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Combivir

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Combivir

INDICATIONS

COMBIVIR, a combination of two nucleoside analogues, is indicated in combination with other antiretrovirals for the treatment of HIV-1 infection.

DOSAGE AND ADMINISTRATION

Adults and Adolescents Weighing ≥ 30 kg

The recommended oral dose of COMBIVIR in HIV-1-infected adults and adolescents weighing greater than or equal to 30 kg is 1 tablet (containing 150 mg of lamivudine and 300 mg of zidovudine) twice daily.

Pediatric Patients

The recommended oral dosage of scored COMBIVIR Tablets for pediatric patients who weigh greater than or equal to 30 kg and for whom a solid oral dosage form is appropriate is 1 tablet administered twice daily.

Before prescribing COMBIVIR Tablets, children should be assessed for the ability to swallow tablets. If a child is unable to reliably swallow a COMBIVIR tablet, the liquid oral formulations should be prescribed: EPIVIR® (lamivudine) Oral Solution and

Patients Requiring Dosage Adjustment

Because COMBIVIR is a fixed-dose combination tablet, it should not be prescribed for pediatric patients weighing less than 30 kg or patients requiring dosage adjustment, such as those with reduced renal function (creatinine clearance less than 50 mL/min), patients with hepatic impairment, or patients experiencing dose-limiting adverse reactions. Liquid and solid oral formulations of the individual components of COMBIVIR are available for these populations.

HOW SUPPLIED

Dosage Forms And Strengths

COMBIVIR Tablets contain 150 mg of lamivudine and 300 mg of zidovudine. The tablets are white, scored, film-coated, modified capsule-shaped tablets, debossed on both tablet faces, such that when broken in half, the full “GX FC3” code is present on both halves of the tablet (“GX” on one face and “FC3” on the opposite face of the tablet).

Storage And Handling

COMBIVIR Tablets, containing 150 mg lamivudine and 300 mg zidovudine, are white, scored, film-coated, modified-capsule-shaped tablets, debossed on both tablet faces, such that when broken in half, the full “GXFC3” code is present on both halves of the tablet (“GX” on one face and “FC3” on the opposite face of the tablet). They are available as follows:

60 Tablets/Bottle (NDC 49702-202-18).
Unit Dose Pack of 120 (NDC 49702-202-29).

Store between 2° and 30°C (36° and 86°F).

Manufactured for: ViiV Healthcare, Research Triangle Park, NC 27709. By: GlaxoSmithKline Research Triangle Park, NC 27709. Lamivudine is manufactured under agreement from Shire Pharmaceuticals Group plc, Basingstoke, UK. November 2011.

Last reviewed on RxList: 12/16/2011
This monograph has been modified to include the generic and brand name in many instances.

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