Country: United States
Language: English
Source: NLM (National Library of Medicine)
AMIODARONE HYDROCHLORIDE (UNII: 976728SY6Z) (AMIODARONE - UNII:N3RQ532IUT)
Gland Pharma Limited
AMIODARONE HYDROCHLORIDE
AMIODARONE HYDROCHLORIDE 50 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
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
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.
Abbreviated New Drug Application
AMIODARONE HYDROCHLORIDE - AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION GLAND PHARMA LIMITED ---------- 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) (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) (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. (4) 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) (5) 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) Read the complete document