Scroll down for Indications, Important Risk Information and Full Prescribing Information
The first 24-hour dose may be individualized for each patient; however, in controlled
clinical trials, mean daily doses above 2100 mg were associated with an increased
risk of hypotension. Do not exceed an initial infusion rate of 30 mg/min.
After the first 24 hours, continue the maintenance infusion rate of 0.5 mg/min.
The rate of the maintenance infusion may be increased to achieve effective arrhythmia
suppression.
In the event of breakthrough episodes of VF or hemodynamically unstable VT, use
150 mg supplemental infusions of NEXTERONE (infused over 10 minutes to minimize
the potential for hypotension).
Single-use only. Administer via central venous catheter whenever possible. Use an
in-line filter.
* Pump displayed is for example only.
Rx only.
SPECTRUM pumps are manufactured by SIGMA and distributed exclusively by Baxter Healthcare Corporation.
NEXTERONE (amiodarone HCI) Premixed Injection Indications and Important Risk Information
Indications and Usage
NEXTERONE (amiodarone HCl) Premixed Injection is 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. NEXTERONE
also can be used to treat patients with VT/VF for whom oral amiodarone is indicated,
but who are unable to take oral medication.
Use NEXTERONE for acute treatment until the patient's ventricular arrhythmias are
stabilized. Most patients will require this therapy for 48 to 96 hours, but NEXTERONE
may be safely administered for longer periods if necessary.
Important Risk Information
NEXTERONE (amiodarone HCl) Premixed Injection is contraindicated in patients with:
- Known hypersensitivity to any of the components of NEXTERONE, including iodine
- Cardiogenic shock
- Marked sinus bradycardia
- Second- or third-degree atrio-ventricular (AV) block unless a functioning pacemaker
is available
- NEXTERONE should be administered only by physicians who are experienced in the treatment
of life-threatening arrhythmias, who are thoroughly familiar with the risks and
benefits of amiodarone therapy, and who have access to facilities adequate for monitoring
the effectiveness and side effects of treatment.
- Hypotension is the most common adverse reaction seen with intravenous amiodarone.
In clinical trials, treatment-emergent, drug-related hypotension was reported in
16% (288/1836) of patients treated with intravenous amiodarone. Monitor the initial
rate of infusion closely and do not exceed the recommended rate. In some cases,
hypotension may be refractory and result in a fatal outcome. Treat hypotension initially
by slowing the infusion; additional standard therapy may be needed, including: vasopressors,
positive inotropic agents and volume expansion.
- In 4.9% (90/1836) of patients in clinical trials, drug-related bradycardia that
was not dose-related occurred while patients were receiving intravenous amiodarone
for life-threatening VT/VF. Treat bradycardia by slowing the infusion rate or discontinuing
NEXTERONE. Treat patients with a known predisposition to bradycardia or AV block
with NEXTERONE in a setting where a temporary pacemaker is available.
- Like all antiarrhythmics, NEXTERONE may cause worsening of existing arrhythmias
or precipitate a new arrhythmia.
- The most common adverse reactions leading to discontinuation (1-2%) 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, liver function test abnormalities, pulmonary disorders, and thyroid abnormalities.
- Drug Interactions: 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 p-glycoprotein. 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.
View Full Prescribing Information for NEXTERONE (amiodarone HCI)
