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Vaginal Dryness Medications


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

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

Learn more about Vaginal Dryness

Medical Encyclopedia:

Vaginal dryness
Drug List:
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Vaginal anti-infectives


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

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

See also

Medical conditions associated with vaginal anti-infectives:

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

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Gynazole-1 Cream


Pronunciation: byoo-toe-KOE-na-zole
Generic Name: Butoconazole
Brand Name: Gynazole-1
Gynazole-1 Cream is used for:

Treating vaginal yeast infections.

Gynazole-1 Cream is an antifungal agent. It works by weakening the cell wall of sensitive fungi, causing the cell contents to leak. This kills the fungi.

Do NOT use Gynazole-1 Cream if: you are allergic to any ingredient in Gynazole-1 Cream

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

Before using Gynazole-1 Cream:

Some medical conditions may interact with Gynazole-1 Cream. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances

Some MEDICINES MAY INTERACT with Gynazole-1 Cream. However, no specific interactions with Gynazole-1 Cream are known at this time.

Ask your health care provider if Gynazole-1 Cream may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Gynazole-1 Cream:

Use Gynazole-1 Cream as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Gynazole-1 Cream is for vaginal use only. Do not use in the eyes or take by mouth. Wash your hands before and after using Gynazole-1 Cream. Insert 1 applicator-full of cream into the vagina. Throw the applicator away after using it. Only one dose of Gynazole-1 Cream is required. If you forget to use Gynazole-1 Cream, use it as soon as you remember.

Ask your health care provider any questions you may have about how to use Gynazole-1 Cream.

Important safety information: If your symptoms do not get better within a few days or if they get worse, check with your doctor. If your infection clears up and occurs again in a few weeks, see your doctor. Recurrent vaginal infections, especially those that are difficult to cure, may be an early sign of HIV infection in women who are considered at risk for HIV infection. Gynazole-1 Cream may be used during your period. Use a sanitary pad rather than a tampon to prevent staining of clothing. Gynazole-1 Cream contains mineral oil, which may weaken latex or rubber products such as condoms and diaphragms. Do not use condoms or diaphragms within 72 hours of using Gynazole-1 Cream. Gynazole-1 Cream should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Gynazole-1 Cream while you are pregnant. It is not known if Gynazole-1 Cream is found in breast milk. If you are or will be breast-feeding while you use Gynazole-1 Cream, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Gynazole-1 Cream:

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

Burning, itching, soreness, or swelling in or around the vagina not present before using Gynazole-1 Cream.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); pain or cramping in the stomach or pelvic area.

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

See also: Gynazole-1 side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Gynazole-1 Cream may be harmful if swallowed.

Proper storage of Gynazole-1 Cream:

Store Gynazole-1 Cream at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Keep Gynazole-1 Cream out of the reach of children and away from pets.

General information: If you have any questions about Gynazole-1 Cream, please talk with your doctor, pharmacist, or other health care provider. Gynazole-1 Cream is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Gynazole-1 Cream. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Gynazole-1 resources Gynazole-1 Side Effects (in more detail) Gynazole-1 Use in Pregnancy & Breastfeeding Gynazole-1 Support Group 2 Reviews for Gynazole-1 - Add your own review/rating Compare Gynazole-1 with other medications Vaginal Yeast Infection
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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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Monistat 1 Combo Pack Cream


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

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

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

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

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

Before using Monistat 1 Combo Pack Cream:

Some medical conditions may interact with Monistat 1 Combo Pack Cream. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have the blood disease porphyria or a history of liver disease, or you have been exposed to HIV if you have stomach, shoulder, or lower back pain; fever; chills; nausea; foul-smelling vaginal discharge; or vomiting if this is the first time you have had vaginal itching and discomfort if you have vaginal yeast infections often (eg, once a month or 3 in 6 months) if you are taking antibiotics

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

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

This may not be a complete list of all interactions that may occur. Ask your health care provider if Monistat 1 Combo Pack Cream may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Monistat 1 Combo Pack Cream:

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

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

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

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

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

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

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

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

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

See also: Monistat Combo Pack side effects (in more detail)

If OVERDOSE is suspected:

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

Proper storage of Monistat 1 Combo Pack Cream:

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

General information: If you have any questions about Monistat 1 Combo Pack Cream, please talk with your doctor, pharmacist, or other health care provider. Monistat 1 Combo Pack Cream is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Monistat 1 Combo Pack Cream. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Monistat 1 Combo Pack resources Monistat 1 Combo Pack Side Effects (in more detail) Monistat 1 Combo Pack Use in Pregnancy & Breastfeeding Monistat 1 Combo Pack Drug Interactions 0 Reviews for Monistat Combo Pack - Add your own review/rating Compare Monistat 1 Combo Pack with other medications Vaginal Yeast Infection
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Monistat 3 Cream


Pronunciation: mi-KON-a-zole
Generic Name: Miconazole
Brand Name: Monistat 3
Monistat 3 Cream is used for:

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

Monistat 3 Cream is an antifungal agent. It works by weakening the cell membrane of the fungus, resulting in the death of the fungus.

