Amlozep
Generic Name
Amlodipine
Manufacturer
Hypothetical Pharma Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| amlozep 5 mg capsule | ৳ 6.04 | ৳ 60.40 |
Description
Overview of the medicine
Amlodipine is a long-acting calcium channel blocker used to treat high blood pressure and angina. It works by relaxing blood vessels, allowing blood to flow more easily, thereby reducing blood pressure and relieving chest pain.
Uses & Indications
Dosage
Adults
Initial dose 5 mg orally once daily. Maximum dose 10 mg once daily. Adjust dosage based on patient response and tolerability over 1-2 weeks.
Elderly
Initial dose 2.5 mg once daily. Titrate gradually and monitor for signs of hypotension.
Renal_impairment
No dosage adjustment necessary. Amlodipine is not dialyzable.
How to Take
Orally, with or without food. Can be taken at any time of day but should be taken 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 peripheral arterial vasodilation, leading to a reduction in systemic vascular resistance and blood pressure. It also reduces myocardial oxygen demand and increases myocardial oxygen supply in vasospastic angina.
Pharmacokinetics
Onset
Gradual onset, typically within hours for blood pressure reduction. Full therapeutic effect may take 1-2 weeks.
Excretion
Mainly via urine (about 60% as inactive metabolites, 10% as unchanged drug), remainder via feces.
Half life
30-50 hours, allowing once-daily dosing.
Absorption
Well absorbed from the GI tract (bioavailability 64-90%), peak plasma concentrations reached in 6-12 hours. Food does not affect absorption.
Metabolism
Extensively metabolized in the liver (approximately 90%) to inactive metabolites via CYP3A4.
Side Effects
Contraindications
- Hypersensitivity to amlodipine or other dihydropyridine derivatives
- Severe hypotension
- Cardiogenic shock
- Obstructive outflow tract disease (e.g., severe aortic stenosis)
- Unstable angina or acute myocardial infarction (in absence of an ACE inhibitor)
Drug Interactions
Simvastatin
Limit simvastatin dose to 20 mg/day in patients taking amlodipine, due to increased risk of myopathy/rhabdomyolysis.
Immunosuppressants (e.g., cyclosporine, tacrolimus)
Amlodipine may increase plasma concentrations of these drugs. Monitor blood levels of immunosuppressants.
CYP3A4 inducers (e.g., rifampicin, carbamazepine, phenobarbital, phenytoin)
May decrease amlodipine plasma concentrations, potentially reducing its efficacy. Blood pressure monitoring is recommended.
CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, diltiazem)
May increase amlodipine exposure, especially in elderly patients, potentially leading to increased hypotension and edema. Dose reduction may be considered.
Storage
Store below 30°C (86°F) in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
Symptoms include excessive peripheral vasodilation with marked hypotension, and possibly reflex tachycardia. Management involves active cardiovascular support, including frequent monitoring of cardiac and respiratory function, elevation of extremities, and management of circulating fluid volume and urine output. Intravenous calcium gluconate may be beneficial to reverse the effects of calcium channel blockade. Vasopressors may be used if hypotension remains refractory.
Pregnancy & Lactation
Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is unknown whether amlodipine is excreted in human milk, so caution should be exercised when administered to a breastfeeding mother.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from the manufacturing date, consult the packaging for exact expiry.
Availability
Pharmacies, Hospitals
Approval Status
Approved by major regulatory bodies (e.g., FDA, DGDA)
Patent Status
Off-patent
WHO Essential Medicine
YesClinical Trials
Extensive clinical trials have established amlodipine's efficacy and safety in hypertension and angina. Key trials include the ALLHAT study (Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial) which demonstrated its cardiovascular benefits, and CAMELOT (Comparison of Amlodipine vs. Enalapril to Limit Occurrences of Thrombosis) study.
Lab Monitoring
- Monitor blood pressure regularly, especially during dose titration.
- Monitor liver function tests periodically, particularly in patients with hepatic impairment, as amlodipine is extensively metabolized in the liver.
Doctor Notes
- Educate patients on the importance of consistent medication adherence, especially for chronic conditions like hypertension.
- Counsel on lifestyle modifications (diet, exercise, sodium restriction) to enhance therapeutic outcomes.
- Monitor for peripheral edema, particularly with higher doses, and consider dose adjustment or alternative agents if bothersome.
- Assess for drug interactions, especially with CYP3A4 inhibitors/inducers and simvastatin.
Patient Guidelines
- Take the medicine exactly as prescribed by your doctor.
- Do not stop taking amlodipine suddenly, even if you feel well, without consulting your doctor.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
- Report any severe or persistent side effects to your doctor immediately.
Missed Dose Advice
If you miss a dose, take it as soon as you remember, unless it is more than 12 hours late or almost time for your next dose. Do not take a double dose to make up for a missed one.
Driving Precautions
Amlodipine may cause dizziness, fatigue, or visual disturbances, especially at the start of treatment or after a dose increase. Exercise caution when driving or operating machinery until you know how this medicine affects you.
Lifestyle Advice
- Maintain a healthy diet low in sodium and saturated fats.
- Engage in regular physical activity as advised by your doctor.
- Avoid excessive salt intake.
- Limit alcohol consumption, as it can worsen blood pressure and side effects.
- Quit smoking if you smoke.
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Global Brand Names
International brand names for this medicine. Click a brand to search for detailed information.