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.

Action ⬆ ⬇

Affects the synthesis of the fungal cell wall.

Therapeutic effects:

Decreased symptoms of fungal infection.

Pharmacokinetics ⬆ ⬇

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.

Time/Action Profile ⬆ ⬇

(resolution of symptoms/lesions)

ROUTE	ONSET	PEAK	DURATION
Topical	unknown	unknown	unknown

Contraind./Precautions ⬆ ⬇

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 ⬆ ⬇

Derm: ↑hair loss (shampoo)

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

Interactions ⬆ ⬇

Drug-drug:

None significant since absorption is minimal with topical therapy.

Route/Dosage ⬆ ⬇

(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.

Availability ⬆ ⬇

(Generic available)

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

Assessment ⬆ ⬇

Inspect involved areas of skin and mucous membranes before and frequently during therapy. Increased skin irritation may indicate need to discontinue medication.

Implementation ⬆ ⬇

Consult health care professional for proper cleansing technique before applying medication.
Apply small amount to cover affected area completely. Avoid the use of occlusive wrappings or dressings unless directed by health care professional.
Ketoconazole shampoo: Moisten hair and scalp thoroughly with water. Apply sufficient shampoo to produce enough lather to wash scalp and hair and gently massage it over the entire scalp area for approximately 1 min. Rinse hair thoroughly with warm water. Repeat process, leaving shampoo on hair for an additional 3 min. After the second shampoo, rinse and dry hair with towel or warm air flow. Shampoo twice a wk for 4 wk with at least 3 days between each shampooing and then intermittently as needed to maintain control.
Foam: Hold container upright and dispense foam into cap of can or other smooth surface; dispensing directly on to hand is not recommended as the foam begins to melt immediately on contact with warm skin. Pick up small amounts with fingertips and gently massage into affected areas until absorbed. Move hair to allow direct application to skin.

Patient/Family Teaching ⬆ ⬇

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.

Evaluation/Desired Outcomes ⬆ ⬇

Decrease in skin irritation and resolution of infection. Early relief of symptoms may be seen in 2–3 days. For Candida, tinea cruris, and tinea corporis, 2 wk are needed, and for tinea pedis, therapeutic response may take 4–6 wk. Use for seborrheic for 4 wk (2 wk with gel). Recurrent fungal infections may be a sign of systemic illness.

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