Do NOT use Monistat 3 Cream if: you are allergic to any ingredient in Monistat 3 Cream you have never had a vaginal yeast infection diagnosed by a doctor

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

Before using Monistat 3 Cream:

Some medical conditions may interact with Monistat 3 Cream. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have the blood disease porphyria or a history of liver disease, or you have been exposed to HIV if you have stomach, shoulder, or lower back pain; fever; chills; nausea; foul-smelling vaginal discharge; or vomiting if this is the first time you have had vaginal itching and discomfort if you have vaginal yeast infections often (eg, once a month or 3 in 6 months) if you are taking antibiotics

Some MEDICINES MAY INTERACT with Monistat 3 Cream. Tell your health care provider if you are taking any other medicines, especially any of the following:

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

This may not be a complete list of all interactions that may occur. Ask your health care provider if Monistat 3 Cream may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Monistat 3 Cream:

Use Monistat 3 Cream as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Monistat 3 Cream comes with an additional patient leaflet. Read it carefully and reread it each time you get Monistat 3 Cream refilled. Monistat 3 Cream is for vaginal use only. Do not use in the eyes or take by mouth. Suppositories - Using the applicator provided, insert 1 suppository high into the vagina at bedtime for 3 days. Some forms of this product come with 3 disposable applicators. If this product contains disposable applicators, throw away each applicator after use. Some forms of this product come with one applicator to be used for all 3 days of treatment. If this product contains only one applicator, do not throw it away after use. Separate the pieces of the applicator and wash with warm, soapy water immediately after use. Rinse thoroughly. Make sure the applicator is completely dry before the next use. External cream - Squeeze a small amount of cream onto your finger and gently spread the cream onto the itchy, irritated skin outside the vagina as directed by your doctor or on the packaging. Wash your hands immediately after using Monistat 3 Cream. To clear up your infection completely, continue using Monistat 3 Cream for the full course of treatment. If you miss a dose of Monistat 3 Cream, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Monistat 3 Cream.

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

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

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

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

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

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

See also: Monistat 3 side effects (in more detail)

If OVERDOSE is suspected:

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

Proper storage of Monistat 3 Cream:

Store Monistat 3 Cream at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Do not use if the wrapper on the applicator or suppository is torn or damaged. Keep Monistat 3 Cream out of the reach of children and away from pets.

General information: If you have any questions about Monistat 3 Cream, please talk with your doctor, pharmacist, or other health care provider. Monistat 3 Cream is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Monistat 3 Cream. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Monistat 3 resources Monistat 3 Side Effects (in more detail)Monistat 3 Use in Pregnancy & BreastfeedingMonistat 3 Drug InteractionsMonistat 3 Support Group0 Reviews for Monistat 3 - Add your own review/rating Compare Monistat 3 with other medications Vaginal Yeast Infection
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Mycelex-7 Combo Pack Cream


Pronunciation: kloe-TRIM-a-zole
Generic Name: Clotrimazole
Brand Name: Mycelex-7 Combo Pack
Mycelex-7 Combo Pack Cream is used for:

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

Mycelex-7 Combo Pack Cream is an antifungal agent. It works by weakening the cell membrane of the fungus, resulting in the death of the fungus.

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

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

Before using Mycelex-7 Combo Pack Cream:

Some medical conditions may interact with Mycelex-7 Combo Pack Cream. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have the blood disease porphyria or a history of liver disease or diabetes, or you have been exposed to HIV if this is the first time you have had vaginal itching and discomfort if you have vaginal yeast infections often (eg, your symptoms return within 2 months) or your symptoms do not clear up with treatment if you are taking antibiotics

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

Ask your health care provider if Mycelex-7 Combo Pack Cream may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Mycelex-7 Combo Pack Cream:

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

An extra patient leaflet is available with Mycelex-7 Combo Pack Cream. Talk to your pharmacist if you have questions about this information. Mycelex-7 Combo Pack Cream is for vaginal use only. Do not use it rectally or take by mouth. Suppositories - Using the applicator provided, insert 1 suppository high into the vagina at bedtime for 7 days. Mycelex-7 Combo Pack Cream comes with one applicator to be used for all 7 days of treatment. Do not throw away applicator after use. Separate the pieces of the applicator and wash with warm, soapy water immediately after use. Rinse thoroughly. Make sure the applicator is completely dry before the next use. External cream - Squeeze a small amount of cream onto your finger and gently spread the cream onto the itchy, irritated skin outside the vagina as directed by your doctor or on the packaging. Wash your hands immediately after using Mycelex-7 Combo Pack Cream. To clear up your infection completely, use Mycelex-7 Combo Pack Cream for the full course of treatment. Keep using it even if you feel better in a few days. If you miss a dose of Mycelex-7 Combo Pack Cream, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

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

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

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

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

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

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

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

See also: Mycelex-7 Combo Pack side effects (in more detail)

