SPL Set ID: f5f7c0d9-a247-4308-8269-32accc490ea6

1 drug(s) with this SPL Set ID

Open DailyMed details

ABACAVIR, LAMIVUDINE AND ZIDOVUDINE ABACAVIR LAMIVUDINE AND ZIDOVUDINE
LUPIN PHARMACEUTICALS, INC. FDA Rx Only

Abacavir, lamivudine and zidovudine tablets contain the following 3 synthetic nucleoside analogues: abacavir (ZIAGEN ® ), lamivudine (also known as EPIVIR ® or 3TC), and zidovudine (also known as RETROVIR ® , azidothymidine, or ZDV) with inhibitory activity against HIV-1. Abacavir, lamivudine and zidovudine tablets are for oral administration. Each film-coated tablet contains the active ingredients 300 mg of abacavir as abacavir sulfate, 150 mg of lamivudine, and 300 mg of zidovudine, and the inactive ingredients crospovidone, magnesium stearate, microcrystalline cellulose, povidone, and yellow ferric oxide. The tablets are coated with a film opadry green that is made of FD&C blue no. 2, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide and yellow ferric oxide. Abacavir Sulfate The chemical name of abacavir sulfate is (1 S,cis )-4-[2-amino-6-(cyclopropylamino)-9 H -purin-9-yl]-2-cyclopentene-1-methanol sulfate (salt) (2:1). Abacavir sulfate is the enantiomer with 1S , 4R absolute configuration on the cyclopentene ring. It has a molecular formula of (C 14 H 18 N 6 O) 2 ·H 2 SO 4 and a molecular weight of 670.74 g per mol. It has the following structural formula: Abacavir sulfate is a white to off-white powder and soluble in water. Dosages are expressed in terms of abacavir. Lamivudine The chemical name of lamivudine is (2R,cis)-4-amino-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)-(1H)-pyrimidin-2-one, 0.2 hydrate. 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 C 8 H 11 N 3 O 3 S·0.2H 2 O and a molecular weight of 232.86 g per mol. It has the following structural formula: Lamivudine is a white to off-white solid and is soluble in water. Zidovudine The chemical name of zidovudine is 3'-azido-3'-deoxythymidine. It has a molecular formula of C 10 H 13 N 5 O 4 and a molecular weight of 267.24 g per mol. It has the following structural formula: Zidovudine is a white to yellowish powder with a solubility of 20.1 mg/mL in water at 25°C. Abacavir Sulfate Lamivudine Zidovudine

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