Ketoconazole Topical

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.

There may be other drugs that can affect ketoconazole topical. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Do not use ketoconazole topical to treat any skin condition that has not been checked by your doctor.

Wash your hands before and after using this medication.

Clean and dry the affected area. Apply a thin layer of the cream or gel to the affected skin area as directed. This medicine is usually used for only 2 to 4 weeks.

Wait at least 20 minutes after applying this medicine before you use cosmetics or sunscreen on the treated skin area. Do not wash the treated skin for at least 3 hours after applying ketoconazole topical.

Do not use bandages or dressings over the treated skin areas, unless your doctor has told you to.

Use the shampoo twice per week, unless your doctor has told you otherwise. Apply enough shampoo to create a lather and massage the scalp for 1 minute. Rinse thoroughly and repeat, leaving the lather on for an additional 3 minutes. Then rinse it off completely. Allow at least 3 days to pass between uses of ketoconazole shampoo.

Call your doctor if your condition does not improve within 2 weeks, or if your symptoms get worse.

Use this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antifungal medication.

Store ketoconazole topical at room temperature away from moisture and heat.

Ketoconazole topical gel is flammable. Avoid using near open flame, and do not smoke until the gel has completely dried on your skin.

An overdose of ketoconazole topical is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

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

Dermatophytoses

Treatment of tinea corporis, tinea cruris, and tinea pedis caused by Epidermophyton floccosum, Trichophyton mentagrophytes, or T. rubrum.1 2 25 27 28 56 58 59 60 61 62 66 78 79 110

A drug of first choice for topical treatment of tinea corporis or tinea cruris.81 85 Oral antifungals preferred when tinea corporis or tinea cruris is extensive, dermatophyte folliculitis is present, infection is chronic or does not respond to topical therapy, or patient is immunocompromised or has coexisting disease.80 81 82 83 84

Treatment of tinea manuum† caused by Trichophyton2 25 58 59 60 61 62 and tinea corporis caused by Microsporum†.2 25 59

Cutaneous Candidiasis

Treatment of cutaneous candidiasis caused by Candida albicans.1 2 25 58 59 67 68 69 110

Pityriasis (Tinea) Versicolor

Treatment of pityriasis (tinea) versicolor caused by or presumed to be caused by Malassezia furfur (Pityrosporum orbiculare or P. ovale).1 2 25 26 63 72 97 110

Seborrheic Dermatitis and Dandruff

Treatment of seborrheic dermatitis, including seborrheic dermatitis of the scalp.1 12 42 43 44 67 71 73 76 98 99 101 103 105 106 107 108 109

Self-medication (OTC use) for reduction of flaking, scaling, and itching associated with dandruff.74 75 77 99 100 101 102 104

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

Cutaneous candidiasis: Topical: Cream: Apply once daily to cover the affected and immediate surrounding area for 2 weeks. Note: Canadian labeling recommends a duration of 2 to 3 weeks.

Dandruff: Topical:

Shampoo 1% (OTC labeling): Apply to wet hair, lather, and rinse thoroughly; repeat. Use every 3 to 4 days for up to 8 weeks; then apply only as needed to control dandruff.

Shampoo 2% (Canadian product only): Apply 5 to 10 mL to wet scalp, lather, leave on 3 to 5 minutes, and rinse; apply once every 1 to 2 weeks (prophylaxis) or twice weekly for 2 to 4 weeks (treatment).

Seborrheic dermatitis: Topical:

Cream: Apply to the affected area twice daily for 4 weeks or until clinical response is noted

Foam: Apply to affected area twice daily for 4 weeks

Gel: Apply to the affected area once daily for 2 weeks

Shampoo 2% (Canadian product only; OTC labeling): Apply 5 to 10 mL to wet scalp, lather, leave on 3 to 5 minutes, and rinse; apply twice weekly for 2 to 4 weeks.

Tinea corporis, tinea cruris, tinea pedis: Topical: Cream: Apply to the affected and immediate surrounding area once daily.

Duration of treatment:

US labeling: Tinea corporis, cruris: 2 weeks; tinea pedis: 6 weeks.

Canadian labeling: Tinea corporis: 3 to 4 weeks; tinea cruris: 2 to 4 weeks; tinea pedis: 4 to 6 weeks.

Tinea versicolor: Topical:

Cream: Apply once daily to cover the affected and immediate surrounding area for 2 weeks. Note: Canadian labeling recommends a duration of 2 to 3 weeks.

Shampoo 2%: Apply to affected area of damp skin, lather, leave on 5 minutes, and rinse (one application is usually sufficient)

Susceptible fungal infections in the oral cavity (candidiasis, oral thrush, and chronic mucocutaneous candidiasis) (off-label use): Topical: Cream: Apply locally as directed with a thin coat to inner surface of denture and affected areas after meals

Dandruff: Topical:

Shampoo 1% (OTC labeling): Children ≥12 years and Adolescents: Refer to adult dosing.

Shampoo 2% (Canadian product only): Children >12 years and Adolescents: Refer to adult dosing.

Seborrheic dermatitis: Topical:

Foam, gel: Children ≥12 years and Adolescents: Refer to adult dosing.

Shampoo 2% (Canadian product only): Children >12 years and Adolescents: Refer to adult dosing.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use.

Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

2% Cream: Apply to the affected and immediate surrounding area once a day for 2 weeks.

Comments:
-May see clinical improvement fairly soon after start of therapy; duration of 2 weeks recommended to reduce possibility of recurrence.

Uses: For the topical treatment of tinea corporis and tinea cruris due to Trichophyton rubrum, T mentagrophytes, and Epidermophyton floccosum; in the treatment of cutaneous candidiasis due to Candida species

2% Cream: Apply to affected area twice a day for 4 weeks or until clinical clearing.
2% Foam: Apply to affected area(s) twice a day for 4 weeks.
2% Gel: Apply to affected area once a day for 2 weeks.

Comments:
-The foam and the gel are indicated for use in immunocompetent patients.

1% Shampoo: Use topically every 3 or 4 days for up to 8 weeks and then only as needed to control dandruff.

Comments:
-The shampoo should be applied to completely wet hair, lathered generously, and then rinsed thoroughly; this should be repeated.
-The shampoo should not be used on a broken or inflamed scalp.

Uses: To control flaking, scaling, and itching associated with dandruff

12 years or older:
2% Foam: Apply to affected area(s) twice a day for 4 weeks.
2% Gel: Apply to affected area once a day for 2 weeks.

Comments:
-The foam and the gel are indicated for use in immunocompetent patients.