METOPROLOL TARTRATE

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 a dose of 100mg per day should be prescribed either as single or divided doses. Depending upon the response the dosage may be increased by 100mg per day at weekly intervals to 200mg daily given in single or divided doses. Combination therapy with a diuretic or vasodilator may also be considered to further reduce blood pressure.

Metoprolol Tartrate 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 Tartrate added into the regime with adjustment of the previous therapy if necessary.

Angina Pectoris:

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

Cardiac Arrhythmias:

A dosage of 50mg two or three times daily is usually sufficient. If necessary the dose can be increased up to 300mg per day administered 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 Infarction- Early intervention:

In order to achieve optimal benefits from intravenous metoprolol, suitable patients should present within 12 hours of the onset of chest pain. Therapy should commence with 5mg iv every 2 minutes to a maximum of 15mg total as determined by blood pressure and heart rate.

26 seconds, or if there is any aggravation of dyspnoea or cold sweating. Orally, therapy should commence 15 minutes after the injection with 50mg every 6 hours for 48 hours. v. dose should be given half the suggested oral dose.

Maintenance:

The usual maintenance dose is 200mg 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: 100-200mg daily, given 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.

In patients with significant hepatic dysfunction the lower dosage recommendations will be more appropriate. 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 Metoprolol tartrate tablets should be administered orally and swallowed unchewed.

The tablets should be taken on an empty stomach.

g. blurred vision, dry eyes and/or eye irritation Ear and labyrinth disorders Tinnitus, and, in doses exceeding those recomme nded, "hearing disorders (eg. hypoacusi s or deafness) Cardiac disorders Bradycardi a Heart failure, cardiac arrhythmi as, palpitatio n Cardiac conductio n disorders, precordial pain Increase in existing intermitte nt claudicati on Vascular disorders Orthostatic hypotension (occasional ly with syncope) Oedema, Raynaud's phenomen on Gangrene in patients with pre existing severe peripheral circulator y disorders Respirat ory, thoracic and mediasti nal disorders Exertional dyspnoea Bronchos pasm (which may occur in patients without a history of obstructiv e lung disease) Rhinitis Gastroin testinal disorders Nausea and vomiting, abdominal pain Diarrhoea or constipati on Dry mouth Retroperit oneal fibrosis* Hepatobili ary disorders Hepatitis Skin and Subcutane ous tissue disorders Skin rash (in the form of urticaria, psoriasifo rm and dystrophi c skin lesions) s Photosens itivity, hyperhidr osis, alopecia, worsening of psoriasis Occurrenc e of antinuclea r antibodies (not associated with SLE) Musculo skelet al and connecti ve Muscle cramps Arthritis tissue disorders Reprodu ctive system and breast disorders Disturban ces of Libido and potency Peyronie's disease* General disorders and administ ration site condition s Fatigue Dysgeusia (Taste disturbanc es) Investiga tions Weight increase, liver function test abnormal * (relationship to Metoprolol has not been definitely established).

Beta-blockers may mask the symptoms of thyrotoxicosis or hypoglycaemia. Post Marketing Experience The following adverse reactions have been reported during post-approval use of Metoprolol Tartrate: confusional state, an increase in blood triglycerides and a decrease in high density lipoprotein (HDL).

Because these reports are from a population of uncertain size and are subject to confounding factors, it is not possible to reliably estimate their frequency. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. .

Abrupt cessation of therapy with a beta-blocker should be avoided especially in patients with ischaemic heart disease. When possible, metoprolol should be withdrawn gradually over a period of 10 days, the doses diminishing to 25mg for the last 6 days.

If necessary, at the same time, initiating replacement therapy, to prevent exacerbation of angina pectoris. In addition, hypertension and arrhythmias may develop. When it has been decided to interrupt a betablockade in preparation for surgery, therapy should be discontinued for at least 24 hours.

Continuation of betablockade reduces the risk of arrhythmias during induction and intubation, however the risk of hypertension may be increased as well. If treatment is continued, caution should be observed with the use of certain anaesthetic drugs.

The patient may be protected against vagal reactions by intravenous administration of atropine. During its withdrawal the patient should be kept under close surveillance. Although cardioselective beta-blockers may have less effect on lung function than non selective beta-blockers these should be avoided in patients with reversible obstructive airways disease unless there are compelling clinical reasons for their use.

Although metoprolol has proved safe in a large number of asthmatic patients, it is advisable to exercise care in the treatment of patients with chronic obstructive pulmonary disease. Therapy with a beta2-stimulant may become necessary or current therapy require adjustment.

