Description
Amlodipine besilate is a long‑acting dihydropyridine calcium‑channel blocker used to lower high blood pressure and treat certain types of angina by relaxing and dilating blood vessels.
Prescription
Prescription-only (Rx‑only) in most countries including the US, UK, EU, and Australia .
Therapeutic Category
Cardiovascular agent – antihypertensive and anti-anginal.
Active Ingredients / Composition
Each tablet contains 5 mg amlodipine (as amlodipine besilate), equivalent to 5 mg amlodipine base.
Vitamins
None.
Minerals
None.
Variant
Film-coated immediate‑release oral tablet, strength ‑ 5 mg; alternate salt forms (e.g., amlodipine mesylate or maleate) are considered therapeutically equivalent.
Consume Type
Oral administration (swallowed whole), with or without food.
Directions / Usage
- Typical adult dose: 5 mg once daily, starting at 2.5 mg–5 mg per day; maximum 10 mg/day.
- For elderly or those with liver impairment, starting dose often 2.5 mg/day.
- Take at same time daily; if a dose is missed and within 12 hours, take it; otherwise skip and resume schedule.
Common Side Effects
- Lower limb edema (swelling of legs/ankles)
- Fatigue, tiredness, drowsiness
- Nausea, abdominal pain, dizziness, flushing
- Palpitations or irregular heartbeat, rarely worsening angina or heart attack upon initiation or dose increase.
Package Type
Usually in blister strips or bottles, depending on manufacturer — typical counts: 10, 28, 30 tablets per pack.
Storage Advice
Keep at room temperature (20–25 °C / 68–77 °F), allow excursions between 15–30 °C (59–86 °F); store in dry place, protected from light, avoid bathroom moisture, and keep out of reach of children.
Safety Advice
- Not to be used in patients with allergy to dihydropyridines or amlodipine.
- Use with caution in severe aortic stenosis, heart failure, or recent myocardial infarction .
- Adjust dose in hepatic impairment.
- Pregnancy / breastfeeding safety unclear; consult healthcare provider .
- Check for drug interactions (e.g. with simvastatin, cyclosporine, antifungals) .
- Do not suddenly discontinue—monitor blood pressure regularly.
Product Substitutes
Generic or branded equivalents (5 mg tablets) widely available globally: e.g., Norvasc (Pfizer’s original), generic Amlodipine by Teva, Sandoz, Eurogenerics, Biogaran, Accel, Mylan, etc.
Manufacturer / Marketer
Various manufacturers produce amlodipine 5 mg tablets:
- Teva Pharmaceuticals markets generic Amlodipine Besylate Tablets, USP (e.g. 5 mg) in the U.S.
- Others include Eurogenerics (Luxembourg), Sandoz (Luxembourg), Biogaran (France), Aurovitas (Poland), Norma (Malta/Greece) and others.
Country of Origin
Depends on manufacturer: examples include Luxembourg, France, Poland, Malta, India, and others — country varies by brand/generic maker
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