Tenvir- EM
Each tablet contains
Emtricitabine ………………………..200 mg
Tenofovir disoproxil fumarate………..300 mg
Equivalent to tenofovir disoproxil ….245 mg

TENVIR-EM is indicated in combination with other antiretroviral agents (such as non-nucleoside reverse transcriptase inhibitors or protease inhibitors) for the treatment of HIV-1 infection in adults.

The following points should be considered when initiating therapy with TENVIR EM for the treatment of HIV-1 infection:

• It is not recommended that TENVIR EM be used as a component of a triple nucleoside regimen.
• TENVIR EM should not be coadministered with lamivudine+tenofovir DF+Efavirenz, emtricitabine, tenofovir DF or lamivudine-containing products [see WARNINGS AND PRECAUTIONS ] .
• In treatment experienced patients, the use of TENVIR EM should be guided by laboratory testing and treatment history.

The dosage of TENVIR-EM is one tablet (containing 200 mg of emtricitabine and 300 mg of tenofovir DF) once daily taken orally with or without food.

Dose adjustment for renal impairment

Significantly increased drug exposures occurred when emtricitabine or tenofovir DF were administered to patients with moderate to severe renal impairment. Therefore, the dosing interval of TENVIR-EM should be adjusted in patients with baseline creatinine clearance of 30-49 mL/min using the recommendations in Table 2. The safety and effectiveness of these dosing interval adjustment recommendations have not been clinically evaluated; therefore, clinical response to treatment and renal function should be closely monitored in these patients.

No dose adjustment is necessary for patients with mild renal impairment (creatinine clearance of 50–80 mL/min). Routine monitoring of calculated creatinine clearance and serum phosphorus should be performed in patients with mild renal impairment [see WARNINGS AND PRECAUTIONS ] .

Table 2: Dosage Adjustment for Patients with Altered Creatinine Clearance

a Calculated using ideal (lean) body weight

Special Population

Pediatric Use
Safety and effectiveness in pediatric patients have not been established.

Geriatric Use
Clinical studies of emtricitabine or tenofovir DF did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. In general, dose selection for elderly patients should be cautious, keeping in mind the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

TENVIR-EM tablets ……………. Container of 30 tablets