AMIODARONE HYDROCHLORIDE injection

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

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Download 제품 특성 요약 (SPC)
26-11-2019

유효 성분:

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

제공처:

Wockhardt USA LLC.

관리 경로:

INTRAVENOUS

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Amiodarone 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 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, patients may be transferred to oral amiodarone therapy [see Dosage and Administration (2)] . Use amiodarone for acute treatment until the patient's ventricular arrhythmias are stabilized. Most patients will require this therapy for 48 to 96 hours, but amiodarone may be safely administered for longer periods if necessary. Amiodarone is contraindicated in patients with: - Known hypersensitivity to any of the components of Amiodarone Injection, including iodine. Hypersensitivity reactions may involve rash, angioedema, cutaneous/mucosal hemorrhage (bleeding), fever, arthralgias (joint pains),

제품 요약:

Amiodarone hydrochloride injection is available, as follows: NDC 64679-739-01    50 mg/mL, 150 mg in 3 mL, single-dose vial, carton of 1 vial. NDC 64679-739-02    50 mg/mL, 150 mg in 3 mL, single-dose vial, carton of 10 vials. NDC 64679-739-04    50 mg/mL, 150 mg in 3 mL, single-dose vial, carton of 5 vials. 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.

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

                                AMIODARONE HYDROCHLORIDE- AMIODARONE HYDROCHLORIDE INJECTION
WOCKHARDT USA LLC.
----------
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: 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):
o Initial Load: 150 mg in 100 mL (in D W) infused over 10 minutes
o Followed by: 1 mg/min for 6 hours
o Followed by: 0.5 mg/min thereafter
For breakthrough episodes of VF or hemodynamically unstable VT, repeat
the Initial Load (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: Slow the infusion; as needed, add vasopressor drugs,
positive inotropic agents, and volume expansion_._
(5.1)
Bradycardia and AV block: Slow the infusion or discontinue. (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,
VT, and cardiogenic shock. (6)
Other important adverse reactions are, torsade de pointes, congestive
heart failure, and liver function test
abnormalities. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT WOCKHARDT
                                
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