Treatment of hypertension. Amlodipine is also indicated for the treatment of chronic stable angina and vasospastic (Prinzmetal's) angina where approved.
Adult:
Hypertension: Initial dose: 2.5–5 mg once a day
Maximum dose: 10 mg per day.
Angina: Initial dose: 5 mg once a day
Maximum dose: 10 mg per day.
Children (6–17 years):
Hypertension: Initial dose: 2.5 mg once a day
Maximum dose: 5 mg per day.
Children under 6 years must not be taken unless recommended by physician.
Elderly:
Initial dose: 2.5 mg once a day
Maintenance dose: 2.5–10 mg once a day
Maximum dose: 10 mg per day.
Each tablet contains:
Amlodipine Besilate B.P equivalent to Amlodipine ........ 5 mg.
Amlodipine is a long-acting dihydropyridine calcium-channel blocker used primarily in the management of hypertension and angina.
Amlodipine inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle.
Its antihypertensive action results primarily from relaxation of vascular smooth muscle and reduction in peripheral vascular resistance.
In patients with angina, it reduces myocardial oxygen demand through peripheral vasodilation and may improve coronary blood flow.
Following oral administration, amlodipine is gradually absorbed, with peak plasma concentrations generally occurring approximately 6–12 hours after administration.
Its terminal elimination half-life is approximately 30–50 hours, allowing once-daily administration. It is extensively metabolized in the liver.
Contraindicated in patients with known hypersensitivity to amlodipine, other dihydropyridines or any component of the formulation.
Use with caution in patients with severe hypotension, hepatic impairment and certain forms of significant cardiac disease.
Because of its long half-life, dose adjustments should be made gradually when necessary.
Common adverse effects include peripheral/ankle oedema, headache, flushing, dizziness, fatigue and palpitations.
Gastrointestinal symptoms such as nausea and abdominal discomfort may also occur.
Significant overdose may result in excessive peripheral vasodilation with marked and potentially prolonged hypotension.
Cardiovascular and respiratory functions should be monitored and appropriate supportive treatment instituted.
Amlodipine may have additive blood-pressure-lowering effects when administered with other antihypertensive agents.
CYP3A4 inhibitors may increase amlodipine exposure, while CYP3A4 inducers may alter its plasma concentration. Clinically relevant interactions should be considered according to concomitant therapy.
Store below 30*C in cool and dry place. Protect from light and moisture. Keep out or reach and sight of children.
3 x 10’s Alu-Alu Blisters.