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.
2.2 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 RETROVIR® (zidovudine) Syrup.
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.
DOSAGE FORMS AND STRENGTHS
COMBIVIR 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 (âGXâ on one face and "FC3" on the opposite face of the tablet).