Drug Catalog - Product Detail
ABACAVIR SULFATE 300MG TB 60
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 69097-0514-03 | CIPLA USA | 60 | 300MG | TABLET |
PACKAGE FILES
Generic Name
ABACAVIR
Substance Name
ABACAVIR SULFATE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA078119
Description
11 DESCRIPTION Abacavir sulfate is a synthetic carbocyclic nucleoside analogue with inhibitory activity against HIV-1. 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. Abacavir tablets USP 300 mg are for oral administration. Each tablet contains abacavir sulfate equivalent to 300 mg of abacavir as active ingredient and the following inactive ingredients: microcrystalline cellulose, sodium starch glycolate, corn starch, hypromellose, magnesium stearate, colloidal silicon dioxide and opadry yellow 15C52843 (consist of hypromellose, titanium dioxide, polyethylene glycol, iron oxide yellow, polysorbate 80). In vivo, abacavir sulfate dissociates to its free base, abacavir. Dosages are expressed in terms of abacavir. abacavir
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Abacavir tablets USP 300 mg, containing abacavir sulfate equivalent to 300 mg abacavir are yellow coloured, capsule shaped, biconvex, film coated tablets, having scoreline on both sides with "5" and "14" debossed on either side of scoreline on one side. They are packaged as follows: Bottles of 60 tablets (NDC 69097-514-03). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
Indications & Usage
1 INDICATIONS AND USAGE Abacavir tablet, 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. Abacavir tablets USP 300 mg, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus (HIV-1) infection.
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Before initiating abacavir tablets, 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 tablets Screen for the HLA-B*5701 allele prior to initiating therapy with abacavir tablets [see Boxed Warning, Warnings and Precautions ( 5.1 )] . 2.2 Recommended Dosage for Adults Patients The recommended dosage of abacavir sulfate 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 sulfate 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 tablet 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 Scored Tablets in Pediatric Patients Weight (kg) Once-Daily Dosing Regimen 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)] . 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 2.4 Recommended Dosage for Patients with Hepatic Impairment The recommended dose of abacavir sulfate 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 sulfate is contraindicated in these patients.