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|Trosyd J cream

TIOCONAZOLE (Topical)*

Some commonly used brand names are:

In Canada—

• Trosyd AF cream
• Trosyd J cream

* Not commercially available in the U.S.

Category

• Antifungal, topical

Description

Tioconazole (tye-o-KON-a-zole) belongs to the family of medicines called antifungals, which are used to treat infections caused by a fungus or yeast. They work by killing the fungus or yeast or preventing its growth.

Tioconazole cream is applied to the skin to treat :

• ringworm of the body (tinea corporis);
• ringworm of the foot (tinea pedis; athlete"s foot);
• ringworm of the groin (tinea cruris; jock itch);
• tinea versicolor (sometimes called ``sun fungus""); and
• yeast infection of the skin (cutaneous candidiasis).

Tioconazole is available in the following dosage forms:

• Topical
• Cream (Canada)

Before Using This Medicine

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

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to tioconazole, ketoconazole, miconazole, or another imidazole antifungal medicine. Also tell your doctor and pharmacist if you are allergic to any other substances, such as preservatives or dyes.

Pregnancy—Topical tioconazole has not been studied in pregnant women. When used vaginally during various stages in pregnancy, tioconazole has not been shown to cause birth defects or other problems in humans. However, studies in animals showed an increased number of stillbirths and delays in development when rats were given tioconazole by mouth or injection. Before using this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—It is not known whether topical tioconazole passes into the breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are taking this medicine and who wish to breast-feed should discuss this with their doctor.

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

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

Other 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 health care professional if you are using any other topical prescription or nonprescription (over the counter [OTC]) medicine that is to be applied to the same area of the skin.

Proper Use of This Medicine

Apply enough tioconazole to cover the affected and surrounding skin areas, and rub in gently.

Keep this medicine away from the eyes .

Do not apply an occlusive dressing (airtight covering, such as kitchen plastic wrap) over this medicine unless you have been directed to do so by your doctor . To do so may cause irritation of the skin.

To help clear up your infection completely, it is very important that you keep using tioconazole for the full time of treatment , even if your symptoms begin to clear up after a few days. Since fungus infections may be very slow to clear up, you may have to continue using this medicine every day for several weeks or more. If you stop using this medicine too soon, your symptoms may return. Do not miss any doses .

Dosing—The dose of topical tioconazole 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 tioconazole. If your dose is different, do not change it unless your doctor tells you to do so.

The number of doses you use each day, the time allowed between doses, and the length of time you use the medicine depend on the medical problem for which you are using topical tioconazole.

• For topical cream dosage form:
  • For ringworm of the body or yeast infection of the skin:
    • Adults—Use two times a day for 2 to 4 weeks.
    • Children— Dose must be determined by your doctor.
  • For ringworm of the foot:
    • Adults—Use two times a day for up to 6 weeks.
    • Children— Dose must be determined by your doctor.
  • For ringworm of the groin:
    • Adults—Use two times a day for up to 2 weeks.
    • Children— Dose must be determined by your doctor.
  • For tinea versicolor (“sun fungus”):
    • Adults—Use two times a day for 1 to 4 weeks.
    • Children— Dose must be determined by your doctor.

Missed dose—If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage—To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Keep the medicine from freezing. Do not refrigerate.
• Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

If your skin problem does not improve within:

• 2 weeks for ringworm of the body or yeast infection of the skin, tinea versicolor, or ringworm of the groin;
• 4 to 6 weeks for ringworm of the foot;

To help clear up your infection completely and to help make sure it does not return, good health habits are also required . The following measures will help reduce chaffing and irritation and will also help keep the area cool and dry:

• For patients using tioconazole for ringworm of the groin (tinea cruris; jock itch) :
  • Avoid wearing underwear that is tight-fitting or made from synthetic materials (for example, rayon or nylon). Instead, wear loose-fitting, cotton underwear.
• For patients using tioconazole for ringworm of the foot (tinea pedis; athlete"s foot) :
  • Carefully dry the feet, especially between the toes, after bathing.
  • Avoid wearing socks made from wool or synthetic materials (for example, rayon or nylon). Instead wear clean, cotton socks and change them daily or more often if the feet sweat a lot.
  • Wear sandals or other well-ventilated shoes.
• For patients using tioconazole for ringworm of the body (tinea corporis) :
  • Carefully dry yourself after bathing.
  • Avoid too much heat and humidity if possible.
  • Wear well-ventilated, loose-fitting clothing.

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

Side Effects of This Medicine

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

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

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

Developed: 06/12/2000

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