Tenvira

Tenvira Special Precautions

tenofovir disoproxil fumarate

Manufacturer:

Aristopharma

Distributor:

KTZ
Full Prescribing Info
Special Precautions
Co-Administration with Other Drugs: Tenofovir should not be administered concurrently with emtricitabine and 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 of 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.
Use in 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.
Use in lactation: It is not known whether it is excreted in human milk. Mothers should be instructed not to breastfeed if they are receiving tenofovir.
Use in children: The use of tenofovir is not recommended for pediatric patients.
Use in the elderly: 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.
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