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|Nizoral Shampoo Topical

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KETOCONAZOLE (Topical)

Some commonly used brand names are:

In the U.S.—

Nizoral Cream
Nizoral A-D Shampoo
Nizoral Shampoo

In Canada—

Nizoral Cream
Nizoral Shampoo

Description

Ketoconazole (kee-toe-KOE-na-zole) is used to treat infections caused by a fungus or yeast. It works by killing the fungus or yeast or preventing its growth.

Ketoconazole cream is used to treat:

Athlete"s foot (tinea pedis; ringworm of the foot);
Ringworm of the body (tinea corporis);
Ringworm of the groin (tinea cruris; jock itch);
Seborrheic dermatitis;
``Sun fungus"" (tinea versicolor; pityriasis versicolor); and
Yeast infection of the skin (cutaneous candidiasis).

Ketoconazole 1% shampoo is used to treat dandruff.

Ketoconazole 2% shampoo is used to treat ``sun fungus"" (tinea versicolor; pityriasis versicolor).

This medicine may also be used for other fungus infections of the skin as determined by your doctor.

Ketoconazole is available without a doctor"s prescription, in the following dosage form:

Topical
Shampoo (1%) (U.S.)

Ketoconazole is available only with your doctor"s prescription, in the following dosage forms:

Topical
Cream (U.S. and Canada)
Shampoo (2%) (U.S. and 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 ketoconazole, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to ketoconazole, miconazole or other imidazoles, or sulfites. The cream form of ketoconazole contains sulfites. Also tell your health care professional if you are allergic to any other substances, such as preservatives or dyes.

Pregnancy—Ketoconazole has not been studied in pregnant women. However, studies in animals have shown that ketoconazole causes birth defects or other problems. 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 ketoconazole, used on a regular basis, is absorbed into the mother"s body enough to pass into the breast milk. However, the cream was not absorbed through the skin after a single dose was applied to the chest, back, and arms of volunteers. Also, the shampoo was not absorbed through the skin after frequent shampooing by volunteers. Therefore, it is unlikely to cause problems in nursing babies.

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of this medicine in children with use in other age groups.

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 or if they cause different side effects or problems in older people. There is no specific information comparing use of topical ketoconazole in the elderly with use in other age groups.

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 prescription or nonprescription (over-the-counter [OTC]) medicine.

Proper Use of This Medicine

Keep this medicine away from the eyes .

For patients using the cream form of this medicine:

Apply enough ketoconazole cream to cover the affected and surrounding skin areas, and rub in gently.
To help clear up your infection completely, it is very important that you keep using ketoconazole cream for the full time of treatment , even if your symptoms begin to clear up after a few days. Since fungus or yeast infections may be very slow to clear up, you may have to continue using this medicine every day for up to several weeks. If you stop using this medicine too soon, your symptoms may return. Do not miss any doses .

For patients using the 1% shampoo form of this medicine:

Wet your hair and scalp well with water.
Apply enough shampoo to work up a good lather and gently massage it over your entire scalp.
Rinse your hair and scalp with warm water.
Repeat application.
Rinse your hair and scalp well with warm water, and dry your hair.

For patients using the 2% shampoo form of this medicine:

Wet your hair and scalp well with water.
Apply the shampoo to the skin of the affected area and a wide margin surrounding this area.
Work up a good lather and leave it in place for 5 minutes.
Rinse your hair and scalp well with warm water, and dry your hair.

Dosing—The dose of topical ketoconazole 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 topical ketoconazole. 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 ketoconazole .

For cream dosage form:
- For cutaneous candidiasis, tinea corporis, tinea cruris, tinea pedis, or pityriasis versicolor:
  - Adults—Apply once a day to the affected skin and surrounding area.
  - Children—Use and dose must be determined by your doctor.
- For seborrheic dermatitis:
  - Adults—Apply two times a day to the affected skin and surrounding area.
  - Children—Use and dose must be determined by your doctor.
For 1% shampoo dosage form:
- For dandruff:
  - Adults—Use every 3 or 4 days for up to 8 weeks. Then use only as needed to keep dandruff under control.
  - Children—Use and dose must be determined by your doctor.
For 2% shampoo dosage form:
- For pityriasis versicolor:
  - Adults—Use once.
  - Children—Use and 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 keep outdated medicine or medicine no longer needed. 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 cutaneous candidiasis, pityriasis versicolor, tinea corporis, or tinea cruris;
4 weeks for seborrheic dermatitis; or
4 to 6 weeks for tinea pedis;

or if it becomes worse, check with your doctor.

For patients using the cream form of this medicine:

To help clear up your infection completely and to help make sure it does not return, good health habits are also required .
For patients using ketoconazole cream for athlete"s foot (tinea pedis; ringworm of the foot), the following instructions will help keep the feet cool and dry.
- 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 your feet sweat a lot.
- Wear sandals or well-ventilated shoes (for examples, shoes with holes).
- Use a bland, absorbent powder (for example, talcum powder) or an antifungal powder between the toes, on the feet, and in socks and shoes one or two times a day. It is best to use the powder between the times you use ketoconazole cream.
  If you have any questions about these instructions, check with your health care professional.
For patients using ketoconazole cream for ringworm of the groin (tinea cruris; jock itch), the following instructions will help reduce chafing and irritation and will also help keep the groin area cool and dry.
- Avoid wearing underwear that is tight-fitting or made from synthetic materials (for example, rayon or nylon). Instead, wear loose-fitting, cotton underwear.
- Use a bland, absorbent powder (for example, talcum powder) or an antifungal powder on the skin. It is best to use the powder between the times you use ketoconazole cream.
  If you have any questions about these instructions, 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:

Less common—For cream or shampoo

Itching, stinging, or irritation not present before use of this medicine

Rare—For cream

Skin rash

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

Less common—For shampoo

Dry skin; dryness or oiliness of the hair and scalp

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

Revised: 06/14/1999

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