"The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended 150 mg lamivudine/300 mg raltegravir (Dutrebis, Merck Sharp & Dohme Limited) for the treatment of HIV 1 infection in adults, adolesce"...
DOSAGE AND ADMINISTRATION
Screening For HLA-B*5701 Allele Prior To Starting EPZICOM
Recommended Dosage For Adult Patients
The recommended dosage of EPZICOM for adults is one tablet taken orally once daily, in combination with other antiretroviral agents, with or without food.
Recommended Dosage For Pediatric Patients
The recommended oral dose of EPZICOM for pediatric patients weighing at least 25 kg is one tablet daily in combination with other antiretroviral agents [see Clinical Studies]. Before prescribing EPZICOM tablets, pediatric patients should be assessed for the ability to swallow tablets.
Not Recommended Due To Lack of Dosage Adjustment
Because EPZICOM is a fixed-dose tablet and cannot be dose adjusted, EPZICOM is not recommended for:
- patients with creatinine clearance less than 50 mL per minute [see Use in Specific Populations].
- patients with mild hepatic impairment. EPZICOM is contraindicated in patients with moderate or severe hepatic impairment [see CONTRAINDICATIONS, Use in Specific Populations].
Use of EPIVIR® (lamivudine) oral solution or tablets and ZIAGEN® (abacavir) 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 : ViiV Healthcare, Research Triangle Park, NC 27709. by: GlaxoSmithKline Research Triangle Park, NC 27709. Revised: September 2015This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 10/23/2015
Additional Epzicom Information
Epzicom - User Reviews
Epzicom User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Get breaking medical news.