Amiodarone: uses, dosing, side effects & brands

How amiodarone is dosed

From the FDA label for Amiodarone Hydrochloride (application ANDA075761). Other amiodarone products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.

Amiodarone shows considerable interindividual variation in response. Although a starting dose adequate to suppress life-threatening arrhythmias is needed, close monitoring with adjustment of dose is essential. The recommended starting dose of amiodarone is about 1000 mg over the first 24 hours of therapy, delivered by the following infusion regimen: Table 1: AMIODARONE DOSE RECOMMENDATIONS: FIRST 24 HOURS Loading infusions First Rapid: 150 mg over the FIRST 10 minutes (15 mg/min). Add 3 mL of amiodarone (150 mg) to 100 mL D 5 W (concentration = 1.5 mg/mL). Infuse 100 mL over 10 minutes. Followed by Slow: 360 mg over the NEXT 6 hours (1 mg/min). Add 18 mL of amiodarone (900 mg) to 500 mL D 5 W (concentration = 1.8 mg/mL). Infuse 200 mL at a rate of 0.556 mL/min. Maintenance infusion 540 mg over the REMAINING 18 hours (0.5 mg/min ). Decrease the rate of the slow loading infusion to 0.278 mL/min. After the first 24 hours , continue the maintenance infusion rate of 0.5 mg/min (720 mg per 24 hours) utilizing a concentration of 1 to 6 mg/mL (Use a central venous catheter for amiodarone concentrations greater than 2 mg/mL). The rate of the maintenance infusion may be increased to achieve effective arrhythmia suppression. In the event of breakthrough episodes of VF or hemodynamically unstable VT, use 150 mg supplemental infusions of amiodarone (mixed in 100 mL of D 5 W and infused…

Amiodarone side effects

The following adverse reactions are described elsewhere in labeling: • Hypotension [see Warnings and Precautions ( 5.1 )] • Hepatic injury [see Warnings and Precautions ( 5.3 )] • Rhythm disturbances [see Warnings and Precautions ( 5.4 )] • Pulmonary injury [see Warnings and Precautions ( 5.5 )] • Thyroid injury [see Warnings and Precautions ( 5.7 )] • Hypersensitivity [see Warnings and Precautions ( 5.11 )] • The most common adverse reactions (1-2%) leading to discontinuation of intravenous amiodarone therapy are hypotension, asystole/cardiac arrest/pulseless electrical activity, VT, and cardiogenic shock. ( 6 ) • Other important adverse reactions are, torsade de pointes, congestive heart failure, and liver function test abnormalities. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In a total of 1836 patients in controlled and uncontrolled clinical trials, 14% of patients received intravenous amiodarone for at least one week, 5% received it for at least 2 weeks, 2% received it for at least…

Amiodarone and food

• Grapefruit & grapefruit juice

  Avoid grapefruit and grapefruit juice with this medicine unless your pharmacist or the label says it's fine — check, because not every drug in a class is affected the same way.

  Grapefruit Juice and Some Drugs Don't Mix — U.S. FDA ↗

Every amiodarone product we track (3)

Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.

What amiodarone pills look like

Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.