Guidelines for Imdelltra Infusion
Imdelltra (amiodarone HCl) infusion should be administered at an initial loading dose of 1000 mg over the first 24 hours, followed by a maintenance infusion of 0.5 mg/min (720 mg/24 hours), using a volumetric infusion pump and preferably through a dedicated central venous catheter. 1
Initial Loading Dose Protocol
The recommended loading dose regimen for Imdelltra is:
- First rapid loading: 150 mg over the first 10 minutes (15 mg/min)
- Followed by: 360 mg over the next 6 hours (1 mg/min)
- Then: 540 mg over the remaining 18 hours (0.5 mg/min)
Administration Requirements
Infusion Equipment and Setup
- Must use a volumetric infusion pump - drop counter infusion sets may lead to underdosing by up to 30%
- Central venous access is preferred, especially for:
- Infusions longer than 1 hour
- Concentrations greater than 2 mg/mL
- Extended therapy (days to weeks)
- In-line filter should be used during administration
Solution Preparation
- Concentration should be 1-6 mg/mL in D5W
- For peripheral administration: limit concentration to ≤2 mg/mL to reduce phlebitis risk
- For central line administration: concentrations up to 6 mg/mL can be used
- Use glass or polyolefin bottles containing D5W for infusions exceeding 2 hours
- Do not use evacuated glass containers for admixing (risk of precipitation)
Monitoring and Dose Adjustments
- Close monitoring with dose adjustment is essential due to considerable interindividual variation
- For breakthrough VF or hemodynamically unstable VT: supplemental 150 mg infusions over 10 minutes may be administered
- Maintenance infusion rate may be increased to achieve effective arrhythmia suppression
- Maximum daily dose: Generally should not exceed 2100 mg due to increased hypotension risk
- Maximum initial infusion rate: Should not exceed 30 mg/min
Duration of Therapy
- Maintenance infusion of up to 0.5 mg/min can be cautiously continued for 2-3 weeks
- Limited experience exists with infusions longer than 3 weeks
Important Safety Considerations
- High concentration/rapid infusion warning: Infusions at higher concentrations and rates than recommended have resulted in hepatocellular necrosis and acute renal failure, leading to death
- Peripheral vein phlebitis risk: Concentrations >3 mg/mL in D5W have high incidence of phlebitis
- Adsorption to PVC tubing: Amiodarone adsorbs to PVC tubing; clinical dosing accounts for this
- Plasticizer leaching: Amiodarone and polysorbate 80 (a component) leach plasticizers including DEHP from IV tubing
Contraindications and Precautions
- Check for admixture incompatibilities before combining with other medications
- Monitor for hypotension, especially with higher doses
- Regular liver enzyme monitoring is recommended due to risk of hepatocellular necrosis
- Visually inspect solution for particulate matter before administration
By following these guidelines, healthcare providers can safely administer Imdelltra infusions while minimizing risks of adverse events and ensuring optimal therapeutic effect for patients requiring this antiarrhythmic medication.