04 Jun 2009

ADIZEM-XL (Diltiazem - angina) - United Kingdom

Updated: 04 Jun 2009

ADIZEM-XL

Management of angina pectoris. Treatment of mild to moderate hypertension.

ADIZEM-XL Description, Presentation and Dosage

ADIZEM-XL Description

ADIZEM-XL Drug Class Description

Calcium-channel blockers (class III calcium antagonists).

ADIZEM-XL Drug Description

ADIZEM-XL capsules 120 mg have a pale pink body and a navy blue cap, marked DCR 120. ADIZEM-XL capsules 180 mg have a dark pink body and a royal blue cap marked DCR 180. ADIZEM-XL capsules 200 mg have a brown body and a brown cap marked DCR 200. ADIZEM-XL capsules 240 mg have a dark red body and a blue cap marked DCR 240. ADIZEM-XL capsules 300 mg have a dark maroon body and a pale blue cap marked DCR 300.

ADIZEM-XL Generic Name

Diltiazem - angina

ADIZEM-XL Presentation

ADIZEM-XL Presentation

Prolonged release capsules. ADIZEM-XL capsules 120 mg have a pale pink body and a navy blue cap, marked DCR 120. ADIZEM-XL capsules 180 mg have a dark pink body and a royal blue cap marked DCR 180. ADIZEM-XL capsules 200 mg have a brown body and a brown cap marked DCR 200. ADIZEM-XL capsules 240 mg have a dark red body and a blue cap marked DCR 240. ADIZEM-XL capsules 300 mg have a dark maroon body and a pale blue cap marked DCR 300.

ADIZEM-XL Manufacturer

Napp

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ADIZEM-XL Dosage

ADIZEM-XL Adult Dosage

Route of administration

Oral

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.

The capsules should be swallowed whole and not chewed.

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.

ADIZEM-XL Child Dosage

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

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 (refer to Section 4.5, Interactions with other Medicinal Products and Other Forms of Interaction).

ADIZEM-XL Elderly Dosage

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.

ADIZEM-XL Precautions, Reactions and Contraindications

ADIZEM-XL Special Precautions

ADIZEM-XL Special Precautions

Route of administration

Oral

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.

The capsules should be swallowed whole and not chewed.

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.

ADIZEM-XL Adverse Reactions

ADIZEM-XL Adverse Reactions

Diltiazem is generally well tolerated. Occasional undesirable effects:

  • nausea
  • headache
  • oedema of the legs
  • flushing
  • hypotension
  • fatigue
  • gastrointestinal disturbance
  • gingival hyperplasia which disappear on cessation of treatment.

Serious skin reactions such as exfoliative dermatitis and allergic skin reactions, such as angioneurotic oedema, erythema multiforme and vasculitis have been reported.

Diltiazem may cause depression of atrioventricular nodal conduction and bradycardia. Isolated cases of moderate and transient increased liver transaminases have been observed at the start of treatment. Isolated cases of clinical hepatitis have been reported, which resolved when diltiazem was withdrawn.

ADIZEM-XL Contraindications

ADIZEM-XL Contraindications

Pregnancy and in women of child bearing capacity. Patients with bradycardia (less than 50 bpm), second or third degree heart block, sick sinus syndrome, decompensated cardiac failure, patients with left ventricular dysfunction following myocardial infarction. Concurrent use with dantrolene infusion because of the risk of ventricular fibrillation.

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