Selomet Tablet 50mg

Product Information

SELOMET

Selomet®(Metoprolol)

Presentation

Selomet-25 tablet: Blue, shield shaped, scored tablet, having engraved on other side; each tablet contains Metoprolol Tartrate USP

25 mg.

Selomet-50 tablet: Blue, parallel capsule shaped, scored tablet, having engraved on other side; each tablet contains Metoprolol

Tartrate USP 50 mg.

Indications

ln the management of hypertension and angina pectoris. Cardiac arrhythmias, especially supraventricular tachyarrhythmias. Adjunct

to the treatment of hyperthyroidism. Early intervention with Metoprolol in acute myocardial infarction reduces infarct size and

the incidence of ventricular fibrillation. Pain relief may also decrease the need for opiate analgesics. Metoprolol has been shown

to reduce mortality when administered to patients with acute myocardial infarction.

Dosage and administration

Hypertension: Total daily dosage Metoprolol 100 – 400 mg to be given as a single or twice daily dose. The starting dose is 100 mg

(two Selomet-50 tablets) per day. This may be increased by 100 mg per day at weekly intervals. lf full control is not achieved

using a single daily dose, a b.i.d. regimen should be initiated. Combination therapy with a diuretic or other anti-hypertensive

agent may also be considered.

Angina: Usually Metoprolol 50 mg (one Selomet-50 tablet) to 100 mg (two Selomet-50 tablets) twice or three times daily.

Cardiac arrhythmias: Metoprolol 50 mg (one Selomet-50 tablet) b.i.d or t.i.d should usually control the condition. It necessary

the dose can be increased up to 300 mg per day in divided doses. Following the treatment of an acute arrhythmia with Metoprolol

injection, continuation therapy with Metoprolol tablets should be initiated 4-6 hours later. The initial oral dose should not

exceed 50 mg t.i.d.

Hyperthyroidism: Metoprolol 50 mg (one Selomet-50 tablet) four times a day.The dose should be reduced as the euthyroid state is

achieved.

Myocardial infarction: Orally, therapy should commence 15 minutes after the last injection with 50 mg every 6 hours for 48 hours.

Patients who fail to tolerate the full intravenous dose should be given half the suggested oral dose. Maintenance – The usual

maintenance dose is 200 mg daily given in divided doses. Elderly’ There are no special dosage requirements in otherwise

healthy elderly patients. Signidcant hepatic dysfunction: A reduction in dosage may be necessary.

Contra-indications, warnings, etc.

Contra-indications: AV block, Uncontrolled heart failure, severe bradycardia, sick-sinus syndrome, cardiogenic shock and severe

peripheral arterial disease. Known hypersensitivity to Metoprolol or other B-blockers. Metoprolol is also contra-indicated when

myocardial infarction is complicated by significant bradycardia, first degree heart block, systolic hypotension (<100mmHg)

and/or severe heart failure. Warnings: Metoprolol may aggravate bradycardia, symptoms of peripheral arterial circulatory disorders

and anaphylactic shock. Abrupt interruption of B-blockers is to be avoided. When possible, Metoprolol should be withdrawn

gradually over a period of 10 days, in diminishing doses to 25 mg daily for the last 6 days. During its withdrawal patients should

be kept under close surveillance, especially those with known ischaemic heart disease. Metoprolol may be administered when heart

failure has been controlled. Digitalisation and/or diuretic therapy should also be considered for patients with a history of heart

failure, or patients known to have a poor cardiac reserve. Although cardioselective B-blockers may have less effect on lung

function than non-selective [3-blockers, as with all B-blockers these should be avoided in patients with reversible obstructive

ainlvays disease unless there are compelling clinical reasons for their use. When administration is necessary, use of a

B2-bronchodilator (e.g. terbutaline) may be advisable in some patients. In labile and insulin-dependent diabetes it may be

necessary to adjust the hypoglycaemic therapy. In patients with a phaeochromocytoma, an on-blocker should be given concomitantly.

In the presence of liver cirrhosis the bioavailability of Metoprolol may be increased. The administration of adrenaline to

patients undergoing [5-blockade can result in an increase in blood pressure and bradycardia, although this is less likely to occur

with B1-selective drugs. Metoprolol therapy must be reported to the anaesthetist prior to general anaesthesia. If withdrawal of

Metoprolol is considered desirable, this should if possible be completed at least 48 hours before general anaesthesia. However, in

some patients it may be desirable to employ a Bblocker as premedication. By shielding the heart against the effects of stress the

B-blocker may prevent excessive sympathetic stimulation provoking cardiac arrhythmias or acute coronary insufficiency. If a

B-blocker is given for this purpose, an anaesthetic with little negative inotropic activity should be selected to minimise the

risk olmyocardial depression.

