NEXTERONE

Absorption: Amiodarone exhibits complex disposition characteristics after intravenous administration. Peak serum concentrations after single 5 mg/kg 15-minute intravenous infusions in healthy subjects range between 5 and 41 mg/L. Peak concentrations after 10-minute infusions of 150 mg intravenous amiodarone in patients with ventricular fibrillation (VF) or hemodynamically unstable ventricular tachycardia (VT) range between 7 and 26 mg/L. Because of rapid distribution, serum concentrations declin...

Apart from studies in patients with VT or VF, described below, there are two other studies of amiodarone showing an antiarrhythmic effect before significant levels of DEA could have accumulated. A placebo-controlled study of intravenous amiodarone (300 mg over 2 hours followed by 1200 mg/day) in post-coronary artery bypass graft patients with supraventricular and 2- to 3-consecutive-beat ventricular arrhythmias showed a reduction in arrhythmias from 12 hours on. A baseline-controlled study using a similar IV regimen in patients with recurrent, refractory VT/VF also showed rapid onset of antiar...

The following adverse reactions are described elsewhere in labeling:

• Hypotension [see Warnings and Precautions (5.2) ]
• Primary Graft Dysfunction (PGD) Post Cardiac Transplant [see Warnings and Precautions (5.3) ]
• Hepatic injury [see Warnings and Precautions (5.5) ]
• Proarrhythmia [see Warnings and Precautions (5.6) ]
• Pulmonary injury [see Warnings and Precautions (5.7) ]
• Thyroid injury [see Warnings and Precautions (5.9) ]
• Hypersensitivity [ see Warnings and Precautions (5.11)...

NEXTERONE Premixed Injection is contraindicated in patients with:

• Known hypersensitivity to any of the components of NEXTERONE Premixed Injection, including iodine [see Warnings and Precautions (5.9) ].
• Cardiogenic shock.
• Marked sinus bradycardia.
• Second- or third-degree atrioventricular (AV) block unless a functioning pacemaker is available. NEXTERONE Premixed Injection, is contraindicat...

• Hypotension: Slow the infusion; as needed, add vasopressor drugs, positive inotropic agents, and volume expansion. (5.2)
• Primary Graft Dysfunction (PGD) Post Cardiac Transplant ( 5.3 )
• Bradycardia and AV block: Slow the infusion or discontinue. ( 5.4 ) 5.1 Persistence of Adverse Effects Because of the long half-life of amiodarone (9 to 36 days) and its metabolite desethylamiodarone (9 to 30 days), adverse reactions or interactions, as well as observed adverse effects, can persist following...

7 DRUG INTERACTIONS Drug interactions with amiodarone are described in Table 4 below.

Table 4Amiodarone Drug Interactions Concomitant Drug Class/Name Examples Clinical Comment QT Prolonging Drugs class I and III antiarrhythmics, lithium, certain phenothiazines, tricyclic antidepressants, certain fluoroquinolone and macrolide antibiotics, azole antifungals, halogenated inhalation anesthetic agent...