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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"...
Additional important information on the use of EPZICOM for treatment of HIV-1 infection:
- EPZICOM is one of multiple products containing abacavir. Before starting EPZICOM, 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].
- As part of a triple-drug regimen, EPZICOM tablets are recommended for use with antiretroviral agents from different pharmacological classes and not with other nucleoside/nucleotide reverse transcriptase inhibitors.
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.
- EPZICOM can be taken with or without food.
The recommended oral dose of EPZICOM for adults is one tablet daily, in combination with other antiretroviral agents.
Because it is a fixed-dose combination, EPZICOM should not be prescribed for:
- patients requiring dosage adjustment such as those with creatinine clearance less than 50 mL per min,
- patients with hepatic impairment.
Use of EPIVIR® (lamivudine) oral solution or tablets and ZIAGEN® (abacavir sulfate) oral solution may be considered.
Dosage Forms And Strengths
EPZICOM tablets contain 600 mg of abacavir as abacavir sulfate and 300 mg of lamivudine. The tablets are modified capsule-shaped, orange, film-coated, and debossed with “GS FC2” on one side with no markings on the reverse side.
Storage And Handling
EPZICOM is available as tablets. Each tablet contains 600 mg of abacavir as abacavir sulfate and 300 mg of lamivudine. The tablets are orange, film-coated, modified capsule-shaped, and debossed with GS FC2 on one side with no markings on the reverse side. They are packaged as follows:
Bottles of 30 tablets (NDC 49702-206-13).
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) (see USP Controlled Room Temperature).
Manufactured for: Healthcare, ViiV Healthcare, Research Triangle Park, NC 27709 by: GlaxoSmithKline, Research Triangle Park, NC 27709. Revised: February 2015
Last reviewed on RxList: 3/5/2015
This monograph has been modified to include the generic and brand name in many instances.
Additional Epzicom Information
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