Generic name: emtricitabine 200mg, rilpivirine hydrochloride 25mg, tenofovir disoproxil fumarate 300mg
Dosage form: tablet, film coated
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The recommended dose of COMPLERA in patients 12 years of age and older and weighing at least 35 kg is one tablet taken orally once daily with food [See Use in Specific Populations (8.4) and Clinical Pharmacology (12.3)].
Renal Impairment: Because COMPLERA is a fixed-dose combination, it should not be prescribed for patients requiring dose reduction, such as those with moderate or severe renal impairment (estimated creatinine clearance below 50 mL per minute).
Rifabutin Coadministration: If COMPLERA is coadministered with rifabutin, an additional 25 mg tablet of rilpivirine (Edurant®) once per day is recommended to be taken concomitantly with COMPLERA and with a meal for the duration of the rifabutin coadministration [See Drug Interactions (7.5) and Clinical Pharmacology (12.3)].
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