AMIODARONE HYDROCHLORIDE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Amiodarone Hydrochloride (UNII: 976728SY6Z) (Amiodarone - UNII:N3RQ532IUT)

Available from:

Physicians Total Care, Inc.

INN (International Name):

Amiodarone Hydrochloride

Composition:

Amiodarone Hydrochloride 50 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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, including iodine. Hypersensitivity reactions may involve rash, angioedema, cutaneous/mucosal hemorrhage (bleeding), fever, arthralgias (joint pains), eosinophilia (abnormal b

Product summary:

Amiodarone HCl Injection, 50 mg/mL, is available in: 150 mg/3 mL - 3 mL single use vial - NDC #54868-5722-0, packages of 10. Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F). See USP Controlled Room Temperature. Protect from light and excessive heat. Use carton to protect contents from light until used. Stoppers do not contain natural rubber latex.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMIODARONE HYDROCHLORIDE - AMIODARONE HYDROCHLORIDE INJECTION,
SOLUTION
PHYSICIANS TOTAL CARE, INC.
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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: 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):
-
-
-
In the event of breakthrough episodes of VF or hemodynamically
unstable VT (2):
-
Increase the rate of the maintenance infusion to achieve effective
arrhythmia suppression. (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: 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
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 function test
abnormalities. (6)
TO REPORT SUSPECTED ADVERSE