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have been on prolonged treatment with topical corticosteroids, it is recommended that the steroid therapy be gradually withdrawn over a period of 2 to 3 weeks, while using Ketoconazole cream to prevent any potential rebound effect.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