching can cause more irritation and spread the infection.

Discuss with your physician any medication you are already taking. Certain types of medication can make your vagina more susceptible to infection.

Eat nutritious meals to promote your general health.

Manufactured by

Alpharma USPD Inc.

Baltimore, MD 21244

FORM NO. 1738

Rev. 12/05

VC2723


Miconazole NITRATE 
Miconazole nitrate  suppository Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0472-1738 Route of Administration VAGINAL DEA Schedule      INGREDIENTS Name (Active Moiety) Type Strength Miconazole Nitrate (Miconazole) Active 200 MILLIGRAM  In 1 SUPPOSITORY Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 0472-1738-03 3 SUPPOSITORY In 1 CARTON None
Revised: 01/2008Actavis Mid Atlantic LLC More Miconazole resources Miconazole Use in Pregnancy & Breastfeeding Miconazole Drug Interactions Miconazole Support Group 8 Reviews for Miconazole - Add your own review/rating 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) M-Zole Dual Pack Concise Consumer Information (Cerner Multum) Micatin Cream MedFacts Consumer Leaflet (Wolters Kluwer) Monistat 3 Cream MedFacts Consumer Leaflet (Wolters Kluwer) Monistat 7 Cream MedFacts Consumer Leaflet (Wolters Kluwer) Zeasorb-AF Gel MedFacts Consumer Leaflet (Wolters Kluwer) Compare Miconazole with other medications Cutaneous Candidiasis Oral Thrush Tinea Corporis Tinea Cruris Tinea Pedis Tinea Versicolor Vaginal Yeast Infection
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antifungal, azole Vaginal


Class Name: antifungal, azole (Vaginal route)

Commonly used brand name(s)

In the U.S.

3 Day Vaginal Cream Femizol-M Gynazole-1 Gyne-Lotrimin Monistat 1 Mycelex-3 Mycelex-7 Terazol 3 Terazol 7 Tioconazole 1 Vagistat-1 Zazole

In Canada

Canesten 2 Canesten 3 Canesten 6 Day Canesten Combi-Pak 1 Day Canesten Combi-Pak 3 Day Canesten External Cream Clotrimaderm Gyne Cure Gyno-Trosyd Miconazole 3 Day Ovule Treatment Miconazole Nitrate Monistat 1 Combination Pack Vaginal Ovule

Available Dosage Forms:

Ointment Kit Cream Suppository Tablet Tampon Uses For This Medicine

Vaginal azoles are used to treat yeast (fungus) infections of the vagina.

For first-time users, make sure your doctor has checked and confirmed that you have a vaginal yeast infection before you use the vaginal azole antifungal medicines that do not require a prescription. Vaginal yeast infections can reoccur over time and, when the same symptoms occur again, self-treating with these medicines is recommended. However, you should see your doctor if the symptoms occur again within 2 months.

Vaginal antifungal azoles are available both over-the-counter (OTC) and with your doctor's prescription.

Before Using This Medicine Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group 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 these medicines have been done only in adult patients, and there is no specific information comparing use of vaginal azoles in children with use in other age groups. It is recommended that these medicines not be used in children up to 12 years of age.

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 azoles in the elderly with use in other age groups, they are not expected to cause different side effects or problems in older people than they do in younger adults.

Pregnancy

Studies have not been done in humans for use of all azole antifungals during the first trimester of pregnancy. These medicines are safe and effective when used for at least 7 days during the second and third trimesters of pregnancy. However, check with your doctor before using this medicine during the first trimester of pregnancy. Also, use of 1- and 3-day treatments may not be effective during pregnancy.

Breast Feeding

It is not known whether vaginal azoles pass into the breast milk. However, these medicines have not been shown to cause problems in nursing babies.

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 This Medicine

Vaginal azoles usually come with patient directions. Read them carefully before using this medicine.

Use this medicine at bedtime, unless otherwise directed by your doctor. The vaginal tampon form of miconazole should be left in the vagina overnight and removed the next morning.

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

Some of the vaginal suppositories or tablets come packaged with a small tube of cream. This cream can be applied outside of the vagina in the genital area to treat itching. The packages are called combination, dual, or twin packs.

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, do not stop using this medicine if your menstrual period starts during the time of treatment.

