Tenoviral
Generic Name
Tenofovir Disoproxil Fumarate
Manufacturer
Healthcare Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| tenoviral 300 mg tablet | ৳ 85.26 | ৳ 511.56 |
Description
Overview of the medicine
Tenoviral 300 mg Tablet contains Tenofovir Disoproxil Fumarate, an antiviral medication used to treat HIV-1 infection and chronic Hepatitis B virus infection in adults and some pediatric patients. It works by interfering with the replication of the viruses.
Uses & Indications
Dosage
Adults
300 mg once daily orally, with or without food.
Elderly
No specific dose adjustment for elderly patients with normal renal function. Monitor renal function.
Renal_impairment
Dose adjustment required. Creatinine clearance 30-49 mL/min: 300 mg every 48 hours. Creatinine clearance 10-29 mL/min: 300 mg every 72-96 hours. Hemodialysis patients: 300 mg every 7 days or after 12 hours of hemodialysis.
How to Take
Administer orally once daily with or without food. For patients with difficulty swallowing, the tablet may be dispersed in water or juice.
Mechanism of Action
Tenofovir Disoproxil Fumarate is a prodrug of tenofovir, which is a nucleoside analog reverse transcriptase inhibitor (NtRTI). It is intracellularly phosphorylated to its active metabolite, tenofovir diphosphate. Tenofovir diphosphate inhibits HIV-1 reverse transcriptase and Hepatitis B virus (HBV) DNA polymerase by competing with the natural substrate deoxyadenosine 5’-triphosphate and, after incorporation into DNA, by DNA chain termination.
Pharmacokinetics
Onset
Antiviral effects begin within hours to days, but clinical benefits are seen over weeks to months.
Excretion
Primarily excreted unchanged by the kidneys via glomerular filtration and active tubular secretion.
Half life
Elimination half-life of tenofovir is approximately 12-18 hours.
Absorption
Rapidly absorbed after oral administration. Bioavailability is approximately 25%.
Metabolism
Not metabolized by CYP450 enzymes. Primarily hydrolyzed to tenofovir.
Side Effects
Contraindications
- Hypersensitivity to tenofovir or any component of the tablet
Drug Interactions
Didanosine (ddI)
Co-administration with tenofovir is not recommended due to increased ddI systemic exposure and risk of pancreatitis and lactic acidosis.
Adefovir dipivoxil
Co-administration is not recommended due to increased risk of renal adverse events.
Nephrotoxic agents
Avoid co-administration with other nephrotoxic agents (e.g., aminoglycosides, high-dose NSAIDs) due to increased risk of renal dysfunction. Monitor renal function closely if unavoidable.
Atazanavir/Ritonavir
Decreased atazanavir exposure. Administer atazanavir with food and an additional 100 mg of ritonavir.
Storage
Store at room temperature (below 30°C) in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
Limited experience with acute overdose. In case of overdose, monitor for evidence of toxicity and provide supportive treatment. Hemodialysis can remove tenofovir, with an extraction coefficient of approximately 54%.
Pregnancy & Lactation
Pregnancy Category B. Studies in animals have not shown harm to the fetus. Use during pregnancy only if clearly needed. Tenofovir is excreted in human milk; mothers receiving tenofovir should not breastfeed due to the potential for HIV transmission and adverse effects in the infant.
Side Effects
Contraindications
- Hypersensitivity to tenofovir or any component of the tablet
Drug Interactions
Didanosine (ddI)
Co-administration with tenofovir is not recommended due to increased ddI systemic exposure and risk of pancreatitis and lactic acidosis.
Adefovir dipivoxil
Co-administration is not recommended due to increased risk of renal adverse events.
Nephrotoxic agents
Avoid co-administration with other nephrotoxic agents (e.g., aminoglycosides, high-dose NSAIDs) due to increased risk of renal dysfunction. Monitor renal function closely if unavoidable.
Atazanavir/Ritonavir
Decreased atazanavir exposure. Administer atazanavir with food and an additional 100 mg of ritonavir.
Storage
Store at room temperature (below 30°C) in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
Limited experience with acute overdose. In case of overdose, monitor for evidence of toxicity and provide supportive treatment. Hemodialysis can remove tenofovir, with an extraction coefficient of approximately 54%.
Pregnancy & Lactation
Pregnancy Category B. Studies in animals have not shown harm to the fetus. Use during pregnancy only if clearly needed. Tenofovir is excreted in human milk; mothers receiving tenofovir should not breastfeed due to the potential for HIV transmission and adverse effects in the infant.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24-36 months from manufacturing date.
Availability
Pharmacies, Hospitals
Approval Status
Approved by regulatory bodies for HIV and HBV treatment
Patent Status
Generic available
WHO Essential Medicine
YesClinical Trials
Extensive clinical trials have demonstrated the efficacy and safety of tenofovir disoproxil fumarate in treating HIV-1 and chronic HBV infection. Key studies include GS-901, GS-903, and multiple Phase 3 trials leading to approval.
Lab Monitoring
- Renal function (serum creatinine, estimated CrCl, urine glucose and protein) at baseline and regularly during treatment
- Liver function tests (ALT, AST, bilirubin) at baseline and regularly
- Serum phosphate (monitor if at risk of renal dysfunction)
- Bone mineral density (consider in patients with history of fracture or other risk factors)
Doctor Notes
- Counsel patients on the importance of adherence to therapy and potential for HBV exacerbation upon discontinuation.
- Monitor renal function (CrCl, serum phosphate) and bone density regularly, especially in patients with pre-existing renal disease or risk factors for bone loss.
- Be aware of potential drug interactions with nephrotoxic agents and other antivirals.
- Screen all patients for HBV before initiating tenofovir to prevent unforeseen HBV exacerbations if discontinued.
Patient Guidelines
- Take the medication exactly as prescribed by your doctor.
- Do not stop taking the medication without consulting your doctor, especially if you have HBV, as it can lead to severe exacerbations.
- Report any new or worsening symptoms, especially related to kidney or liver problems, to your doctor immediately.
- Maintain regular follow-up appointments and lab tests as advised by your doctor.
Missed Dose Advice
If a dose is missed, take it as soon as possible, unless it is almost time for the next dose. Do not double the dose. If more than a few hours late, just skip the missed dose and continue with the regular dosing schedule.
Driving Precautions
Tenofovir may cause dizziness in some patients. Patients should be advised not to drive or operate machinery if they experience dizziness.
Lifestyle Advice
- Maintain a healthy diet and stay hydrated.
- Avoid excessive alcohol consumption to protect liver health.
- Practice safe sex to prevent transmission of HIV and HBV to others.
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Global Brand Names
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