WARNINGS AND PRECAUTIONS
Contact Sensitization
Extina Foam may result in contact sensitization, including photoallergenicity . [See 6. ADVERSE REACTIONS (6.2 Dermal Safety Studies)]
Flammable Contents
The contents of Extina Foam include alcohol and propane/butane, which are flammable. Avoid fire, flame and/or smoking during and immediately following application. Do not puncture and/or incinerate the containers. Do not expose containers to heat and/or store at temperatures above 120°F (49°C).
Systemic Effects
Hepatitis has been seen with orally administered ketoconazole (1:10,000 reported incidence). Lowered testosterone and ACTH–induced corticosteroid serum levels have been seen with high doses of orally administered ketoconazole. These effects have not been seen with topical ketoconazole.
USE IN SPECIFIC POPULATIONS
Pregnancy
Teratogenic Effects, Pregnancy Category C: Ketoconazole has been shown to be teratogenic (syndactylia and oligodactylia) in the rat when given orally in the diet at 80 mg/kg/day (4.8 times the maximum expected human topical dose based on a mg/m2 comparison, assuming 100% absorption from 8 g of foam). However, these effects may be partly related to maternal toxicity, which was also observed at this dose level. [See 12.3 Pharmacokinetics ]
No reproductive studies in animals have been performed with Extina Foam. There are no adequate and well-controlled studies of Extina Foam in pregnant women.
Extina Foam should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers
It is not known whether Extina Foam administered topically could result in sufficient systemic absorption to produce detectable quantities in breast milk. Because many drugs are excreted in human milk, caution should be exercised when Extina Foam is administered to women who are breastfeeding.
Pediatric Use
The safety and effectiveness of Extina Foam in pediatric patients less than 12 years of age have not been established.
Of the 672 subjects treated with Extina Foam in the clinical trials, 44 (7%) were from 12 to 17 years of age. [See 14. CLINICAL STUDIES ]
Geriatric Use
Of the 672 subjects treated with Extina Foam in the clinical trials, 107 (16%) were 65 years and over.
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