AMIODARONE HYDROCHLORIDE injection, solution

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

AMIODARONE HYDROCHLORIDE (UNII: 976728SY6Z) (AMIODARONE - UNII:N3RQ532IUT)

Disponível em:

REMEDYREPACK INC.

Via de administração:

INTRAVENOUS

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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 (abnormal blood counts), urticaria (hives), thrombotic thrombocytopenic purpura, or severe periarteritis (inflammation around blood vessels). - Cardiogenic shock. - Marked sinus bradycardia. - Second- or third-degree atrio-ventricular (AV) block unless a functioning pacemaker is available. Pregnancy Category D [see Warnings and Precautions ( 5.8)] . Teratogenic Effects Amiodarone and desethylamiodarone cross the placenta. Reported risks include: - neonatal bradycardia, QT prolongation, and periodic ventricular extrasystoles - neonatal hypothyroidism (with or without goiter) detected antenatally or in the newborn and reported even after a few days of exposure - neonatal hyperthyroxinemia - neurodevelopmental abnormalities independent of thyroid function, including speech delay and difficulties with written language and arithmetic, delayed motor development, and ataxia. - jerk nystagmus with synchronous head titubation - fetal growth retardation - premature birth Amiodarone has caused a variety of adverse effects in animals. Amiodarone was given intravenously to rabbits at dosages of 5, 10, or 25 mg/kg per day (about 0.1, 0.3, and 0.7 times the human intravenous maintenance dose of 0.5 mg/min on a body surface area basis), during gestation days 8 to 16 (organogenesis). The incidence of maternal deaths increased with increasing dose and occurred in all treated groups, and controls. Mean fetal weights were significantly decreased in the low and middle dose groups and embryotoxicity (as manifested by fewer full- term fetuses and increased resorptions) occurred at dosages of 10 mg/kg and above. There were no significant differences in the number of minor fetal abnormalities and no major fetal abnormalities were observed. Amiodarone was administered by continuous intravenous infusion to rats at dosages of 25, 50, or 100 mg/kg per day (about 0.3, 0.7, and 1.3 times the human intravenous maintenance dose of 0.5 mg/min on a body surface area basis) during gestation days 8 to 16 (organogenesis). Maternal toxicity (manifest as reduced weight gain and food consumption) and embryotoxicity (manifest as increased resorptions, decreased live litter size and fetal body weights, and delayed sternal and metacarpal ossification) were observed in the 100 mg/kg group. The delayed ossification was reversible and related to decreased fetal weight. Fetal thyroid tissues appeared normal in all groups. Nonteratogenic Effects Very high concentrations of amiodarone and desethylamiodarone may be found in testes. Elevated follicle-stimulating hormone and luteinizing hormone levels, suggestive of testicular dysfunction, have been reported in men on long-term amiodarone treatment. While planning pregnancy after discontinuation of amiodarone treatment, consider the long half-life of amiodarone and its metabolite DEA. It is not known whether the use of amiodarone during labor or delivery has any immediate or delayed adverse effects. Preclinical studies in rodents have not shown any effect on the duration of gestation or on parturition. Amiodarone and one of its major metabolites, desethylamiodarone (DEA), are excreted in human milk, suggesting that breast-feeding could expose the nursing infant to a significant dose of the drug. Nursing offspring of lactating rats administered amiodarone have demonstrated reduced viability and reduced body weight gains. The risk of exposing the infant to amiodarone must be weighed against the potential benefit of arrhythmia suppression in the mother. Advise the mother to discontinue nursing. The safety and effectiveness of amiodarone in pediatric patients have not been established; therefore, the use of amiodarone in pediatric patients is not recommended. In a pediatric trial of 61 patients, aged 30 days to 15 years, hypotension (36%), bradycardia (20%), and AV block (15%) were common dose- related adverse reactions and were severe or life-threatening in some cases. Injection site reactions were seen in 5 (25%) of the 20 patients receiving intravenous amiodarone through a peripheral vein irrespective of dose regimen. Amiodarone injection contains the preservative benzyl alcohol [see Description ( 11)] . There have been reports of fatal “gasping syndrome” in neonates (children less than one month of age) following the administration of intravenous solutions containing the preservative benzyl alcohol. Symptoms include a striking onset of gasping respiration, hypotension, bradycardia, and cardiovascular collapse. Clinical studies of amiodarone did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Carefully consider dose selection in an elderly patient. In general, start at the low end of the dosing range in the elderly to reflect the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant disease or other drug therapy.

Resumo do produto:

Amiodarone Hydrochloride Injection, USP is supplied as: 150 mg per 3 mL (50 mg per mL) NDC: 70518-2792-00 NDC: 70518-2792-01 PACKAGING: 25 in 1 TRAY PACKAGING: 3 mL in 1 VIAL, SINGLE DOSE TYPE 0 The container closure is not made with natural rubber latex. 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. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Status de autorização:

Abbreviated New Drug Application

Características técnicas

AMIODARONE HYDROCHLORIDE- AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION
REMEDYREPACK INC.
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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
Amiodarone Hydrochloride Injection, USP, 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: 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 (1-2%) 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 A