Food and Drug Administration - February 7, 2008
Richard Klein & Kimberly Struble

FDA has approved a new formulation of Epivir (lamivudine) designed to facilitate dosing in appropriate pediatric patients who can reliably swallow tablets. Epivir is now available as 150 mg scored tablets. The scored tablets allow for dosing recommendations in pediatric patients. The DOSING AND ADMINISTRATION section of the Epivir label was revised as follows:

Pediatric Patients

The recommended oral dose of EPIVIR Oral Solution in HIV 1-infected pediatric patients 3 months to 16 years of age is 4 mg/kg twice daily (up to a maximum of 150 mg twice a day), administered in combination with other antiretroviral agents.

EPIVIR is also available as a scored tablet for HIV 1-infected pediatric patients who weigh 14 kg for whom a solid dosage form is appropriate. Before prescribing EPIVIR Tablets, children should be assessed for the ability to swallow tablets. If a child is unable to reliably swallow EPIVIR Tablets, the oral solution formulation should be prescribed. The recommended oral dosage of EPIVIR Tablets for HIV 1-infected pediatric patients is presented in Table 1.

A pdf version of Table 1 is available here: Epivir_Pediatric.pdf

Epivir is a Nucleoside Reverse Transcriptase Inhibitor (NRTI) manufactured by GlaxoSmithKline.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration

080207
FD080201

SOURCE: Food and Drug Administration (FDA).

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