Amlodipine 5 mg Tablet
Amlodipine is a dihydropyridine calcium antagonist, with a long duration of action, used for the treatment of hypertension and angina pectoris.
Hypertension: Amlodipine is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents. Stable angina: Amlodipine is indicated for the treatment of stable angina. Amlodipine may be used alone or in combination with other antianginal agents. Vasospastic angina : Amlodipine is indicated for the treatment of confirmed or suspected vasospastic angina.
Dosage and Administrations
The usual initial antihypertensive oral dose is 5 mg once daily with a maximum dose of 10 mg once daily. Elderly individuals or patients with hepatic insufficiency may be started on 2.5 mg once daily dose and this dose may be used when adding Amlodipine to other antihypertensive therapy. Dosage should be adjusted according to each patient`s need. The recommended dose for stable or vasospastic angina is 5-10 mg, with the lower dose suggested in the elderly and in patients with hepatic insufficiency.
Peripheral oedema may occasionally be severe but is fully reversible. As with other calcium antagonist drugs, peripheral oedema and skin erythema occur in a proportion of patients (5-10%) and facial flushing in 2-5% of patients. Complain of fatigue was also reported more frequently than in placebo treated patients.
There is evidence that this effects are more common in patients treated with doses greater than 10 mg daily.
Amlodipine is contraindicated in patients with known hypersensitivity to any component of the product.
Use of Amlodipine together with thiazide diuretics or angiotensin-converting-enzyme inhibitors in the treatment of hypertension is additive. There are no hazardous interaction of Amlodipine with Digoxin, Cimetidine, Warfarin and food.
General: Since the vasodilatation induced by Amlodipine is gradual in onset, acute hypotension has rarely been reported after oral administration of Amlodipine. Caution should be exercised when administering Amlodipine as with any other peripheral vasodilator, particularly, in patients with severe aortic stenosis. Use in patient with congestive heart failure: Although haemodynamic studies and a controlled trial in class II-III heart failure patients have shown that Amlodipine did not lead to clinical deterioration as measured by exercise tolerance, left ventricular ejection fraction and clinical symptomatology in general, all calcium channel blockers should be used with caution in patients with heart failure. Beta-blocker withdrawal: Amlodipine gives no protection against the danger of abrupt beta blocker withdrawal; any such withdrawal should be gradual reduction of the dose of beta-blocker. Hepatic failure: Since Amlodipine is extensively metabolized by the liver, so caution should be exercised when administering Amlodipine to patients with hepatic impairment. Use in pregnancy : Safety of Amlodipine in human pregnancy has not been established. Accordingly, use in pregnancy is recommended only when there is no safer alternative and when the disease itself carries greater risk for the mother and foetus. Use in lactation: Safety of Amlodipine in lactation has not been established. Use in children: Safety and effectiveness of Amlodipine in children have not been established.
In humans, experience with intentional overdosage of Amlodipine is limited. If massive overdosage occurs, active cardiac and respiratory monitoring should be instituted. Frequent blood pressure monitoring is essential.
Store in a cool dry place protected from light. Keep out of reach of children.
Amlocard® 10 tablet: Box containing 4X7 tablets in blister pack and each tablet contains Amlodipine Besilate BP equivalent to 5 mg Amlodipine.