METOPROLOL-WGR XL

What it is

METOPROLOL-WGR XL is a modified release tablet containing metoprolol succinate, available in strengths of 23.75 mg, 47.5 mg, 95 mg, and 190 mg.

Approved indications

— Stable, chronic heart failure as an adjunct to other heart failure therapy.

Dosing overview

METOPROLOL-WGR XL is recommended for once daily treatment and is preferably taken together with the morning meal. The dose should be individually adjusted in patients with chronic heart failure stabilised on other heart failure treatment, with patients titrated from an initial low dose starting at 23.75 mg daily for 2 weeks, then increasing to 47.5 mg daily for 2 weeks, then 95 mg daily for 2 weeks. Patients with moderate to severe heart failure (NYHA III–IV) should start with half a 23.75 mg tablet once daily for one week, then take a full 23.75 mg tablet once daily for the second week. During long term treatment the aim should be to reach 190 mg once daily or the highest tolerated dose. The patient should be carefully evaluated at each dose level with regard to tolerability.

Key safety warnings

Some patients may experience an initial, usually transient, worsening of the symptoms and signs of heart failure when starting treatment with METOPROLOL-WGR XL, and if this occurs, the patient should be monitored very closely and the dose should be reduced if symptoms continue to worsen. METOPROLOL-WGR XL should not be ceased abruptly due to the risk of rebound hypertension and tachycardia; if treatment is to be discontinued, it should be reduced gradually. If there is a need to discontinue treatment, this should be done gradually over at least two weeks with the dose reduced by half in each step, down to a final dose of half a 23.75 mg tablet, and the final dose should be taken for at least four days before discontinuation. METOPROLOL-WGR XL should be used with caution in patients with diabetes mellitus, especially those receiving insulin or oral hypoglycaemic agents, as β-blockers affect glucose metabolism and may mask some important premonitory signs of acute hypoglycaemia, such as tachycardia. Acute initiation of high-dose metoprolol to patients undergoing non-cardiac surgery should be avoided, since it has been associated with bradycardia, hypotension and stroke including fatal outcome in patients with cardiovascular risk factors.

Contraindications

METROPROLOL-WGR XL is contraindicated in any patient with a history of airways obstruction or a tendency to bronchospasm. Additional contraindications include right ventricular failure secondary to pulmonary hypertension, significant right ventricular hypertrophy, second and third degree atrioventricular block, shock, unstable decompensated congestive heart failure, continuous or intermittent inotropic therapy acting through β-receptor agonism, clinically relevant sinus bradycardia (less than 45–50 beats per minute), non-compensated congestive heart failure, sick-sinus syndrome unless a permanent appropriately functioning pacemaker is in place, severe peripheral arterial circulatory disorders, suspected acute myocardial infarction with a heart rate of less than 45 beats per minute, a P–R interval of greater than 0.24 seconds or a systolic blood pressure of less than 100 mmHg, and untreated phaeochromocytoma, and hypersensitivity to any component of METROPROLOL-WGR XL and related derivatives.

PBS listing

No source document contains information about PBS listing.

Regulatory history

METOPROLOL-WGR XL was first listed on the ARTG on 12 June 2024 in strengths of 23.75 mg, 47.5 mg, 95 mg, and 190 mg.