ISOPTIN Solution for injection / infusion Ref.[51033] Active ingredients: Verapamil

Adults

The recommended intravenous doses of verapamil hydrochloride are as follows:

Initial dose: 5 mg initially, given slowly (over approximately 2 minutes), keeping the patient under constant observation and if possible under ECG and blood pressure monitoring.

Repeat dose: If the therapeutic effect is not achieved, a further 5 mg may be injected after 5 to 10 minutes. Drip infusion to maintain the therapeutic effect: 5‐10 mg/hour in physiological saline, glucose, laevulose or similar solutions (pH ≤ 6.5) on average up to a total dose of 100mg/day.

Special Populations

Paediatric population

The safety and efficacy of verapamil hydrochloride injection have been established in neonates, infants, children and adolescents:

Newborn 0.75‐1 mg (= 0.3‐0.4 ml).

Infants 0.75‐2 mg (= 0.3‐0.8 ml).

If there are any signs of tachycardia‐induced heart failure (energetic exhaustion of the myocardium), digitalisation is necessary before administering Isoptin intravenously.

Children aged 1‐5 years, 2‐3 mg (= 0.8‐1.2 ml), aged 6‐14 years, 2.5‐5 mg (= 1‐2 ml) of Isoptin. The injection should be given only until the onset of action.

Elderly patients

The dose should be administered over at least 3 minutes to minimise the risk of untoward drug effects.

Intravenous infusion in hypertensive crisis: Initial treatment with 0.05‐0.1 mg/kg/hour and, if the effect proves to be insufficient, increase the dose at 30‐60 minute intervals until twice the dose or more is reached. Average total dose up to 1.5 mg/kg/day.

Method of administration

For intravenous use only.

Verapamil hydrochloride should be given as a slow intravenous injection over at least a two minute period of time under continuous electrocardiographic and blood pressure monitoring.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Verapamil hydrochloride is physically compatible and chemically stable for at least 24 hours at 25°C protected from light in most common large volume parenteral solutions. Use only if solution is clear and vial seal is intact.

Unused amount of solution should be discarded immediately following withdrawal of any portion of contents.

For stability reasons this product is not recommended for dilution with sodium lactate injection, USP in polyvinyl chloride bags.

Admixing intravenous verapamil hydrochloride with albumin, amphotericin B, hydralazine hydrochloride or trimethoprim and sulfamethoxazole should be avoided.

Verapamil hydrochloride will precipitate in any solution with a pH above 6.0.

Verapamil should not be taken with grapefruit juice (see Section 4.5, Interactions).

Symptoms

Hypotension, bradycardia up to high degree AV block and sinus arrest, hyperglycemia, stupor, metabolic acidosis and acute respiratory distress syndrome. Fatalities have occurred as a result of overdose.

Treatment

The usual intensive care measures should be taken. Verapamil hydrochloride cannot be removed by haemodialysis.

The specific antidote is calcium, e.g. 10‐20 ml in a 10% calcium gluconate solution administered intravenously (2.25‐4.5 mmol), repeated if necessary or given as a continuous drip infusion (e.g. 5 mmol/hour). The following measures may also be necessary: In the case of 2^nd or 3^rd degree AV block, sinus bradycardia, asystole: Atropine, isoprenaline, orciprenaline or pacemaker therapy. Asystole should be handled by the usual measures including beta adrenergic stimulation (e.g., isoproterenol hydrochloride).

In the case of hypotension: Dopamine, dobutamine, norepinephrine.

If there are any signs of continuing myocardial failure: Dopamine, dobutamine, if necessary repeated calcium injections, and possibly other medication that increases cardiac contractility combined with isoprenaline.

36 months.

Do not store above 30°C. Keep the ampoules in the outer carton in order to protect from light.

2ml ampoules of Ph. Eur. type I glass.

Each pack contains: 5 × 2ml ampoules.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.