Drug Catalog - Product Detail
ABACAVIR ORAL SUSPENSION USP 20MG/ML 240ML
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 64980-0405-24 | RISING PHARMACEUTICALS | 240 | 20MG/ML | SOLUTION |
PACKAGE FILES
Generic Name
ABACAVIR SULFATE
Substance Name
ABACAVIR SULFATE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA077950
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 USP is a white to off-white solid and is soluble in water. Abacavir oral solution USP is for oral administration. Each milliliter (1 mL) of abacavir oral solution USP contains abacavir sulfate USP equivalent to 20 mg of abacavir (i.e., 20 mg per mL) as active ingredient and the following inactive ingredients: artificial strawberry and banana flavors, citric acid anhydrous, methylparaben and propylparaben (added as preservatives), propylene glycol, saccharin sodium, sodium citrate (dihydrate), noncrystallizing sorbitol solution, and water. In vivo , abacavir sulfate dissociates to its free base, abacavir. Dosages are expressed in terms of abacavir. Chemical Structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Abacavir Oral Solution USP: It is a clear to opalescent, yellowish, strawberry-banana-flavored liquid. Each mL of the solution contains abacavir sulfate USP equivalent to 20 mg of abacavir. It is packaged in opaque bottles with child-resistant closure. This product does not require reconstitution. Bottles of 240 mL NDC 64980-405-24 Store at 20 ° to 25 °C (68° to 77 °F). [see USP Controlled Room Temperature ]. DO NOT FREEZE. May be refrigerated.
Indications & Usage
1 INDICATIONS AND USAGE Abacavir oral solution, in combination with other antiretroviral agents, is 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 oral solution, 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 Oral Solution Screen for the HLA-B*5701 allele prior to initiating therapy with abacavir oral solution [see Boxed Warning , Warnings and Precautions (5.1) ] . 2.2 Recommended Dosage for Adult Patients The recommended dosage of abacavir oral solution 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. 2.4 Recommended Dosage for Patients with Hepatic Impairment The recommended dose of abacavir oral solution 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 oral solution is contraindicated in these patients.