"The US Food and Drug Administration (FDA) has approved atazanavir and cobicistat (Evotaz, Bristol-Myers Squibb) for treatment of adults with human immunodeficiency virus (HIV-1) infection.
Atazanavir/cobicistat is a fixed-dos"...
TRIZIVIR is indicated in combination with other antiretrovirals or alone for the treatment of HIV-1 infection.
Additional important information on the use of TRIZIVIR for treatment of HIV-1 infection:
- TRIZIVIR is one of multiple products containing abacavir. Before starting TRIZIVIR, review medical history for prior exposure to any abacavir-containing product in order to avoid reintroduction in a patient with a history of hypersensitivity to abacavir [see WARNINGS AND PRECAUTIONS, ADVERSE REACTIONS].
- TRIZIVIR is a fixed-dose combination of 3 nucleoside analogues: abacavir, lamivudine, and zidovudine and is intended only for patients whose regimen would otherwise include these 3 components.
- Limited data exist on the use of TRIZIVIR alone in patients with higher baseline viral load levels ( > 100,000 copies/mL) [see Clinical Studies].
DOSAGE AND ADMINISTRATION
- A Medication Guide and Warning Card that provide information about recognition of hypersensitivity reactions should be dispensed with each new prescription and refill.
- TRIZIVIR can be taken with or without food.
Adults and Adolescent Patients
The recommended oral dose of TRIZIVIR is one tablet twice daily.
TRIZIVIR is not recommended in adolescents who weigh less than 40 kg because it is a fixed-dose tablet and cannot be dose adjusted.
Because it is a fixed-dose combination, TRIZIVIR should not be prescribed for:
- patients requiring dosage adjustment such as those with creatinine clearance < 50 mL/min,
- patients with hepatic impairment.
Dosage Forms and Strengths
TRIZIVIR Tablets contain 300 mg of abacavir as abacavir sulfate, 150 mg of lamivudine, and 300 mg of zidovudine. The tablets are blue-green, capsule-shaped, film-coated, and imprinted with "GX LL1" on one side with no markings on the reverse side.
TRIZIVIR is available as tablets. Each tablet contains 300 mg of abacavir as abacavir sulfate, 150 mg of lamivudine, and 300 mg of zidovudine. The tablets are blue-green capsule-shaped, film-coated, and imprinted with GX LL1 on one side with no markings on the reverse side. They are packaged as follows:
Bottles of 60 Tablets (NDC 49702-217-18).
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) (see USP Controlled Room Temperature).
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 pic, Basingstoke, UK. Revised: May 2012
Last reviewed on RxList: 6/7/2012
This monograph has been modified to include the generic and brand name in many instances.
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