DESCRIPTION
COMBIVIR™ Tablets
(lamivudine/zidovudine tablets)
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WARNING:
ZIDOVUDINE, ONE OF THE TWO ACTIVE
INGREDIENTS IN COMBIVIR, HAS BEEN ASSOCIATED WITH
HEMATOLOGIC TOXICITY INCLUDING NEUTROPENIA AND SEVERE
ANEMIA, PARTICULARLY IN PATIENTS WITH ADVANCED
HIV DISEASE (SEE WARNINGS). PROLONGED USE
OF ZIDOVUDINE HAS BEEN ASSOCIATED WITH SYMPTOMATIC
MYOPATHY.
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 ZIDOVUDINE
AND LAMIVUDINE (SEE WARNINGS).
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COMBIVIR Tablets are combination tablets containing lamivudine
and zidovudine. Lamivudine (EPIVIR® 3TC) and zidovudine
(RETROVIR® azidothymidine, AZT, or ZDV) are synthetic
nucleoside analogues with activity against human immunodeficiency
virus (HIV).
COMBIVIR Tablets are for oral administration. Each film-coated
tablet contains 150 mg of lamivudine, 300 mg of zidovudine,
and the inactive ingredients colloidal silicon dioxide,
magnesium stearate, microcrystalline cellulose, and sodium
starch glycolate. The film-coating solution contains Opadry
YS-1-7706-G White and purified water.
Lamivudine: 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
20°C.
Zidovudine: The chemical name of zidovudine
is 3’-azido-3’-deoxythymidine. It has a molecular
formula of C10H13N5O4 and a molecular weight of 267.24.
Zidovudine is a white to beige, odorless, crystalline
solid with a solubility of 20.1 mg/mL in water at 25°C
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