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 chronic stable angina. It 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 drug may be used as single therapy or in combination with other antianginal drugs.
Amlodipine is a dihydropyridine calcium-channel blocker, with a long duration of action, used for the treatment of hypertension and angina pectoris. Amlodipine influences the myocardial cells, the cells within the specialized conducting system of the heart, and the cells of vascular smooth muscle. Administration of Amlodipine results primarily in vasodilation, with reduced peripheral resistance, blood pressure and afterload, increased coronary blood flow and a reflex increase in coronary heart rate. This in turn results in an increase in myocardial oxygen supply and cardiac output.
The dose should be individualized according to the goal of therapy and patient response. The usual initial oral dose for stable or vasospastic angina and hypertension is 5 mg once daily with a maximum dose of 10 mg once daily.
Drug Interactions-
Potentially hazardous interactions: Little or no data are available in patients with markedly impaired cardiac left ventricular function; however, as with other calcium antagonist drugs, the combination of Amlodipine and p-blockers should be avoided in such patients.
Other Significant Interactions-
Digoxin: Absence of any interaction between Amlodipine and Digoxin in healthy volunteers has been documented in a controlled clinical study.
Cimetidine: An unpublished clinical study indicated no interaction between, Amlodipine and Cimetidine in healthy volunteers.
Warfarin: An unpublished clinical study in healthy volunteers indicates that Amlodipine did not significantly alter the effect of Warfarin on prothrombin time.
Food: Food does not alter the rate or extent of absorption of Amlodipine.
Amlodipine is contraindicated in patients with- 1. Hypersensitivity to amlodipine, dihydropyridine derivatives or any of the excipients 2. Shock (including cardiogenic shock) 3. Obstruction of the outflow-tract of the left ventricle (e.g. high grade aortic stenosis) 4. Unstable angina 5. Hemodynamically unstable heart failure after acute myocardial infarction (during the first 28 days) 6. Severe hypotension
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 these effects are more common in patients treated with doses greater than 10 mg daily.
Pregnancy Category C. The safety of amlodipine in human pregnancy has not been established. In animal studies, reproductive toxicity was observed at high doses. Use in pregnancy is only recommended when there is no safer alternative and when the disease itself carries greater risk for the mother and fetus. Lactation: It is not known whether amlodipine is excreted in breast milk. A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with amlodipine should be made taking into account the benefit of breast-feeding to the child and the benefit of amlodipine therapy to the mother.
Symptoms: Available data suggest that large overdosage could result in excessive peripheral vasodilatation and possibly reflex tachycardia. Marked and probably prolonged systemic hypotension up to and including shock with fatal outcome have been reported.
Management: Clinically significant hypotension due to amlodipine overdosage calls for active cardiovascular support including frequent monitoring of cardiac and respiratory function, elevation of extremities, and attention to circulating fluid volume and urine output.
A vasoconstrictor may be helpful in restoring vascular tone and blood pressure, provided that there is no contraindication to its use. Intravenous calcium gluconate may be beneficial in reversing the effects of calcium channel blockade. Gastric lavage may be worthwhile in some cases. In healthy volunteers the use of charcoal up to 2 hours after administration of amlodipine 10 mg has been shown to reduce the absorption rate of amlodipine. Since amlodipine is highly protein-bound, dialysis is not likely to be of benefit.
Keep all medicines out of reach of children. Store in a cool & dry place, protected from light.
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