Each tablet contains: Amlodipine (as besilate) 5 mg/10 mg.
Action
Pharmacology: Pharmacokinetics: Amlodipine is well absorbed following oral administration with peak blood concentrations occurring after 6 to 12 hours. The bioavailability is about 60-65%. Amlodipine is reported to be 97.5% bound to plasma proteins. It has a prolonged terminal elimination half-life of 35 to 50 hours and steady state plasma concentrations are not achieved until after 7 to 8 days of administration. Amlodipine is extensively metabolized in the liver; metabolites are mostly excreted in the urine together with less than 10% of a dose as unchanged drug.
Indications/Uses
Amlodipine is used in the management of hypertension and angina pectoris. It may be used in combination with other antihypertensive and antianginal agents.
Dosage/Direction for Use
The usual initial antihypertensive dose of Amlodipine is 5 mg once daily, with a maximum dose of 10 mg once daily.
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 when adding Amlodipine to other antihypertensive therapy or as prescribed by a physician.
Dose may be increased depending on the patient's response.
The recommended dose for chronic stable or vasospastic angina is 5-10 mg, with the lower dose suggested in the elderly and in patients with hepatic insufficiency. Most patients will require 10 mg for adequate effects or as prescribed by a physician.
Amlodipine is given by mouth as the besilate, but doses are usually expressed in terms of the base.
Overdosage
Activated charcoal may be administered in case of overdosage. Hypotension may respond to placing the patient in supine position with the feet raised and the administration of plasma expanders. If hypotension is not corrected, calcium gluconate or calcium chloride should be given intravenously. If hypotension persists, intravenous administration of a sympathomimetic agent such as isoprenaline, dopamine or noradrenaline (norepinephrine) may be given. Dialysis is not useful as amlodipine is highly protein bound.
Contraindications
Amlodipine is contraindicated in patients with known sensitivity to amlodipine. Cardiogenic shock, unstable angina, significant aortic stenosis and obesity.
Special Precautions
Amlodipine should be used with caution in patients with hypotension, in patients whose cardiac reserve is poor, and in those with heart failure since deterioration of heart failure has been noted. Amlodipine should not be used in cardiogenic shock, in patients who have recently suffered a myocardial infarction, or in acute unstable angina. Amlodipine should not be used to treat an anginal attack in chronic stable angina. In patients with severe aortic stenosis, amlodipine may increase the risk of developing heart failure. The dose may need to be reduced in patients with hepatic impairment. Amlodipine should be discontinued in patients who experience ischaemic pain following its administration and should be avoided in pregnancy.
Amlodipine may enhance the antihypertensive effects of other hypertensive drugs such as beta blockers, although the combination is generally tolerated. It may modify insulin and glucose response and therefore, diabetic patients may need to adjust their antidiabetic treatment.
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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