Amiodarone Hcl Injection Generic Name & Formulations
Legal Class
Rx
General Description
Amiodarone HCl 50mg/mL; soln for IV infusion after dilution; contains polysorbate 80.
Pharmacological Class
Class III antiarrhythmic.
How Supplied
Contact supplier
Manufacturer
Amiodarone Hcl Injection Indications
Indications
Documented, life-threatening recurrent refractory ventricular fibrillation or hemodynamically unstable ventricular tachycardia when oral therapy is not feasible.
Amiodarone Hcl Injection Dosage and Administration
Adult
Individualize. Loading infusions: 150mg over the first 10 mins (15mg/min) by rapid IV infusion, then 360mg over the next 6hrs (1mg/min) by slow IV infusion. Maintenance infusion: 540mg over the remaining 18hrs (0.5mg/min) by slow IV infusion. Switching to oral amiodarone: see full labeling.
Children
Not established.
Amiodarone Hcl Injection Contraindications
Contraindications
Severe sinus node dysfunction. 2nd- or 3rd-degree AV block. Bradycardia with syncope unless paced. Cardiogenic shock.
Amiodarone Hcl Injection Boxed Warnings
Not Applicable
Amiodarone Hcl Injection Warnings/Precautions
Warnings/Precautions
Be experienced with the treatment and monitoring of life-threatening arrhythmias before prescribing this medication. Before use, correct potassium and magnesium deficiencies. Increased risk of pulmonary toxicity or liver injury; monitor, reduce dose or discontinue if either occurs. Perform baseline pulmonary function tests at initiation, then every 3–6 months. Surgery. Monitor thyroid function. Assess implantable cardiac devices. Do regular ophthalmic exams. Withdraw cautiously. Elderly. Neonatal injury (monitor). Labor & delivery. Pregnancy (increased risk for fetal toxicity). Nursing mothers: not recommended.
Amiodarone Hcl Injection Pharmacokinetics
See Literature
Amiodarone Hcl Injection Interactions
Interactions
Interactions may persist months after discontinuing. Increased risk of torsade de pointes with QT prolonging drugs (eg, class I or III antiarrhythmics, lithium, certain phenothiazines, tricyclic antidepressants, certain fluoroquinolones or macrolides, azole antifungals, halogenated inhalation anesthetics); avoid. Potentiated by CYP3A4 inhibitors (eg, certain fluoroquinolones or macrolides, azole antifungals, grapefruit juice, cimetidine); avoid. Potentiates antiarrhythmics (eg, quinidine, procainamide, flecainide); reserve concomitant use for those who are unresponsive to a single agent; reduce their doses by 30–50% for several days after transitioning to oral amiodarone. Potentiates cyclosporine, digoxin (reduce digoxin dose by ½ or discontinue), warfarin (reduce anticoagulant dose by ⅓ to ½ and monitor INR), phenytoin, lidocaine, fentanyl; monitor. Myopathy with statins metabolized by CYP3A4; limit simvastatin dose to 20mg daily or lovastatin dose to 40mg daily. Additive bradycardia, sinus arrest, and AV block with β-blockers, digoxin, verapamil, diltiazem, ivabradine, clonidine; monitor heart rate. Exacerbation of arrhythmias with antiarrhythmics. Symptomatic bradycardia when co-administered with sofosbuvir. Antagonized by St. John’s wort, cholestyramine. May affect thyroid function tests. See full labeling.
Amiodarone Hcl Injection Adverse Reactions
Adverse Reactions
Hypotension, alveolitis, pulmonary inflammation or fibrosis, post-op adult respiratory distress syndrome, exacerbation of arrhythmias, heart block or failure, sinus bradycardia, hepatotoxicity, corneal deposits, optic neuropathy/neuritis (reevaluate if occurs), photosensitivity, skin pigmentation, thyroid disorders, malaise, peripheral neuropathy, constipation, anorexia, blood dyscrasias, pancreatitis; peripheral vein phlebitis (w. concentrated solutions; see full labeling).
Amiodarone Hcl Injection Clinical Trials
See Literature
Amiodarone Hcl Injection Note
Notes
Formerly known under the brand name Cordarone.
Amiodarone Hcl Injection Patient Counseling
See Literature