Amiodarone Hydrochloride Injection, Solution
Product Images NDC 0404-9772
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Product Visual Gallery
This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Amiodarone Hydrochloride (NDC 0404-9772). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.
As provided by Henry Schein, Inc., these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.
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This is a recommended dosing guideline for administering amiodarone in the first 24 hours, including loading infusions and maintenance infusion. The loading infusions involve initial rapid administration of 150 mg over 10 minutes followed by a slower infusion of 360 mg over 6 hours. The maintenance infusion recommends administering 540 mg over the remaining 18 hours at a rate of 0.5 mg/min.*
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Description: The text provides information on the stability of Amiodarone Hydrochloride solution at different concentrations and container types. It indicates that the solution is physically compatible with Dextrose in Water and has minimal amiodarone loss under specified conditions. The stability data includes details on the percentage of amiodarone loss at 2 hours at room temperature for a specified concentration in a PVC container, and the absence of loss at 24 hours at room temperature in a Polyolefin or Glass container with a different concentration in Dextrose in Water.*
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This text provides recommendations for oral dosage of amiodarone after intravenous infusion based on the duration of the infusion period. It specifies the recommended dosages for different durations of amiodarone infusion, ranging from less than a week to more than three weeks. Additionally, it mentions that intravenous amiodarone is not meant for maintenance treatment.*
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This is a table displaying adverse reactions in patients receiving intravenous amiodarone from controlled and open-label studies. The table includes details on the incidence of adverse events such as fever, bradycardia, congestive heart failure, hypotension, and abnormal liver function tests among others. These statistics can be helpful for healthcare professionals in understanding the potential side effects associated with intravenous amiodarone use.*
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This text appears to be a table showing the effects of intravenous and oral amiodarone on electrophysiologic parameters. The table includes symbols representing different effects, with a disclaimer stating "© No change". The table seems to contain information related to the impact of the administration route of amiodarone on various electrophysiologic parameters.*
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Amiodarone Hydrochloride Injection is available in two different packaging options: 3 mL Single Dose Vials in cartons containing either 10 vials or 25 vials. The concentration of the injection is 50 mg/mL. The National Drug Code (NDC) numbers for these options are 0143-9875-10 for the 10-vial carton and 0143-9875-25 for the 25-vial carton.*
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* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.