Medically reviewed by Drugs.com. Last updated on Mar 26, 2021.
Generic name: EFAVIRENZ 600mg, EMTRICITABINE 200mg, TENOFOVIR DISOPROXIL FUMARATE 300mg
Dosage form: tablet, film coated
Testing Prior to Initiation and During Treatment with ATRIPLA
Prior to or when initiating ATRIPLA, test patients for hepatitis B virus infection [see Warnings and Precautions (5.1)].
Prior to initiation and during use of ATRIPLA, on a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose and urine protein in all patients. In patients with chronic kidney disease, also assess serum phosphorus [see Warnings and Precautions (5.7)].
Monitor hepatic function prior to and during treatment with ATRIPLA [see Warnings and Precautions (5.3)].
Recommended Dosage for Adults and Pediatric Patients Weighing at Least 40 kg
ATRIPLA is a three-drug fixed-dose combination product containing 600 mg of efavirenz (EFV), 200 mg of emtricitabine (FTC), and 300 mg of tenofovir disoproxil fumarate (TDF). The recommended dosage of ATRIPLA in adults and pediatric patients weighing at least 40 kg is one tablet once daily taken orally on an empty stomach. Dosing at bedtime may improve the tolerability of nervous system symptoms [see Clinical Pharmacology (12.3)].
Not Recommended in Patients with Moderate or Severe Renal Impairment
ATRIPLA is not recommended in patients with moderate or severe renal impairment (estimated creatinine clearance below 50 mL/min) [see Warnings and Precautions (5.7), Use in Specific Populations (8.6)].
Not Recommended in Patients with Moderate to Severe Hepatic Impairment
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