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:

Sagent Pharmaceuticals

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

Product summary:

Amiodarone Hydrochloride Injection, USP is supplied as follows: Storage Conditions Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light and excessive heat. Do not freeze. Use carton to protect contents from light until used. Sterile, Nonpyrogenic, DEHP-free, PVC-free. The container closure is not made with natural rubber latex.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMIODARONE HYDROCHLORIDE- AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION
SAGENT PHARMACEUTICALS
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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):
Initial Load: 150 mg in 100 mL (in D W) infused over 10 minutes
Followed by: 1 mg/min for 6 hours
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 per 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