DENEX Tablet Ref.[28171] Active ingredients: Metoprolol

Source: Υπουργείο Υγείας (CY)  Revision Year: 2021  Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

4.1. Therapeutic indications

Hypertension and angina pectoris, cardiac arrhythmias, especially supraventricular tachyarrhythmias. Adjunct to treatment of thyrotoxicosis.

Early intervention with metoprolol in 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. Prophylaxis of migraine.

4.2. Posology and method of administration

Method of administration

Denex tablets should be administered orally and swallowed unchewed. The dose must always be adjusted to the individual requirements of the patient, but should not exceed 400 mg/day.

Posology

Adults

Hypertension

Initially a dose of 100 mg per day should be prescribed either as single or divided doses. Depending upon the response the dosage may be increased by 100 mg per day at weekly intervals to 200 mg daily given in single or divided doses. Over the dosage range most patients may be expected to respond rapidly and satisfactorily. A further reduction in blood pressure may be achieved if Denex is used in conjunction with an antihypertensive diuretic or other hypotensive agent.

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

Angina Pectoris

50 mg-100 mg 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 50-100 mg twice daily.

Cardiac Arrhythmias

A dosage οf 50 mg two or three times daily is usually sufficient. If necessary the dose can be increased up to 300 mg per day administered in divided doses.

Hyperthyroidism

50mg four times daily. The dosage should be progressively reduced as euthyroid state is slowly achieved.

Myocardial Infarction

Early intervention: 50mg every 6 hours for 48 hours, preferably within 12 hours of the onset of chest pain.

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

Prophylaxis of migraine

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

Elderly

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 excessively pronounced 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.

Pediatric population

Not recommended.

4.9. Overdose

Signs and symptoms

In more severe cases an overdosage of metoprolol may lead to severe hypotension, sinus bradycardia, atrioventricular block, heart failure, cardiogenic shock, cardiac arrest, bronchospasm, impairment of consciousness, coma, convulsions, nausea, vomiting, cyanosis, hypoglycaemia and occasionally hyperkalaemia.

The first manifestations of overdosage appear 20 minutes to 2 hours after ingestion of Denex. The effects of massive overdose may persist for several days, despite declining plasma concentrations.

Treatment

Patients should be admitted to hospital and generally should be managed in an intensive care setting with continuous monitoring of cardiac function, blood gases and blood biochemistry. Emergency supportive measures such as artificial ventilation or cardiac pacing should be instituted if appropriate. Even apparently well patients who have taken a small overdose should be closely observed for signs of poisoning for at least 4 hours.

In the event of a potentially life-threatening oral overdose, use induction of vomiting or gastric lavage (if within 4 hours after ingestion of Denex) and/or activated charcoal to remove the drug from the gastrointestinal tract. Metoprolol cannot be effectively removed by haemodialysis.

Atropine may be given intravenously to control significant bradycardia. Intravenous beta-agonists such as prenalterol or isoprenaline should be used to treat bradycardia and hypotension; very high doses may be needed to overcome the beta-blockade. Dopamine, dobutamine or noradrenaline may be given to maintain blood pressure. Glucagons has positive inotropic and chronotropic effects on the heart that are independent of beta-adrenergic receptors and has proved effective in the treatment of resistant hypotension and heart failure associated with beta-blocker overdose.

Diazepam is the drug of choice for controlling seizures. A β2-agonist or aminophylline can be used to reverse bronchospasm; patients should be monitored for evidence of cardiac arrhythmias during and after administration of the bronchodilator.

6.3. Shelf life

5 years.

6.4. Special precautions for storage

Store below 25°C.

6.5. Nature and contents of container

PVC-Al blisters of 10 tablets in packs of 30, 50, 100, 500 and 1000 tablets.

Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

Not applicable.

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