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Drug Catalog - Product Detail

ABACAVIR TB 300MG 5X10 UD

NDC Mfr Size Str Form
00904-6523-06 MAJOR PHARMACEUTICALS 50 300MG TABLET
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Description
11 DESCRIPTION Abacavir sulfate is a synthetic carbocyclic nucleoside analogue with inhibitory activity against HIV-1. The chemical name of abacavir sulfate is ( 1S ,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, USP is a white to off-white solid with a solubility of approximately 77 mg per mL in distilled water at 25°C. It has an octanol per water (pH 7.1 to 7.3) partition coefficient (log P ) of approximately 1.20 at 25°C. Abacavir tablets, USP are for oral administration. Each tablet contains abacavir sulfate, USP equivalent to 300 mg of abacavir as active ingredient and the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, and croscarmellose sodium. The tablets are coated with a film that is made of hypromellose, polyethylene glycol, yellow iron oxide, and titanium dioxide. In vivo , abacavir sulfate dissociates to its free base, abacavir. All dosages for abacavir tablets are expressed in terms of abacavir. structural-formula
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Abacavir Tablets, USP are available containing abacavir sulfate, USP equivalent to 300 mg of abacavir. The 300 mg tablets are yellow, biconvex, scored, modified capsule-shaped, film-coated tablets engraved with “APO” on one side and “AB” bisect “300” on the other side. They are packaged as follows: Cartons of 30 tablets (10 tablets each blister pack x 3) NDC 0904-6523-04 Cartons of 50 tablets (10 tablets each blister pack x 5) NDC 0904-6523-06 Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in original container with attached prescribing information that contains the Medication Guide and a Warning Card.
Indications & Usage
1 INDICATIONS AND USAGE Abacavir tablets, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus (HIV-1) infection. Abacavir, a nucleoside analogue human immunodeficiency virus (HIV-1) reverse transcriptase inhibitor, is 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, screen for the HLA-B*5701 allele. ( 2.1 ) • Adults: 600 mg daily, administered as either 300 mg twice daily or 600 mg once daily. ( 2.2 ) • Pediatric Patients Aged 3 Months and Older: Administered either once or twice daily. Dose should be calculated on body weight (kg) and should not exceed 600 mg daily. ( 2.3 ) • Patients with Hepatic Impairment: Mild hepatic impairment – 200 mg twice daily. ( 2.4 ) 2.1 Screening for HLA-B*5701 Allele prior to Starting Abacavir Screen for the HLA-B*5701 allele prior to initiating therapy with abacavir [see Boxed Warning , Warnings and Precautions (5.1 )]. 2.2 Recommended Dosage for Adult Patients The recommended dosage of abacavir tablets for adults is 600 mg daily, administered orally as either 300 mg twice daily or 600 mg once daily, in combination with other antiretroviral agents. 2.3 Recommended Dosage for Pediatric Patients The recommended dosage of abacavir oral solution in HIV-1-infected pediatric patients aged 3 months and older is 8 mg per kg orally twice daily or 16 mg per kg orally once-daily (up to a maximum of 600 mg daily) in combination with other antiretroviral agents. Abacavir is also available as a scored tablet for HIV-1-infected pediatric patients weighing greater than or equal to 14 kg for whom a solid dosage form is appropriate. Before prescribing abacavir tablets, children should be assessed for the ability to swallow tablets. If a child is unable to reliably swallow abacavir tablets, the oral solution formulation should be prescribed. The recommended oral dosage of abacavir tablets for HIV-1-infected pediatric patients is presented in Table 1. Table 1. Dosing Recommendations for Abacavir Tablets in Pediatric Patients Weight (kg) Once-Daily Dosing Regimen a Twice-Daily Dosing Regimen AM Dose PM Dose Total Daily Dose 14 to <20 1 tablet (300 mg) ½ tablet (150 mg) ½ tablet (150 mg) 300 mg ≥20 to <25 1½ tablets (450 mg) ½ tablet (150 mg) 1 tablet (300 mg) 450 mg ≥25 2 tablets (600 mg) 1 tablet (300 mg) 1 tablet (300 mg) 600 mg a Data regarding the efficacy of once-daily dosing is limited to subjects who transitioned from twice-daily dosing to once-daily dosing after 36 weeks of treatment [see Clinical Studies ( 14.2 )]. 2.4 Recommended Dosage for Patients with Hepatic Impairment The recommended dose of abacavir tablets in patients with mild hepatic impairment (Child-Pugh Class A) is 200 mg twice daily. To enable dose reduction, abacavir oral solution (10 mL twice daily) should be used for the treatment of these patients. The safety, efficacy, and pharmacokinetic properties of abacavir have not been established in patients with moderate to severe hepatic impairment; therefore, abacavir tablets are contraindicated in these patients.