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 20C.
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 25C.
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