If OVERDOSE is suspected:

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

Proper storage of Mycelex-7 Combo Pack Cream:

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

General information: If you have any questions about Mycelex-7 Combo Pack Cream, please talk with your doctor, pharmacist, or other health care provider. Mycelex-7 Combo Pack Cream is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Mycelex-7 Combo Pack Cream. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Mycelex-7 Combo Pack resources Mycelex-7 Combo Pack Side Effects (in more detail) Mycelex-7 Combo Pack Use in Pregnancy & Breastfeeding Mycelex-7 Combo Pack Support Group 0 Reviews for Mycelex-7 Combo Pack - Add your own review/rating Compare Mycelex-7 Combo Pack with other medications Cutaneous Candidiasis Tinea Corporis Tinea Cruris Tinea Pedis Tinea Versicolor Vaginal Yeast Infection
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Aquadrate 10% w / w Cream


Aquadrate 10% w/w Cream

(Urea)

What is this leaflet about?

This leaflet is a summary of information about Aquadrate Cream. Read it carefully and keep it in case you need to refer to it again. If you have any questions about the cream, or your illness, ask your pharmacist (chemist) or doctor.

What is in Aquadrate Cream?

Aquadrate Cream contains the active ingredient Urea (10% w/w) and comes in tubes of 30g and 100g. Each 30g/100g tube contains 3g/10g of urea.

The cream also contains white soft paraffin, maize starch, isopropyl myristate, glyceryl tribehenate, palmitic acid, sorbitan laurate and polyoxyethylene fatty glyceride.

Who makes Aquadrate Cream?

The Marketing Authorisation holder is

Alliance Pharmaceuticals Ltd Avonbridge House Chippenham Wiltshire SN15 2BB England

and is licensed to sell Aquadrate Cream in the UK and Eire. It is made by

Laboratoires Chemineau Vouvray France What is Aquadrate Cream used for?

It is used to treat dry, scaly skin conditions. The urea in the cream helps to soften and moisturise your skin.

Is Aquadrate Cream right for you?

Tell your doctor if :

you are using any other medicines that are applied to the skin, as Aquadrate might affect the action of the other medicine. you have ever had a reaction to this cream or to any of its ingredients (these are listed above). you are pregnant or breastfeeding. the cream irritates your skin or there is no improvement in your condition. How to use Aquadrate Cream

The cream is for external use only and should only be applied to the skin. It should not be used on moist or broken skin. Application of Aquadrate Cream may cause skin irritation (redness, burning or itching). If you forget to use the cream on any occasion, do not worry, just continue as normal.

Adults, Children and the Elderly:-

Wash affected areas well, rinse off all traces of soap, dry and apply a small amount of the cream twice daily. Your doctor may tell you to cover this with a special "occlusive" dressing, but this is not usually necessary.

Does Aquadrate Cream have side effects?

If used correctly, as directed by your doctor, the cream is unlikely to cause side effects.

Some people experience irritation when they apply the cream. If you notice this or any other unusual effect, tell your doctor.

Storing Aquadrate Cream

Keep all medicines out of the reach and sight of children and do not store above 30°C.

Do not use after the expiry date shown on the base of the tube.

PL Number 16853/0061

PA Number: 943/5/1

Legal category: P

This leaflet was last revised in May 2006

Aquadrate is a registered Trade mark

©Alliance Pharmaceuticals, Limited

AN 0729 004


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Mycostatin Vaginal Cream


Generic Name: nystatin (Vaginal route)

nye-STAT-in

Commonly used brand name(s)

In Canada

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

Available Dosage Forms:

Cream Tablet

Therapeutic Class: Antifungal

Chemical Class: Polyene

Uses For Mycostatin Vaginal Cream

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

Nystatin is available only with your doctor's prescription.

Before Using Mycostatin Vaginal Cream

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

Allergies

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

Pediatric

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

Geriatric

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

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

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

Proper Use of nystatin

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

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

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

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

Dosing

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

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

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

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

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Mycostatin Vaginal Cream

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

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

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

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

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

Mycostatin Vaginal Cream Side Effects

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

Check with your doctor as soon as possible if any of the following side effects occur:

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

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

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

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

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

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


Boots Antifungal Cream

(Clotrimazole)

for fungal infections of the skin

20 g

Read all of this carton for full instructions.

What this medicine is for

An antifungal cream for the treatment of fungal skin infections including ringworm, athlete’s foot, fungal nappy rash, infections of the armpit, groin, toes and skin folds and thrush of the vulva or penis.

Before you use this medicine Do not use: If you are allergic to any of the ingredients If you are pregnant or breastfeeding, unless your doctor or midwife tells you to

Information about some of the ingredients: The ingredients in the cream may affect the latex used in contraceptives such as condoms and diaphragms. This may reduce the effectiveness of the contraceptives. You should therefore use other methods of contraception for at least 5 days after using this medicine in the genital area. You may, for example, use a spermicide gel in addition to the condom or diaphragm. If you need more advice about this speak to your pharmacist.

