AMIODARONE HYDROCHLORIDE injection, solution

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

General Injectables and Vaccines, Inc.

Rotta amministrattiva:

INTRAVENOUS

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

Amiodarone Hydrochloride 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. Amiodarone Hydrochloride Injection also can be used to treat patients with VT/VF for whom oral amiodarone is indicated, but who are unable to take oral medication. During or after treatment with Amiodarone Hydrochloride Injection, patients may be transferred to oral amiodarone is indicated, but who are unable to take oral medication. During or after treatment with Amiodarone Hydrochloride Injection, patients may be transferred to oral amiodarone therapy [see Dosage and Administration (2)]. Use Amiodarone Hydrochloride Injection for acute treatment until the patient's ventricular arrhythmias are stabilized. Most patients will require this therapy for 48 to 96 hours, but Amiodarone Hydrochloride Injection may be safely administered for longer periods if necessary. Amioda

Sommarju tal-prodott:

Amiodarone Hydrochoride Injection, 50 mg/mL, is supplied as follows: NDC 0143-9875-10          3 mL Single Dose Vials (Cartons of 10 vials) NDC 0143-9875-25          3 mL Single Dose Vials (Cartons of 25 vials) Store at 20º-25ºC (68º-77ºF) [See USP Controlled Room Temperature]. Protect from light and excessive heat. Use carton to protect contents from light until time of use.

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

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
HYDROCHLORIDE INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
AMIODARONE HYDROCHLORIDE INJECTION.
AMIODARONE HYDROCHLORIDE 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) (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) (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
ADVERSE REACTIONS
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.
(6)
Other important adverse reactions are, torsade de pointes (TdP),
congestive heart failure, and liver
func