Nizoral topical

Antifungal; azole (imidazole derivative).1 3 4 5 6 11 23 32 72 105 106 110

Contraindications

• Hypersensitivity to ketoconazole or any ingredient in the formulation.1 72 105 110

Warnings/Precautions

Sensitivity Reactions

Contact dermatitis reported following topical application of ketoconazole or other imidazole-derivative azole antifungals.61 89 90 91 92 93 94 110

If a reaction suggesting sensitivity or chemical irritation occurs (e.g., rash), discontinue the drug.1 72 104 105 106 110

Possible cross-sensitization among the imidazole derivatives.89 90 91 92 93 94

Some formulations of the 2% cream contain sodium sulfite, which may cause allergic-type reactions (including anaphylaxis and life-threatening or less severe asthmatic episodes) in certain susceptible individuals.110 Overall prevalence of sulfite sensitivity in the general population is unknown, but probably low; such sensitivity appears to occur more frequently in asthmatic than in nonasthmatic individuals.110

General Precautions

Although hepatotoxicity, decreased testosterone concentrations, and decreased ACTH-induced corticosteroid concentrations have been reported with oral ketoconazole,32 105 110 these adverse effects have not been reported with topical ketoconazole105 110 and are unlikely since the drug does not appear to be appreciably absorbed following topical application to skin.2 56 57

2% foam and gel are flammable.105 106 Avoid fire, flame, and/or smoking during and immediately after application of foam or gel.105 106 (See Storage under Stability.)

Specific Populations

Category C.1 72 105 106 110

2% cream, foam, gel, or shampoo: Use during pregnancy only when potential benefits justify possible risks to the fetus.1 72 105 106 110

1% shampoo: Pregnant women considering self-medication should consult a clinician before using the preparation.104

Not known whether ketoconazole distributed into milk following topical application.1 105 106 110

2% cream: Discontinue nursing or the cream.1 110

2% foam, gel, or shampoo: Use with caution.72 105 106

1% shampoo: Nursing women considering self-medication should consult clinician before using the preparation.104

2% cream: Safety and efficacy not established in children;1 110 has been used without unusual adverse effect in children 2 days to 12 years of age.15 17

2% foam: Safety and efficacy not established in children <12 years of age.106

2% gel: Safety and efficacy not established in children <12 years of age.105

1% shampoo: Safety and efficacy for self-medication not established in children <12 years of age.104

2% shampoo: Safety and efficacy not established in children.72

Common Adverse Effects

2% cream: Local reactions at application site (severe irritation, pruritus, stinging).1 2 25 26 58 59 60 61 110

2% foam: Application site reactions (e.g., burning).106 109

2% gel: Application site reactions (e.g., burning), headache.105 107 108

2% shampoo: When applied to the skin, pruritus, application site reaction, dry skin.72 When applied to scalp, increased hair loss, irritation, abnormal hair texture, loss of hair curl in patients with permanently waved (“permed”) hair, scalp pustules, dry skin, pruritus, oiliness or dryness of the hair and scalp.72

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

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 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 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.

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:

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

• Acne
• bleeding from 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

• Hair loss and irritation

• Pain

• 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 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:

• Dryness or oiliness of the hair and scalp
• headache

• 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.

Avoid getting this medication in your eyes, mouth, and nose, or on your lips. If it does get into any of these areas, wash with water.

Avoid covering treated skin areas with tight-fitting, synthetic clothing (such as nylon or polyester) that doesn't allow air to circulate to your skin. If you are treating your feet, wear clean cotton socks and sandals or shoes that allow for air circulation. Keep your feet as dry as possible.

Avoid using other skin or hair products that can cause irritation, such as harsh soaps or shampoos or skin cleansers, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime. Do not use other medicated skin products unless your doctor has told you to.

Stinging, swelling, irritation, or redness of the treated skin may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these unlikely but serious side effects occur: blistering, open sores.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.