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U.S. Department of Health and Human Services

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New Epivir tablets to facilitate pediatric dosing

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.

 Table 1. Dosing Recommendations for EPIVIR Tablets in Pediatric Patients
Weight (kg) Dosage Regimen Using Scored 150 mg Tablet Total Daily Dose
AM Dose PM Dose
14 to 21 ½ tablet (75 mg) ½ tablet (75 mg) 150 mg
>21 to <30 ½ tablet (75 mg) 1 tablet (150 mg) 225 mg
> 30 1 tablet (150 mg) 1 tablet (150 mg) 300 mg

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