Amlodipine is a dihydropyridine calcium antagonist,
with a long duration of action, used for the treatment of hypertension and
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.
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.
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
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
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
Store in a cool dry place protected from light. Keep out of reach of