BETALOC Solution for injection Ref.[7777] Active ingredients: Metoprolol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Recordati Ireland Ltd., Raheens East, Ringaskiddy, Co. Cork, Ireland

Therapeutic indications

Control of tachyarrhythmias, especially supraventricular tachyarrhythmias.

Early intervention with Betaloc I.V. Injection in acute myocardial infarction reduces infarct size and the incidence of ventricular fibrillation. Pain relief may also decrease the need for opiate analgesics.

Betaloc I.V. Injection has been shown to reduce mortality when administered to patients with acute myocardial infarction.

Posology and method of administration

Posology

The dose must always be adjusted to the individual requirements of the patient. The following are guidelines:

Cardiac arrhythmias

Initially up to 5 mg injected intravenously at a rate of 1-2 mg per minute. The injection can be repeated at 5 minute intervals until a satisfactory response has been obtained. A total dose of 10-15 mg generally proves sufficient.

Because of the risk of a pronounced drop of blood pressure, the I.V. administration of Betaloc I.V. Injection to patients with a systolic blood pressure below 100 mmHg should only be given with special care.

During Anaesthesia

2-4 mg injected slowly I.V. at induction is usually sufficient to prevent the development of arrhythmias during anaesthesia. The same dosage can also be used to control arrhythmias developing during anaesthesia. Further injections of 2 mg may be given as required to a maximum overall dose of 10 mg.

Myocardial infarction

Intravenous Betaloc I.V. Injection should be initiated in a coronary care or similar unit when the patient’s haemodynamic condition has stabilised. Therapy should commence with 5 mg I.V. every 2 minutes to a maximum of 15 mg total as determined by blood pressure and heart rate. The second or third dose should not be given if the systolic blood pressure is <90 mmHg, the heart rate is <40 beats/min and the P-Q time is >0.26 seconds, or if there is any aggravation of dyspnoea or cold sweating. Oral 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.

Renal impairment

Dose adjustment is generally not needed in patients with impaired renal function.

Hepatic Impairment

Dose adjustment is normally not needed in patients suffering from liver cirrhosis because metoprolol has a low protein binding (5–10%). However, in patients with severe hepatic dysfunction a reduction in dosage may be necessary.

Elderly

Several studies indicate that age related physiological changes have negligible effects on the pharmacokinetics of metoprolol. Dose adjustment is not needed in the elderly, but careful dose titration is important in all patients.

Paediatric population

The safety and efficacy of metoprolol in children has not been established.

Overdose

Symptoms

Symptoms of overdose may include hypotension, cardiac insufficiency, bradycardia and bradyarrhythmia, cardiac conduction disturbances and bronchospasm.

Management

Care should be provided at a facility that can provide appropriate supporting measures, monitoring and supervision.

Atropine, adrenostimulating drugs or pacemaker to treat bradycardia and conduction disorders.

Hypotension, acute cardiac failure, and shock to be treated with suitable volume expansion, injection of glucagon (if necessary, followed by an intravenous infusion of glucagon), intravenous administration of adrenostimulating drugs such as dobutamine, with α1 receptor agonistic drugs added in presence of vasodilation. Intravenous use of Ca2+ can also be considered.

Bronchospasm can usually be reversed by bronchodilators.

Shelf life

4 years.

Special precautions for storage

Protect from light. Store below 25°C.

Nature and contents of container

5 ml glass ampoule.

Special precautions for disposal and other handling

No special requirements.

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