Amdocal
Generic Name
Amlodipine Besylate 5 mg
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| amdocal 5 mg tablet | ৳ 5.50 | ৳ 82.43 |
Description
Overview of the medicine
Amlodipine is a dihydropyridine calcium antagonist (calcium ion antagonist or slow channel blocker) that inhibits the transmembrane influx of calcium ions into cardiac and vascular smooth muscle. It is used to treat hypertension and angina.
Uses & Indications
Dosage
Adults
Initial dose is 5 mg once daily. Maximum dose is 10 mg once daily.
Elderly
Initial dose is 2.5 mg once daily, adjusted based on patient response and tolerability. Max 10mg once daily.
Renal_impairment
No dosage adjustment is generally required for patients with renal impairment.
How to Take
Amdocal tablet should be taken orally once daily with or without food. It can be taken at any time of day, but it is best to take it at the same time each day.
Mechanism of Action
Amlodipine selectively inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. This causes vasodilation, reducing peripheral vascular resistance, and consequently lowering blood pressure. In angina, it increases myocardial oxygen supply by dilating coronary arteries and reduces myocardial oxygen demand by reducing afterload.
Pharmacokinetics
Onset
Onset of antihypertensive action is gradual, typically within hours, with peak effect observed at 6-12 hours.
Excretion
Excreted predominantly by the kidneys as inactive metabolites (approximately 60% of administered dose), with 20-25% eliminated in feces.
Half life
Plasma elimination half-life is 30-50 hours, allowing once-daily dosing.
Absorption
Well absorbed orally, peak plasma concentrations reached 6-12 hours after administration. Absolute bioavailability is estimated to be 64-80%.
Metabolism
Extensively metabolized in the liver to inactive metabolites (approximately 90%).
Side Effects
Contraindications
- Hypersensitivity to Amlodipine or other dihydropyridine derivatives
- Severe hypotension
- Cardiogenic shock
- Clinically significant aortic stenosis
- Unstable angina (except Prinzmetal's angina)
Drug Interactions
Simvastatin
Increased risk of myopathy/rhabdomyolysis; limit simvastatin dose to 20 mg/day.
Clarithromycin
Increased risk of hypotension and acute kidney injury in patients receiving Amlodipine.
CYP3A4 inducers (e.g., Rifampicin, Carbamazepine)
May decrease plasma concentrations of Amlodipine, reducing its effect.
CYP3A4 inhibitors (e.g., Ketoconazole, Ritonavir)
May increase plasma concentrations of Amlodipine, requiring dosage adjustment.
Storage
Store in a cool, dry place, below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Overdose may lead to excessive peripheral vasodilation with marked hypotension and possibly a reflex tachycardia. Management involves symptomatic treatment and supportive measures. Gastric lavage and activated charcoal may be considered if ingestion is recent. Intravenous calcium gluconate may be beneficial. If hypotension persists, IV fluids and vasopressors may be needed.
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; the decision to discontinue breastfeeding or the drug should take into account the importance of the drug to the mother.
Side Effects
Contraindications
- Hypersensitivity to Amlodipine or other dihydropyridine derivatives
- Severe hypotension
- Cardiogenic shock
- Clinically significant aortic stenosis
- Unstable angina (except Prinzmetal's angina)
Drug Interactions
Simvastatin
Increased risk of myopathy/rhabdomyolysis; limit simvastatin dose to 20 mg/day.
Clarithromycin
Increased risk of hypotension and acute kidney injury in patients receiving Amlodipine.
CYP3A4 inducers (e.g., Rifampicin, Carbamazepine)
May decrease plasma concentrations of Amlodipine, reducing its effect.
CYP3A4 inhibitors (e.g., Ketoconazole, Ritonavir)
May increase plasma concentrations of Amlodipine, requiring dosage adjustment.
Storage
Store in a cool, dry place, below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Overdose may lead to excessive peripheral vasodilation with marked hypotension and possibly a reflex tachycardia. Management involves symptomatic treatment and supportive measures. Gastric lavage and activated charcoal may be considered if ingestion is recent. Intravenous calcium gluconate may be beneficial. If hypotension persists, IV fluids and vasopressors may be needed.
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; the decision to discontinue breastfeeding or the drug should take into account the importance of the drug to the mother.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from the date of manufacture.
Availability
Pharmacies, hospitals
Approval Status
Approved (Commonly available worldwide)
Patent Status
Generic available, original patent expired
WHO Essential Medicine
YesClinical Trials
Numerous clinical trials have established the efficacy and safety of Amlodipine for hypertension and angina, supporting its widespread use.
Lab Monitoring
- Routine blood pressure monitoring
- Renal function tests (e.g., creatinine, BUN) in patients with severe renal impairment
- Liver function tests in patients with hepatic impairment
Doctor Notes
- Consider lower initial dose in elderly patients and those with hepatic impairment.
- Monitor blood pressure regularly and assess for peripheral edema.
- Counsel patients on adherence and lifestyle modifications for optimal management of hypertension and angina.
Patient Guidelines
- Take the medicine exactly as prescribed by your doctor.
- Do not stop taking Amdocal without consulting your doctor, even if you feel well.
- Inform your doctor about all other medications you are taking, including over-the-counter drugs and herbal supplements.
- Avoid activities requiring mental alertness, such as driving, if you experience dizziness or fatigue.
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 with your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Amdocal may cause dizziness, headache, or fatigue, especially at the start of treatment or when the dose is increased. If you experience these symptoms, 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.
- Limit alcohol consumption.
- Quit smoking to improve cardiovascular health.
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