Atovaquone Oral Suspension
Product Images NDC 81033-105

Product Visual Gallery

This gallery contains 13 technical images submitted to the FDA as part of the official labeling for Atovaquone Oral Suspension (NDC 81033-105). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Kesin Pharma Corporation, 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

20 Count Carton (Atovaquone Susp 5ml Carton 2x20)

Atovaquone Oral Suspension USP 750 mg per 5 mL label for unit dose cups. The packaging includes NDC 81033-105-22 and states delivery of 5 mL per dose. It is distributed by Kesin Pharma Corporation, Oldsmar, FL, marked Rx Only and for institutional use only. The label shows storage instructions between 59°F to 77°F (15°C to 25°C) and package size of 20 x 5 mL unit dose cups.*

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42 Count Carton (Atovaquone Susp 5ml Carton 2x42)

Label for Atovaquone Oral Suspension, USP 750 mg per 5 mL, packaged in 42 individual 5 mL unit dose cups. The label states the product is for institutional use only, distributed by Kesin Pharma Corporation, Oldsmar, FL, and is Rx Only. Storage instructions indicate 59°F to 77°F (15°C to 25°C).*

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Kesin Pharma Logo (Kesin Logo)

FDA Label Image

Chemical Structure (Figure 01)

Chemical structure of Atovaquone, the active ingredient in Atovaquone Oral Suspension 750 mg/5mL by Kesin Pharma Corporation. The diagram shows the molecular bonds and arrangement of atoms including a chlorophenyl group and quinone moiety.*

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Table 01 (Table 01)

A data table comparing the percentage of subjects with selected adverse reactions requiring discontinuation of treatment in a PCP prevention trial. It shows adverse reactions including rash, nausea, diarrhea, and vomiting. The table compares Atovaquone Oral Suspension at 1,500 mg/day (n=536) with Dapsone at 100 mg/day (n=521), listing percentages for each adverse reaction for both treatments.*

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Table 02 (Table 02)

A data table titled 'Percentage (≥20%) of Subjects with Selected Adverse Reactions in the Aerosolized Pentamidine Comparative PCP Prevention Trial.' It compares adverse reaction rates between Atovaquone Oral Suspension 1,500 mg/day (n=175) and Aerosolized Pentamidine (n=186) for reactions including diarrhea, rash, headache, nausea, fever, and rhinitis, showing percentages for each reaction in both groups.*

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Table 03 (Table 03)

A table comparing the percentage of subjects experiencing selected adverse reactions of 10% or more in a treatment trial for PCP. The table lists adverse reactions such as rash, nausea, diarrhea, headache, vomiting, fever, and insomnia, comparing data between Atovaquone Tablets (n=203) and TMP-SMX (n=205).*

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Table 04 (Table 04)

A comparative data table showing the percentage of subjects experiencing selected adverse reactions (≥10%) during a Pentamidine Comparative PCP Treatment Trial. The table compares Atovaquone tablets (n=73) with Pentamidine (n=71) across several reactions including fever, nausea, rash, diarrhea, insomnia, headache, vomiting, cough, sweat, and oral monilia.*

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Table 05 (Table 05)

A data table presenting average steady-state plasma atovaquone concentrations (Css) in pediatric subjects by age groups (1-3 months, >3-24 months, >2-13 years) and dose levels of atovaquone oral suspension (10 mg/kg, 30 mg/kg, 45 mg/kg). Values are given in mcg/mL with mean and standard deviation for each group and dose.*

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Table 06 (Table 06)

A data table titled 'Relationship between Plasma Atovaquone Concentrations and Successful Treatment Outcome,' showing ranges of plasma atovaquone concentrations (mcg/mL) in one column and corresponding number and percentage of successful treatment outcomes in the other column.*

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Table 07 (Table 07)

A data table titled "Table 7. Confirmed or Presumed/Probable PCP Events (As-Treated Analysis)" comparing assessments of Atovaquone Oral Suspension at various dosages and Dapsone or Aerosolized Pentamidine in clinical trial groups, presenting percentages, relative risks, and confidence intervals for each treatment group.*

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Table 8 (Table 08)

A data table titled 'Outcome of Treatment for PCP-Positive Subjects Enrolled in the TMP-SMX Comparative Trial' comparing the number and percentage of subjects experiencing therapy success, therapy failure (due to lack of response, adverse reaction, or unvaluableness), and required alternate PCP therapy during trial between Atovaquone Tablets (n=160) and TMP-SMX (n=162).*

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Table 9 (Table 09)

A data table titled 'Outcome of Treatment for PCP-Positive Subjects (%) Enrolled in the Pentamidine Comparative Trial.' It compares outcomes between Atovaquone and Pentamidine during primary treatment and salvage treatment for therapy success, therapy failure reasons, and requirement for alternate PCP therapy.*

* 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.