Generic Name
Tenofovir Disoproxil Fumarate
Indications:
Tenofovir is indicated for the treatment of -
1. Chronic hepatitis B virus infection in adults
2. HIV-infected adults in combination with other antiretroviral agents
Presentation:
Each tablet contains Tenofovir Disoproxil Fumarate INN 300 mg.
Description:
Tenofovir Disoproxil Fumarate, an acyclic nucleotide analogue of adenosine monophosphate, is a prodrug of Tenofovir. It shows activity against HBV polymerase and HIV reverse transcriptase after phosphorylation to the active diphosphate form. Tenofovir diphosphate inhibits viral polymerase (reverse transcriptase) by directly competing with the natural substrate deoxyribonucleotide and by causing DNA chain termination after its incorporation into viral DNA.
Dosage & Administration:
The recommended dose of Tenofovir in chronic hepatitis B virus infection in adults 18 years of age and older with adequate renal function is 300 mg once daily with or without food.
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
Dose Adjustment in Hepatic Impairment: No dose adjustment is required in patients with hepatic impairment.
Side Effects:
The most common side effects are nausea, vomiting, diarrhea, and flatulence
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 exacerbation of hepatitis
Use in Pregnancy & Lactation:
Pregnancy: Pregnancy category B. There are, however, no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if clearly needed.
Lactation: It is not known whether it is excreted in human milk. Mothers should be instructed not to breastfeed if they are taking Tenofovir.
Paediatric Use
The safety and effectiveness of Tenofovir in patients under 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.
Interaction:
Co-administration of Tenofovir with anti-retroviral, entecavir, lamivudine, methadone, oral contraceptives, ribavirin and tacrolimus did not result in significant drug interactions. The effects of co-administration of Tenofovir with other drugs that are renally eliminated or are known to affect renal function have not been evaluated.
Overdose:
There is no experience of Tenofovir overdosage reported in patients.
Tenofovir is indicated for the treatment of -
1. Chronic hepatitis B virus infection in adults
2. HIV-infected adults in combination with other antiretroviral agents
Presentation:
Each tablet contains Tenofovir Disoproxil Fumarate INN 300 mg.
Description:
Tenofovir Disoproxil Fumarate, an acyclic nucleotide analogue of adenosine monophosphate, is a prodrug of Tenofovir. It shows activity against HBV polymerase and HIV reverse transcriptase after phosphorylation to the active diphosphate form. Tenofovir diphosphate inhibits viral polymerase (reverse transcriptase) by directly competing with the natural substrate deoxyribonucleotide and by causing DNA chain termination after its incorporation into viral DNA.
Dosage & Administration:
The recommended dose of Tenofovir in chronic hepatitis B virus infection in adults 18 years of age and older with adequate renal function is 300 mg once daily with or without food.
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
Dose Adjustment in Hepatic Impairment: No dose adjustment is required in patients with hepatic impairment.
Side Effects:
The most common side effects are nausea, vomiting, diarrhea, and flatulence
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 exacerbation of hepatitis
Use in Pregnancy & Lactation:
Pregnancy: Pregnancy category B. There are, however, no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if clearly needed.
Lactation: It is not known whether it is excreted in human milk. Mothers should be instructed not to breastfeed if they are taking Tenofovir.
Paediatric Use
The safety and effectiveness of Tenofovir in patients under 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.
Interaction:
Co-administration of Tenofovir with anti-retroviral, entecavir, lamivudine, methadone, oral contraceptives, ribavirin and tacrolimus did not result in significant drug interactions. The effects of co-administration of Tenofovir with other drugs that are renally eliminated or are known to affect renal function have not been evaluated.
Overdose:
There is no experience of Tenofovir overdosage reported in patients.
Storage:
Do not store above 30 °C. Protect from light and high humidity. Keep out of the reach of children.
Do not store above 30 °C. Protect from light and high humidity. Keep out of the reach of children.
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