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Betaloc
metoprolol tartrate

Composition
Each tablet contains metoprolol tartrate 50 and 100 mg respectively.

For excipients see List of excipients.

Pharmaceutical form
Betaloc 50 mg tablet is white, bisected, marked A/BB on one side, 8 mm.

Betaloc 100 mg tablet is white, bisected, marked A/mE on one side, 8 mm.

Therapeutic indication
Hypertension - to reduce blood pressure and to reduce the risk of cardiovascular and coronary mortality (including sudden death) and morbidity.
Angina pectoris.
Disturbances of cardiac rhythm, including especially supraventricular tachycardia.

Confirmed or suspected myocardial infarction - prevention of cardiac death and reinfarction.
Functional heart disorders with palpitations.
Migraine prophylaxis
Hyperthyroidism.

Dosage and Method of Administration
Dosage should be adjusted individually to avoid bradycardia. The tablets should be taken on an empty stomach. Concomitant intake of food increases the bioavailability of metoprolol with 40%. The following is valid as guidelines:

Hypertension
100-200 mg daily divided on one or two occasions. The tablets should be taken in the morning if once-daily dosage. In patients not responding to 200 mg, the dose could be combined with other anti hypertensive agents, preferably diuretics and calcium antagonists of the dihydropyridine type, or increased.

Angina pectoris
100-200 mg daily divided on one or two occasions.
If needed, the dose can be combined with nitrates or increased.

Cardiac arrhythmias
100-200 mg daily divided on one or two occasions. If needed, the dose can be increased.

Prophylactic therapy after myocardial infarction
As maintenance dosage, 100 mg morning and evening.

Functional heart disorders with palpitations
100 mg once daily. If needed, the dose can be increased.

Migraine prophylaxis
100-200 mg daily divided on one or two occasions.

Hyperthyroidism
The recommended dosage is 150-200 mg daily, divided in 3-4 doses. If needed, the dose can be increased.

Impaired renal function
The elimination rate is insignificantly affected by renal function, and dose adjustment is not needed in patients with impaired renal function.

Impaired hepatic function
Usually Betaloc is given in the same dose to patients suffering from liver cirrhosis as to patients with normal liver function. Only, when there are signs of serious impairment of liver function (e.g. shunt-operated patients) a dose reduction should be considered.

Elderly
Dose adjustment is not needed in the elderly.

Children
There is limited experience with Metoprolol Tartrate (Betaloc) treatment in children.

Contraindications
Cardiogenic shock. Sick-sinus syndrome. Atrioventricular block of second or third degree. Patients with unstable, not compensated heart failure (pulmonary edema, hypoperfusion or hypotension), and patients with continuous or intermittent inotropic therapy acting through β-receptor agonism. Sinus bradycardia or hypotension.

Metoprolol Tartrate (Betaloc) should not be given to patients with suspected acute myocardial infarction as long as the heart rate is <45 beats/min, the P-Q interval is >0.24 sec or the systolic blood pressure is <100 mm Hg. Serious peripheral vascular disease with gangrene threat.

Metoprolol Tartrate (Betaloc) tablets are contra-indicated in patients who have shown hypersensitivity to any component of the product or to other R-blockers.

Special warnings and precautions for use
Intravenous administration of the verapamil-type should not be given to patients treated with β-blockers.

Metoprolol may aggravate the symptoms of peripheral arterial circulatory disorders e.g. intermittent claudication. Severely impaired renal function. Serious acute conditions with metabolic acidosis. Combination treatment with digitalis.

Betaloc should not be given to patients with latent or manifested heart insufficiency without concomitant treatment. In patients with Prinzmetal's angina the frequency and the extent of angina attacks may increase due to alpha-receptor mediated contraction of the coronary vessels. For this reason non-selective beta-blockers must not be used in these patients. Beta1-selective receptor blockers should be used with caution.

During treatment with metoprolol the risk for interfering with carbohydrate metabolism or masking hypoglycaemia is less than with non-selective beta-blockers.

Very rarely, a pre-existing AV conduction disorder of moderate degree may become aggravated (possibly leading to AV block).

Treatment with beta-blockers may aggravate the treatment of an anaphylactic reaction. Adrenaline treatment in normal dose does not always give the expected therapeutic effect. If Betaloc is given to a patient with phaeochromocytoma, treatment with an alpha-blocker should be considered.

Withdrawal of Betaloc should, when possible, be done gradually over 2 weeks. The dose should be reduced gradually until a final dose of 25 mg is reached (half a 50 mg tablet). During this period especially patients with known ischemic heart disease should be kept under close surveillance. The risk for coronary events, including sudden death, may increase during withdrawal of beta-blockers.

Prior to surgery the anaesthetist should be informed that the patient is receiving Metoprolol Tartrate (Betaloc). It is not recommended to stop β-blocker treatment in patients undergoing surgery.

The tablet contains lactose. Patients with any of the following rare hereditary conditions should not use this medicine: galactose intolerance, total lactase deficiency or glucose-galactose malabsorption.

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