Truvada Tablet 200mg/300mg

TABLET, FILM COATED

**2 DOSAGE AND ADMINISTRATION** **2.1 Recommended Dose** The recommended dose of TRUVADA is one tablet (containing 200 mg of emtricitabine and 300 mg of tenofovir DF) once daily taken orally with or without food. **2.2 Dose Adjustment for Renal Impairment** Significantly increased drug exposures occurred when emtricitabine or tenofovir were administered to subjects with moderate to severe renal impairment _\[See Warnings and Precautions (5.3) and Clinical Pharmacology (11.2)_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _\]_. Therefore, adjust the dosing interval of TRUVADA in patients with baseline creatinine clearance 30–49 mL/min using the recommendations in Table 1. These dosing interval recommendations are based on modeling of single-dose pharmacokinetic data in non-HIV infected subjects. The safety and effectiveness of these dosing interval adjustment recommendations have not been clinically evaluated in patients with moderate renal impairment, therefore clinical response to treatment and renal function should be closely monitored in these patients _\[See Warnings and Precautions (5.3)_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _\]_. No dose adjustment is necessary for patients with mild renal impairment (creatinine clearance 50–80 mL/min).  Routine monitoring of estimated creatinine clearance, serum phosphorus, urine glucose, and urine protein should be performed in all individuals with mild renal impairment _\[See Warnings and Precautions (5.3)_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _\]_.