Ketodan Kit (Topical)

Ketoconazole is used to treat infections caused by fungus or yeast. It works by killing the fungus or yeast or stopping it from growing.

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 foam or gel 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 fungal infections of the skin as decided by your doctor.

Most forms of this medicine are available only with your doctor's prescription. Some forms can be obtained without a prescription. However, your doctor may have specific instructions on how to use it for your medical condition.

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

Do not use this medicine for a skin issue that has not been examined by your doctor.

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

Good health habits are also important for patients using the cream form of this medicine to help completely clear your infection and to help prevent it from coming back.

For patients using the cream for athlete's foot (tinea pedis; ringworm of the foot), the following instructions will help keep your feet cool and dry:

• Avoid wearing socks made from wool or synthetic materials (e.g., rayon or nylon). Wear clean, cotton socks and change them daily or more often if your feet sweat a lot.
• Wear sandals or well-ventilated shoes (e.g., shoes with holes).
• Use a bland, absorbent powder (e.g., 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, contact your doctor.

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 tight-fitting underwear or underwear made from synthetic materials (e.g., rayon or nylon). Wear loose-fitting, cotton underwear instead.
• Use a bland, absorbent powder (e.g., 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, contact your doctor.

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.

This medicine may cause a serious allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical help. Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using this medicine.

Tell your doctor if you experience the following symptoms while using the ketoconazole 2% shampoo: hair discoloration, abnormal hair texture, loss of curl from permanently waved hair, hair loss, itching, burning sensation on the skin, or blistering, peeling, or redness of the skin.

Stop using this medicine and contact your doctor right away if you or your child experience a skin rash, burning, stinging, swelling, or irritation on the skin.

In deciding to use a medicine, you need to consider the risks and benefits of taking it. This is a choice you will make with your doctor. For this medicine, you should think about the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, like to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

There have not been appropriate studies on how ketoconazole topical affects children younger than 12 years. Safety and effectiveness have not been established for this age group.

Geriatric

Current studies have not shown any specific problems in older adults that would limit the effectiveness of ketoconazole topical. However, some older patients may be more sensitive to the side effects of this medicine.

Breast Feeding

There are no adequate studies to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits and risks before using this medication while breastfeeding.

Interactions with Medicines

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

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around mealtimes or with certain foods because interactions may happen. Using alcohol or tobacco with certain medicines can also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Along with its needed effects, this medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may need medical attention.

Check with your doctor right away if any of the following side effects happen:

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

• Itching, stinging, burning, or irritation not present before using this medicine

Rare—For cream, foam, or gel

• Acne
• Bleeding from a sore in the mouth
• Blistering, crusting, irritation, itching, or reddening of the skin
• Burning, crawling, itching, numbness, prickling, "pins and needles," or tingling feelings
• Cracked, dry, or scaly skin
• Discoloration of the 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 the mouth or on the gums
• Swelling of the face

Rare—For shampoo

• Hair loss and irritation

Incidence not known—For gel

• Pain

Incidence not known—For shampoo

• Blistering, burning, crusting, dryness, or flaking of the skin
• Burning sensation of the skin
• Burning, itching, redness, skin rash, swelling, or soreness at the application site
• Discoloration of the hair
• Dry skin
• Fast heartbeat
• Fever
• Hives
• Hoarseness
• Irritation
• Itching, scaling, severe redness, or soreness of the skin
• Joint pain, stiffness, or swelling
• Rash
• Shortness of breath
• Swelling of the eyelids, face, lips, hands, or feet
• Thinning of the hair
• Tightness in the chest
• Troubled breathing or swallowing
• Wheezing

Some side effects may happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also be able to tell you how 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

Rare—For shampoo

• Abnormal hair texture
• Mild dryness of the skin
• Scalp pustules

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.

In the U.S.

• Extina
• Ketodan Kit
• Kuric
• Nizoral
• Nizoral A-D
• Xolegel

In Canada

• Ketoderm

Available Dosage Forms:

• Shampoo
• Cream
• Foam
• Gel/Jelly

Therapeutic Class: Antifungal

Chemical Class: Imidazole

It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects or skin irritation.

This medicine is for use on the skin only. Do not get it in your eyes, nose, mouth, or vagina. Do not use it on skin areas that have cuts, scrapes, or burns. If it does get on these areas, rinse it off right away with water.

For patients using the cream:

• Apply enough 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 the 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:

• 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:

• 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:

• 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:

• 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 to the affected area of the skin and the surrounding area once a day. Children—Use and dose must be determined by your doctor. For seborrheic dermatitis: Adults—Apply to the affected area of the skin and the surrounding area two times per day. Children—Use and dose must be determined by your doctor.
• For foam dosage form:For seborrheic dermatitis: Adults—Apply to the affected area of the skin and the surrounding area two times per day for 4 weeks. Children—Use and dose must be determined by your doctor.
• For gel dosage form:For seborrheic dermatitis: Adults, teenagers, and children 12 years of age and older—Apply to the affected area of the skin and the surrounding area once a day for 2 weeks. Children younger than 12 years of age—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.