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For Consumers

New Dosing approved for Epivir (lamivudine)

7/2/2002

FDA approved on, June 26, 2002, a supplemental new drug application from GlaxoSmithKline expanding the labeled indication to provide for the use of Epivir (lamivudine) once daily for the treatment of HIV infection in combination with other antiretroviral agents, and a new 300 mg tablet. The product label has been modified to reflect these changes. The " Dosage and Administration" section of the label reads:

DOSAGE AND ADMINISTRATION:
Adults: The recommended oral dose of EPIVIR for adults is 300 mg daily, administered as either
150 mg twice daily or 300 mg once daily, in combination with other antiretroviral agents (see
DESCRIPTION OF CLINICAL STUDIES, PRECAUTIONS, MICROBIOLOGY, and CLINICAL
PHARMACOLOGY). If lamivudine is administered to a patient dually infected with HIV and HBV, the dosage indicated for HIV therapy should be used as part of an appropriate combination regimen (see WARNINGS).

A copy of the complete product label can be found at:
http://www.fda.gov/cder/approval/index.htm
by clicking " E" in the index and scrolling down to Epivir.
Label is dated 6/25/02


Richard Klein
Office of Special Health Issues
Food and Drug Administration

Page Last Updated: 08/01/2014
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