Company: Clonmel Healthcare Ltd.
Legal category: Prescription. GMS reimbursable. Sport permitted.
Active ingredient: Amlodipine (as besilate) 5mg, 10mg.
Description: White, round tablets. 10mg: Break score on one side.
Presentation: 5mg-28, €2.00; 10mg-28, €3.00.
Indications: Hypertension, chronic stable angina pectoris, vasospastic (Prinzmetal’s) angina.
Pharmacology: Amlodipine is a calcium ion influx inhibitor of the dihydropyridine group (slow channel blocker or calcium ion antagonist) and inhibits transmembrane influx of calcium ions into cardiac and vascular smooth muscle. The antihypertensive action of amlodipine is due to a direct relaxant effect on vascular smooth muscle. It reduces total ischaemic burden by dilating peripheral arterioles, thus reducing total peripheral resistance (afterload) against which the heart works. Since the heart rate remains stable, unloading of the heart reduces myocardial energy consumption and oxygen requirements. Amlodipine also probably involves dilatation of the main coronary arteries and coronary arterioles, both in normal and ischaemic regions, which increases myocardial oxygen delivery in patients with coronary artery spasm (Prinzmetal’s or variant angina).
Dosage: Adult: Initially 5mg once daily, may increase to maximum 10mg. Hypertension: Can use in combination with thiazide diuretic, alpha blocker, beta blocker, or an angiotensin-converting enzyme inhibitor. Angina: May use as monotherapy or in combination with other antianginal agents where angina is refractory to nitrates/adequate doses of beta-blockers. Hepatic impairment (caution): Initiate at lower end of the dosing range. Titrate slowly and carefully monitor if severe. Elderly: Increase dose with care. Children: Under 18 years, not recommended.
Contraindications: Hypersensitivity to dihydropyridine derivatives, amlodipine or to any of the excipients. Severe hypotension, shock (including cardiogenic shock), left ventricle outflow-tract obstruction, haemodynamically unstable HF after acute MI. Pregnancy, lactation.
Special precautions: Caution: Heart failure. Renal impairment (amlodipine not dialyzable). Hypertensive crisis (no data). Driving/using machines (caution).
Drug interactions: Avoid: Dantrolene (infusion) (malignant hyperthermia patients or susceptible). Not recommended: Grapefruit. Caution: CYP3A4 inducers, other antihypertensives, simvastatin. Strong or moderate CYP3A4 inhibitors.
Adverse drug reactions: Somnolence, dizziness, headache, palpitations, flushing, abdominal pain, nausea, ankle swelling, oedema and fatigue.
Full prescribing information and references available from Clonmel Healthcare Ltd. Telephone: (052) 617 7777. Fax: (052) 617 7791. E-mail: medicalinformation@clonmel-health.ie