Products Affected - Description

• • Amiodarone injection, Hikma, 50 mg/mL, 3 mL vial, 25 count, NDC 00143-9875-25
  • Amiodarone injection, Slate Run Pharmaceuticals, 50 mg/mL, 3 mL vial, 10 count, NDC 70436-0232-52

Reason for the Shortage

• • AuroMedics discontinued amiodarone in mid-2021.
  • Baxter has Nexterone premixed bags available.
  • Fresenius Kabi has amiodarone injection available.
  • Hikma did not provide a reason for the shortage.
  • Viatris did not provide a reason for the shortage.
  • Sagent discontinued amiodarone 50 mg/mL 3 mL syringes in June 2019.
  • Slate Run Pharmaceuticals has amiodarone on shortage due to increased demand.

Available Products

• • Nexterone injection, Baxter, 150 mg/100 mL, premixed bag, 12 count, NDC 43066-0150-10
  • Nexterone injection, Baxter, 360 mg/200 mL, premixed bag, 10 count, NDC 43066-0360-20
  • Amiodarone injection, Fresenius Kabi, 50 mg/mL, 3 mL vial, 10 count, NDC 63323-0616-03
  • Amiodarone injection, Fresenius Kabi, 50 mg/mL, 9 mL vial, 10 count, NDC 63323-0616-09
  • Amiodarone injection, Mylan Institutional (Viatris), 50 mg/mL, 18 mL vial, 10 count, NDC 67457-0153-18
  • Amiodarone injection, Mylan Institutional (Viatris), 50 mg/mL, 3 mL vial, 10 count, NDC 67457-0153-03
  • Amiodarone injection, Mylan Institutional (Viatris), 50 mg/mL, 9 mL vial, 10 count, NDC 67457-0153-09
  • Amiodarone injection, Slate Run Pharmaceuticals, 50 mg/mL, 18 mL vial, 1 count, NDC 70436-0232-50
  • Amiodarone injection, Slate Run Pharmaceuticals, 50 mg/mL, 9 mL vial, 10 count, NDC 70436-0232-62

• • Hikma has amiodarone 50 mg/mL 3 mL vials on back order and the company estimates a release date of late-September 2025.
  • Slate Run Pharmaceuticals has amiodarone 50 mg/mL 3 mL vials on back order and the company estimates a release date of mid-October 2025.

• • This drug is used for the management of life-threatening ventricular arrhythmias, including hemodynamically unstable ventricular tachycardia and recurring ventricular fibrillation.[1]
  • Off-label indications include but are not limited to the following: prevention of implantable cardioverter defibrillator shocks, atrial fibrillation management, supraventricular tachycardia, and symptomatic ventricular premature beats.[1]

• • Amiodarone injection in 5% dextrose is incompatible with many admixtures (eg, ceftazidime, furosemide, heparin, piperacillin-tazobactam); use separate intravenous lines if coadministration with other agents is needed.[2]
  • Amiodarone injection is not intended for continuous maintenance treatment.[2]
  • Amiodarone injection daily dosage may be converted to amiodarone oral daily dosage. Start amiodarone tablets at a dosage of 600-800 mg orally daily if amiodarone injection was administered for 1-3 weeks or 800-1,600 mg orally daily if amiodarone injection was administered for < 1 week. If the injection was administered for > 3 weeks then start amiodarone tablets at 400 mg orally a day.[2]

• • Sotalol 75 mg IV every 12 hours is an alternative agent used to treat arrythmias. This medication is the same class of medication as amiodarone.[3]
  • Other antiarrhythmic medications administered intravenously include esmolol 0.5 mg/kg bolus then 0.05 mg/kg/min, metoprolol 5 mg every 5 minutes up to 3 doses, propranolol 1 mg - 3 mg every 5 minutes up to a total of 5 mg, verapamil 2.5 mg - 5 mg every 15 minutes to 30 minutes, among others.[3]
  • Alternative antiarrhythmic medications administered by mouth include acebutolol 200 mg - 1,200 mg daily, atenolol 25 mg to 100 mg daily or twice daily, carvedilol 3.125 mg to 25 mg every 12 hours, among others.[3]

• 1. Amiodarone injection [prescribing information]. Lake Zurich, IL: Fresenius Kabi; August 2024.
  2. Amiodarone. Lexicomp Online. Wolters Kluwer Clinical Drug Information. Hudson, Ohio, USA; Accessed August 28, 2025
  3. Al-Khatib SM, Stevenson WG, Ackerman MJ, et al. 2017 AHA/ACC/HRS guideline for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: executive summary. Circulation. 2018;138(13):e210-217.