Drug Catalog - Product Detail
ABACAVIR SULFATE AND LAMIVUDINE TB 600/300MG 30
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 66993-0482-30 | PRASCO LABORATORIES | 30 | 600-300MG | TABLET |
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Description
11 DESCRIPTION Abacavir and Lamivudine Tablets Abacavir and Lamivudine tablets 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 are for oral administration. Each orange, film-coated tablet contains the active ingredients 600 mg of abacavir as abacavir sulfate and 300 mg of lamivudine, 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 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 670.76 g per mol. It has the following structural formula: Abacavir sulfate is a white to off-white solid and is soluble in water. In vivo, abacavir sulfate dissociates to its free base, abacavir. 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. 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 and a molecular weight of 229.3 g per mol. It has the following structural formula: Lamivudine is a white to off-white crystalline solid and is soluble in water. abacavir sulfate structural formula Lamivudine chemical structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Each Abacavir and Lamivudine tablet contains 600 mg of abacavir as abacavir sulfate and 300 mg of lamivudine. The tablets are orange, film-coated, modified capsule-shaped, and debossed with GS FC2 on one side with no markings on the reverse side. They are packaged as follows: Bottles of 30 tablets (NDC 66993-482-30). Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) (see USP Controlled Room Temperature).
Indications & Usage
1 INDICATIONS AND USAGE Abacavir and Lamivudine tablets, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. Abacavir and Lamivudine tablets, containing two nucleoside analogue HIV-1 reverse transcriptase inhibitors, are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. ( 1 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION • Before initiating Abacavir and Lamivudine tablets, screen for the HLA‑B*5701 allele because Abacavir and Lamivudine tablets contain abacavir. ( 2.1 ) • Adults: One tablet orally once daily. ( 2.2 ) • Pediatric patients weighing at least 25 kg: One tablet daily. ( 2.3 ) • Because Abacavir and Lamivudine tablets are a fixed-dose tablet and cannot be dose adjusted, Abacavir and Lamivudine tablets are not recommended in patients requiring dosage adjustment or patients with hepatic impairment. ( 2.4 , 4 ) 2.1 Screening for HLA-B*5701 Allele prior to Starting Abacavir and Lamivudine Tablets Screen for the HLA-B*5701 allele prior to initiating therapy with Abacavir and Lamivudine tablets [see Boxed Warning , Warnings and Precautions ( 5.1 )] . 2.2 Recommended Dosage for Adult Patients The recommended dosage of Abacavir and Lamivudine tablets for adults is one tablet taken orally once daily, in combination with other antiretroviral agents, with or without food. 2.3 Recommended Dosage for Pediatric Patients The recommended oral dose of Abacavir and Lamivudine tablets for pediatric patients weighing at least 25 kg is one tablet daily in combination with other antiretroviral agents [see Clinical Studies ( 14.2 )] . Before prescribing Abacavir and Lamivudine tablets, pediatric patients should be assessed for the ability to swallow tablets. 2.4 Not Recommended Due to Lack of Dosage Adjustment Because Abacavir and Lamivudine tablets are fixed-dose tablets and cannot be dose adjusted, Abacavir and Lamivudine tablets are not recommended for: • patients with creatinine clearance less than 50 mL per minute [see Use in Specific Populations ( 8.6 )] . • patients with mild hepatic impairment. Abacavir and Lamivudine tablets are contraindicated in patients with moderate or severe hepatic impairment [see Contraindications ( 4 ), Use in Specific Populations ( 8.7 )] . Use of EPIVIR (lamivudine) oral solution or tablets and ZIAGEN (abacavir) oral solution may be considered.