PLUAMLO 10 Tablet

Hypertension, angina including chronic stable and vasospastic types.

Dosage and Administration

Amlodipine is taken orally with a liquid and without chewing.

In hypertensive patients amlodipine has been used in combination with a thiazide diuretic, alpha-blocker, beta-adrenoreceptor blocking agent or an angiotensin converting enzyme inhibitor. For angina amlodipine may be used as a monotherapy or in combination with other antianginal drugs in patients with angina that is refractory to nitrates and/or adequate doses of beta blockers. Amlodipine is well tolerated in patients with heart failure and a history of hypertension or ischaemic heart disease.

In adults: For both hypertension and angina the usual initial dose is 5mg amlodipine once daily which may be increased to a maximum dose of 10mg depending upon the individual patient’s response. No dose adjustment is required upon concomitant administration of thiazide diuretics, beta-blockers, and angiotensin-converting enzyme inhibitors.

Use in children: Not recommended.

In patients with known sensitivity to dihydropyridines, amlodipine, or any of the inert ingredients.

Pregnancy and lactation.

Headache, fatigue, somnolence, dizziness, flushing, palpitations, nausea, peripheral oedema and abdominal pain.

Amlodipine has been safely administered in patients with thiazide diuretics, alpha blockers, beta-blockers, angiotensin converting enzyme inhibitors, long-acting nitrates, sublingual glyceryl trinitrate, NSAIDs, antibiotics and oral hypoglycaemic agents. In vitro data from studies with human plasma indicate that amlodipine has not effect on protein binding of digoxin, phenytoin, warfarin or indomethacin.

Contraindicated.

See the package insert about the details below:

- Use in renal failure.

- Use in patients with impaired hepatic function.

- Use in patient with renal impairment.

Amlodipine is calcium-iron influx inhibitor of the dihydropyridine group (slow channel blocker or calcium iron antagonist) and inhibits the transmembrane influx of calcium ion into cardiac and vascular smooth muscle and cardiac muscle. The mechanism of the antihypertensive action is due to a direct relaxant effect on vascular smooth muscle in arterial blood vessels. The precise mechanism by which amlodipine relieves angina has not been fully determined but amlodipine reduces total ischaemic burden by the following two actions.

1) Amlodipine dilates peripheral arterioles and thus, reduces the total peripheral resistance (afterload) against which the heart works. Since the heart rate remains stable, this unloading of the heart reduces myocardial energy consumption and oxygen requirements.

2) The mechanism of action of amlodipine also probably involves dilatation of the main coronary arteries and coronary arterioles, both in normal and ischaemic regions. This dilatation increases myocardial oxygen delivery in patients with coronary artery spasm (Prinzmetals or variant angina).

In patients with hypertension, once daily dosing provides clinically significant reductions of blood pressure in both the supine and standing positions which lasts for 24 hours. Due to the slow onset of action, acute hypotension is not a feature of amlodipine administration.

In patients with angina, once daily administration of amlodipine increases total exercise time, time to angina onset, and time to 1mm ST segment depression, and decreases both frequency of anginal attacks and glyceryl trinitrate tablet consumption.