METROL-XL

What it is

METROL-XL is a modified release tablet containing metoprolol succinate. The medicine is available in four strengths: 23.75 mg, 47.5 mg, 95 mg, and 190 mg. METROL-XL is recommended for once daily treatment and is preferably taken together with the morning meal.

Approved indications

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

Dosing overview

The dose of METROL-XL should be individually adjusted in patients with chronic heart failure stabilised on other heart failure treatment. Patients are recommended to be titrated from an initial low dose, starting with METROL-XL 23.75 mg at half or one tablet daily for two weeks, increasing to METROL-XL 47.5 mg for two weeks, then METROL-XL 95 mg for two weeks. Patients with moderate to severe heart failure (NYHA III-IV) should start treatment with half a METROL-XL 23.75 mg tablet once daily for one week, then take a full METROL-XL 23.75 mg tablet once daily for the second week. During long term treatment the aim should be to reach METROL-XL 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 METROL-XL. If this occurs, the patient should be monitored very closely and the dose of METROL-XL should be reduced if symptoms continue to worsen. METROL-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 with METROL-XL, 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. The final dose should be taken for at least four days before discontinuation. Where METROL-XL is prescribed for patients known to be suffering from asthma, an inhaled β2-agonist should be administered. The dosage of β2-agonists may require adjustment (increase), however the risk of METROL-XL interfering with β2-receptors is less than with conventional tablet formulations of β1-selective blockers. METROL-XL should be used with caution in patients with diabetes mellitus, especially those receiving insulin or oral hypoglycaemic agents. Diabetic patients should be warned that β-blockers affect glucose metabolism and may mask some important premonitory signs of acute hypoglycaemia, such as tachycardia. In patients with insulin or non-insulin dependent diabetes, especially labile diabetes, or with a history of spontaneous hypoglycaemia, β-blockade may result in the loss of diabetic control and delayed recovery from hypoglycaemia. The dose of insulin or oral hypoglycaemic agent may need to be adjusted.

Contraindications β-blockers are contraindicated in any patient with a history of airways obstruction or a tendency to bronchospasm because β-adrenergic blockade of the smooth muscle of bronchi and bronchioles may result in an increased airways resistance and reduce the effectiveness of asthma treatment. Other contraindications include allergic disorders (including allergic rhinitis) which may suggest a predisposition to bronchospasm; right ventricular failure secondary to pulmonary hypertension; significant right ventricular hypertrophy; second and third degree atrioventricular block; shock (including cardiogenic and hypovolaemic shock); and unstable decompensated congestive heart failure (pulmonary oedema, hypoperfusion or hypotension). Additional contraindications are continuous or intermittent inotropic therapy acting through β-receptor agonism; clinically relevant sinus bradycardia (less than 45-50 beats/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/minute, a P-R interval of greater than 0.24 seconds or a systolic blood pressure of less than 100 mmHg, and/or moderate to severe non-compensated heart failure; hypotension; untreated phaeochromocytoma; and hypersensitivity to any component of METROL-XL and related derivatives.

Regulatory history

METROL-XL 23.75 mg, 47.5 mg, and 95 mg modified release tablets were first listed on the ARTG on 4 March 2022.