Cetyl alcohol and stearyl alcohol in this medicine may cause skin reactions (e.g. contact dermatitis).

How to use this medicine

Check the tube seal is not broken before first use. If it is, do not use the cream.

Pierce tube seal with end of cap.

Adults and children: Apply to the affected area two or three times a day. Use the cream for at least 2 weeks. In some cases it may be necessary to continue to use the cream for more than 4 weeks.

If you are using the cream for a foot infection, make sure your feet, especially between the toes, are washed and thoroughly dried before applying the cream. Apply to the skin only.

Do not use more than the amount recommended above.

If symptoms do not go away talk to your doctor.

If anyone accidentally swallows some: Talk to a doctor straight away.

Possible side effects

Most people will not have problems, but some may get some.

If you get these side effects, stop using the cream and see a doctor: Allergic reaction (e.g. skin rash, red or itchy skin) These other effects are less serious. If they bother you talk to a pharmacist: Rarely, mild burning or irritation immediately after using the cream Pain

If any side effect becomes severe, or you notice any side effect not listed here, please tell your pharmacist or doctor.

Keep all medicines out of the sight and reach of children.

Use by the date on the end flap of the carton.

Active ingredient

This topical cream contains Clotrimazole 1% w/w.

Also contains: purified water, 2-octyldodecanol, stearyl alcohol, cetyl alcohol, cetyl esters wax, sorbitan stearate, polysorbate 60, benzyl alcohol.

PL 10622/0004 [P]

Text prepared 8/08

Manufactured for The Boots Company PLC Nottingham NG2 3AA

by

Thornton & Ross Ltd Linthwaite Huddersfield West Yorkshire HD7 5QH Marketing Authorisation held by PLIVA Pharma Ltd Vision House Bedford Road Petersfield Hampshire GU32 2QB

If you need more advice ask your pharmacist.

1498cXPil


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Vaniqa Cream


Pronunciation: eh-FLOOR-neh-theen
Generic Name: Eflornithine
Brand Name: Vaniqa
Vaniqa Cream is used for:

Slowing the growth of unwanted facial hair in women.

Vaniqa Cream is an enzyme inhibitor. It works by blocking an enzyme necessary for hair to grow.

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

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

Before using Vaniqa Cream:

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

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have scraped or broken skin, or sores on the affected area

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

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

How to use Vaniqa Cream:

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

Vaniqa Cream comes with an additional patient leaflet. Read it carefully and reread it each time you get Vaniqa Cream refilled. Ask your doctor or pharmacist any questions that you may have about Vaniqa Cream. Apply a thin layer of Vaniqa Cream to the affected areas of the face and under the chin, at least 5 minutes after hair removal (eg, plucking, shaving). Rub in thoroughly. Do not wash the treated area for at least 4 hours. Wait at least 8 hours between applications of Vaniqa Cream. Cosmetics or sunscreens may be applied to treated areas after Vaniqa Cream has dried. If you miss a dose of Vaniqa Cream, skip the missed dose and return to your regular dosing schedule. Do not apply 2 doses at once.

Ask your health care provider any questions you may have about how to use Vaniqa Cream.

Important safety information: Vaniqa Cream is for external use only. Avoid contact with the vaginal area, eyes, nose, or mouth. Vaniqa Cream does not remove hair. You will need to continue your routine method of hair removal while using Vaniqa Cream. You may need to use Vaniqa Cream for at least 4 to 8 weeks before you begin to see improvement. If your symptoms do not improve or become worse, contact your doctor. Use Vaniqa Cream with extreme caution in CHILDREN younger than 12 years of age. Safety and effectiveness in this age group have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Vaniqa Cream during pregnancy. It is unknown if Vaniqa Cream is excreted in breast milk. If you are or will be breast-feeding while you are using Vaniqa Cream, check with your doctor or pharmacist to discuss the risks to your baby. Possible side effects of Vaniqa Cream:

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

Redness; skin tingling; temporary stinging or burning.

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); bleeding or irritation of the skin.

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

See also: Vaniqa side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Vaniqa Cream may be harmful if swallowed. Symptoms may include dizziness; facial swelling; hair loss; headache; hearing loss; loss of appetite; seizures; unusual bruising or bleeding; upset stomach; weakness.

Proper storage of Vaniqa Cream:

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

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

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

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Vaniqa resources Vaniqa Side Effects (in more detail) Vaniqa Use in Pregnancy & Breastfeeding Vaniqa Support Group 8 Reviews for Vaniqa - Add your own review/rating Compare Vaniqa with other medications Hirsutism
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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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Topicort Ointment



Dosage Form: ointment
Topicort®
(Desoximetasone Ointment USP) 0.05%

For topical use only. Not for oral, ophthalmic, or intravaginal use.

Rx only

Topicort Ointment Description

Topicort® (desoximetasone ointment USP) 0.05% contains the active synthetic corticosteroid desoximetasone. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents.

