ABOUT

Extina® (ketoconazole) Foam, 2%  is indicated for the topical treatment of seborrheic dermatitis in immunocompetent patients 12 years of age and older.  Safety and efficacy of EXTINA Foam for treatment of fungal infections have not been established.

 

EXTINA Foam is applied twice a day for 4 weeks. With minimum residue, this foam penetrates through hair and dissolves quickly, allowing ketoconazole to stay on the scalp or skin and treat the affected area. The foam may be used with routine hair care products and can be applied when skin or hair is wet or dry. EXTINA Foam is fragrance-free, nonstaining, and nonbleaching.

 

EXTINA Foam is for topical use only and not for ophthalmic, oral, or intravaginal use.  This preparation may be irritating to mucous membranes.  Contact with eyes, nostrils, and mouth should be avoided.


IMPORTANT SAFETY INFORMATION


Full Prescribing Information


  • The safety and efficacy of this ketoconazole preparation for the treatment of fungal infections have not been established.

  • Extina® (ketoconazole) Foam, 2% is for topical use only and not for ophthalmic, oral, or intravaginal use. This preparation may be irritating to mucous membranes. Contact with eyes, nostrils, and mouth should be avoided.

  • Use of EXTINA Foam may result in contact sensitization, including photoallerginicity.

  • The most common adverse reactions observed in clinical trials (incidence > 1%) were application site burning (10%) and application site reaction (6%).

  • EXTINA Foam should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.

  • Advise patients who are breastfeeding to exercise caution when applying this product.

  • Hepatitis and, at high doses, lowered testosterone and ACTH-induced corticosteroid serum levels have been seen with orally administered ketoconazole; however, these effects have not been seen with topical formulations.

  • The contents of EXTINA Foam are flammable; patients should avoid fire, flame, and/or smoking during and immediately following application.








EXTINA Foam is indicated for the topical treatment of seborrheic dermatitis in immunocompetent patients 12 years of age and older.

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