SPL Set ID: d12e80eb-906c-4932-bb03-b4060ba1d31c

1 drug(s) with this SPL Set ID

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Abacavir and Lamivudine ABACAVIR AND LAMIVUDINE
LAURUS LABS LIMITED FDA Rx Only

Abacavir and Lamivudine Abacavir and lamivudine tablets, USP contain the following 2 synthetic nucleoside analogues: abacavir (ZIAGEN, also a component of TRIZIVIR) and lamivudine (also known as EPIVIR or 3TC) with inhibitory activity against HIV-1. Abacavir and lamivudine tablets, USP are for oral administration. Each orange colored, capsule-shaped, biconvex film coated tablet contains the active ingredients 600 mg of abacavir as abacavir sulfate USP and 300 mg of lamivudine USP, and the inactive ingredients magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The tablets are coated with a film (OPADRY orange YS-1-13065-A) that is made of FD&C Yellow No.6, hypromellose, polyethylene glycol 400, polysorbate 80, and titanium dioxide. Abacavir Sulfate, USP The chemical name of abacavir sulfate, USP is ( 1 S, 4R)- 4-[2-amino-6-(cyclopropylamino)-9 H -purin-9­yl]-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, USP is a white to almost white powder and is soluble in water. In vivo , abacavir sulfate dissociates to its free base, abacavir. Dosages are expressed in terms of abacavir. Lamivudine, USP The chemical name of lamivudine, USP is (2(1 H )-Pyrimidinone,4-amino-1-[2-(hydroxymethyl)-1,3-oxathiolan-5-yl]-, (2 R - cis )-. Lamivudine, USP is the (-)enantiomer of a dideoxy analogue of cytidine. Lamivudine, USP 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 and a molecular weight of 229.26 g per mol. It has the following structural formula: Lamivudine, USP is a white to almost white solid and is soluble in water, sparingly soluble in methanol, slightly soluble to practically insoluble in 96% ethanol and practically insoluble in acetone. FDA approved dissolution test specifications differ from USP. abacavir structure lamivudine structure

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