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:

Mylan Institutional LLC

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Amiodarone hydrochloride 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: Pregnancy Category D [see Warnings and Precautions (5.8)] . Amiodarone and desethylamiodarone cross the placenta. Reported risks include: Amiodarone has caused a variety of adverse effects in animals. Amiodarone was given int

Product summary:

Amiodarone Hydrochloride Injection USP, 50 mg/mL, is available in: 450 mg/9 mL - single-dose vial - NDC 72078-046-09, packages of 10. 900 mg/18 mL - single-dose vial - NDC 72078-046-18, packages of 1. 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. Discard unused portion. Stoppers are not made with natural rubber latex.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMIODARONE HYDROCHLORIDE- AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION
MYLAN INSTITUTIONAL LLC
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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 hydrochloride 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
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DOSAGE FORMS AND STRENGTHS
Injection, 50 mg/mL (3)
CONTRAINDICATIONS
Amiodarone is contraindicated in patients with (4):
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
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TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT MYLAN AT 1-877-446-3679
(1-877-4-INFO-
RX) OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
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USE IN SPECIFIC POPULATIONS
The recommended starting dose is about 1000 mg over the first 24 hours
of therapy, delivered by the
following infusion regimen (2):
o
o
o
Initial Load: 150 mg in 100 mL (in D W) infused over 10 minutes
5
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)
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.
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)
The most common adverse reactions (1% to 2%) leading to
discontinuation of intravenous
amiodarone therapy are hypotension, asystol