Tenobis-A
Generic Name
Tenofovir Disoproxil Fumarate + Lamivudine
Manufacturer
Eskayef Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| tenobis a 25 mg tablet | ৳ 6.00 | ৳ 84.00 |
Description
Overview of the medicine
Tenobis-A is a combination antiretroviral medication containing Tenofovir Disoproxil Fumarate and Lamivudine. It is primarily used in the treatment of HIV-1 infection and chronic Hepatitis B infection.
Uses & Indications
Dosage
Adults
One tablet (Tenofovir Disoproxil Fumarate 300 mg + Lamivudine 300 mg) orally once daily.
Elderly
No specific dose adjustment is required for elderly patients, but renal function should be monitored.
Renal_impairment
Dose adjustment is necessary for patients with creatinine clearance < 50 mL/min. Consult prescribing information for specific recommendations.
How to Take
For oral administration. Can be taken with or without food.
Mechanism of Action
Tenofovir Disoproxil Fumarate is a nucleotide reverse transcriptase inhibitor (NtRTI) and Lamivudine is a nucleoside reverse transcriptase inhibitor (NRTI). Both agents inhibit viral reverse transcriptase, an enzyme critical for HIV and HBV replication, thereby reducing viral load.
Pharmacokinetics
Onset
Antiviral effects typically begin within weeks of initiating therapy.
Excretion
Both tenofovir and lamivudine are primarily eliminated by renal excretion via glomerular filtration and active tubular secretion.
Half life
The intracellular half-life of tenofovir is approximately 17 hours. Lamivudine has a plasma half-life of about 5-7 hours.
Absorption
Tenofovir Disoproxil Fumarate is a prodrug, rapidly absorbed and converted to tenofovir. Oral bioavailability is about 25%. Lamivudine is rapidly and extensively absorbed after oral administration, with bioavailability around 80-85%.
Metabolism
Tenofovir is minimally metabolized in the liver. Lamivudine is minimally metabolized, with only a small fraction undergoing metabolism.
Side Effects
Contraindications
- Hypersensitivity to tenofovir disoproxil fumarate, lamivudine, or any of the excipients.
- Coadministration with adefovir dipivoxil.
Drug Interactions
Didanosine
Coadministration with tenofovir may increase didanosine exposure and lead to didanosine-related adverse events. Close monitoring is recommended.
Nephrotoxic agents
Coadministration with other nephrotoxic agents (e.g., aminoglycosides, high-dose NSAIDs) may increase the risk of renal dysfunction. Close monitoring of renal function is advised.
Storage
Store below 30°C in a dry place, away from direct sunlight and moisture. Keep out of reach of children.
Overdose
Limited experience with overdose. Management should include general supportive measures, including monitoring vital signs and observing the patient's clinical status. Hemodialysis can remove both tenofovir and lamivudine.
Pregnancy & Lactation
Use during pregnancy should only be considered if the potential benefit outweighs the potential risk to the fetus. It is not recommended to breastfeed while taking Tenobis-A due to potential for HIV transmission and adverse effects in the infant.
Side Effects
Contraindications
- Hypersensitivity to tenofovir disoproxil fumarate, lamivudine, or any of the excipients.
- Coadministration with adefovir dipivoxil.
Drug Interactions
Didanosine
Coadministration with tenofovir may increase didanosine exposure and lead to didanosine-related adverse events. Close monitoring is recommended.
Nephrotoxic agents
Coadministration with other nephrotoxic agents (e.g., aminoglycosides, high-dose NSAIDs) may increase the risk of renal dysfunction. Close monitoring of renal function is advised.
Storage
Store below 30°C in a dry place, away from direct sunlight and moisture. Keep out of reach of children.
Overdose
Limited experience with overdose. Management should include general supportive measures, including monitoring vital signs and observing the patient's clinical status. Hemodialysis can remove both tenofovir and lamivudine.
Pregnancy & Lactation
Use during pregnancy should only be considered if the potential benefit outweighs the potential risk to the fetus. It is not recommended to breastfeed while taking Tenobis-A due to potential for HIV transmission and adverse effects in the infant.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24-36 months from manufacturing date, depending on specific formulation and packaging.
Availability
Available in pharmacies across Bangladesh
Approval Status
Approved by DGDA, Bangladesh
Patent Status
Generic components' patents expired, brand patent in country
WHO Essential Medicine
YesClinical Trials
Extensive clinical trials have established the efficacy and safety of Tenofovir Disoproxil Fumarate and Lamivudine in the treatment of HIV-1 and chronic Hepatitis B infections. Ongoing research explores new formulations and extended indications.
Lab Monitoring
- Renal function (creatinine, creatinine clearance, phosphorus) prior to initiation and periodically during therapy.
- Liver function tests (ALT, AST, alkaline phosphatase, bilirubin).
- HIV viral load and CD4+ cell counts for HIV patients.
- HBV DNA levels for Hepatitis B patients.
- Bone mineral density (if risk factors for bone loss are present).
Doctor Notes
- Emphasize the importance of strict adherence to the prescribed regimen to minimize the risk of drug resistance and treatment failure.
- Monitor renal function, bone mineral density, and liver enzymes regularly, especially in patients with pre-existing conditions or those on concomitant nephrotoxic agents.
- Educate patients about the risk of HBV exacerbation if treatment is discontinued, and counsel on safe sex practices.
Patient Guidelines
- Take Tenobis-A exactly as prescribed by your doctor. Do not stop treatment without consulting your doctor, as this may lead to drug resistance or worsening of your condition.
- Report any new or worsening symptoms to your doctor immediately.
- Adherence to therapy is crucial for effective treatment and to prevent the development of drug resistance.
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 take a double dose to make up for a missed one. Continue with the regular dosing schedule.
Driving Precautions
Tenobis-A may cause dizziness or fatigue. Patients should be cautioned about operating machinery or driving if they experience these side effects.
Lifestyle Advice
- Maintain a healthy diet and regular exercise routine.
- Avoid excessive alcohol consumption, especially if you have liver issues.
- Practice safe sex to prevent transmission of HIV and other sexually transmitted infections.
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