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:

Hikma Pharmaceuticals USA Inc.

INN (International Name):

AMIODARONE HYDROCHLORIDE

Composition:

AMIODARONE HYDROCHLORIDE 50 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Amiodarone Hydrochloride Injection, USP 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 Hydrochloride Injection, USP 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 Hydrochloride Injection, USP patients may be transferred to oral amiodarone therapy [see Dosage and Administration (2)] . Use Amiodarone Hydrochloride Injection, USP for acute treatment until the patient's ventricular arrhythmias are stabilized. Most patients will require this therapy for 48 to 96 hours, but Amiodarone Hydrochloride Injection 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

Product summary:

Amiodarone Hydrochloride Injection, USP 50 mg/mL, is supplied as follows: NDC 0143-9875-10          3 mL Single Dose Vials (Cartons of 10 vials) NDC 0143-9875-25          3 mL Single Dose Vials (Cartons of 25 vials) Store at 20º-25ºC (68º-77ºF) [See USP Controlled Room Temperature]. Protect from light and excessive heat. Use carton to protect contents from light until time of use.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMIODARONE HYDROCHLORIDE- AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION
HIKMA PHARMACEUTICALS USA INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMIODARONE
HYDROCHLORIDE INJECTION, USP SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR
AMIODARONE HYDROCHLORIDE INJECTION, USP.
AMIODARONE HYDROCHLORIDE INJECTION, USP FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1995
INDICATIONS AND USAGE
Amiodarone Hydrochloride Injection, USP 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 per 100 mL (in D W) infused over 10 minutes
-Followed by: 1 mg/min for 6 hours
-Followed by: 0.5 mg/min thereafter
In the event of breakthrough episodes of VF or hemodynamically
unstable VT (2):
-Repeat the Initial Load described above as needed (infused over 10
minutes)
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
intrav