|WARNING: LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY
WITH STEATOSIS, INCLUDING FATAL CASES, HAVE BEEN REPORTED WITH THE
USE OF ANTIRETROVIRAL NUCLEOSIDE ANALOGUES ALONE OR IN COMBINATION,
INCLUDING LAMIVUDINE (SEE WARNINGS).
EPIVIR (formerly known as 3TC) is the brand name for lamivudine, a synthetic
nucleoside analogue with activity against HIV. The chemical name of lamivudine
is (2R, cis)-4-amino-1-(2-hydroxymethyl-1 ,3-oxathiolan-5-yl)-(1H)-pyrimidin-2-one.
Lamivudine is the (-) enantiomer of a dideoxy analogue of cytidine. Lamivudine
has also been referred to as (-) 2, 3-dideoxy, 3- thiacytidine. It
has a molecular formula of C8H11N3O3S
and a molecular weight of 229.3.
Lamivudine is a white to off-white crystalline solid with a solubility
of approximately 70 mg/mL in water at 20C.
EPIVIR Tablets are for oral administration. Each tablet contains
150 mg of lamivudine and the inactive ingredients magnesium stearate,
microcrystalline cellulose, and sodium starch glycolate. Opadry YS-1-7706-G
White is the coloring agent in the tablet coating.
EPIVIR Oral Solution is for oral administration. One milliliter
(1 mL) of EPIVIR Oral Solution contains 10 mg of lamivudine (10 mg/mL)
in an aqueous solution and the inactive ingredients artificial strawberry
and banana flavors, citric acid (anhydrous), edetate disodium, ethanol
(6% v/v), methylparaben, propyleneglycol, propylparaben, and sucrose.