Each gram of Topicort® (desoximetasone ointment USP) 0.05% contains 0.5 mg of desoximetasone in an ointment base consisting of mineral oil and white petrolatum.

The chemical name of desoximetasone is Pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 21-dihydroxy- 16-methyl-,(11?,16?)-.

Desoximetasone has the molecular formula C22H29FO4 and a molecular weight of 376.47. The CAS Registry Number is 382-67-2.

The structural formula is:

Topicort Ointment - Clinical Pharmacology

Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions.

The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.

Pharmacokinetics

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.

Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses.

Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

Pharmacokinetic studies in men with Topicort® (desoximetasone) Ointment 0.25% with tagged desoximetasone showed no detectable level (limit of sensitivity: 0.003 µg/mL) in 1 subject and 0.004 and 0.006 µg/mL in the remaining 2 subjects in the blood when it was applied topically on the back followed by occlusion for 24 hours. The extent of absorption for the ointment was 7% based on radioactivity recovered from urine and feces. Seven days after application, no further radioactivity was detected in urine or feces. Studies with other similarly structured steroids have shown that predominant metabolite reaction occurs through conjugation to form the glucuronide and sulfate ester.

Indications and Usage for Topicort Ointment

Topicort® (desoximetasone ointment USP) 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Contraindications

Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Warnings

Keep out of reach of children.

Precautions General

Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for clinical glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of the topical corticosteroid.

Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression. Factors that predispose a patient using a topical corticosteroid to HPA axis suppression include the use of more potent steroids, use over large surface areas, use over prolonged periods, use under occlusion, use on an altered skin barrier, and use in patients with liver failure.

An ACTH stimulation test may be helpful in evaluating patients for HPA axis suppression. If HPA axis suppression is documented, an attempt should be made to gradually withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids. Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids.

Cushing's syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can also result from systemic absorption of topical corticosteroids.

Use of more than one corticosteroid-containing product at the same time may increase the total systemic corticosteroid exposure.

Pediatric patients may be more susceptible to systemic toxicity from use of topical corticosteroids.

Local Adverse Reactions with Topical Corticosteroids

Local adverse reactions may be more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids. Reactions may include atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria. Some local adverse reactions may be irreversible.

Allergic Contact Dermatitis with Topical Corticosteroids

Allergic contact dermatitis to any component of topical corticosteroids is usually diagnosed by a failure to heal rather than a clinical exacerbation. Clinical diagnosis of allergic contact dermatitis can be confirmed by patch testing.

Concomitant Skin Infections

Concomitant skin infections should be treated with an appropriate antimicrobial agent. If the infection persists, Topicort® (desoximetasone ointment USP) 0.05% should be discontinued until the infection has been adequately treated.

Information for the Patient

Patients using topical corticosteroids should receive the following information and instructions:

This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes. Patients should be advised not to use this medication for any disorder other than that for which it was prescribed. The treated skin area should not be bandaged or otherwise covered or wrapped so as to be occlusive unless directed by the physician. Patients should report any signs of local adverse reactions, especially under occlusive dressings. Other corticosteroid-containing products should not be used with Topicort® (desoximetasone ointment USP) 0.05% without first consulting with the physician.

As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 4 weeks, contact the physician.

Laboratory Tests

The following tests may be helpful in evaluating the hypothalamic-pituitary-adrenal (HPA) axis suppression:

  Urinary free cortisol test   ACTH stimulation test Carcinogenesis, Mutagenesis, and Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids.

Desoximetasone was nonmutagenic in the Ames test.

Pregnancy Teratogenic Effects Pregnancy Category C

Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals.

Desoximetasone has been shown to be teratogenic and embryotoxic in mice, rats, and rabbits when given by subcutaneous or dermal routes of administration in doses 15 to 150 times the human dose of Topicort® (desoximetasone ointment USP) 0.05%.

There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, Topicort® (desoximetasone ointment USP) 0.05% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.

Nursing Mothers

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.

Pediatric Use

Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio.

Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in pediatric patients include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Administration of topical corticosteroids to pediatric patients should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of pediatric patients.

Adverse Reactions

The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence:

Burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria.

In controlled clinical studies the incidence of adverse reactions was low (0.2%) for Topicort® (desoximetasone ointment USP) 0.05% and included mild burning sensation at the site of application.

Overdosage

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).

Topicort Ointment Dosage and Administration

Apply a thin film of Topicort® (desoximetasone ointment USP) 0.05% to the affected skin areas twice daily. Rub in gently.

How is Topicort Ointment Supplied

Topicort® (desoximetasone ointment USP) 0.05% is supplied in:

15 gram tubes (NDC 51672-5263-1) and 60 gram tubes (NDC 51672-5263-3).

Store at controlled room temperature between 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]

Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1

Dist. by: TaroPharma a division of Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532

Topicort® and TaroPharma® are registered trademarks of Taro Pharmaceuticals U.S.A., Inc. and/or its affiliates.

