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) [See Warnings and Precautions (5.3)].
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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- Drug class: antiviral combinations