AMIODARONE HYDROCHLORIDE injection solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

AMIODARONE HYDROCHLORIDE (UNII: 976728SY6Z) (AMIODARONE - UNII:N3RQ532IUT)

Available from:

Hospira, Inc.

INN (International Name):

AMIODARONE HYDROCHLORIDE

Composition:

AMIODARONE HYDROCHLORIDE 50 mg in 1 mL

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMIODARONE HYDROCHLORIDE- AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION
HOSPIRA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMIODARONE SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR AMIODARONE INJECTION.
AMIODARONE HCL INJECTION FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1985
INDICATIONS AND USAGE
Amiodarone injection 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. (1)
DOSAGE AND ADMINISTRATION
The recommended starting dose is about 1000 mg over the first 24 hours
of therapy, delivered by the following
infusion regimen (2):
Initial Load: 150 mg per 100 mL (in D W) infused over 10 minutes
Followed by: 1 mg/min for 6 hours
Followed by: 0.5 mg/min thereafter
In the event of breakthrough episodes of VF or hemodynamically
unstable VT (2):
Repeat the Initial Load described above as needed (infused over 10
minutes)
Increase the rate of the maintenance infusion to achieve effective
arrhythmia suppression. (2)
DOSAGE FORMS AND STRENGTHS
Injection, 50 mg/mL. (3)
CONTRAINDICATIONS
Amiodarone is contraindicated in patients with (4):
Known hypersensitivity to any of the components of amiodarone,
including iodine.
Cardiogenic shock.
Marked sinus bradycardia.
Second- or third-degree atrio-ventricular (AV) block unless a
functioning pacemaker is available.
WARNINGS AND PRECAUTIONS
Hypotension: Treat initially by slowing the infusion; additional
standard therapy may be needed, including the following:
vasopressor drugs, positive inotropic agents, and volume expansion.
(5.1)
Bradycardia and AV block: Treat by slowing the infusion rate or
discontinuing amiodarone. (5.2)
ADVERSE REACTIONS
The most common adverse reactions (1 to 2%) leading to discontinuation
of intravenous amiodarone therapy are
hypotension, asystole/cardiac arrest/pulseless electrical activity,