Included as part of the PRECAUTIONS section.

Contact Sensitization

Extina Foam may result in contact sensitization, including photoallergenicity. [See ADVERSE REACTIONS]

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.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic or photo-carcinogenic potential of Extina Foam. In oral carcinogenicity studies in mice (18-months) and rats (24-months) at dose levels of 5, 20 and 80 mg/kg/day ketoconazole was not carcinogenic. The high dose in these studies was approximately 2.4 to 4.8 times the expected topical dose in humans based on a mg/m² comparison. In a bacterial reverse mutation assay, ketoconazole did not express any mutagenic potential. In three in vivo assays (sister chromatid exchange in humans, dominant lethal and micronucleus tests in mice), ketoconazole did not exhibit any genotoxic potential. At oral dose levels of 75 mg/kg/day (4.5 times the expected topical human dose in mg/m²), ketoconazole impaired reproductive performance and fertility when administered to male rats (increased abnormal sperm, decreased sperm mobility and decreased pregnancy in mated females).

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 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 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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