Aminophylline Injection, Solution
Product Images NDC 0404-9814

Product Visual Gallery

This gallery contains 14 technical images submitted to the FDA as part of the official labeling for Aminophylline (NDC 0404-9814). 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 aminophylline dihydrate showing its molecular formula C16H24N10O4 · 2(H2O) with a molecular weight of 456.46, depicted as a detailed diagram with labeled chemical groups and atoms.*

FDA Label Image

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A data table presenting mean and range of total body clearance and half-life of theophylline related to age and physiological states. It categorizes population characteristics by age groups, including premature neonates, term infants, children, adults, and elderly, showing corresponding values for total body clearance (mL/kg/min) and half-life (hours). Some data points are marked as NR (not reported).*

FDA Label Image

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A table presenting initial theophylline infusion rates following an appropriate loading dose, categorized by patient population and age. It lists infusion rates in mg/kg/hr for neonates, infants, young children, older children, adolescents (smokers and nonsmokers), adults, elderly, and patients with specific medical conditions like cardiac decompensation or sepsis. Footnotes provide dosage targets and special considerations.*

FDA Label Image

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A table titled 'Final Dosage Adjustment Guided by Serum Theophylline Concentration' showing dosage adjustment recommendations based on various ranges of peak serum theophylline concentrations, from less than 9.9 mcg/mL to greater than 30 mcg/mL, including instructions for increasing, maintaining, decreasing, or stopping infusion rates, and notes on rechecking serum concentrations and managing overdose.*

FDA Label Image

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A data table showing unit of sale and total strength/total volume concentration for Aminophylline injection, solution. It lists two NDC packages: 25 units per carton with 250 mg/10 mL total strength (25 mg/mL concentration), and 25 units per carton with 500 mg/20 mL total strength (25 mg/mL concentration).*

FDA Label Image

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A data table titled 'Concurrent Illness Or Altered Physiological State' showing clearance and volume of blood cleared of theophylline in various conditions such as acute pulmonary edema, COPD, cystic fibrosis, liver disease types, pregnancy trimesters, sepsis, and thyroid disease. Values include median and ranges with notes on populations and pharmacokinetics.*

FDA Label Image

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A data table titled 'Clinically Significant Drug Interactions With Theophylline' listing various drugs, types of interaction, and effects. It details how theophylline interacts with drugs like adenosine, alcohol, allopurinol, and others, describing mechanisms such as receptor blocking and enzyme activity modulation, with corresponding effects including percentage increases or decreases in clearance and clinical implications.*

FDA Label Image

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A data table showing drug interactions affecting the clearance of theophylline. It lists drugs like Erythromycin, Estrogen, Halothane, Interferon, Isoproterenol, and others, describing their effects on theophylline clearance and corresponding changes in serum concentration or clinical risk.*

FDA Label Image

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A data table listing drug interactions affecting the clearance and efficacy of theophylline. It details various drugs such as Pancuronium, Pentoxifylline, Phenobarbital, Phenytoin, Propafenone, Propranolol, Rifampin, Sulfinpyrazone, Tacrine, Thiabendazole, Ticlopidine, Troleandomycin, and Verapamil, with corresponding notes on their impact on theophylline pharmacokinetics or pharmacodynamics and percentage changes in clearance or concentration.*

FDA Label Image

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A text panel excerpt providing information on precautions and drug interactions related to aminophylline and its clinical pharmacologic effects, specifically mentioning theophylline concentration and variability in patient response.*

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A data table titled 'Drugs That Have Been Documented Not to Interact With Theophylline or Drugs That Produce No Clinically Significant Interaction With Theophylline.' It lists various drugs including albuterol, amoxicillin, atenolol, azithromycin, caffeine, diltiazem, famotidine, hydrocortisone, influenza vaccine, ketoconazole, lomefloxacin, metronidazole, prednisone, ranitidine, sucralfate, terfenadine, tetracycline, and others. The table notes to refer to the drug's precautions and interactions information for details.*

FDA Label Image

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A table titled 'Manifestations of Theophylline Toxicity' presenting percentages of patients with various signs or symptoms reported in two studies of acute overdose and two studies of chronic overdosage. Symptoms are categorized as gastrointestinal, metabolic/other, and cardiovascular with percentage values or 'NR' for not reported.*

FDA Label Image

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A data table summarizing adverse effects associated with theophylline toxicity, including categories like ventricular arrhythmias, hypotension/shock, and neurologic symptoms such as nervousness, tremors, disorientation, seizures, and death. The table includes incidence percentages from two different studies, with footnotes explaining study details and reporting nuances.*

FDA Label Image

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Aminophylline injection, USP single-dose vial label showing 500 mg per 20 mL (25 mg/mL) intravenous solution. The label includes usage instructions, storage conditions (68°F to 77°F), and safety warnings. It displays the NDC number 0404-9814-20, packaging and manufacturer details for Henry Schein, Inc., located in Bastian, VA, along with barcode and lot/expiration placeholders.*

* 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.