Clinical Pharmacology Details


AMIODARONE


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Indications & Dose:

Treatment of arrhythmias, particularly when other drugs are ineffective or contra-indicated (including paroxysmal supraventricular, nodal and ventricular


tachycardias, atrial fibrillation and flutter, ventricular fibrillation, and tachyarrhythmias associated with Wolff-Parkinson-White syndrome) (initiated in hospital orunder specialist supervision)



Adult: 200 mg 3 times a day for 1 week, then reduced to


200 mg twice daily for a further week, followed by maintenance dose, usually 200mg daily or the minimum dose required to control arrhythmia



Adult: Initially 5 mg/kg, to be given over 20–120 minutes with ECG monitoring, subsequent infusions given if necessary according to response; maximum 1.2 g per day


Ventricular fibrillation or pulseless ventricular tachycardia refractory to defibrillation (for cardiopulmonary resuscitation)



Adult: Initially 300 mg, dose to be considered after administration of adrenaline, dose should be given from a pre-filled syringe or diluted in 20mL Glucose 5%, then (by intravenous injection) 150 mg if required, followed by (by intravenous infusion) 900 mg/24 hours


Children < year of age : Calculate dose using body surface area .Children: Loading dose is 10-15mg/ kg/day or 600-800mg /1.73m2/day for 4-14 days or untill adequate control of arrhythmia or prominent adverse effects occurs; doses should be reduced to 5mg/kg/day or 200-400mg/1.732 /day given once daily for several weeks; if arrhythemia dose not recur reduce to lowest effective doses possible; usually daily daily minimal doses; 2.5mg/kg; maintainance doses may be given for 5-7days /week.

Contraindications:

Severe sinusnode dysfunction, with resultant marked sinus bradycardia; 2nd and 3rd degree AV block; syncope caused by episodes of bradycardia (except when used in conjunction with a pacemaker); hypersensitivity. Pregnancy & breast-feeding.

Side Effects:

Adverse reactions occur in about 75% of patients receiving doses >400 mg/day and cause discontinuation of drug in 7%-18 % of patients


CNS: Ataxia, dizziness, fatigue, headache, insomnia, involuntary movements, lack of coordination, malaise, paresthesias, peripheral neuropathy, tremors


CV: Bradycardia, cardiac conduction abnormalities, CHF, dysrhythmias, hypotension, sinoatrial node dysfunction, sinus arrest EENT: Blurred vision, corneal microdeposits, dry eyes, halos, loss of vision, optic neuritis, optic neuropathy, photophobia


GI: Abdominal pain, anorexia, constipation, diarrhea, hepatotoxicity, nausea, vomiting


METAB: Hyperthyroidism or hypothyroidism


MS: Pain in extremities, weakness


RESP: Cough, dyspnea, pulmonary fibrosis (1/ 1000), pulmonary inflammation


SKIN: Alopecia, angioedema, bluegray skin discoloration, photosensitivity, rash, spontaneous ecchymosis


MISC:Abnormal salivation, abnormal taste or smell, coagulation abnormalities, edema, flushing


 

Cautions:

Precautions:

Thyroid disease, 2nd or 3rd degree AV block, electrolyte imbalances, bradycardia, pulmonary disease (poorer prognosis should pulmonary toxicity develop)


.Old age: Use with caution.

Interaction:

Drugs


Aprinidine: Increased aprinldlne concentrations


ß-adrenergic blockers: Bradycardia, cardiac arrest, or ventricular arrhythmia shortly after initiation of ß-adrenergic blockers that undergo extensive hepatic metabolism (propranolol, sotalol, metoprolol)


Calcium channel blockers: Cardiotoxicity with bradycardia and decreased cardiac output with diltiaze and, potentially, verapamil Cholestyramine, Colestipol: Decreased amiodarone plasma concentrations


Cimetidine: Increased amiodarone plasma concentrations (other H2 blockers likely have no effect)


Cyclosporine, Tacrolimus: Increased cyclosporine, tacrolimus concentrations


Digitalis glycosides: Accumulation of digoxin


Flecainide, Ecainide: Increased flecainide, ecainide serum concentrations


Oral anticoagulants: Enhanced hypoprothrombinemic response to warfarin


Phenytoin: Increased serum phenytoin concentrations, decreased amiodarone concentrations 


Procainamide:Increased procainamide  concentrations


Quinidine: Increased quinidine plasma concentrations


Theophylline: Increased theophylline levels

Warnings:

Adverse Effects:

Lactations:

Special Precautions:

Counselling:

Side Effects Or Adverse Reactions:

Patient And Carer Advice: