AMLOCOR-10 Tablet

・Hypertension: Amlocor is indicated as monotherapy for the first line treatment of mild to moderate hypertension. Amlocor can also be used in combination with thiazide diuretics, beta adrenoceptor-blockers or angiotensin-converting enzyme inhibitors for the patients not responding adequately to monotherapy with any of these antihypertensive agents.

・Chronic Stable Angina: Amlocor is indicated for the first-line management of myocardial ischaemia due to fixed obstruction of the coronary vasculature (stable angina). Amlocor may be used as monotherapy, or in combination with other antianginal drugs in patients with angina that is refractory to nitrates and/or adequate does of beta-adrenoceptor blocking agents.

・Variant (Prinzmetal’s or Vasospastic) Angina: Amlocor is indicated for the management of confirmed or suspected variant angina where it may be used either as a monotherapy or in combination with other anti-anginal agents.

Dosage and method of administration

Oral

Adults: For both hypertension and angina, the recommended initial dose is 5mg orally once daily which may be increased to a maximum dose of 10mg depending on the individual patient’s response.

Small, fragile or elderly patients or patients with hepatic insufficiency may be started on Amlocor 2.5mg once daily and this dose may be used when adding Amlocor to Amlocor can be administered with or without food.

Use in elderly: Although elderly patients may higher plasma concentrations of Amlocor than younger patients, the terminal elimination half-lives in both are similar. Amlocor is similarly well-tolerated in elderly or younger patients. Therefore, the normal dosage of Amlocor is recommended for elderly people.

See the package insert about the details below:

- Use in patients with renal impairment

- Use in patients with impaired hepatic function

In patients with a known hypersensitivity to Amlodipine and other dihydropyridines (e.g. nifedipine, nicardipine, isradipine).

The most commonly observed side effects are headache, oedema, fatigue, flushing and dizziness.

Less common side effects include nausea, abdominal pain, somnolence and palpitations.

Rare side effects include muscle cramps, frequency of micturition or nocturia, coughing, breathlessness, epistaxis, impotence, nervousness and conjunctivitis. No clinically significant pattern of laboratory test abnormalities related to Amlodipine has been observed.

Amlodipine has not been associated with any adverse metabolic effects or changes in plasma lipids. Amlodipine has been used safely in patients with well compensated congestive heart failure, peripheral vascular disease, chronic obstructive pulmonary disease, abnormal lipid profiles and diabetes mellitus.

Amlocor has been safely administered with thiazide diuretics, beta-adrenoceptor blocking drugs, angiotensin-converting enzyme inhibitors, long-acting nitrates, sublingual glyceryl trinitrate, NSAIDs, antibiotics, and oral hypoglycaemic agents.

Co-administration of Amlodipine with digoxin did not change serum digoxin levels or digoxin renal clearance in normal volunteers. Co-administration of cimetidine did not alter the pharmacokinetics of Amlodipine.

In healthy volunteers, co-administration of Amlodipine did not significantly alter the effect of warfarin on prothrombin time. The introduction of Amlodipine is not likely to result in the need modification of an established warfarin regimen.

There are no adequate and well controlled studies with Amlodipine in pregnant women. Amlodipine should not be administered during pregnancy or to women of child-bearing potential unless effective contraception is ensured.

Since there is no clinical experience with Amlodipine in children, use of Amlocor is not currently recommended for children and adolescents of less than 18 years of age.

The half-life of Amlocor is prolonged in patients with impaired liver functions; Amlocor should be administered with caution in such patients. Amlocor should be administered with caution in patients receiving either peripheral vasodilators especially in patients with severe aortic stenosis) or in patients with severe heart failure.

Amlodipine, acts primarily by inhibiting extracellular calcium influx through cardiac and vascular smooth muscle cell membranes; this inhibition is achieved mainly by blockade of L-type ‘voltage-operated’ calcium channels. Its main site of action is the peripheral vasculature, although it also produces vasodilation in coronary vascular beds.

In patients with angina, the mechanism by which Amlodipine is thought to lower the total ischaemic burden depends on two actions.

1. Dilation of peripheral arterioles leads to reduction in total peripheral resistance (afterload), generally without reflex tachycardia, and subsequent decreases in myocardial oxygen consumption and oxygen requirements.

2. Dilation of both coronary arteries and arterioles in normal and ischaemic regions improves myocardial oxygen delivery.