TN-METOPROLOL

What it is

TN-METOPROLOL is metoprolol tartrate 50 mg and 100 mg 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. TN-METOPROLOL Tablets should always be taken in standard relation to meals.

Key safety warnings

Patients with bronchospastic disease should not generally be given beta-blockers, including TN-METOPROLOL, and 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 or chronic myocardial insufficiency, 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, and it is recommended that the dosage be reduced gradually over a period of about 8–14 days. Beta-blockers may reduce placental perfusion and cause bradycardia in the foetus, and during the later stages of pregnancy these drugs should only be given after weighing the needs of the mother against the risk to the foetus.

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 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 or other specified haemodynamic parameters, 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

TN-METOPROLOL 50 mg was first listed on the ARTG on 25 March 2015, and TN-METOPROLOL 100 mg was first listed on the ARTG on 25 March 2015.