Tensareal
Generic Name
tensareal-5-mg-tablet
Manufacturer
Hypothetical Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| tensareal 5 mg tablet | ৳ 0.25 | N/A |
Description
Overview of the medicine
Tensareal 5 mg Tablet contains an active ingredient (assumed to be Amlodipine Besylate for comprehensive data generation) which is a long-acting calcium channel blocker used to treat high blood pressure (hypertension) and certain types of chest pain (angina). It works by relaxing blood vessels, allowing blood to flow more easily.
Uses & Indications
Dosage
Adults
For hypertension and angina, the usual initial dose is 5 mg once daily. The maximum dose is 10 mg once daily.
Elderly
A lower initial dose of 2.5 mg once daily may be considered. Dosage should be titrated with caution.
Renal_impairment
No dosage adjustment is required for patients with renal impairment. The drug is not dialyzable.
How to Take
Tensareal 5 mg Tablet should be taken orally, once daily, with or without food. It is recommended to take it at the same time each day to maintain consistent drug levels.
Mechanism of Action
As a calcium channel blocker, the active ingredient (e.g., Amlodipine) inhibits the influx of extracellular calcium ions across the membranes of myocardial and vascular smooth muscle cells. This directly relaxes peripheral arteriolar smooth muscle and reduces peripheral vascular resistance, leading to a reduction in blood pressure. It also dilates coronary arteries and arterioles, increasing myocardial oxygen delivery.
Pharmacokinetics
Onset
Gradual onset of action, with full blood pressure lowering effect observed within 6-12 hours after dosing.
Excretion
Excretion occurs primarily via the kidneys (about 60% as metabolites, 10% as unchanged drug), with about 20-25% excreted in feces.
Half life
Plasma elimination half-life is approximately 30-50 hours, allowing for once-daily dosing.
Absorption
Well absorbed after oral administration, with peak plasma concentrations occurring 6-12 hours after dosing. Absolute bioavailability is estimated to be 64-90%.
Metabolism
Extensively metabolized in the liver to inactive metabolites (approximately 90%).
Side Effects
Contraindications
- Hypersensitivity to the active ingredient or other dihydropyridines
- Severe hypotension
- Cardiogenic shock
- Outflow tract obstruction of the left ventricle (e.g., severe aortic stenosis)
- Unstable angina or myocardial infarction during treatment
Drug Interactions
Simvastatin
Coadministration with simvastatin may increase the risk of myopathy. Limit simvastatin dose to 20 mg daily.
Clarithromycin
May increase systemic exposure to the active ingredient. Monitor for symptoms of hypotension.
CYP3A4 inducers (e.g., Rifampicin, Carbamazepine)
May decrease plasma concentrations of the active ingredient, potentially reducing its effectiveness.
CYP3A4 inhibitors (e.g., Ketoconazole, Itraconazole, Ritonavir)
May significantly increase plasma concentrations of the active ingredient, increasing the risk of adverse effects. Dose reduction may be necessary.
Storage
Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children.
Overdose
Overdose may result in excessive peripheral vasodilation with marked and possibly prolonged systemic hypotension and reflex tachycardia. Management involves symptomatic and supportive measures. Gastric lavage may be considered. Intravenous fluids and vasopressors may be needed to restore blood pressure. Calcium gluconate may be beneficial in reversing the effects of calcium channel blockade.
Pregnancy & Lactation
Pregnancy Category C. Use only if the potential benefit justifies the potential risk to the fetus. The active ingredient (e.g., Amlodipine) is known to be excreted in human milk; however, the effect on the breastfed infant is unknown. Exercise caution when administered to a nursing woman.
Side Effects
Contraindications
- Hypersensitivity to the active ingredient or other dihydropyridines
- Severe hypotension
- Cardiogenic shock
- Outflow tract obstruction of the left ventricle (e.g., severe aortic stenosis)
- Unstable angina or myocardial infarction during treatment
Drug Interactions
Simvastatin
Coadministration with simvastatin may increase the risk of myopathy. Limit simvastatin dose to 20 mg daily.
Clarithromycin
May increase systemic exposure to the active ingredient. Monitor for symptoms of hypotension.
CYP3A4 inducers (e.g., Rifampicin, Carbamazepine)
May decrease plasma concentrations of the active ingredient, potentially reducing its effectiveness.
CYP3A4 inhibitors (e.g., Ketoconazole, Itraconazole, Ritonavir)
May significantly increase plasma concentrations of the active ingredient, increasing the risk of adverse effects. Dose reduction may be necessary.
Storage
Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children.
Overdose
Overdose may result in excessive peripheral vasodilation with marked and possibly prolonged systemic hypotension and reflex tachycardia. Management involves symptomatic and supportive measures. Gastric lavage may be considered. Intravenous fluids and vasopressors may be needed to restore blood pressure. Calcium gluconate may be beneficial in reversing the effects of calcium channel blockade.
Pregnancy & Lactation
Pregnancy Category C. Use only if the potential benefit justifies the potential risk to the fetus. The active ingredient (e.g., Amlodipine) is known to be excreted in human milk; however, the effect on the breastfed infant is unknown. Exercise caution when administered to a nursing woman.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24 to 36 months from the date of manufacture, depending on the manufacturer.
Availability
Available in pharmacies and hospitals
Approval Status
Approved
Patent Status
Off-patent (Generic available)
WHO Essential Medicine
YesClinical Trials
Extensive clinical trials have established the efficacy and safety of the active ingredient (e.g., Amlodipine) in the treatment of hypertension and angina across diverse patient populations.
Lab Monitoring
- Routine blood pressure monitoring is essential.
- Monitor liver function tests periodically in patients with severe hepatic impairment.
- Monitor renal function tests in patients with severe renal impairment, though dose adjustment is not typically needed.
Doctor Notes
- Educate patients on the importance of adherence to daily dosing and lifestyle modifications.
- Monitor blood pressure regularly and assess for common side effects, especially edema.
- Consider combination therapy if monotherapy is insufficient for blood pressure control.
Patient Guidelines
- Take this medicine exactly as prescribed by your doctor.
- Do not stop taking this medicine suddenly without consulting your doctor, even if you feel well.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
- Report any unusual or persistent side effects to your doctor.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
This medicine may cause dizziness, fatigue, or somnolence, especially at the beginning of treatment or when the dose is increased. Avoid driving or operating machinery until you know how this medication affects you.
Lifestyle Advice
- Maintain a healthy diet low in sodium and saturated fats.
- Engage in regular physical activity as advised by your doctor.
- Limit alcohol intake and avoid smoking.
- Regularly monitor your blood pressure at home if recommended by your doctor.
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