Abacavir Sulfate Tablets
Name: Abacavir Sulfate Tablets
- Abacavir Sulfate Tablets tablet
- Abacavir Sulfate Tablets 300 mg
- Abacavir Sulfate Tablets abacavir sulfate tablets dosage
- Abacavir Sulfate Tablets 600 mg
- Abacavir Sulfate Tablets dosage
- Abacavir Sulfate Tablets drug
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.
|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.
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 tablet, film coated
|Labeler - Cipla USA Inc. (078719707)|
|Registrant - Cipla USA Inc. (078719707)|
|Cipla Patalganga||916940208||ANALYSIS(69097-514), LABEL(69097-514), MANUFACTURE(69097-514), PACK(69097-514)|
|Cipla Kurkumbh||917066446||API MANUFACTURE(69097-514)|
|Mylan-Laboratories Limited||650438158||API MANUFACTURE(69097-514)|