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Ricovir

Ricovir Dosage/Direction for Use

tenofovir disoproxil fumarate

Manufacturer:

Mylan Healthcare

Distributor:

Zuellig Pharma
Full Prescribing Info
Dosage/Direction for Use
Recommended Dose in Adults: For the treatment of HIV-1 or chronic hepatitis B: The dose is one 300 mg Tenofovir Disoproxil Fumarate 300 mg Tablets once daily taken orally, without regard to food.
In the treatment of chronic hepatitis B, the optimal duration of treatment is unknown.
Dose Adjustment for Renal Impairment in Adults: Significantly increased drug exposures occurred when Tenofovir Disoproxil Fumarate 300 mg Tablets was administered to subjects with moderate to severe renal impairments. Therefore, the dosing interval of Tenofovir Disoproxil Fumarate 300 mg Tablets should be adjusted in patients with baseline creatinine clearance <50 mL/min using the recommendations in table. These dosing interval recommendations are based on modeling of single-dose pharmacokinetic data in non-HIV and NON-HBV infected subjects with varying degrees of renal impairment, including end-stage renal disease requiring hemodialysis. The safety and effectiveness of these dosing interval adjustment recommendations have not been clinically evaluated in patients with moderate or severe renal impairment, 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 table.)

Click on icon to see table/diagram/image

Tenofovir Disoproxil Fumarate 300 mg Tablets 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.
No data are available to make dose recommendations in pediatric patients 12 years of age and older with renal impairment.
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