Issued: November, 2010

PK-6692-0 83

PRINCIPAL DISPLAY PANEL - 15 g Tube Carton

NDC 51672-5263-1

15 g

Rx only

0.05%

OINTMENT

Topicort®
Desoximetasone Ointment USP, 0.05%
FOR TOPICAL USE ONLY. NOT FOR ORAL, OPHTHALMIC, OR INTRAVAGINAL USE.

Keep this and all medications out of the reach of children.

TaroPharma®


TOPICORT 
desoximetasone  ointment Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 51672-5263 Route of Administration TOPICAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Desoximetasone (Desoximetasone) Desoximetasone 0.5 mg  in 1 g Inactive Ingredients Ingredient Name Strength mineral oil   petrolatum   Product Characteristics Color WHITE (off-white) Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 51672-5263-5 10 TUBE In 1 CARTON contains a TUBE 1 5 g In 1 TUBE This package is contained within the CARTON (51672-5263-5) 2 51672-5263-1 1 TUBE In 1 CARTON contains a TUBE 2 15 g In 1 TUBE This package is contained within the CARTON (51672-5263-1) 3 51672-5263-3 1 TUBE In 1 CARTON contains a TUBE 3 60 g In 1 TUBE This package is contained within the CARTON (51672-5263-3)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA018594 01/17/1985
Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370) Establishment Name Address ID/FEI Operations Taro Pharmaceuticals Inc. 206263295 MANUFACTURE Revised: 12/2010Taro Pharmaceuticals U.S.A., Inc. More Topicort Ointment resources Topicort Ointment Side Effects (in more detail) Topicort Ointment Use in Pregnancy & Breastfeeding Topicort Ointment Drug Interactions Topicort Ointment Support Group 9 Reviews for Topicort - Add your own review/rating Compare Topicort Ointment with other medications Atopic Dermatitis Dermatitis Eczema Psoriasis
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terconazole vaginal


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

What is terconazole vaginal?

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

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

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

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

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

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

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

a fever;

stomach pain; or

foul-smelling vaginal discharge.

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

diabetes;

HIV or AIDS.; or

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

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

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

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

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

Wash your hands before and after using this medication.

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

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

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

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

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

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. What should I avoid while using terconazole vaginal? Avoid getting this medication in your eyes, nose, or mouth. If this does happen, rinse with water.

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

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

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

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

severe vaginal burning or irritation; or

fever, chills, flu symptoms.

Less serious side effects may include:

headache; or

menstrual cramps.

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

Terconazole vaginal Dosing Information

Usual Adult Dose for Vaginal Candidiasis:

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

What other drugs will affect terconazole vaginal?

It is not likely that other drugs you take orally or inject will have an effect on vaginally applied terconazole. But many drugs can interact with each other. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More terconazole vaginal resources Terconazole vaginal Side Effects (in more detail) Terconazole vaginal Dosage Terconazole vaginal Use in Pregnancy & Breastfeeding Terconazole vaginal Support Group 6 Reviews for Terconazole - Add your own review/rating Compare terconazole vaginal with other medications Vaginal Yeast Infection Where can I get more information? Your pharmacist can provide more information about terconazole vaginal.

See also: terconazole side effects (in more detail)


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Estrace Vaginal Cream local


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

What is estradiol vaginal (local)?

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

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

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

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

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

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

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

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

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

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

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

a bleeding or blood-clotting disorder;

a history of stroke or circulation problems;

abnormal vaginal bleeding that a doctor has not checked; or

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

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

high blood pressure, angina, or heart disease;

high cholesterol or triglycerides;

liver disease; kidney disease;

asthma;

epilepsy or other seizure disorder;

migraines;

diabetes;

depression;

gallbladder disease; or

if you have had your uterus removed (hysterectomy).

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

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

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

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

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

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

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

To use the estradiol vaginal ring:

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

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

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

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

To use the estradiol vaginal cream:

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

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

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

To use the estradiol vaginal tablets:

Each vaginal tablet is supplied in a disposable applicator.

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

Throw the applicator away.

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

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

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

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

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

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

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

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

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

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

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

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

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

abnormal vaginal bleeding;

pain, swelling, or tenderness in your stomach;

jaundice (yellowing of the skin or eyes); or

a lump in your breast.

Less serious side effects may include:

nausea, vomiting, loss of appetite;

swollen breasts;

acne or skin color changes;

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

migraine headaches or dizziness;

vaginal pain, dryness, or discomfort;

swelling of your ankles or feet;

depression; or

changes in your menstrual periods, break-through bleeding.

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

What other drugs will affect estradiol vaginal (local)?

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

St. John's wort;

phenobarbital (Solfoton);

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

ritonavir (Norvir, Kaletra);

carbamazepine (Carbatrol, Tegretol);

rifampin (Rifadin, Rifater, Rifamate, Rimactane);

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

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

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

More Estrace Vaginal Cream resources Estrace Vaginal Cream Side Effects (in more detail) Estrace Vaginal Cream Use in Pregnancy & Breastfeeding Estrace Vaginal Cream Drug Interactions Estrace Vaginal Cream Support Group 12 Reviews for Estrace Vaginal - Add your own review/rating Compare Estrace Vaginal Cream with other medications Atrophic Urethritis Atrophic Vaginitis Hypoestrogenism Where can I get more information? Your pharmacist can provide more information about estradiol vaginal (local).

