Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
AMIODARONE HYDROCHLORIDE (UNII: 976728SY6Z) (AMIODARONE - UNII:N3RQ532IUT)
REMEDYREPACK INC.
INTRAVENOUS
PRESCRIPTION DRUG
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 Hydrochloride Injection 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, patients may be transferred to oral amiodarone therapy [see Dosage and Administration ( 2)] . Use Amiodarone Hydrochloride Injection 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. Hype
Amiodarone Hydrochloride Injection, 50 mg/mL, is supplied as follows: NDC: 70518-1231-00 NDC: 70518-1231-01 PACKAGING: 3 mL in 1 VIAL, TYPE 0 PACKAGING: 25 in 1 BOX 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. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762
Abbreviated New Drug Application
AMIODARONE HYDROCHLORIDE- AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION REMEDYREPACK INC. ---------- 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 INJECTION. AMIODARONE HYDROCHLORIDE INJECTION FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 1995 INDICATIONS AND USAGE Amiodarone Hydrochlroide 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 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 intravenous amiodarone therapy are hypotensio Lire le document complet