Amocal
Generic Name
amocal-10-mg-tablet
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| amocal 10 mg tablet | ৳ 6.04 | ৳ 84.56 |
Description
Overview of the medicine
Amocal 10 mg Tablet contains Amlodipine Besilate, a dihydropyridine calcium antagonist. It is primarily used to treat high blood pressure (hypertension) and certain types of chest pain (angina pectoris), including chronic stable angina and vasospastic (Prinzmetal's or variant) angina.
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 adjusted with caution.
Renal_impairment
No dosage adjustment is generally required for patients with renal impairment. Amlodipine is not dialyzable.
How to Take
Take Amocal 10 mg Tablet orally once daily with a glass of water, with or without food. Try to take it at the same time each day.
Mechanism of Action
Amlodipine inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. This causes vasodilation, primarily of the peripheral arterioles, which reduces peripheral vascular resistance and, consequently, blood pressure. In angina, it increases myocardial oxygen supply by dilating coronary arteries and arterioles.
Pharmacokinetics
Onset
Antihypertensive effect begins within 6-12 hours, with full effect taking several days to weeks to achieve steady state.
Excretion
Primarily excreted via the urine as inactive metabolites (approximately 60%) and 20-25% in feces.
Half life
Plasma elimination half-life is 30-50 hours, allowing once-daily dosing.
Absorption
Well absorbed orally, with absolute bioavailability of 64-90%. Peak plasma concentrations are achieved 6-12 hours after oral dosing.
Metabolism
Extensively metabolized in the liver to inactive metabolites (approximately 90%).
Side Effects
Contraindications
- Hypersensitivity to amlodipine, other dihydropyridines, or any component of the formulation
- Severe hypotension
- Cardiogenic shock
- Obstructive outflow tract disease (e.g., severe aortic stenosis)
- Hemodynamically unstable heart failure after acute myocardial infarction
Drug Interactions
Simvastatin
Coadministration with amlodipine increases simvastatin exposure. Limit simvastatin dose to 20 mg/day in patients on amlodipine.
Other antihypertensives
Additive hypotensive effects may occur.
CYP3A4 inducers (e.g., rifampicin, St. John's Wort)
May decrease amlodipine exposure, potentially reducing its effectiveness. Blood pressure monitoring is recommended.
CYP3A4 inhibitors (e.g., ketoconazole, erythromycin, ritonavir)
May increase amlodipine exposure, requiring dose reduction and monitoring for adverse effects.
Storage
Store in a cool, dry place, below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include excessive peripheral vasodilation with marked hypotension and reflex tachycardia. Management involves symptomatic and supportive measures, including monitoring cardiac and respiratory function, elevation of extremities, and administration of intravenous fluids. Vasopressors may be useful to restore vascular tone and blood pressure.
Pregnancy & Lactation
Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Amlodipine is excreted in human milk; therefore, caution should be exercised when administered to a nursing mother.
Side Effects
Contraindications
- Hypersensitivity to amlodipine, other dihydropyridines, or any component of the formulation
- Severe hypotension
- Cardiogenic shock
- Obstructive outflow tract disease (e.g., severe aortic stenosis)
- Hemodynamically unstable heart failure after acute myocardial infarction
Drug Interactions
Simvastatin
Coadministration with amlodipine increases simvastatin exposure. Limit simvastatin dose to 20 mg/day in patients on amlodipine.
Other antihypertensives
Additive hypotensive effects may occur.
CYP3A4 inducers (e.g., rifampicin, St. John's Wort)
May decrease amlodipine exposure, potentially reducing its effectiveness. Blood pressure monitoring is recommended.
CYP3A4 inhibitors (e.g., ketoconazole, erythromycin, ritonavir)
May increase amlodipine exposure, requiring dose reduction and monitoring for adverse effects.
Storage
Store in a cool, dry place, below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include excessive peripheral vasodilation with marked hypotension and reflex tachycardia. Management involves symptomatic and supportive measures, including monitoring cardiac and respiratory function, elevation of extremities, and administration of intravenous fluids. Vasopressors may be useful to restore vascular tone and blood pressure.
Pregnancy & Lactation
Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Amlodipine is excreted in human milk; therefore, caution should be exercised when administered to a nursing mother.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
36 months from the date of manufacture when stored under recommended conditions.
Availability
Available in pharmacies and hospitals nationwide
Approval Status
Approved by health authorities (e.g., DGDA)
Patent Status
Off-patent
WHO Essential Medicine
YesClinical Trials
Amlodipine has undergone extensive clinical trials demonstrating its efficacy and safety in managing hypertension and angina across various patient populations.
Lab Monitoring
- Regular blood pressure monitoring is essential.
- Monitor renal and hepatic function periodically, especially in patients with pre-existing impairment.
Doctor Notes
- Regularly monitor patient's blood pressure, especially at the initiation of therapy and after dose adjustments.
- Advise patients about common side effects like peripheral edema and provide strategies for management.
- Use with caution in patients with severe aortic stenosis or severe obstructive coronary artery disease due to potential for decreased coronary perfusion.
Patient Guidelines
- Take Amocal 10 mg Tablet exactly as prescribed by your doctor.
- Do not stop taking the medicine suddenly without consulting your doctor, as this may worsen your condition.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
- Report any unusual or severe side effects to your doctor immediately.
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 continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Amlodipine may cause dizziness, fatigue, or drowsiness, especially at the start of treatment or when the dose is increased. Exercise caution when driving or operating machinery until you know how this medicine affects you.
Lifestyle Advice
- Maintain a healthy and balanced diet, rich in fruits, vegetables, and whole grains.
- Engage in regular physical activity as advised by your doctor.
- Limit your intake of salt and processed foods.
- Avoid smoking and excessive alcohol consumption.
- Regularly monitor your blood pressure at home if recommended by your doctor.
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