Naftin Labeling Updated with Pediatric Usage Information

The Food and Drug Administration (FDA) has approved new labeling for Naftin (naftifine HCl cream 2%; Merz Pharmaceuticals) adding additional information regarding use in the pediatric population. 

In addition to being safe and effective for children 12 years of age and over for the treatment of interdigital tinea pedis and tinea cruris, the labeling now states that Naftin Cream has been found to be safe and effective in pediatric patients age 2 years and above with tinea corporis. Use in these age groups is supported by evidence from well-controlled trials in adults and children as well as an additional safety study conducted in 49 pediatric patients exposed to Naftin Cream.  

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The safety and effectiveness of treatment however has not been established in children younger than 12 years for interdigital tinea pedis and tinea cruris and those under 2 years of age for tinea corporis.

While the exact mechanism of action against fungi is unknown, naftifine HCl appears to interfere with sterol biosynthesis by inhibiting the enzyme squalene2, 3-epoxidase. This inhibition of enzyme activity results in decreased amounts of sterols,especially ergosterol, and a corresponding accumulation of squalene in the cells.

Naftin Cream 2% is available in 30g, 45g, and 60g tubes.

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