VERAPAMIL Oral solution Ref.[7556] Active ingredients: Verapamil

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2022  Publisher: Essential Pharma Ltd, 7 Egham Business Village, Crabtree Road, Egham, Surrey, TW20 8RB, UK

Therapeutic indications

1. Treatment of mild to moderate hypertension.

2. Treatment and prophylaxis of chronic stable angina, vasospastic angina and unstable angina.

3. Treatment and prophylaxis of paroxysmal supraventricular tachycardia and the reduction of ventricular rate in atrial flutter/fibrillation. Verapamil should not be used when atrial flutter/fibrillation complicates Wolff-Parkinson-White syndrome (see Contraindications).

Posology and method of administration

Adults

Hypertension: Initially 120mg b.d. increasing to 160mg b.d. when necessary. In some cases, dosages of up to 480mg daily, in divided doses, have been used. A further reduction in blood pressure may be obtained by combining verapamil with other antihypertensive agents, in particular diuretics. For concomitant administration with betablockers see Precautions.

Angina: 120mg t.d.s. is recommended. 80mg t.d.s. can be completely satisfactory in some patients with angina of effort. Less than 120mg t.d.s is not likely to be effective in variant angina.

Supraventricular tachycardia: 40-120mg, t.d.s. according to the severity of the condition.

Hepatic Impairment

Verapamil is extensively metabolised in liver and for those patients with impaired liver function, the dose should be reduced and carefully titrated.

Renal Impairment

About 70% of an administered dose of verapamil is excreted as metabolites in the urine. Verapamil should be prescribed cautiously when renal function is impaired. Careful patient monitoring is recommended.

Children

Up to 2 years: 20mg, 2-3 times a day.

2 years and above: 40-120mg, 2-3 times a day, according to age and effectiveness.

Elderly

The adult dose is recommended unless liver or renal function is impaired (see Precautions).

Overdose

The course of symptoms in verapamil intoxication depends on the amount taken, the point in time at which detoxification measures are taken and myocardial contractility (age-related).

The main symptoms are as follows: blood pressure fall (at times to values not detectable), shock symptoms, 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, sinus bradycardia, sinus arrest hyperglycaemia, stupor and metabolic acidosis, acute respiratory distress syndrome. Fatalities have occurred as a result of overdose. The therapeutic measures to be taken depend on the point in time at which verapamil was taken and the type and severity of intoxication symptoms. Gastric lavage, taking the usual precautionary measures may be appropriate even later than 12 hours after ingestion, if no gastrointestinal motility (peristaltic sounds) is detectable.

The usual intensive resuscitation measures, such as extrathoracic heart massage, respiration, defibrillation and/or pacemaker therapy. Specific measures to be taken: Elimination of cardiodepressive effects, hypotension or bradycardia. The specific antidote is calcium, e.g. 10–20ml of a 10% calcium gluconate solution administered intravenously (2.25–4.5mmol), repeated if necessary or given as a continuous drip infusion (e.g. 5mmol/hour).

The following measures may also be necessary: In case of second and third degree AV block, sinus bradycardia, asystole: atropine, isoprenaline, orciprenaline or pacemaker therapy. In case of hypotension after appropriate positioning of the patient: dopamine, dobutamine, noradrenaline. If there are signs of continuing myocardial failure: dopamine, dobutamine, cardiac glycosides or if necessary, repeated calcium gluconate injections.

Shelf life

36 months.

3 months once open.

Special precautions for storage

Do not store above 25°C.

Nature and contents of container

Bottle: Amber (Type III) glass.

Closure: HDPE, EPE wadded, tamper evident, child resistant closure.

Pack Size: 150ml.

Special precautions for disposal and other handling

Not applicable.

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