Teravir – Tenofovir 300mg

Teravir – Tenofovir 300mg

Brand Name: Teravir
Generic Name: Tenofovir disoproxil fumarate
Contents: Tenofovir disoproxil fumarate 300mg
Form: Tablets
Manufactured By: Natco Pharma Limited
Other Brand Name: Viread
Pricing: Price Per Pack of 30 TabletsTeravirTablets

Each film-coated tablet contains
Tenofovir disoproxil fumarate …………….. 300 mg

INDICATIONS

TeravirTablets 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)

DOSAGE AND ADMINISTRATION

The dose of TeravirTablets 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

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.