APO-METOPROLOL

What it is

APO-METOPROLOL 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.

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.

Key safety warnings

Beta-adrenergic blockade of the smooth muscle of bronchi and bronchioles may result in an increased airways resistance and reduces the effectiveness of asthma treatment, which may be dangerous in susceptible patients. 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. 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 APO-METOPROLOL. If this treatment is essential, it should only be undertaken in a Coronary or Intensive Care Unit. APO-METOPROLOL should be used with caution in patients with diabetes mellitus. Diabetic patients should be warned that beta-blockers affect glucose metabolism and may mask some important premonitory signs of acute hypoglycaemia, such as tachycardia. In patients with labile diabetes or with a history of spontaneous hypoglycaemia, beta-blockade may result in the loss of diabetic control and delayed recovery from hypoglycaemia. Care should be taken if beta-blockers have to be discontinued abruptly in patients with coronary artery disease. Severe exacerbation of angina and precipitation of myocardial infarction and ventricular arrhythmias have occurred following abrupt discontinuation of beta-blockade. The dosage should be reduced gradually over a period of about 8–14 days.

Contraindications

APO-METOPROLOL is contraindicated in 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 which may suggest a predisposition to bronchospasm; and severe bronchial asthma or history of severe bronchospasm.

Regulatory history

APO-METOPROLOL metoprolol tartrate 50 mg tablets were first listed on the ARTG on 8 January 2013, and APO-METOPROLOL metoprolol tartrate 100 mg tablets were first listed on 8 January 2013.