dronedarone hydrochloride: clinical use

Prescribing considerations

• Initiate and monitor under specialist supervision only after alternative rhythm-control options have been considered.
• Confirm successful cardioversion and clinical stability; discontinue if atrial fibrillation becomes permanent.
• Stop class I or III antiarrhythmics before initiation. Switching from amiodarone requires specialist planning.
• Correct potassium or magnesium deficiency and review QT-prolonging, rate-limiting, CYP3A4 and P-glycoprotein-interacting medicines.
• Confirm absence of pregnancy where relevant and discuss effective contraception.

Contraindications and cautions

• Permanent atrial fibrillation
• Current or previous heart failure, left-ventricular systolic dysfunction or unstable haemodynamic status
• Relevant conduction disease without a functioning pacemaker, marked bradycardia or QTc Bazett interval of at least 500 milliseconds
• Severe hepatic impairment or severe renal impairment
• Previous amiodarone-associated liver or lung toxicity
• Concomitant dabigatran, potent CYP3A4 inhibitors, class I or III antiarrhythmics, or other specified torsades-inducing medicines
• Hypersensitivity to dronedarone or an excipient

Monitoring

• Baseline ECG, cardiac assessment, liver tests, renal function and electrolytes.
• Repeat ECG serially and at least every six months.
• Check liver function after one week and one month, monthly for six months, at months nine and twelve, and periodically thereafter.
• Recheck creatinine after seven days; investigate continued or larger rises.
• Assess promptly for heart-failure, pulmonary-toxicity and liver-injury symptoms.
• Monitor interacting medicines where applicable, including INR, digoxin and immunosuppressant concentrations.

Clinical pharmacology

A multichannel antiarrhythmic with class I, II, III and IV electrophysiological actions, principally classified as class III. It is extensively metabolised by CYP3A4, inhibits CYP3A4, CYP2D6 and P-glycoprotein to varying degrees, and has an active N-debutyl metabolite. Food materially increases bioavailability.

Formulation and product differences

• The selected product is a white, oblong film-coated tablet supplied in blisters.
• It contains lactose monohydrate and is unsuitable for certain rare hereditary disorders of galactose handling.
• The tablet should be swallowed whole and cannot be divided into equal portions.
• No special storage conditions are required.

Tablet

Route: Oral

Strengths: 400 mg