NEXTERONE is an antiarrhythmic agent indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (VT) in patients refractory to other therapy.

• 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.
• Other important adverse reactions are, torsade de pointes (TdP), congestive heart failure, and liver function test abnormalities.

• Since amiodarone is a substrate for CYP3A and CYP2C8, drugs/substances that inhibit these isoenzymes may decrease the metabolism and increase serum concentration of amiodarone.
• Amiodarone inhibits p-glycoprotein and certain CYP450 enzymes, including CYP1A2, CYP2C9, CYP2D6, and CYP3A. This inhibition can result in unexpectedly high plasma levels of other drugs which are
metabolized by those CYP450 enzymes or are substrates for pglycoprotein.
• If simvastatin is co-administered with amiodarone, do not exceed doses greater than 20 mg daily of simvastatin.
• If lovastatin is co-administered with amiodarone, do not exceed doses greater than 40 mg daily of lovastatin.
• Fluoroquinolones, macrolide antibiotics, and azoles are known to cause QTc prolongation. There have been reports of QTc prolongation, with or without TdP, in patients taking amiodarone when fluoroquinolones,
macrolide antibiotics, or azoles were administered concomitantly.

• Hypotension: Treat initially by slowing the infusion; additional standard therapy may be needed, including the following: vasopressor drugs, positive inotropic agents, and volume expansion.
• Bradycardia and AV block: Treat by slowing the infusion rate or discontinuing NEXTERONE.