Drug Catalog - Product Detail
ABACAVIR SULFATE TB 300MG 60
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00378-4105-91 | MYLAN | 60 | 300MG | TABLET |
Generic Name
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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 (1 S ,4 R )-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 an off-white to cream colored crystalline powder and is soluble in water. 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, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, red iron oxide, sodium starch glycolate, titanium dioxide and yellow iron oxide. In vivo , abacavir sulfate dissociates to its free base, abacavir. Dosages are expressed in terms of abacavir. Abacavir Sulfate 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 peach, film-coated, capsule shaped, functionally scored tablets debossed with M on one side of the score and 120 on the other side of the score on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-4105-91 carton of one bottle containing 60 tablets NDC 69189-4105-1 single dose pack with 1 tablet as repackaged by Avera McKennan Hospital Store at 20° to 25°C (68° to 77°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 USP, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus (HIV-1) infection. Abacavir tablets USP, a nucleoside analogue human immunodeficiency virus (HIV-1) reverse transcriptase inhibitor, 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 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 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 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 (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 Scored Tablets in Pediatric Patients Weight (kg) Twice-daily Dosing Regimen AM Dose PM Dose Total Daily Dose 14 to < 20 ½ tablet (150 mg) ½ tablet (150 mg) 300 mg ≥ 20 to < 25 ½ tablet (150 mg) 1 tablet (300 mg) 450 mg ≥ 25 1 tablet (300 mg) 1 tablet (300 mg) 600 mg Additional pediatric use information for patients aged 3 months and above is approved for ViiV Healthcare Company’s ZIAGEN ® (abacavir sulfate) tablets and oral solution. However, due to ViiV Healthcare Company’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. 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.