Amdocal
Generic Name
Amlodipine Besylate
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| amdocal 25 mg tablet | ৳ 3.00 | ৳ 30.00 |
Description
Overview of the medicine
Amlodipine is a calcium channel blocker used to treat high blood pressure (hypertension) and chest pain (angina). It helps relax blood vessels so blood can flow more easily, lowering blood pressure and reducing the frequency of angina attacks.
Uses & Indications
Dosage
Adults
Initial dose is usually 2.5 mg or 5 mg orally once daily. Maximum dose is 10 mg once daily. For 2.5mg, it is often a starting dose for specific patient groups.
Elderly
A lower initial dose of 2.5 mg once daily is recommended. Dosage should be adjusted based on clinical response.
Renal_impairment
No dosage adjustment is required for patients with renal impairment. Use with caution in dialysis patients.
How to Take
Take Amdocal 2.5 mg tablet orally, once daily, with or without food. Swallow the tablet whole with water. Do not chew, crush, or break the tablet.
Mechanism of Action
Amlodipine is a dihydropyridine calcium antagonist (calcium ion antagonist or slow-channel blocker) that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. This causes peripheral arterial vasodilation, leading to reduced peripheral vascular resistance and blood pressure reduction. It also increases myocardial oxygen supply in patients with vasospastic angina.
Pharmacokinetics
Onset
Gradual onset of antihypertensive action over 6-12 hours, minimizing the risk of acute hypotension.
Excretion
Approximately 60% of the administered dose is excreted in the urine as inactive metabolites; 10% as unchanged drug. The remaining 20-25% is excreted in feces.
Half life
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 60-65%.
Metabolism
Extensively metabolized in the liver to inactive metabolites (approximately 90%) via CYP3A4 pathways.
Side Effects
Contraindications
- Hypersensitivity to amlodipine or other dihydropyridines, or to any of the excipients.
- Severe hypotension.
- Cardiogenic shock.
- Obstruction of the outflow tract of the left ventricle (e.g., high-grade aortic stenosis).
- Haemodynamically unstable heart failure after acute myocardial infarction.
Drug Interactions
Simvastatin
Limit simvastatin dose to 20 mg daily in patients on amlodipine.
CYP3A4 Inducers
Decreased amlodipine exposure (e.g., rifampicin, St. John's Wort).
Grapefruit juice
May increase amlodipine exposure; avoid excessive consumption.
CYP3A4 Inhibitors
Increased amlodipine exposure, requiring dose adjustment (e.g., ketoconazole, itraconazole, ritonavir).
Ciclosporin/Tacrolimus
Monitor ciclosporin/tacrolimus levels and adjust dose as needed.
Storage
Store below 30°C in a dry place, away 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 supportive cardiovascular care, including monitoring cardiac and respiratory function, elevation of extremities, and management of circulating fluid volume and urine output. Vasopressors and IV calcium gluconate may be administered.
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; lactation is not recommended during treatment.
Side Effects
Contraindications
- Hypersensitivity to amlodipine or other dihydropyridines, or to any of the excipients.
- Severe hypotension.
- Cardiogenic shock.
- Obstruction of the outflow tract of the left ventricle (e.g., high-grade aortic stenosis).
- Haemodynamically unstable heart failure after acute myocardial infarction.
Drug Interactions
Simvastatin
Limit simvastatin dose to 20 mg daily in patients on amlodipine.
CYP3A4 Inducers
Decreased amlodipine exposure (e.g., rifampicin, St. John's Wort).
Grapefruit juice
May increase amlodipine exposure; avoid excessive consumption.
CYP3A4 Inhibitors
Increased amlodipine exposure, requiring dose adjustment (e.g., ketoconazole, itraconazole, ritonavir).
Ciclosporin/Tacrolimus
Monitor ciclosporin/tacrolimus levels and adjust dose as needed.
Storage
Store below 30°C in a dry place, away 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 supportive cardiovascular care, including monitoring cardiac and respiratory function, elevation of extremities, and management of circulating fluid volume and urine output. Vasopressors and IV calcium gluconate may be administered.
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; lactation is not recommended during treatment.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
2-3 years from manufacturing date, depending on specific formulation and manufacturer.
Availability
Available in pharmacies and hospitals
Approval Status
Approved by regulatory authorities like FDA, DGDA.
Patent Status
Off-patent, generic available
WHO Essential Medicine
YesClinical Trials
Amlodipine has undergone extensive clinical trials demonstrating its efficacy and safety in the treatment of hypertension and angina. Ongoing research continues to explore its role in various cardiovascular conditions.
Lab Monitoring
- Routine laboratory monitoring is generally not required.
- Monitor liver function tests in patients with hepatic impairment.
Doctor Notes
- Start amlodipine at a low dose (e.g., 2.5 mg) in elderly or frail patients, and titrate slowly.
- Educate patients about the possibility of peripheral edema and its management (e.g., leg elevation).
- Amlodipine can be used safely in patients with renal impairment without dose adjustment.
- Monitor blood pressure regularly, especially during dose adjustments.
Patient Guidelines
- Take the medicine regularly as prescribed by your doctor, even if you feel well.
- Do not stop taking Amdocal suddenly without consulting your doctor.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
- Report any unusual 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 resume your regular dosing schedule. Do not double the dose to catch up.
Driving Precautions
Amdocal may cause dizziness, fatigue, or headache, particularly at the start of treatment or when the dose is increased. If affected, avoid driving or operating machinery.
Lifestyle Advice
- Maintain a healthy diet low in sodium and saturated fats.
- Engage in regular physical activity as advised by your doctor.
- Avoid smoking and limit alcohol consumption.
- Regularly monitor your blood pressure at home if advised by your doctor.
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