See also: Estrace Vaginal side effects (in more detail)


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Boots Lip and Cold Sore Cream


Boots Lip and Cold Sore Cream

Relieves cracked lips and cold sores

5 g

Read all of this carton for full instructions.

What this medicine is for

An antibacterial and protective cream for cracked lips and cold sores.

You can use this medicine if you are pregnant or breastfeeding.

How to use this medicine

Adults and children: Use a very small amount on the affected area every hour, when you need to.

Apply to the skin only.

Do not use more than the amount recommended above.

If symptoms do not go away talk to your doctor.

If anyone accidentally swallows some: Talk to a doctor.

Possible side effects

Cetostearyl alcohol may cause skin reactions (e.g. contact dermatitis).

If this becomes severe, or you notice any side effect, please tell your pharmacist or doctor.

How to store this medicine

Store below 25°C.

Keep all medicines out of the sight and reach of children.

Use by the date on the end flap of the carton.

Active ingredients

This cream contains Cetrimide 0.5% w/w, Chlorocresol 0.1% w/w, Dimeticone 9% w/w, Urea 1% w/w.

Also contains: deionised water, liquid paraffin, cetostearyl alcohol.

PL 30306/0028

Text prepared 8/07

Manufactured for The Boots Company PLC Nottingham NG2 3AA

by

CCS Clean Chemicals Sweden AB Borl?nge SE 78173 Sweden Marketing Authorisation held by Actavis Group PTC ehf Reykjv?kurvegi 76 – 78 220 Hafnarfjorur Iceland

If you need more advice ask your pharmacist .

2787bXPil


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Amino-Cerv Cream


Pronunciation: uh-MEE-no AS-ids/SO-dee-uhm PRO-pee-oh-nate/you-REE-ah
Generic Name: Amino Acids/Sodium Propionate/Urea Cervical
Brand Name: Amino-Cerv
Amino-Cerv Cream is used for:

Treating inflammation or injury of the cervix. It is usually used after childbirth or certain medical procedures. It may also be used to treat other conditions as determined by your doctor.

Amino-Cerv Cream is an amino acid, antifungal, and urea combination. The amino acids help wounds to heal. They also help to increase cell growth. Sodium propionate kills sensitive fungi. Urea helps to break down dead tissue. It also increases new tissue growth.

Do NOT use Amino-Cerv Cream if: you are allergic to any ingredient in Amino-Cerv Cream

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

Before using Amino-Cerv Cream:

Some medical conditions may interact with Amino-Cerv Cream. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparations, or dietary supplement if you have allergies to medicines, foods, or other substances

Some MEDICINES MAY INTERACT with Amino-Cerv Cream. Because little, if any, of Amino-Cerv Cream 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 Amino-Cerv Cream may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Amino-Cerv Cream:

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

An extra patient leaflet is available with Amino-Cerv Cream. Talk to your pharmacist if you have questions about this information. Use Amino-Cerv Cream before going to bed unless directed otherwise by your doctor. If you are wearing a pessary, remove it before you use Amino-Cerv Cream. Do not tape over the pinhole on the top of the bulb on the applicator. To use Amino-Cerv Cream, attach the applicator to the tube. Squeeze the tube from the bottom until the medicine reaches the correct dose mark on the applicator. Detach the applicator from the tube. Insert it 3 4 inch into the vagina. Do NOT insert it all the way into the vagina. Squeeze the bulb firmly once. This will deposit the cream into the vagina. Do not release the bulb until you have removed the applicator from the vagina. Clean the applicator right away. Hold it under water and flush it (squeeze the bulb) several times. Wipe the threads of the tube and the inside of the cap. Recap the tube tightly. Do not use other feminine sprays or vaginal or cervical medicines. They may interact with Amino-Cerv Cream. If you miss a dose of Amino-Cerv Cream, use it as soon as possible. If you do not remember until the next day, skip the missed dose. 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 Amino-Cerv Cream.

Important safety information: Amino-Cerv Cream is for vaginal use only. Do not get it in your eyes, nose, or mouth. If you get it in your eyes, rinse at once with cool water. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Amino-Cerv Cream while you are pregnant. It is unknown if Amino-Cerv Cream is found in breast milk. If you are or will be breast-feeding while you use Amino-Cerv Cream, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Amino-Cerv Cream:

All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with Amino-Cerv Cream. Seek medical attention right away if any of these SEVERE side effects occur:

Seek medical attention right away if any of these SEVERE side effects occur: Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

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

See also: Amino-Cerv side effects (in more detail)

If OVERDOSE is suspected:

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

Proper storage of Amino-Cerv Cream:

Store Amino-Cerv Cream at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Amino-Cerv Cream out of the reach of children and away from pets.