Use in pregnancy and lactation: Metoprolol should not be used in pregnancy or lactating mothers unless the physician considers

that the benefit outweighs the possible hazard to the foetus/infant.

Drug interactions: The effects of Metoprolol and other antihypertensive drugs on blood pressure are usually additive, and care

should be taken to avoid hypotension. However, combinations of antihypertensive drugs may often be used with benefit to improve

control of hypertension. Metoprolol can reduce myocardial contractility and impair intracardiac conduction. Care should be

exercised when drugs with similar activity, e.g. antiarrhythmic agents, general anaesthetics, are given concurrently. Like all

other B-blockers, Metoprolol should not be given in combination with verapamil since this may cause bradycardia, hypotension and

asystole. Care should also be exercised when [5-blockers are given in combination with sympathetic ganglion blocking agents, other

B-blockers (i.e. eye drops) or MAO inhibitors. lf combination treatment with clonidine is to be discontinued, Metoprolol should be

withdrawn several days before clonidine. As [3-blockers may affect the peripheral circulation, care should be exercised when drugs

with similar activity e.g. ergotamine are given concurrently Metoprolol will antagonise the [31 -effects of sympathomimetic agents

but should have little influence on the bronchodilator effects of B2- agonists at normal therapeutic doses. Enzyme inducing agents

(e.g. rifampicin) may reduce plasma concentrations of Metoprolol, whereas enzyme inhibitors (e.g.cimetidine) may increase plasma

concentrations. Metoprolol may impair the elimination of lignocaine. lndomethacin may reduce the antihypertensive effect of

[3-blockers.

Side-effects: These are usually mild and infrequent. The most common appear to be lassitude, GI disturbances (nausea, vomiting or

abdominal pain) and disturbances of sleep pattern. ln many cases these effects have been transient or have disappeared after a

reduction in dosage. Effects related to the CNS which have been reported occasionally are dizziness and headache and

rarely paraesthesia, muscle cramps, depression and decreased mental alertness. There have also been isolated reports of

personality disorders. Cardiovascular effects which have been reported occasionally are bradycardia, postural hypotension and

rarely, heart failure, palpitation, cardiac arrhythmias, Ftaynauds phenomenon, peripheral oedema and precordial pain. There have

also been isolated reports of cardiac conduction abnormalities and gangrene in patients with preexisting severe peripheral

circulatory disorders. Common gastro-intestinal disturbances have been described above but rarely diarrhoea or constipation also

occur and there have been isolated cases of dry mouth and abnormal liver function. Skin rashes (urticaria,

psoriasiform, dystrophic skin lesions) and positive anti-nuclear antibodies (not associated with SLE) occur rarely. Isolated cases

of photosensitivity, increased sweating and alopecia have been reported. Flespiratory effects include occasional reports of

dyspnoea on exertion and rare reports of bronchospasm and isolated cases of rhinitis. Isolated cases of weight gain,

thrombocytopenia, disturbances of vision, conjunctivitis, tinnitus and dry or irritated eyes have also been reported. The reported

incidence of skin rashes and/or dry eyes is small and in most cases the symptoms have cleared when treatment was withdrawn.

Discontinuation of the drug should be considered if any such reaction is not otherwise explicable.

Overdosage: 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 2 hours after drug

ingestion. Treatment: Treatment should include close monitoring of cardiovascular, respiratory and renal function, and blood

glucose and electrolytes. Further absorption may be prevented by induction of vomiting, gastric lavage or administration of

activated-charcoal if ingestion is recent. Cardiovascular complications should be treated symptomatically, which may require the

use of sympathomimetic agents (e.g. noradrenaline, metaramionl), atropine or inotropic agents (e.g. dopamine, dobutamine).

Temporary pacing may be required for AV block. Glucagon can reverse the effects of excessive B-blockade, given in a dose of 1-10

mg intravenously. Intravenous B2-stimulants e.g. terbutaline may be required to relieve bronchospasm. Metoprolol cannot be

effectively removed by haemodialysis.

Pharmaceutical precautions

Store in a cool and dry place, protected from light.

Packaging quantities

Selomet-25 tablet: Cartons containing 30 tablets in blister.

Selomet-50 tablet: Cartons containing 30 tablets in blister.