Each uncoated tablet contains: Amlodipine Besilate B.P. equivalent to Amlodipine 5 or 10 mg.
Pharmacology: Pharmacodynamics: Mechanism of Action: Amlodipine is a dihydropyridine calcium-channel blocker. Calcium-channel blockers, also known as calcium antagonists, calcium-entry blockers, and slow-channel blockers, inhibit the cellular influx of calcium which is responsible for maintenance of the plateau phase of the action potential. Thus calcium-channel blockers primarily affect tissues in which depolarisation is dependent upon calcium rather than sodium influx, and these include vascular smooth muscle, myocardial cells, and cells within the sino-atrial (SA) and atrioventricular (AV) nodes. The main actions of the calcium-channel blockers include dilatation of coronary and peripheral arteries and arterioles, with little or no effect on venous tone, a negative inotropic action, reduction of heart rate, and slowing of AV conduction.
For the treatment of hypertension and prophylaxis of angina.
It is given by mouth as the besilate, alone or in combination with other agents, in the management of hypertension, in doses equivalent to 5 mg amlodipine daily, as a single dose. The dose may be increased, if necessary, to the equivalent of 10 mg daily. Similar doses are given in the treatment of stable angina and Prinzmetal's angina. Small, fragile, or elderly individuals, or patients with hepatic insufficiency may be started on 2.5 mg once daily and this dose may be used in combination with other antihypertensives.
Overdosage might be expected to cause excessive peripheral vasodilation with marked hypotension and possibly a reflex tachycardia. If massive overdosage should occur, active cardiac and respiratory monitoring should be instituted. Frequent blood pressure measurements are essential. Should hypotension occur, cardiovascular support including elevation of the extremities and the judicious administration of fluids should be initiated. Intravenous calcium gluconate may help to reverse the effects of calcium entry blockade.
Contraindicated in patients with known sensitivity to amlodipine.
Rarely patients, particularly those with severe obstructive coronary artery disease, have developed documented increased frequency, duration and/or severity of angina or acute myocardial infarction on starting calcium channel blocker therapy.
General: Since the vasodilatation induced by amlodipine is gradual in onset, acute hypertension has rarely been reported after oral administration. Nonetheless, caution should be exercised when administrating amlodipine with any other peripheral vasodilator particularly in patients with severe aortic stenosis.
Use in patients with Congestive Heart Failure: In general, amlodipine should be used with caution in patients with heart failure.
Beta-Blocker Withdrawal: Amlodipine is not a beta blocker and hence gives no protection against the dangers of abrupt beta blocker withdrawal; any such withdrawal should be by gradual reduction of the dose of beta blocker.
Patients with Hepatic Failure: Since amlodipine is extensively metabolised by the liver and the plasma elimination half-life is 56 hours in patients with impaired hepatic function, caution should be exercised when administrating amlodipine to such patients.
The most common adverse effects of Amlodipine are associated with the vasodilatory action, such as dizziness, flushing, headache, hypotension and peripheral oedema. Gastro-intestinal disturbances, increased micturition frequency, lethargy, eye pain, and mental depression have also occurred. A paradoxical increase in ischaemic chest pain may occur at the start of treatment and in a few patients excessive fall in blood pressure has led to cerebral or myocardial ischaemia or transient blindness.
There have been reports of rashes, fever, and abnormalities in liver function due to hypersensitivity reactions. Gingival hyperplasia has been reported but is often reversible on drug withdrawal.
In-vitro data in human plasma indicate that amlodipine has no effect on the protein binding of digoxin, phenytoin, warfarin and indomethacin.
It potentiates effects of thiazide diuretics and ACE inhibitors.
Store at a temperature not exceeding 30°C. Protect from light.
C08CA01 - amlodipine ; Belongs to the class of dihydropyridine derivative selective calcium-channel blockers with mainly vascular effects. Used in the treatment of cardiovascular diseases.
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