ETOCAR

What it is

ETOCAR contains metoprolol tartrate 50 mg or 100 mg in film coated tablets. Metoprolol is a relatively cardioselective beta-blocker that acts on beta₁-receptors mainly located in the heart at lower doses than those needed to influence the beta₂-receptors mainly located in the bronchi and peripheral vessels. Metoprolol has little membrane-stabilising effect and does not display partial agonist activity at doses required to produce beta-blockade.

Approved indications

— Hypertension as monotherapy or for use in combination with other antihypertensives. — Angina pectoris for long-term prophylaxis. — Confirmed or suspected myocardial infarction. — Prevention of migraine.

Dosing overview

The maximum daily dose should not exceed 400 mg. Although twice daily dosage is optimal, in those patients whose maintenance dosage is 150 mg daily or less, it may be administered as a single dose. Film coated tablets should be swallowed whole with a glass of water and always taken in standard relation to meals.

Key safety warnings

Patients with bronchospastic disease should not be given beta-blockers of any type, including ETOCAR, although if such therapy must be used, great caution should be exercised. Beta-blockade depresses myocardial contractility and may precipitate cardiac failure in some patients with a history of cardiac failure, chronic myocardial insufficiency or unsuspected cardiomyopathy, and in patients without a history of cardiac failure, continuing depression of the myocardium may lead to cardiac failure. There is a risk of exacerbating the number and duration of coronary artery spasms if patients with Prinzmetal angina or variant angina pectoris are treated with ETOCAR, and if this treatment is essential, it should only be undertaken in a Coronary or Intensive Care Unit. ETOCAR should be used with caution in patients with diabetes mellitus, especially those receiving insulin or oral hypoglycaemic agents, as beta-blockers affect glucose metabolism and may mask some important premonitory signs of acute hypoglycaemia such as tachycardia. Care should be taken if beta-blockers have to be discontinued abruptly in patients with coronary artery disease, as severe exacerbation of angina and precipitation of myocardial infarction and ventricular arrhythmias have occurred, and therefore it is recommended that the dosage be reduced gradually over a period of about 8–14 days.

Contraindications

ETOCAR is contraindicated in patients with known hypersensitivity to metoprolol and related derivatives, hypersensitivity to any of the excipients, sensitivity to other beta-blockers, atrioventricular block of second or third degree, congestive heart failure, sinus bradycardia (less than 45 to 50 beats per minute), sick-sinus syndrome, severe peripheral arterial circulatory disorders, shock (including cardiogenic and hypovolaemic shock), myocardial infarction patients with a heart rate of less than 45 beats per minute, a P-R interval of greater than 0.24 seconds, a systolic blood pressure of less than 100 mm Hg, and/or moderate to severe heart failure, right ventricular failure secondary to pulmonary hypertension, significant right ventricular hypertrophy, hypotension, untreated phaeochromocytoma, allergic disorders (including allergic rhinitis) which may suggest a predisposition to bronchospasm, and severe bronchial asthma or history of severe bronchospasm.

Regulatory history

ETOCAR metoprolol tartrate 50 mg and 100 mg film-coated tablets were first listed on the ARTG on 25 March 2015.