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

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

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Amino-Cerv resources Amino-Cerv Side Effects (in more detail)Amino-Cerv Use in Pregnancy & BreastfeedingAmino-Cerv Support Group0 Reviews for Amino-Cerv - Add your own review/rating Compare Amino-Cerv with other medications Cervicitis
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Efudix 5% Cream


EFUDIX 5% Cream

Fluorouracil

Please read this leaflet carefully before you start to take your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

What Is Efudix Cream?

Efudix Cream contains the active ingredient fluorouracil, which belongs to a group of medicines known as antimetabolites, at a concentration of 5%. It works by interfering with the growth of abnormal cells which are eventually destroyed. It also contains the inactive ingredients stearyl alcohol, white soft paraffin, polysorbate 60, propylene glycol, methyl parahydroxybenzoate (methyl paraben), propyl parahydroxybenzoate (propyl paraben) and purified water.

The cream is supplied in tubes of 20 g and 40 g.

The Product Licence/Authorisation for Efudix Cream is held by Meda Pharmaceuticals Ltd. Skyway House Parsonage Road Takeley Bishop’s Stortford CM22 6PU UK It is made by ICN Polfa Rzesz?w S.A. ul. Przemys?owa 2 35-959 Rzesz?w Poland What Is Efudix Cream Used For?

Efudix Cream is used to treat certain skin conditions caused by abnormal cell growth including different types of keratoses (a horny growth of the skin), keratocanthoma (a firm nodule on the skin), Bowen’s disease and some simple skin cancers.

When Must Efudix Cream Not Be Used? If you are pregnant or breast feeding. If you are allergic to Efudix Cream or any of its ingredients including parabens. It is not recommended for use by children. When Should You Be Extra Careful When Using Efudix Cream?

Make sure your doctor knows if you are using any other medicines you apply to the areas of skin being treated (e.g. creams and ointments), including ones bought by yourself without a prescription.

May Efudix Cream Be Used During Pregnancy Or While Breast Feeding?

You must not use Efudix Cream if you are pregnant, think you may be pregnant or are breast feeding.

It is important to tell your doctor if you are pregnant, think you may be pregnant or intend to become pregnant during treatment.

How Should Efudix Cream Be Used? Always use Efudix Cream as your doctor tells you to. It must only be used on the skin. Be careful if applying Efudix Cream around your eyelids, nose and lips and avoid any contact with the eyes or mouth.Wash your hands thoroughly after use. If somebody else is helping you to apply the cream, they should take precautions to avoid cream being absorbed through their skin. It is recommended that they should wear disposable surgical gloves, remove these after use and wash their hands thoroughly. It is not necessary for you to wear gloves as the intended treatment results in some of the cream being absorbed. The cream should be applied in a thin layer to the affected area once or twice daily or as your doctor advises. The total area of skin treated at any one time should not be more than 23x23 cm (500 cm square) or 9x9 inches. Your doctor should tell you if you need to apply a dressing to the treated skin. You will normally need to use the cream for at least three to four weeks.Your skin may appear to be worse after you start the treatment. This is to be expected and you should continue to apply the cream as directed. If your skin becomes much worse, or if you are worried, consult your doctor. After stopping treatment you may find that your skin takes one to two months to heal completely. If the cream is swallowed or someone else accidentally uses it, contact your doctor, pharmacist or nearest hospital straight away. If you miss a dose, apply it as soon as possible. However, if it is nearly time for your next dose, skip the missed dose and carry on as before. Do not apply a double dose. Do not change the prescribed dose yourself. If you think the effect of your medicine is too weak or strong, talk to your doctor. What Are The Possible Unwanted Effects Of Efudix Cream?

In addition to the beneficial effects of Efudix Cream it is possible that unwanted effects will occur during treatment even when it is used as directed.

The cream may sometimes cause redness and discomfort in the affected skin and surrounding healthy skin and skin allergy may develop. Occasionally sores will develop and you may feel some discomfort. Rarely, the sores are round, red and painful. If you are suffering severe discomfort, your doctor may be able to help. Whilst using Efudix your skin may become more sensitive to sunlight.To prevent this you should try to stay out of direct sunlight as much as possible whilst using the cream and do not use a sunlamp or sunbed.

If you are concerned about these or any other unwanted effects, talk to your doctor.

How Should Efudix Cream Be Stored? Keep this medicine out of reach and sight of children. Do not store above 30°C. This medicine should not be used after the date (EXP) printed on the pack. Return any leftover medicine to your pharmacist who will arrange for environment-friendly disposal. Only keep it if your doctor tells you to. Remember this medicine is for you. Only a doctor can prescribe it for you. Never give it to others. It may harm them even if their symptoms are the same as yours. Further Information

You can get more information on Efudix Cream from your doctor or pharmacist.

DATE OF PREPARATION

June 2009

P1EU02

562101V5140UK00


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