Bio-Amiodarone Tablets.
PDF Leaflet Revision Date: 15 March 2023
Clinical Summary
Quick overview from the medicine insert
Indication
Prevention of tachydysrhythmias when other treatments are not suitable.
Dosage (summary)
Initial: 200 mg three times daily for 1 week, then 200 mg twice daily for 1 week. Maintenance: 200 mg daily or less as needed.
Onset of Action / Duration
Onset: 1-2 weeks, Duration: variable
Special Populations
- Elderly
- Renal impairment
- Hepatic impairment
Pregnancy & Breastfeeding
Contraindicated in pregnancy and breastfeeding.
Key Drug Interactions
- Grapefruit juice
- Sofosbuvir
- Digoxin
- Warfarin
- CYP3A4 inhibitors
Contraindications
- Sinus bradycardia
- Hyperthyroidism
- Severe hypotension
- Pregnancy
- Breastfeeding
Common side effects
- Bradycardia
- Pulmonary toxicity
- Hypotension
- Gastrointestinal disorders
- Photosensitivity
Counselling Points
- Monitor for signs of bradycardia
- Regular thyroid function tests
- Avoid sun exposure
- Report vision changes immediately
Serious warnings
- Potentially fatal pulmonary toxicity
- Proarrhythmic effects
- Severe bradycardia with sofosbuvir
Important Disclaimer
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