Amiodarone
آمیودارون
❤️ Cardiovascular SystemClass III antiarrhythmic
Market / country: 🇺🇸 USA
Cordarone (US) · Pacerone (US)
🧮 Dose calculator
Life-threatening ventricular arrhythmia · Regimen source: FDA Amiodarone tablets · 2
- • Load 800–1,600 mg/day (1–3 weeks), then 600–800 mg/day for 1 month, then maintenance. Specialist use; start in hospital. FDA Amiodarone tablets · 2
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Cardiogenic shock; sick sinus or 2nd/3rd-degree block without pacemaker; bradycardia causing syncope; hypersensitivity (including iodine). FDA Amiodarone tablets · 4
Warnings
- • Boxed warning: pulmonary toxicity, hepatic injury and worsened arrhythmia; only for life-threatening arrhythmias. FDA Amiodarone tablets · Boxed Warning
Monitoring
- • Thyroid, liver, lung function and eye examinations. FDA Amiodarone tablets · 5
Important interactions
- • Potentiates warfarin — monitor INR and reduce warfarin. FDA Amiodarone tablets · 7
- • Raises digoxin levels. FDA Amiodarone tablets · 7
Formulations
- 100 mg tablet — tablet 🇺🇸 USA FDA Amiodarone tablets · 3
- 200 mg tablet (scored) — tablet 🇺🇸 USA FDA Amiodarone tablets · 3
- 400 mg tablet (scored) — tablet 🇺🇸 USA FDA Amiodarone tablets · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Amiodarone tablets · 8.1
“Risk Summary Available data from postmarketing reports and published case series indicate that amiodarone use in pregnant women may increase the risk for fetal adverse effects including neonatal hypo- and hyperthyroidism, neonatal bradycardia, neurodevelopmental abnormalities, preterm birth and fetal growth …”
- 🤱 BreastfeedingDangerous / avoid
Label: breastfeeding not recommended, or choose between the drug and breastfeeding. FDA Amiodarone tablets · 8.2
“Breastfeeding is not recommended during treatment with amiodarone hydrochloride tablets [see Warnings and Precautions (5.6 , 5.7) ] .”
- 👶 ChildrenSafety not established
Label: safety and effectiveness in children have not been established. FDA Amiodarone tablets · 8.4
“The safety and effectiveness of amiodarone hydrochloride tablets in pediatric patients have not been established.”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Amiodarone tablets · 8.5
“In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.”
- ⚥ Females & males of reproductive potentialUse with caution
Label has advice on pregnancy testing, contraception or fertility for females and males. FDA Amiodarone tablets · 8.3
“Infertility Based on animal fertility studies, amiodarone hydrochloride tablets may reduce female and male fertility.”
🔗 Reference links
- FDA (approval record)ANDA075389
- DailyMed (FDA label)FDA Amiodarone tablets
- MedlinePlus (NIH)Amiodarone
- WHO ATC/DDDC01BD01
- Darooyab (Iran)Amiodarone
🇮🇷 Registered in Iran Darooyab · G-1521/Amiodarone
Dosage forms with Iranian generic codes, per Darooyab.
- 18637 · AMIODARONE 30MG/ML 1ML VIAL · ویال آمیودارون ۳۰ میلیگرم / میلیلیتر، ۱ میلیلیتر
- 00064 · AMIODARONE HCL 150MG/3ML AMP · آمپول آمیودارون هیدروکلراید ۱۵۰ میلیگرم / ۳ میلیلیتر
- 00063 · AMIODARONE HCL 200MG TAB · قرص آمیودارون هیدروکلراید ۲۰۰ میلیگرم
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Amiodarone tablets · 3FDA Amiodarone tablets · 2FDA Amiodarone tablets · 4FDA Amiodarone tablets · Boxed WarningFDA Amiodarone tablets · 5FDA Amiodarone tablets · 7FDA Amiodarone tablets · 8.1FDA Amiodarone tablets · 8.2FDA Amiodarone tablets · 8.4FDA Amiodarone tablets · 8.5FDA Amiodarone tablets · 8.3FDA Amiodarone tablets · SPL approval / marketing category
- UK SmPC (eMC / MHRA)❌ Not present
- Published guideline❌ Not present
- Licensed reference (medical school)❌ Not present
- Iranian leaflet (IFDA)❌ Not present
- Pharmacy website (secondary, unreliable)✅ PresentDarooyab · G-1521/Amiodarone
- Clinical review⚠ Unverified