ADIZEM-XL Prolonged release capsule Ref.[7555] Active ingredients: Diltiazem

Posology

Dosage requirements may differ between patients with angina and patients with hypertension. In addition, individual patients' responses may vary necessitating careful titration. This range of capsule strengths facilitates titration to the optimal dose.

Adults

For patients new to diltiazem therapy the usual starting dose is one 240 mg capsule daily.

Patients currently receiving a total daily dose of 180 mg diltiazem (as 90 mg b.d. or 60 mg t.i.d.) and transferring to Adizem-XL capsules should be given the 240 mg capsule (o.d.). A patient receiving 240 mg/day of diltiazem (as 120 mg b.d.) should commence treatment on the 240 mg capsule (o.d.), titrating to the 300 mg capsule (o.d.) if required.

Elderly and patients with impaired hepatic and renal function

For patients new to diltiazem therapy, the usual starting dose is one 120 mg capsule daily. If necessary the dose may be gradually increased but careful monitoring of this group of patients is advised.

Elderly patients transferring to Adizem-XL capsules should receive the same total daily dose of diltiazem, titrating upwards as required

Paediatric population

Adizem-XL capsules are not recommended for children. Safety and efficacy in children have not been established.

Route of Administration

Oral.

In order to avoid confusion, it is suggested that patients once titrated to an effective dose using Adizem-XL capsules, should remain on this treatment and should not be changed between different presentations.

Adizem-XL capsules should not be taken at the same time as an alcoholic beverage (see Section 4.5).

The clinical effects of acute overdose can involve pronounced hypotension possibly leading to collapse, sinus bradycardia with or without isorhythmic dissociation and atrioventricular conduction disturbances.

Treatment, in a hospital setting, will include gastric lavage and/or osmotic diuresis. Conduction disturbances may be managed by temporary cardiac pacing.

Proposed corrective treatments: atropine, vasopressors, inotropic agents, glucagon and calcium gluconate infusion.

Symptomatic bradycardia and high grade atrioventricular block may respond to atropine and isoprenaline.

The formulation employs a prolonged release system which will continue to release diltiazem for some hours.

2 years.

Do not store above 25°C.

PVC/PVdC blister packs with aluminium foil (containing 28 capsules).

None.