Itraconazole Capsule
Product Images NDC 16571-245

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Itraconazole (NDC 16571-245). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Rising Pharma Holdings, 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

Label-30s (Label 30s)

The label for Itraconazole Capsules 100 mg by Rising Pharma Holdings, Inc. It shows the prescription drug form as oral capsules with a 30-capsule bulk container. The label includes handling instructions, storage conditions (20° to 25°C), and caution to dispense patient information separately. It also notes the product is made in India and for prescription use only.*

FDA Label Image

Structure (Structure)

Chemical structure diagram of Itraconazole, showing its complex molecular framework with multiple ring structures and functional groups, including triazole rings and dichlorophenyl moieties.*

FDA Label Image

Table 1 (Table 1)

A data table titled 'Examples of Concomitant Drugs Within Class,' detailing drug interaction recommendations for itraconazole. It lists various drug classes including Alpha Blockers, Analgesics, Antiarrhythmics, Antibacterials, Anticoagulants, Anticonvulsants, Antidiabetic Drugs, Anthelmintics, Antineoplastics, Antipsychotics, Antivirals, Beta Blockers, Calcium Channel Blockers, Cardiovascular Drugs, Contraceptives, Diuretics, Gastrointestinal Drugs, Immunosuppressants, Lipid-Lowering Drugs, Respiratory Drugs, SSRIs, Tricyclics and Related Antidepressants, Urologic Drugs, and others. Recommendations include contraindications, monitoring for adverse reactions, dose adjustments, and timing restrictions related to itraconazole treatment.*

FDA Label Image

Table 2 (Table 2)

Data table listing drug interactions with itraconazole, categorizing drugs that increase or decrease itraconazole concentrations and their management recommendations. Categories include antibacterials, antineoplastics, antivirals, calcium channel blockers, anticonvulsants, gastrointestinal drugs, and miscellaneous substances, with specific advisories on monitoring, dose adjustments, and treatment timing relative to itraconazole administration.*

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Table 3 (Table 3)

Data table showing the incidence percentages of adverse events by body system for 602 subjects. Categories include Gastrointestinal, Body as a Whole, Skin and Appendages, Central/Peripheral Nervous System, Psychiatric, Cardiovascular, Metabolic/Nutritional, Urinary System, Liver and Biliary System, and Male Reproductive System. Specific events such as nausea, edema, rash, headache, and impotence are listed with their incidence rates.*

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Table 4 (Table 4)

A table showing the incidence percentages of various adverse events reported with Itraconazole in a sample of 112 patients. The events include elevated liver enzymes, gastrointestinal disorders, rash, hypertension, orthostatic hypotension, headache, malaise, myalgia, vasculitis, and vertigo, with incidence rates ranging from 1% to 4%.*

FDA Label Image

Table 5 (Table 5)

A data table displaying the incidence percentage of adverse events in patients treated with Itraconazole (N=37). It lists two adverse events: Rash/Pruritus with an incidence of 3%, and Hypertriglyceridemia with an incidence of 3%.*

FDA Label Image

Table 6 (Table 6)

A data table listing various disorder categories and corresponding adverse reactions associated with Itraconazole. Categories include blood and lymphatic system, immune system, endocrine, nervous system, eye, ear and labyrinth, cardiac, respiratory, gastrointestinal, hepatobiliary, skin and subcutaneous tissue, musculoskeletal, renal and urinary, reproductive system, general disorders, and investigation findings.*

* 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.