Dosing

The dose medicines in this class 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 these medicines. 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 butoconazole For yeast infection: For vaginal cream dosage form: Adults and teenagers— Women who are not pregnant: 100 milligrams (mg) (one full applicator) of 2% cream inserted into the vagina at bedtime for three nights in a row. Pregnant women, after the third month: 100 mg (one full applicator) of 2% cream inserted into the vagina at bedtime for six nights in a row. Children up to 12 years of age—Use and dose must be determined by your doctor. For vaginal suppository dosage form: Adults and teenagers— Women who are not pregnant: 100 mg (one suppository) inserted into the vagina at bedtime for three nights in a row. Children up to 12 years of age—Use and dose must be determined by your doctor. For clotrimazole For yeast infection: For vaginal cream dosage form: Adults and teenagers—The dose depends on the strength of the cream. 1% cream: 50 milligrams (mg) (one full applicator) inserted into the vagina at bedtime for six to fourteen nights in a row. 2% cream: 100 mg (one full applicator) inserted into the vagina at bedtime for three nights in a row. 10% cream: 500 mg (one full applicator) inserted into the vagina at bedtime for one night only. Children up to 12 years of age—Use and dose must be determined by your doctor. For vaginal tablet dosage form: Adults and teenagers—The dose depends on the strength of the vaginal tablet. Women who are not pregnant: 100-mg tablet: Insert one tablet into the vagina at bedtime for six or seven nights in a row. 200-mg tablet: Insert one tablet into the vagina at bedtime for three nights in a row. 500-mg tablet: Insert one tablet into the vagina at bedtime for one night only. Pregnant women: 100 mg (one vaginal tablet) inserted into the vagina at bedtime for seven nights in a row. Children up to 12 years of age—Use and dose must be determined by your doctor. For econazole For yeast infection: For vaginal suppository dosage form: Adults and teenagers—150 milligrams (mg) (one vaginal suppository) inserted into the vagina at bedtime for three nights in a row. Children up to 12 years of age—Use and dose must be determined by your doctor. For miconazole For yeast infection: For vaginal cream dosage form: Adults and teenagers—20 milligrams (one full applicator) inserted into the vagina at bedtime for seven nights in a row. Treatment may be repeated if needed. Children up to 12 years of age—Use and dose must be determined by your doctor. For vaginal suppository dosage form: Adults and teenagers—The dose depends on the strength of the suppository. 100-milligram (mg) suppository: Insert one vaginal suppository into the vagina at bedtime for seven nights in a row. Treatment may be repeated if needed. 200-mg suppository or 400-mg suppository: Insert one vaginal suppository into the vagina at bedtime for three nights in a row. Treatment may be repeated if needed. 1200-mg suppository: Insert one vaginal suppository into the vagina at bedtime for one night. Children up to 12 years of age—Use and dose must be determined by your doctor. For tampon dosage form: Adults and teenagers—100 mg (one tampon) inserted into the vagina at bedtime and then removed the next morning. This is repeated every night for five nights in a row. Children up to 12 years of age—Use and dose must be determined by your doctor. For terconazole For yeast infection: For vaginal cream dosage form: Adults and teenagers—The dose depends on the strength of the cream. 0.4% cream: 20 milligrams (mg) (one full applicator) inserted into the vagina at bedtime for seven nights in a row. 0.8% cream: 40 mg (one full applicator) inserted into the vagina at bedtime for three nights in a row. Children up to 12 years of age—Use and dose must be determined by your doctor. For vaginal suppository dosage form: Adults and teenagers—80 mg (one vaginal suppository) inserted into the vagina at bedtime for three nights in a row. Children up to 12 years of age—Use and dose must be determined by your doctor. For tioconazole For yeast infection: For vaginal ointment dosage form: Adults and teenagers—300 milligrams (mg) (one full applicator) of 6.5% ointment inserted into the vagina at bedtime for one night only. Children up to 12 years of age—Use and dose must be determined by your doctor. For vaginal suppository dosage form: Adults and teenagers—300 mg (one vaginal suppository) inserted into the vagina at bedtime for one night only. Children up to 12 years of age—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

Keep out of the reach of children.

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

Do not keep outdated medicine or medicine no longer needed.

Keep the vaginal cream, ointment, and suppository forms of this medicine from freezing.

Precautions While Using This Medicine

If your symptoms do not improve within 3 days or have not disappeared in 7 days, or if they become worse, check with your doctor. The 1- or 3-day treatments may take up to 7 days to completely clear up your infection. However, not all vaginal infections are caused by yeast. If symptoms occur again within 2 months, check with your doctor.

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. The use of nonmedicated tampons (like those used for menstrual periods) is not recommended 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 (for example, nylon or rayon) panties. Wear only clean panties.

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

Vaginal yeast infections are not usually spread by having sex and your sex partner does not need to be treated. However, if the sex partner has symptoms of local itching or skin irritation of the penis, he may benefit by being treated also.

If you use latex or rubber birth control devices (condoms, diaphragms, or cervical caps), you should wait 3 days after treatment with azole antifungal agents before using them again. Many brands of vaginal azoles contain oils in the product that can weaken these devices. This increases the chances of a condom breaking during sexual intercourse. The rubber in cervical caps or diaphragms may break down faster and wear out sooner. Check with your health care professional to make sure the vaginal azole product you are using can be used with latex rubber birth control devices.

Check with your doctor before douching to obtain advice about whether you may douche and, if allowed, the proper method.

Side Effects of This Medicine

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:

Less common Vaginal burning, itching, discharge, or other irritation not present before use of this medicine Rare Skin rash or hives

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 or rare Abdominal or stomach cramps or pain burning or irritation of penis of sexual partner headache

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 Healthcare (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 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 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 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 HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Healthcare does not assume any responsibility or risk for your use of the Thomson Healthcare products.


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