Amiodarone Hydrochloride Injection, Solution
Product Images NDC 0404-9772

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.

FDA Label Image

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Chemical structure of amiodarone hydrochloride, showing the arrangement of atoms including iodine, oxygen, nitrogen, and methyl groups in the molecule.*

FDA Label Image

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A data table titled 'AMIODARONE DOSE RECOMMENDATIONS: FIRST 24 HOURS' providing dosing instructions for loading infusions and maintenance infusion of amiodarone. It details the first rapid dose (150 mg over 10 minutes), followed by a slow dose (360 mg over 6 hours), and a maintenance infusion dose (540 mg over 18 hours), specifying infusion rates and amiodarone dilutions in D5W solution.*

FDA Label Image

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A data table titled 'AMIODARONE HYDROCHLORIDE SOLUTION STABILITY' comparing solution types, concentrations, container materials, and comments on physical compatibility and amiodarone loss. It includes 5% Dextrose in Water (D5W) solutions at 1 to 6 mg/mL concentration, tested with PVC and polyolefin or glass containers, noting stability and amiodarone loss at room temperature over 2 to 24 hours.*

FDA Label Image

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A table titled 'Y-SITE INJECTION INCOMPATIBILITY' listing six drugs (Aminophylline, Cefamandole Nafate, Cefazolin Sodium, Mezlocillin Sodium, Heparin Sodium, Sodium Bicarbonate) with their vehicle (all D5W), amiodarone concentration where specified, and comments noting precipitate formation for each drug.*

FDA Label Image

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Table showing recommendations for oral dosage of amiodarone after intravenous infusion. It lists initial daily doses based on the duration of amiodarone infusion: less than 1 week (800 to 1600 mg), 1-3 weeks (600 to 800 mg), and more than 3 weeks (400 mg). Additional notes specify a 720 mg/day infusion assumption and that intravenous amiodarone is not for maintenance treatment.*

FDA Label Image

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Table showing adverse reactions in patients receiving intravenous amiodarone in controlled and open-label studies with incidence of 2% or higher. It lists study events by system (body as a whole, cardiovascular, digestive) with counts and percentages for controlled studies (n=814), open-label studies (n=1022), and total combined patients (n=1836). Adverse reactions include fever, bradycardia, congestive heart failure, heart arrest, hypotension, ventricular tachycardia, abnormal liver function tests, and nausea.*

FDA Label Image

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This table presents the effects of intravenous and oral amiodarone on various electrophysiologic parameters including SCL, QRS, QTc, AH, HV, ERP RA, ERP RV, and ERP AVN. It shows differences in parameter changes such as no change, increase, or other effects corresponding to each formulation.*

FDA Label Image

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Text panel describing Amiodarone Hydrochloride Injection USP 50 mg/mL, listing its packaging as 3 mL single dose vials available in cartons of 10 or 25 vials. NDC codes for each packaging option are also provided.*

FDA Label Image

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Label for Amiodarone Hydrochloride injection, USP, 150 mg per 3 mL (50 mg/mL) single dose vial for intravenous use. Instructions state it must be diluted before use and stored at controlled room temperature. Label includes storage directions, warning to keep out of children's reach, and packaging information from Henry Schein, Inc.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.