METOPROLOL SANDOZ

What it is

TN-METOPROLOL is available as 50 mg and 100 mg film coated tablets containing metoprolol tartrate. 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. The film coated tablets should be swallowed whole with a glass of water and should always be 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. TN-METOPROLOL should be used with caution in patients with diabetes mellitus, and diabetic patients should be warned that 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 following abrupt discontinuation, therefore it is recommended that the dosage be reduced gradually over a period of about 8–14 days. In patients taking beta-blockers, anaphylactic shock assumes a more severe form and may be resistant to normal doses of adrenaline, therefore beta-blockers should be avoided if possible in patients who are at increased risk of anaphylaxis.

Contraindications

TN-METOPROLOL 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/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/min, a P-R interval of greater than 0.24 sec, 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

TN-METOPROLOL 50 mg and 100 mg tablets were first included in the ARTG on 25 March 2015.