VERAPAMIL HYDROCHLORIDE BP

Posology Elderly or patients with impaired liver or kidney function, or cardiac conduction problems may require a reduced dosage.

Angina:

Adults: 120mg, 3 times daily is recommended. Some patients with angina of effort may respond to 80mg, 3 times daily, but this dose is not likely to be effective in angina at rest and variant angina.

Supraventricular tachycardias:

Adults: 40mg to 120mg, 3 times daily according to the severity of the condition. Paediatric population, 2 years and above: 40mg to 120mg, 2 to 3 times daily, according to age and effectiveness.

Hypertension:

Adults: 160mg twice daily. A small number of patients may be controlled successfully on 120mg twice daily, whereas others may require up to 480mg daily, given in divided doses. A further reduction in blood pressure may be obtained by combining Verapamil Tablets with other antihypertensive agents, eg thiazide diuretics.

Verapamil hydrochloride and beta-blockers may be additive, both with respect to conduction and contraction. Verapamil hydrochloride should, therefore, be given with care to those who are receiving beta-blockers.

Paediatric population:

Up to 10mg/kg/day, in divided doses, according to the severity of the condition. Method of Administration For oral use only

Reactions from Post marketing Surveillance or Phase IV Clinical Trials The following adverse events reported with verapamil are listed below by system organ class. Adverse drug reactions are ranked by frequency, using the following convention: very common (≥ 1/10); common (≥ 1/100 to <1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).

g. erythema, pruritus, urticaria) are very rarely seen. g. parkinsonism), dystonia. Ear and labyrinth disorders: vertigo, tinnitus. Cardiac disorders: bradycardic arrhythmias such as sinus bradycardia, sinus arrest with asystole, 2nd and 3rd degree AV block, bradyarrhythmia in atrial fibrillation, palpitations, tachycardia, development or aggravation of heart failure.

hypotension. Vascular disorders: flushing, peripheral oedema. Gastrointestinal disorders: nausea, vomiting, constipation, ileus and abdominal pain/discomfort. Gingival hyperplasia may occur very rarely when the drug is administered over prolonged periods.

This is fully reversible when the drug is discontinued. Skin and subcutaneous tissue disorders: alopecia, ankle oedema, Quincke's oedema, Stevens-Johnson syndrome, erythema multiforme, erythromelalgia, purpura. Musculoskeletal and connective tissue disorders: muscular weakness, myalgia and arthralgia.

Reproductive system and breast disorders: impotence (erectile dysfunction) has been rarely reported and isolated cases of galactorrhoea. Gynaecomastia was observed on very rare occasions in elderly male patients under longer term verapamil treatment, which was fully reversible in all cases when the drug was discontinued.

General disorders and administration site conditions: fatigue.

Investigations:

Since verapamil is extensively metabolised in the liver, careful dose titration is required in patients with liver disease. 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. 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. 8). Hypotension Intravenous verapamil hydrochloride often produces a decrease in blood pressure below baseline levels that is usually transient and asymptomatic but may result in dizziness.

, 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.

Use with caution in the presence of diseases in which neuromuscular transmission is affected (myasthenia gravis, Lambert-Eaton syndrome, advanced Duchenne muscular dystrophy). These tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

1. Cardiogenic shock; acute myocardial infarction complicated by bradycardia, marked hypotension or left ventricular failure; second or third degree atrioventricular (AV) block (except in patients with a functioning artificial pacemaker), sino-atrial block, sick sinus syndrome (except in patients with a functioning artificial pacemaker), uncompensated heart failure; bradycardia of less than 50 beats/minute, hypotension of less than 90 mmHg systolic.

Combination with beta-blockers is contraindicated in patients with poor ventricular function. g. Wolff-Parkinson-White Syndrome) may develop increased conduction across the anomalous pathway and ventricular tachycardia may be precipitated.

Concomitant ingestion of grapefruit juice is contraindicated. 5)