AMIODARONE HYDROCHLORIDE injection solution

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

General Injectables and Vaccines, Inc.

ІПН (Міжнародна Ім'я):

AMIODARONE HYDROCHLORIDE

Склад:

AMIODARONE HYDROCHLORIDE 50 mg in 1 mL

Тип рецепту:

PRESCRIPTION DRUG

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

AMIODARONE HYDROCHLORIDE- AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION
GENERAL INJECTABLES AND VACCINES, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
AMIODARONE HYDROCHLORIDE
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:
1995
INDICATIONS AND USAGE
Amiodarone Hydrochlroide 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 D5W) 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.
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 (1-2%) leading to discontinuation of
intrave