METOPROLOL TARTRATE Tablet Ref.[6983] Active ingredients: Metoprolol

Posology

The following dosage regimes are intended only as a guideline and should always be adjusted to the individual requirements of the patient but should not exceed 400 mg/day.

Adults

Hypertension

Initially 100mg daily. This may be increased, if necessary, to 200mg daily in single or divided doses. Combination therapy with a diuretic or vasodilator may also be considered to further reduce blood pressure.

Metoprolol may be administered with benefit both to previously untreated patients with hypertension and to those in whom the response to previous therapy is inadequate. In the latter type of patient the previous therapy may be continued and metoprolol added in to the regime with adjustment of the previous therapy if necessary.

Angina pectoris

Usually 50-100 mg two or three times daily. In general a significant improvement in exercise tolerance and reduction of angina attacks may be expected with a dose of 50-100mg twice daily.

Cardiac arrhythmias

50mg two or three times daily is usually sufficient. If necessary the dose may be increased to 300mg daily in divided doses.

Following the treatment of an acute arrhythmia with metoprolol tartrate injection, continuation therapy with metoprolol tablets should be initiated 4-6 hours later. The initial oral dose should not exceed 50mg twice daily.

Myocardial infarctions

Early intervention: Orally, therapy should commence 15 minutes after the last intravenous injection with 50mg every 6 hours for 48 hours and preferably within 12 hours of the onset of chest pain. Patients who fail to tolerate the full i.v. dose should be given half the suggested oral dose.

Maintenance: The usual maintenance dose is 200 mg daily given in divided doses. The treatment should be continued for at least 3 months.

Thyrotoxicosis

50mg four times daily. Dose should be reduced progressively as euthyroid state is achieved.

Prophylaxis of migraine

100-200 mg daily in divided doses (morning and evening).

Elderly

The optimum dose should be individually determined according to clinical response. There is no evidence to suggest that dosage requirements are different in otherwise healthy elderly patients. However, caution is indicated in elderly patients as an excessive decrease in blood pressure or pulse rate may cause the blood supply to vital organs to fall to inadequate levels. Dosage should be reduced in the elderly where there is impairment of hepatic function.

Paediatric population

The safety and efficacy of Metoprolol in children has not been established. Metoprolol tartrate is not recommended in children.

Hepatic impairment

In patients with significant hepatic dysfunction dosage reduction may be advised.

Renal impairment

Dose adjustment is not warranted in renal impairment.

Method of Administration

For oral administration.

Poisoning due to an overdose of metoprolol may lead to severe hypotension, sinus bradycardia, atrioventricular block, heart failure, cardiogenic shock, cardiac arrest, bronchospasm, impairment of consciousness, coma, nausea, vomiting, cyanosis, hypoglycaemia and, occasionally, hyperkalaemia. The first manifestations usually appear 20 minutes to two hours after drug ingestion.

After ingestion of an overdose or in case of hypersensitivity, the patient should be kept under close supervision and be treated in an intensive- care ward. Absorption of any drug material still present in the gastrointestinal tract can be prevented by induction of vomiting, gastric lavage, administration of activated charcoal and a laxative. Artificial respiration may be required.

Bradycardia or extensive vagal reactions should be treated by administering atropine or methylatropine. Hypotension and shock should be treated with plasma/plasma substitutes and, if necessary, catecholamines. The beta-blocking effect can be counteracted by slow intravenous administration of isoprenaline hydrochloride, starting with a dose of approximately 5 micrograms/minute, or dobutamine, starting with a dose of 2.5micrograms/minute, until required effect has been obtained. In refractory cases isoprenaline can be combined with dopamine. If this does not produce the desired effect either, intravenous administration of 8-10mg glucagon may be considered. If required the injection should be repeated within one hour, to be followed – if required – by an i.v. infusion of glucagon at an administration rate of 1-3mg/hour. Administration of calcium ions, or the use of a cardiac pacemaker may also be considered. In patients intoxicated with hydrophilic beta-blocking agents haemodialysis or haemoperfusion may be considered.

3 years.

Do not store above 25°C.

Tablets are packed in PVC/PVdC – Aluminium blisters containing 10, 20, 28, 30, 50, 56, 60, 84 and 90 tablets.

Not all pack sizes may be marketed.

No special requirements.

Any unused product or waste material should be disposed of in accordance with local requirements.