ketoconazole (topical)

REMS

Cutaneous fungal infections, including cutaneous candidiasis, tinea pedis (athlete's foot), tinea cruris (jock itch), tinea corporis (ringworm), dandruff (as a shampoo), seborrheic dermatitis, and tinea versicolor.

Contraind./Precautions

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Contraindicated in:

Hypersensitivity to active ingredients, additives, preservatives, or bases;
Some products contain sulfites and should be avoided in patients with known intolerance.

Use Cautiously in:

Nail and scalp infections (may require additional systemic therapy);
OB: Safety not established in pregnancy;
Lactation: Safety not established in breastfeeding.

Adv. Reactions/Side Effects

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Derm: ↑hair loss (shampoo)

Local: burning, itching, local hypersensitivity reactions, redness, stinging

Interactions

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Drug-drug:

None significant since absorption is minimal with topical therapy.

Availability

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(Generic available)

Cream: 2%
Foam: 2%
Shampoo: 1% OTC; 2%

Route/Dosage

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(Adults and Children ≥12 yr): Apply cream once daily for cutaneous candidiasis, tinea corporis, tinea cruris, tinea pedia, and tinea versicolor. Apply cream twice daily for seborrheic dermatitis. Patients with cutaneous candidiasis, tinea cruris, tinea corporis, and tinea versicolor should be treated for 2 wk. Patients with tinea pedis should be treated for 6 wk. Patients with seborrheic dermatitis should be treated for 4 wk (2 wk with gel). For dandruff, use shampoo twice weekly (wait 3–4 days between treatments) for 4 wk, then intermittently.

US Brand Names

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Ketodan, ~~Nizoral,~~ ~~Nizoral A-D,~~ ~~Xolegel~~

Action

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Affects the synthesis of the fungal cell wall.

Therapeutic effects:

Decreased symptoms of fungal infection.

Classifications

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Therapeutic Classification: antifungals

Pharmacologic Classification: imidazoles

Pharmacokinetics

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Absorption: Minimal absorption through intact skin.

Distribution: If absorption occurs, widely distributed; crosses the placenta; enters breast milk. Action after topical administration is primarily local.

Metabolism/Excretion: If absorbed, partially metabolized by the liver then excreted in feces via biliary excretion.

Half-Life: If absorbed, 8 hr.

Canadian Brand Names

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Time/Action Profile

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(resolution of symptoms/lesions)

ROUTE	ONSET	PEAK	DURATION
Topical	unknown	unknown	unknown

Patient/Family Teaching

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Instruct patient to apply medication as directed for full course of therapy, even if feeling better. Emphasize the importance of avoiding the eyes.
Teach patients with athlete's foot to wear well-fitting, ventilated shoes and to change shoes and socks at least once a day.
Advise patient to report increased skin irritation or lack of response to therapy to health care professional.
Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding. Advise breastfeeding women not to apply topical products directly to nipple and areola to avoid direct infant exposure.

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Indications ⬇

Contraind./Precautions ⬆ ⬇

Adv. Reactions/Side Effects ⬆ ⬇

Interactions ⬆ ⬇

Availability ⬆ ⬇

Route/Dosage ⬆ ⬇

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Classifications ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Canadian Brand Names ⬆ ⬇

Time/Action Profile ⬆ ⬇

Patient/Family Teaching ⬆ ⬇

Pronunciation ⬆

Indications