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You are here: Home » eGM Resources » Health Information & Resources Portal|Home » RX Drug List (listed alphabetically) » Drug Reference (L's) » Lamivudine and Zidovudine



DESCRIPTION

COMBIVIR™ Tablets
(lamivudine/zidovudine tablets)

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).

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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