SECURON Solution for injection Ref.[7144] Active ingredients: Verapamil

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2024  Publisher: Mylan Products Ltd., 20 Station Close, Potters Bar, Herts, EN6 1TL, United Kingdom

Therapeutic indications

Securon IV is indicated for the treatment of paroxysmal supraventricular tachycardia and the reduction of ventricular rate in atrial flutter/fibrillation.

Posology and method of administration

For slow intravenous injection.

Adults

5-10 mg by slow intravenous injection over a period of 2 minutes. The patient should be observed continuously, preferably under ECG and blood pressure control. If necessary, e.g. in paroxysmal tachycardia, a further 5 mg may be given after 5 to 10 minutes.

Children

Securon IV must always be administered under ECG monitoring in young patients.

0-1 year: 0.1-0.2 mg/kg bodyweight (usual single dose range: 0.75-2 mg).

1-15 years: 0.1-0.3 mg/kg bodyweight (usual single dose range: 2-5 mg).

The dose may be repeated after 30 minutes if necessary. Many cases are controlled by doses at the lower end of the range. The injection should be stopped at the onset of the desired effect.

Elderly

The dosage should be administered over 3 minutes to minimise the risk of adverse effects.

Dosage in impaired liver and renal function

Significant hepatic and renal impairment should not increase the effects of a single intravenous dose but may prolong its duration of action.

For use with beta-blocker therapy, see ‘Contra-indications’ and ‘Special Warnings and Precautions for Use’.

Overdose

The symptoms of overdosage include hypotension, shock, loss of consciousness, first and second degree AV block (frequently as Wenckebach’s phenomenon with or without escape rhythms), total AV block with total AV dissociation, escape rhythm, asystole, bradycardia up to high degree AV block and, sinus arrest, hyperglycaemia, stupor and metabolic acidosis and acute respiratory distress syndrome.. Fatalities have occurred as a result of overdose.

Treatment of overdosage depends on the type and severity of symptoms. The specific antidote is calcium, e.g. 10-20 ml of 10% calcium gluconate solution i.v. (2.25-4.5 mmol) if necessary by repeated injection or continuous infusion (e.g. 5 mmol/hour). The usual emergency measures for acute cardiovascular collapse should be applied and followed by intensive care. Verapamil hydrochloride cannot be removed by haemodialysis. Similarly, in the case of second or third degree AV block, atropine, orciprenaline, isoprenaline and if required, pacemaker therapy should be considered. If there are signs of myocardial insufficiency, dopamine, dobutamine, cardiac glycosides or calcium gluconate (10-20 ml of a 10% solution) can be administered.

In the case of hypotension, after appropriately positioning the patient, dopamine, dobutamine or noradrenaline may be given.

Shelf life

36 months.

Special precautions for storage

Do not store above 30°C. Protect from light.

Nature and contents of container

2 ml glass ampoule (hydrolytic type 1) containing 5 mg verapamil.

Pack size: 5 × 2 ml ampoules.

Special precautions for disposal and other handling

None.

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