Generic Name and Formulations:
Amiodarone HCl 1.5mg/mL, 1.8mg/mL; premixed in dextrose; soln for IV infusion.
Indications for NEXTERONE:
Initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (VT) in patients refractory to other therapy or when oral form is not feasible.
Individualize. First 24hrs: loading infusions: 150mg over the first 10min (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. After the first 24hrs: continue the maintenance infusion rate of 0.5mg/min (720mg per 24hrs) by direct infusion. Switching to oral amiodarone: see full labeling.
Cardiogenic shock. Marked sinus bradycardia. 2nd- or 3rd-degree AV block unless paced.
Be experienced with the treatment and monitoring of life-threatening arrhythmias before prescribing this medication. Before use, correct potassium, magnesium, and calcium deficiencies. Surgery. Monitor for QTc prolongation during treatment. Evaluate thyroid function before therapy and periodically thereafter. Monitor for pulmonary and liver toxicity; reduce dose or discontinue if either occurs. Corneal refractive laser surgery. Do regular ophthalmic exams. Withdraw cautiously. Corn allergy. Neonates. Pregnancy (Cat.D). Nursing mothers: not recommended.
Class III antiarrhythmic.
Interactions may persist months after discontinuing. Potentiates antiarrhythmics (eg, quinidine, procainamide, flecainide; reduce their doses by ⅓), cyclosporine, digoxin (reduce digoxin dose by ½ or discontinue), warfarin-type anticoagulants (reduce anticoagulant dose by ⅓ to ½ and monitor INR), phenytoin, lidocaine. Myopathy with statins metabolized by CYP3A4; limit simvastatin dose to 20mg daily or lovastatin dose to 40mg daily. Potentiated by protease inhibitors, loratadine, cimetidine, trazodone. Avoid grapefruit juice. Exacerbation of arrhythmias with antiarrhythmics. Additive bradycardia, sinus arrest, and AV block with β-blockers, digoxin, verapamil, diltiazem, ivabradine, clonidine; monitor heart rate. QTc prolongation with class I or III antiarrhythmics, lithium, certain phenothiazines, tricyclic antidepressants, certain fluoroquinolones and macrolides, azole antifungals, halogenated inhalation anesthetics; avoid. Symptomatic bradycardia when co-administered with ledipasvir/sofosbuvir or with sofosbuvir plus simeprevir; monitor heart rate when starting antiviral treatment. Antagonized by rifampin, St. John’s wort, cholestyramine. Possible ineffective inhibition of platelet aggregation with clopidogrel. May affect thyroid function tests. See full labeling.
Hypotension, asystole/cardiac arrest/pulseless electrical activity, cardiogenic shock, CHF, bradycardia, liver function test abnormalities, VT, AV block; torsade de pointes, thyroid disorders, vision loss.
Single-dose containers (100mL, 200mL)—1