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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,
ø8 mm.
Betaloc 100 mg tablet is white,
bisected, marked A/mE on one side,
ø8 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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