METOPROLOL-WGR

What it is

METOPROLOL-WGR 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 nor does it 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. METOPROLOL-WGR tablets should be swallowed whole with a glass of water and always taken in standard relation to meals.

Key safety warnings

Beta-adrenergic blockade of the smooth muscle of bronchi and bronchioles may result in an increased airways resistance and reduce the effectiveness of asthma treatment, which may be dangerous in susceptible patients; therefore, beta-blockers are contraindicated in any patient with a history of airways obstruction or a tendency to bronchospasm. 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. METOPROLOL-WGR 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 important premonitory signs of acute hypoglycaemia such as tachycardia, and may result in the loss of diabetic control and delayed recovery from hypoglycaemia. Care should be taken if beta-blockers are discontinued abruptly in patients with coronary artery disease, as severe exacerbation of angina and precipitation of myocardial infarction and ventricular arrhythmias have occurred; therefore, it is recommended that the dosage be reduced gradually over a period of about 8–14 days.

Contraindications

METOPROLOL-WGR 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 with a P-R interval of greater than 0.24 sec or 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

METOPROLOL-WGR metoprolol tartrate 50 mg and 100 mg tablet blister packs were first listed on the ARTG on 23 September 2015.