VERAPAMIL

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. g. in paroxysmal tachycardia, a further 5 mg may be given after 5 to 10 minutes.

Children:

Verapamil Injection must always be administered under ECG monitoring in young patients. 75-2 mg). 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’.

Adverse events observed in clinical trials are depicted in the following table. Within each system organ class, the adverse drug reactions are ranked under headings of frequency, using the following convention: common (≥1/100, <1/10), uncommon (≥1/1,000, <1/100), rare (≥1/10,000, <1/1,000), very rare (<1/10,000), including isolated reports.

System Organ Class Frequency Undesirable Effects Nervous system disorders common - dizziness - headache Cardiac disorders/vascular disorders common - bradycardia - hypotension uncommon - tachycardia Gastrointestinal disorders uncommon - nausea - abdominal pain Cases of seizures during verapamil hydrochloride injection have been reported.

In rare cases of hypersensitivity, bronchospasm accompanied by pruritis and urticaria has been reported. Other Reactions from Postmarketing Surveillance or Phase IV Clinical Trials Other adverse events reported with verapamil are listed below by system organ class: Psychiatric disorders: on rare occasions, nervousness has been reported.

Nervous system disorders: somnolence and extrapyramidal syndrome. Ear and labyrinth disorders: vertigo. Cardiac disorders/vascular disorders: decreased myocardial contractility has been reported. On rare occasions, 2nd and 3rd block may occur and in extreme cases, this may lead to asystole.

The asystole is usually of short duration and cardiac action returns spontaneously after a few seconds, usually in the form of sinus rhythm. If necessary, the procedures for the treatment of overdosage should be followed as described below.

On rare occasions, flushing has been reported. Gastrointestinal disorders: gingival hyperplasia may occur very rarely when the drug is administered over prolonged periods, and is fully reversible when the drug is discontinued. On rare occasions, vomiting has also been reported.

Verapamil hydrochloride injection should be given as a slow intravenous injection over at least a two-minute period of time under continuous ECG and blood pressure monitoring. A small fraction of patients treated with verapamil hydrochloride respond with life-threatening adverse responses including (rapid ventricular rate (in atrial flutter/fibrillation in the presence of an accessaory bypass tract), marked hypotension or extreme bradycardia/asystole).

Heart Block/ 1st Degree AV block/Bradycardia/Asystole Verapamil hydrochloride affects the AV and SA nodes and prolongs AV conduction time. Use with caution as development of second-or third-degree AV block (contraindication) or unifascicular, bifascicular or trifascicular bundle branch block requires discontinuation in subsequent doses of verapamil hydrochloride and institution of appropriate therapy, if needed.

Verapamil hydrochloride affects the AV and SA nodes and rarely may produce second- or third-degree AV block, bradycardia, and, in extreme cases, asystole. This is more likely to occur in patients with a sick sinus syndrome (SA nodal disease), which is more common in older patients.

Asystole in patients other than those with sick sinus syndrome is usually of short duration (few seconds or less), with spontaneous return to AV nodal or normal sinus rhythm. If this does not occur promptly, appropriate treatment should be initiated immediately.

See Undesirable Effects Section. Although the pharmacokinetics of verapamil in patients with renal impairment are not affected, caution should be exercised and careful patient monitoring is recommended. Verapamil is not removed during dialysis.

, simvastatin, atorvastatin or lovastatin) for patients taking verapamil. These patients should be started at the lowest possible dose of verapamil and titrated upwards. , simvastatin, atorvastatin or lovastatin), refer to advice in the respective statin product information.

Hypersensitivity to the active substance or to any of the excipients. Cardiogenic shock; acute myocardial infarction complicated by bradycardia, marked hypotension or left ventricular failure; second or third degree AV block (except in patients with a functioning artificial ventricular pacemaker); sino-atrial block; sick sinus syndrome (except in patients with a functioning artificial ventricular pacemaker); uncompensated heart failure; bradycardia of less than 50 beats/minute; hypotension of less than 90mmHg systolic; simultaneous administration of intravenous beta-blockers.

g. WPW syndrome) may develop increased conduction across the anomalous pathway and ventricular tachycardia may be precipitated. Combination with ivabradine (see section Interactions with other medicinal products and other forms of interaction).