Therefore, non-selective beta-blockers should not be used for these patients, and beta-1 selective blockers only with the utmost care. Discontinuation of the drug should be considered if any such reaction is not otherwise explicable.

Cessation of therapy with a beta-blocker should be gradual. Metoprolol Tartrate tablets may not be administered to patients with untreated congestive heart failure. The congestive heart failure needs to be brought under control first of all.

If concomitant digoxin treatment is taking place, it must be borne in mind that both medicinal products slow AV conduction and that there is therefore a risk of AV dissociation. In addition, mild cardiovascular complications may occur, manifesting as dizziness, bradycardia, and a tendency to collapse.

When a beta blocker is being taken, a serious, sometimes even life-threatening deterioration in cardiac function can occur, in particular in patients in whom the action of the heart is dependent on the presence of sympathetic system support.

This is due less to an excessive beta-blocking effect and more to the fact that patients with marginal heart function tolerate poorly a reduction in sympathetic nervous system activity, even where this reduction is slight. This causes contractility to become weaker and the heart rate to reduce and slows down AV conduction.

The consequence of this can be pulmonary oedema, AV block, and shock. Occasionally, an existing AV conduction disturbance can deteriorate, which can lead to AV block. In patients with a phaeochromocytoma, an alpha blocker should be given concomitantly Before a patient undergoes an operation, the anaesthetist must be informed that metoprolol is being taken.

Acute initiation of high-dose metoprolol to patients undergoing non-cardiac surgery should be avoided, since it has been associated with bradycardia, hypotension and stroke including fatal outcome in patients with cardiovascular risk factors.

Beta-blockers mask some of the clinical signs of thyrotoxicosis. Therefore, Metoprolol should be administered with caution to patients having, or suspected of developing, thyrotoxicosis, and both thyroid and cardiac function should be monitored closely Simultaneous administration of adrenaline (epinephrine), noradrenaline (norepinephrine) and β blockers may lead to an increase of blood pressure and bradycardia.

Metoprolol may induce or aggravate bradycardia, symptoms of peripheral arterial circulatory disorders and anaphylactic shock. If the pulse rate decreases to less than 50 to 55 beats/min at rest and the patient experiences symptoms related to bradycardia, the dosage should be reduced.

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. Metoprolol may reduce the effect of diabetes treatment and mask the symptoms of hypoglycaemia.

The risk of a carbohydrate metabolism disorder or masking of the symptoms of hypoglycaemia is lower when using metoprolol prolonged-release tablets than when using regular tablet forms for beta1 selective beta blockers and significantly lower than when using non-selective beta blockers.

In labile and insulin- dependent diabetes, it may be necessary to adjust the hypoglycaemic therapy. In case of unstable or insulin-dependent diabetes mellitus, it may be necessary to adjust the hypoglycaemic treatment (because of the likelihood of severe hypoglycaemic conditions).

Beta-blockers could further increase the risk of severe hypoglycaemia when used concurrently with sulfonylureas. 5). In patients with significant hepatic dysfunction it may be necessary to adjust the dosage because metoprolol undergoes biotransformation in the liver.

3). The elderly should be treated with caution, starting with a lower dosage but tolerance is usually good in the elderly. It may be necessary to use a lower strength formulation in elderly patients and patients with hepatic or renal impairment and an alternative product should be prescribed.

Patients with anamnestically known psoriasis should take beta-blockers only after careful consideration as the medicine may cause […]

1 • Asthma or history of bronchospasm • Atrioventricular block of second or third degree • Uncontrolled heart failure • Clinically relevant sinus bradycardia (< 45-50 bpm) • Prinzmetal’s angina • Sick-sinus syndrome (unless a pacemaker is in situ) • Severe peripheral arterial disease • Hypotension • Untreated phaeochromocytoma • Metabolic acidosis.

• Myocardial infarction complicated by significant bradycardia, first degree heart block, systolic hypotension (less than 100mmHg) and/or severe heart failure and cardiogenic shock • Diabetes if associated with frequent episodes of hypoglycaemia • Chronic obstructive pulmonary disease • Renal or hepatic failure • Therapy resistant hypokalaemia and hyponatraemia, hypercalcaemia, symptomatic hyperuricaemia, anuria.

• The concomitant intravenous administration of calcium blockers of the type verapamil and diltiazem other antiarrhythmics (such as disopyramide) is contraindicated (exception: intensive care unit).