Each film coated tablet contains Tenofovir Disoproxil Fumarate INN 300 mg equivalent to Tenofovir Disoproxil 245 mg.
Tenvira is indicated for the treatment of chronic hepatitis B virus infection in adults over 18 years of age. It is also indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.
Dosage & Administration
Recommended dose in adults 18 years of age or older for the treatment of chronic hepatitis B infection: The recommended dose is 300 mg once daily with or without food. However, it is generally recommended to be taken with a meal to improve bioavailability.
Usual adult dose for HIV infection: 300 mg orally once a day.
Patients with renal impairment: No dosage adjustment is necessary for patients with mild renal impairment (creatinine clearance 50-80 mL/min). Since tenofovir is principally eliminated by the kidney, in the case of severe renal impairment, including cases of acute renal failure and Fanconi syndrome- dosage adjustment is required in all patients with creatinine clearance <50 ml/min, as detailed in table.
|Recommended dose||300 mg every 24 hours||300 mg every 48 hours||300 mg every 72 to 96 hours||Every 7 days or after approximately 12 hours of dialysis|
In hepatic impairment: No dose adjustment is required in patients with hepatic impairment.
Usually none. However, Tenofovir is contraindicated to the patients who have hypersensitivity to any components of this drug.
Warning & Precautions
Co-administration with other drugs: Tenofovir should not be administered concurrently with Emtricitabine & Tenofovir combination or Adefovir Dipivoxil.
Lactic acidosis/severe hepatomegaly with steatosis: Though the risk of occurrence of lactic acidosis is low for tenofovir, treatment should be suspended in any patient who develops lactic acidosis or hepatotoxicity.
Exacerbation of hepatitis after discontinuation of treatment: Discontinuation of Tenofovir therapy may be associated with severe acute exacerbations of hepatitis. Monitor liver function tests every 3 months, and viral and serological markers for hepatitis B every 3-6 months. Discontinue if deterioration in liver function, hepatic steatosis, progressive hepatomegaly or unexplained lactic acidosis. Recurrent hepatitis may occur on discontinuation.
The most common side effects are nausea, vomiting, diarrhoea, unusual stomach discomfort, fatigue etc.
Co-administration of Tenofovir with antiretroviral, entecavir, lamivudine, methadone, oral contraceptives, ribavirin and tacrolimus did not result in significant drug interactions. However, since Tenofovir is predominantly eliminated by the kidney, co-administration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either drug.
Use in special groups
Pregnancy(Pregnancy category B):There are no adequate and well-controlled studies in pregnant women. Tenofovir should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Lactation: It is not known whether it is excreted in human milk. Mothers should be instructed not to breast-feed if they are receiving Tenofovir.
Pediatric use: The use of Tenofovir is not recommended for pediatric patients.
Geriatric use: In general, dose selection for the elderly patient should be cautious, keeping in mind the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Each Box contains 10's tablet in alu-alu blister pack.