Xynovir: Each tablet contains Tenofovir Disoproxil Fumarate INN 300 mg.
Chronic hepatitis B virus infection in adults
HIV-infected adults in combination with other antiretroviral agents
Dose Adjustment in renal impairment: Tenofovir is eliminated by renal excretion, so the exposure to tenofovir increases in patients with renal dysfunction. Dosing interval should be adjusted in all patients with creatinine clearance <50 ml/min, as detailed below -
Dosing interval adjustment of Tenofovir in patients with renal impairment
|Creatinine clearance(mL/min)||>= 50||30 to 49||10 to 29||Haemodialysis Patients|
|Recommended dose and dosing interval||300 mg every 24 hours||300 mg every 48 hours||300 mg every 72 to 96 hours||Every 7 days or after a total of approximately 12 hours of dialysis|
Dose Adjustment in hepatic impairment: No dose adjustment is required in patients with hepatic impairment.
Pediatric Use: Safety and effectiveness of Tenofovir in pediatric patients below the age of 12 years have not been established.
Geriatric Use: Clinical studies of Tenofovir did not include sufficient numbers of elderly patients aged 65 years and over to determine whether they respond differently from younger subjects. But care should be taken in dose selection.
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.
In lactation: It is not known whether it is excreted in human milk. Mothers should be instructed not to breast feed if they are taking Tenofovir.