Generic name: ABACAVIR SULFATE 600mg, LAMIVUDINE 300mg
Dosage form: tablet, film coated
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Screening for HLAB*5701 Allele prior to Starting EPZICOM
Screen for the HLA‑B*5701 allele prior to initiating therapy with EPZICOM [see Boxed Warning, Warnings and Precautions (5.1)].
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 (14.2)]. 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 (8.6)].
- patients with mild hepatic impairment. EPZICOM is contraindicated in patients with moderate or severe hepatic impairment [see Contraindications (4), Use in Specific Populations (8.7)].
Use of EPIVIR® (lamivudine) oral solution or tablets and ZIAGEN® (abacavir) oral solution may be considered.
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