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The US Food and Drug Administration (FDA) has approved a fixed-dose combination of the antiretroviral drug darunavir (800 mg) and the pharmacokinetic enhancer cobicistat (150 mg) for HIV"...
COMBIVIR, a combination of 2 nucleoside analogues, is indicated in combination with other antiretrovirals for the treatment of human immunodeficiency virus type 1 (HIV-1) infection.
DOSAGE AND ADMINISTRATION
Recommended Dosage For Adults and Adolescents
The recommended dosage 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) taken orally twice daily.
Recommended Dosage For Pediatric Patients
The recommended 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 orally 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 RETROVIR® (zidovudine) syrup.
Not Recommended Due To Lack Of Dosage Adjustment
Because COMBIVIR is a fixed-dose tablet and cannot be dose adjusted, COMBIVIR is not recommended for:
- pediatric patients weighing less than 30 kg [see Use in Specific Populations].
- patients with creatinine clearance less than 50 mL per minute [see Use in Specific Populations].
- patients with hepatic impairment [see Use in Specific Populations].
- patients experiencing dose-limiting adverse reactions.
Liquid and solid oral formulations of the individual components of COMBIVIR are available for these populations.
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. Revised: Sep 2015This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 10/8/2015
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