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Terbinafine Granules Approved by FDA for Tinea Capitis

Now pediatricians have an FDA-approved alternative to griseofulvin for the treatment of tinea capitis.

For several decades, griseofulvin has been the drug of choice for treating tinea capitis, but in September 2007, the FDA approved a new drug — terbinafine hydrochloride (Lamisil Oral Granules) — for this indication in children ages 4 years and older.

Results of multiple studies and of a 2004 meta-analysis have shown that terbinafine is as effective as or better than griseofulvin for treatment of tinea capitis, with equivalent tolerability and side-effect profile. Terbinafine was consistently more effective than griseofulvin against tinea capitis caused by Trichophyton tonsurans, the most common dermatophyte to cause tinea capitis. Two to 4 weeks of terbinafine treatment is associated with cures rates equal to those for 6 to 8 weeks of griseofulvin treatment.

The approved pediatric dose of terbinafine granules is 125.0 mg, 187.5 mg, or 250.0 mg for children weighing less than 25 kg, 25 to 35 kg, and more than 35 kg, respectively, once daily for up to 6 weeks. The granules come in 125.0-mg or 187.5-mg packets and should be mixed in nonacidic food (i.e., avoid fruit-based foods such as applesauce). Both the manufacturer and the FDA advise serum transaminase testing for all patients before prescribing terbinafine granules. Pediatricians now have an FDA-approved alternative to griseofulvin for the treatment of tinea capitis, in a form that is convenient for administering to young children.

— Cornelius W. Van Niel, MD

Published in Journal Watch Pediatrics and Adolescent Medicine November 21, 2007

Citation(s):

Lamisil [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corp.; Sep 2007. (http://www.fda.gov/cder/foi/label/2007/022071lbl.pdf)

U.S. Food and Drug Administration. (FDA). FDA News. FDA approves Lamisil for pediatric treatment of scalp ingworm. Sep 28 , 2007. (http://www.fda.gov/bbs/topics/NEWS/2007/NEW01715.html)