AMIODARONE HYDROCHLORIDE- amiodarone hydrochloride injection, solution

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

General Injectables and Vaccines, Inc.

INN（国际名称）:

AMIODARONE HYDROCHLORIDE

组成:

AMIODARONE HYDROCHLORIDE 50 mg in 1 mL

给药途径:

INTRAVENOUS

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Amiodarone HCl injection is indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients refractory to other therapy.  Amiodarone HCl 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 HCl injection, patients may be transferred to oral amiodarone therapy (see DOSAGE AND ADMINISTRATION). Amiodarone HCl injection should be used for acute treatment until the patient’s ventricular arrhythmias are stabilized.  Most patients will require this therapy for 48 to 96 hours, but amiodarone HCl injection may be safely administered for longer periods if necessary. Amiodarone HCl injection is contraindicated in patients with known hypersensitivity to any of the components of amiodarone HCl injection, including iodine, or in patients with cardiogenic shock, marked sinus bradycardia, and sec

產品總結:

Amiodarone HCl Injection is supplied as: Vial stoppers do not contain natural rubber latex. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light and excessive heat. Use carton to protect contents from light until used. APP Pharmaceuticals, LLC Schaumburg, IL 60173 45887H Revised: April 2008

授权状态:

Abbreviated New Drug Application

产品特点

AMIODARONE HYDROCHLORIDE- AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION
GENERAL INJECTABLES AND VACCINES, INC.
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AMIODARONE HYDROCHLORIDE
This product’s label may have been revised after this insert was
used in production. For further
product information and current package insert, please visit
www.APPpharma.com or call our medical
information and safety department toll-free at 1-800-551-7176.
DESCRIPTION
Amiodarone Hydrochloride Injection, for intravenous use, contains
amiodarone HCl, a class III
antiarrhythmic drug. Amiodarone HCl is
(2-butyl-3-benzofuranyl)[4-[2-(diethylamino)ethoxy]-3,5-
diiodophenyl] methanone hydrochloride. Amiodarone HCl has the
following structural formula:
Amiodarone HCl is a white to slightly yellow crystalline powder, and
is very slightly soluble in water.
It contains 37.3% iodine by weight. Amiodarone HCl Injection is a
sterile clear, pale-yellow micellular
solution visually free from particulates. Each mL of the Amiodarone
HCl Injection formulation contains
50 mg of amiodarone HCl, 20.2 mg of benzyl alcohol, 100 mg of
polysorbate 80, and water for
injection.
Amiodarone HCl injection contains polysorbate 80, which is known to
leach di-(2-ethylhexyl)phthalate
(DEHP) from polyvinylchloride (PVC) (see DOSAGE AND ADMINISTRATION).
CLINICAL PHARMACOLOGY
Mechanisms of Action
Amiodarone is generally considered a class III antiarrhythmic drug,
but it possesses
electrophysiologic characteristics of all four Vaughan Williams
classes. Like class I drugs,
amiodarone blocks sodium channels at rapid pacing frequencies, and
like class II drugs, it exerts a
noncompetitive antisympathetic action. One of its main effects, with
prolonged administration, is to
lengthen the cardiac action potential, a class III effect. The
negative chronotropic effect of amiodarone
in nodal tissues is similar to the effect of class IV drugs. In
addition to blocking sodium channels,
amiodarone blocks myocardial potassium channels, which contributes to
slowing of conduction and
prolongation of refractoriness in the