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Product
Antiretroviral products (Tenvir)
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Antiretroviral products (Tenvir)
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Tenvir
Tenofovir disoproxil fumarate tablets
COMPOSITION
TENVIR Tablets
Each film-coated tablet contains
Tenofovir disoproxil fumarate …………….. 300 mg
INDICATIONS
TENVIR Tablets are is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.
The following point should be considered when initiating therapy with tenofovir for the treatment of HIV-1 infection:
• Tenofovir should not be used in combination with tenofovir /emtricitabine or emtricitabine /tenofovir/efavirenz (see WARNINGS AND PRECAUTIONS)
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DOSAGE AND ADMINISTRATION
The dose of TENVIR Tablets is 300 mg once daily taken orally, without regard to food.
Dose Adjustment for Renal Impairment
Significantly increased drug exposures occurred when tenofovir disoproxil fumarate was administered to patients with moderate to severe renal impairment. The dosing interval of tenofovir disoproxil fumarate should be adjusted in patients with baseline creatinine clearance <50 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 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
1.Calculated using ideal (lean) body weight.
2.Generally once weekly assuming three hemodialysis sessions a week of approximately 4 hours duration. Tenofovir disoproxil fumarate should be administered following completion of dialysis.
The pharmacokinetics of tenofovir have not been evaluated in non-hemodialysis patients with creatinine clearance <10 mL/min; therefore, no dosing recommendation is available for these patients.
CONTRAINDICATIONS
None.
PACKAGING INFORMATION
Container pack of 30 tablets
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