Amiodarone Hci Injection, Solution
Product Images NDC 51662-1363

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Amiodarone Hci (NDC 51662-1363). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Hf Acquisition Co Llc, Dba Healthfirst, 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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Adverse (Adverse)

A data table showing the incidence of study events in controlled studies (n=814) and open-label studies (n=1022) with a total of 1836 participants. Events are categorized under Body as a Whole, Cardiovascular System, and Digestive System, listing occurrences and percentages for fever, bradycardia, congestive heart failure, heart arrest, hypotension, ventricular tachycardia, abnormal liver function tests, and nausea.*

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Clinical (Clinc 1)

A data table comparing the effects of intravenous (IV) and oral formulations of amiodarone on various cardiac electrophysiological parameters, including SCL, QRS, QTc, AH, HV, and ERP in RA, RV, and AVN. The table uses symbols to indicate changes, such as no change (⇔), increase (↑), and decrease (-).*

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Clinical 2 (Clinic 2)

A data table presenting pharmacokinetic parameters of Amiodarone and Desethylamiodarone. The table shows values for clearance (mL/h/kg), volume of distribution in the central compartment (V c, L/kg), steady-state volume of distribution (V ss, L/kg), and half-life (t½, days) for both drugs.*

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Dosage 2 (Dosage 2)

A data table titled 'AMIODARONE HCL INJECTION SOLUTION STABILITY' showing stability information for solutions of amiodarone HCl in 5% dextrose in water. It lists solution concentration ranges from 1 to 6 mg/mL, container types (PVC and polyolefin/glass), and corresponding comments on physical compatibility and amiodarone loss over time at room temperature.*

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Dosage 3 (Dosage 3)

A data table titled 'Y-SITE INJECTION INCOMPATIBILITY' listing drugs incompatible with co-injection of Amiodarone HCl. It includes drugs aminophylline, cefamandole nafate, cefazolin sodium, mezlocillin sodium, heparin sodium, and sodium bicarbonate, all showing incompatibility (precipitate formation) with the vehicle D5W at specified Amiodarone concentrations.*

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Dosage 4 (Dosage 4)

Table showing recommendations for oral dosage of Amiodarone HCl after intravenous infusion. It outlines initial daily oral doses based on the duration of Amiodarone HCl injection infusion: less than 1 week recommends 800 to 1600 mg, 1 to 3 weeks recommends 600 to 800 mg, and more than 3 weeks recommends 400 mg. Notes clarify that the infusion assumes a 720 mg/day rate and that the injection is not for maintenance treatment.*

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Dosage 1 (Dosage)

A dosage table titled 'Amiodarone HCl Injection Dose Recommendations – First 24 Hours' detailing loading and maintenance infusion rates. It lists the first rapid infusion dose of 150 mg over 10 minutes, followed by a slow infusion of 360 mg over 6 hours, and a maintenance infusion of 540 mg over 18 hours, including preparation instructions using specified concentrations and volumes of Amiodarone HCl Injection.*

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How Supplied (How Supplied)

A data table presenting different package configurations for Amiodarone HCl 50 mg/mL injection solution. It lists product numbers, NDC codes, strength, and vial sizes including 3 mL in 5 mL single dose vials (packaged in 25), 9 mL in 10 mL single dose vials (packaged in 10), and 18 mL in 20 mL multiple dose vials, packaged individually.*

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Logo (Logo)

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Serialized Labeling (Serialized Labeling)

Amber glass vial of Amiodarone HCl Injection with a red and silver flip-off cap. The label indicates a strength of 150 mg/3 mL (equivalent to 50 mg/mL), intended for intravenous use, single dose vial. Distributed by HF Acquisition Co LLC, Mukilteo, WA. Includes barcodes and serialization numbers on the vial label and attached white tag.*

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Structure (Structure)

Chemical structure of Amiodarone HCl depicting its molecular framework, including iodine atoms, aromatic rings, and functional groups characteristic of this active pharmaceutical ingredient.*

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Vial (Vial Label)

AMIODARONE HCI Injection label showing 150 mg/3 mL (50 mg/mL) strength in a 3 mL single dose vial. The label states it must be diluted for IV use only. It includes inactive ingredients, storage instructions, and the labeler name APP Pharmaceuticals, LLC.*

* 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.