Generic Medicine Info
May be taken with or without food. Take consistently w/ or w/o meals. Take w/ meals if high dose or to reduce GI discomfort.
Sinus bradycardia, sino-atrial heart block, severe conduction disturbances (e.g. high-grade AV block, bifascicular or trifascicular block) without a presence of pacemaker, cardiogenic shock, severe hypotension, severe respiratory failure, known or history of thyroid dysfunction, known hypersensitivity to iodine, corneal refractive laser surgery. IV (bolus inj): Hypotension, heart failure, cardiomyopathy. Lactation. Concomitant use with drugs which may induce QT prolongation or torsades de pointes.
Special Precautions
Patient with latent or manifest heart failure, implantable cardioverter defibrillator or pacemaker, decompensated cardiomyopathy, hypotension. Patient undergoing surgery. Elderly. Pregnancy. Patient Counselling This drug may cause eye disorders, if affected, do not drive or operate machinery. Avoid excessive exposure to sunlight and use proper protective measures during treatment. Monitoring Parameters Monitor blood pressure, heart rate and rhythm (ECG), LFT, serum electrolytes (particularly K and Mg); pacing or defibrillation thresholds prior to and during treatment (in patients with implantable cardiac devices). Evaluate thyroid function tests prior to therapy and periodically (every 3-6 months) thereafter. Perform regular ophthalmologic examination, chest X-ray, and pulmonary function tests.
Adverse Reactions
Significant: Bradycardia, QT prolongation, hypotension, peripheral neuropathy, photosensitivity, optic neuropathy and/or optic neuritis. Eye disorders: Corneal microdeposits. Gastrointestinal disorders: Nausea, vomiting, dysgeusia, constipation. General disorders and administration site conditions: Inj site reactions (e.g. pain, erythema, oedema, extravasation, infiltration, inflammation, induration, necrosis, infection, thrombophlebitis, phlebitis, cellulitis). Investigations: Increased serum transaminases, elevated bilirubin levels. Nervous system disorders: Extrapyramidal tremor. Psychiatric disorders: Nightmares, sleep disorders. Skin and subcutaneous tissue disorders: Blue-grey skin discolouration (prolonged use), eczema.
Potentially Fatal: Onset or worsening of arrhythmia, hepatotoxicity (e.g. cirrhosis, hepatitis, jaundice, hepatic failure), pulmonary toxicity (e.g. hypersensitivity pneumonitis, alveolar/interstitial pneumonitis, fibrosis, pleural effusion), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), hyperthyroidism.
Drug Interactions
Increased concentration with inhibitors of CYP3A4 (e.g. HIV-protease inhibitors, cimetidine). Reduced concentration with inducers of CYP3A4 (e.g. rifampicin, phenytoin). May induce bradycardia with β-blockers, Ca channel blockers, and other antiarrhythmic drugs. May increase risk of arrhythmia with stimulant laxatives, diuretics, systemic corticosteroids. May increase concentration of ciclosporin, clonazepam, digoxin, flecainide, procainamide, quinidine, simvastatin, warfarin. May affect drugs that are P-glycoprotein substrates.
CIMS Class
Cardiac Drugs
ATC Classification
C01BD01 - amiodarone ; Belongs to class III antiarrhythmics.
Disclaimer: This information is independently developed by CIMS based on amiodarone from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2023 CIMS. All rights reserved. Powered by
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