Pronunciation:

kee-toe-KOE-na-zole

Brand Names:

• Extina
• Nizoral
• Nizoral A-D
• Xolegel
• Ketoderm

Dosage Forms:

• Cream
• Shampoo
• Solution
• Gel/Jelly
• Foam

Warnings:

When used orally, ketoconazole has been associated with hepatic toxicity, including some fatalities. Patients receiving this drug should be informed by the physician of the risk and should be closely monitored.

Coadministration of terfenadine with ketoconazole tablets is contraindicated. Rare cases of serious cardiovascular adverse events, including death, ventricular tachycardia and torsades de pointes have been observed in patients taking ketoconazole tablets concomitantly with terfenadine, due to increased terfenadine concentrations induced by ketoconazole tablets.

Pharmacokinetic data indicate that oral ketoconazole inhibits the metabolism of astemizole, resulting in elevated plasma levels of astemizole and its active metabolite desmethylastemizole which may prolong QT intervals. Coadministration of astemizole with ketoconazole tablets is therefore contraindicated.

Coadministration of cisapride with ketoconazole is contraindicated. Serious cardiovascular adverse events including ventricular tachycardia, ventricular fibrillation and torsades de pointes have occurred in patients taking ketoconazole concomitantly with cisapride .

When used orally, ketoconazole has been associated with hepatic toxicity, including some fatalities. Patients receiving this drug should be informed by the physician of the risk and should be closely monitored. Coadministration of ketoconazole with terfenadine, astemizole, and cisapride is contraindicated due to the inhibition of metabolism of these drugs by ketoconazole. Coadministration of these drugs with ketoconazole may result in serious cardiovascular events, including death, ventricular tachycardia, ventricular fibrillation, torsades de pointes, and prolongation of the QT interval .

Classifications:

Therapeutic—

Antifungal

Chemical—

Imidazole

Uses of This Medicine:

Ketoconazole 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 gel or foam is used to treat seborrheic dermatitis (scaly areas on your skin or scalp) .

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.

Most forms of this medicine are available only with your doctor's prescription. Some forms are available without a prescription. However, your doctor may have special instructions on the proper use for your medical condition .

Before Using This Medicine:

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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of topical ketoconazole in children below the age of 12 years. Safety and efficacy have not been established .

Older adults—

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of topical ketoconazole in the elderly. However, some elderly patients may be more sensitive to the adverse effects of this medicine .

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

Other interactions—

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

Proper Use of This Medicine:

This medicine should be used only on the skin. Do not get it in your eyes, nose, mouth, or vagina .

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 foam form of this medicine:

• Wash your hands before and after using this medicine.
• Do not spray the foam directly on your hand because it will begin to melt as soon as it touches your skin. Instead, spray the foam into the cap of the medicine can or other cool surface. Then dip your fingertips into the foam to pick up small amounts of the medicine, and apply to the affected skin areas. Gently massage the foam into your skin until it disappears.
• If you are treating skin areas with hair, such as your scalp, move any hair away so the foam can be applied directly to the affected skin.
• This medicine is flammable. Do not use it near heat, an open flame, or while smoking. Do not puncture, break, or burn the medicine can .

For patients using the gel form of this medicine:

• Wash your hands before and after using this medicine.
• Apply enough ketoconazole gel to cover the affected and surrounding skin areas, and rub in gently with your fingertips.
• After applying this medicine, do not wash the affected area for at least 3 hours.
• Cosmetics (makeup or sunscreens) may be used on the treated skin areas no sooner than 20 minutes after this medicine is applied.
• This medicine may be flammable. Do not use it near heat, an open flame, or while smoking .

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 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 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 foam dosage form:
  • For seborrheic dermatitis:
    • Adults—Apply two times a day to the affected skin and surrounding area for 4 weeks.
    • Children—Use and dose must be determined by your doctor .
• For gel dosage form:
  • For seborrheic dermatitis:
    • Adults—Apply once a day to the affected skin and surrounding area for 2 weeks.
    • 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—

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and check you for any problems or unwanted effects that may be caused by this medicine .

Do not use this medicine for a skin problem that has not been checked by your doctor .

If your skin problem does not improve within 2 weeks for cutaneous candidiasis, pityriasis versicolor, tinea corporis, or tinea cruris; or 4 weeks for seborrheic dermatitis; or 4 to 6 weeks for tinea pedis, or if it becomes worse, check with your doctor .

Good health habits are also required 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.

For patients using the 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 example, 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 the cream.
• If you have any questions about these instructions, check with your health care professional.

For patients using the 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 healthcare professional.

The foam form of this medicine may make your skin more sensitive to sunlight. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds .

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 immediately if any of the following side effects occur:

Less common—For cream, shampoo, foam, or gel

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

Rare—For cream, foam, or gel

Acne

bleeding from sore in mouth

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

discoloration of fingernails or toenails

dizziness

eye dryness, irritation, or swelling

red rash with watery, yellow-colored, or pus filled blisters with or without thick yellow to honey-colored crusts

skin dryness, pain, rash, redness, or swelling

sore in mouth or on gums

swelling of face

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common—For shampoo or gel

Dryness or oiliness of the hair and scalp

headache

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