Abacavir Sulfate Tablets

Name: Abacavir Sulfate Tablets

Indications and Usage for Abacavir Sulfate Tablets

Abacavir tablets USP 300 mg, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus (HIV-1) infection.

Abacavir Sulfate Tablets Dosage and Administration

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)].

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.

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 (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)
Twice-Daily Dosage Regimen
AM Dose
PM Dose
Total Daily Dose
14 to <20
½ tablet (150mg)
½ tablet (150mg)
300 mg
≥20 to <25
½ tablet (150mg)
1 tablet (300mg)
450 mg
≥25
1 tablet (300mg)
1 tablet (300mg)
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.

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. 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.

Dosage Forms and Strengths

Abacavir tablets contain 300 mg of abacavir as abacavir sulfate. The tablets are yellow colored, capsule shaped, film coated biconvex tablets with scoreline on both sides.

Overdosage

There is no known specific treatment for overdose with abacavir sulfate. If overdose occurs, the patient should be monitored and standard supportive treatment applied as required. It is not known whether abacavir can be removed by peritoneal dialysis or hemodialysis.

How Supplied/Storage and Handling

Abacavir tablets USP 300 mg, containing abacavir sulfate equivalent to 300 mg abacavir are yellow colored, capsule shaped, film coated biconvex tablets with scoreline on both sides. 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.]

Package label.principal display panel

ABACAVIR 
abacavir tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:69097-514
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ABACAVIR SULFATE (ABACAVIR) ABACAVIR 300 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE  
SODIUM STARCH GLYCOLATE TYPE A CORN  
STARCH, CORN  
MAGNESIUM STEARATE  
SILICON DIOXIDE  
TITANIUM DIOXIDE  
HYPROMELLOSE 2910 (3 MPA.S)  
POLYETHYLENE GLYCOL 400  
FERRIC OXIDE YELLOW  
POLYSORBATE 80  
Product Characteristics
Color YELLOW Score 2 pieces
Shape CAPSULE Size 19mm
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description
1 NDC:69097-514-03 60 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Export only 11/06/2006
Labeler - Cipla USA Inc. (078719707)
Registrant - Cipla USA Inc. (078719707)
Establishment
Name Address ID/FEI Operations
Cipla Patalganga 916940208 ANALYSIS(69097-514), LABEL(69097-514), MANUFACTURE(69097-514), PACK(69097-514)
Establishment
Name Address ID/FEI Operations
Cipla Kurkumbh 917066446 API MANUFACTURE(69097-514)
Establishment
Name Address ID/FEI Operations
Mylan-Laboratories Limited 650438158 API MANUFACTURE(69097-514)
Revised: 05/2017   Cipla USA Inc.
(web3)