NEXTERONE- amiodarone hydrochloride injection, solution

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

Baxter Healthcare Corporation

INN (আন্তর্জাতিক নাম):

AMIODARONE HYDROCHLORIDE

রচনা:

AMIODARONE HYDROCHLORIDE 1.5 mg in 1 mL

প্রশাসন রুট:

INTRAVENOUS

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

NEXTERONE 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. NEXTERONE is contraindicated in patients with: Risk Summary Available data from postmarketing reports and published case series indicate that amiodarone use in pregnant women may increase the risk for fetal adverse effects including neonatal hypo- and hyperthyroidism, neonatal bradycardia, neurodevelopmental abnormalities, preterm birth and fetal growth restriction. Amiodarone and its metabolite, desethylamiodarone (DEA), cross the placenta. Untreated underlying arrhythmias, including ventricular arrhythmias, during pregnancy pose a risk to the mother and fetus (see Clinical Considerations). In animal studies, administration of amiodarone to rabbits, rats, and mice during organogenesis resulted in embryo-fetal toxicity at doses less than the maximum recommended human maintenance dose (see

পণ্য সারাংশ:

NEXTERONE (amiodarone HCl) Premixed Injection is supplied as a ready-to-use, sterile, nonpyrogenic, iso-osmotic solution in 100 mL and 200 mL single-dose GALAXY containers (PL 2501 plastic) packaged in individual cartons as follows: 150 mg/100 mL NDC 43066 – 150 – 10 2G3451 360 mg/200 mL NDC 43066 – 360 – 20 2G3450 Do not add supplementary medication to NEXTERONE Premixed Injection. Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F). See USP Controlled Room Temperature. Protect from light and excessive heat. Protect from freezing. Use carton to protect contents from light until used.

অনুমোদন অবস্থা:

New Drug Application

পণ্য বৈশিষ্ট্য

NEXTERONE- AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION
BAXTER HEALTHCARE CORPORATION
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NEXTERONE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR NEXTERONE.
NEXTERONE (AMIODARONE HCL) PREMIXED INJECTION FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1985
INDICATIONS AND USAGE
NEXTERONE is an antiarrhythmic agent indicated for treatment and
prophylaxis of ventricular fibrillation
(VF) and hemodynamically unstable ventricular tachycardia (VT) in
patients refractory to other therapy. (1)
DOSAGE AND ADMINISTRATION
•
•
DOSAGE FORMS AND STRENGTHS
Injection, 1.5 mg/mL (150 mg/100 mL) Premixed in Dextrose (3)
Injection, 1.8 mg/mL (360 mg/200 mL) Premixed in Dextrose (3)
CONTRAINDICATIONS
NEXTERONE is contraindicated in patients with (4):
•
•
•
•
WARNINGS AND PRECAUTIONS
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•
ADVERSE REACTIONS
•
•
To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare at
1-866-888-2472 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 dosing regimen is: (2)
o
o
o
Initial Load: 150 mg in 100 mL 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)
Known hypersensitivity to any of the components of NEXTERONE,
including iodine
Cardiogenic shock
Marked sinus bradycardia
Second- or third-degree atrio-ventricular (AV) block unless a
pacemaker is available.
Hypotension: Slow the infusion; as needed, add vasopressor drugs,
positive inotropic agents, and
volume expansion. (5.2)
Bradycardia and AV block: Slow the infusion or discontinue. (5.3)
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 torsa