Ketoconazole cream

Indications

Ketoconazole cream is used for: Seborrheic dermatitis of the scalp, Pityriasis versicolor

Adult Dose

Topical Seborrheic Dermatitis Cream: Apply q12hr for 4 weeks or until clear Tinea Corporis, Tinea Cruris, Tinea Pedis Cream: Apply qDay for 2 weeks (6 weeks for tinea pedis), covering affected area

Child Dose

Seborrheic Dermatitis <12 years: Safety and efficacy not established >12 years (cream): Apply to affected area q12hr x4 weeks

Renal Dose

Administration

Contra Indications

Known hypersensitivity to ketoconazole or any of the excipients.

Precautions

In patients who have been on prolonged treatment with topical corticosteroids, it is recommended that the steroid therapy be gradually withdrawn over a period of 2 to 3 weeks, while using Ketoconazole cream to prevent any potential rebound effect. Avoid contact with the eyes.

Pregnancy-Lactation

Pregnancy There are no available data on use in pregnant women to identify a drug-associated risk of birth defects, miscarriage or adverse maternal or fetal outcomes; no reproductive studies in animals have been performed; in animal reproduction studies with pregnant mice, rats and rabbits both embryotoxic and developmental effects (structural abnormalities) were observed following oral dosing of ketoconazole during organogenesis; assuming equivalent systemic absorption of topical and oral ketoconazole doses and a maximum recommended human dose (MRHD) of 8 grams (equivalent to 160 mg ketoconazole), embryotoxic effects were observed at 0.8 to 2.4 times the MRHD and developmental effects were observed at 4.8 times the MRHD. Lactation There is no information available on presence of ketoconazole in human milk, or effects on breastfed child, or effects on milk production after topical application to women who are breastfeeding; in animal studies ketoconazole was found in milk following oral administration; the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on breastfed infant from treatment or from underlying maternal condition.

Interactions

Side Effects

Side effects of Ketoconazole cream : 1-10% Irritation, severe, Pruritus, Stinging

Mode of Action

Ketoconazole interferes w/ biosynthesis of triglycerides and phopholipids by blocking fungal CYP450, thus altering cell membrane permeability in susceptible fungi. It also inhibits other fungal enzymes resulting in the accumulation of toxic concentrations of hydrogen peroxide.