AMIODARONE HCI injection, solution

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

HF Acquisition Co LLC, DBA HealthFirst

প্রশাসন রুট:

INTRAVENOUS

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

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 & 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 secon

পণ্য সারাংশ:

AMIODARONE HCI INJECTION is supplied in the following dosage forms. NDC 51662-1363-1 AMIODARONE HCI INJECTION 150 mg/3 mL (50 mg/mL) 3 mL VIAL HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms 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.

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

AMIODARONE HCI- AMIODARONE HCI INJECTION, SOLUTION
HF ACQUISITION CO LLC, DBA HEALTHFIRST
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AMIODARONE HCI INJECTION 150 MG/3 ML (50 MG/ML) 3 ML VIAL
SPL UNCLASSIFIED
Rx only
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
1-800-551-717
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:
C 25H 29I 2NO 3•HCl M.W. 681.78
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 &
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 contribut