Atovaquone Oral Suspension
Product Images NDC 10702-223

Product Visual Gallery

This gallery contains 13 technical images submitted to the FDA as part of the official labeling for Atovaquone Oral Suspension (NDC 10702-223). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Kvk-tech, 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.

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Carton Label

Not available.*

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Container Label

The text describes a medication named Atovaquone, which is an oral suspension of 750mg/5mL, contained in a bottle of 210 mL. The medication is gluten-free and sugar-free, and contains no more than 0.29% alcohol. It should be stored in a tight container at room temperature and not be frozen. The accompanying prescribing information should be consulted for dosage and administration instructions. The medication is manufactured by KVK-Tech, Inc. in the USA. The National Drug Code (NDC) for the product is 10702-223-21.*

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Figure 01

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Figure 02

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Table 01

This is a table showing the percentage of subjects who experienced adverse reactions and required discontinuation of treatment in a Comparative PCP Prevention Trial between Atovaquone Oral Suspension and Dapsone. The table presents data for two daily doses, 1,500 mg/day and 100 mg/day respectively.*

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Table 02

This table shows the percentage of subjects experiencing adverse reactions in a comparative trial of aerosolized pentamidine for preventing Pneumocystis carinii pneumonia (PCP). The trial included 186 subjects in the aerosolized pentamidine group and 175 subjects in the comparative group. Adverse reactions with a frequency of more than 20% are reported, including rash, headache, nausea, fever, and rhinitis. The percentage of subjects experiencing each reaction is provided for both groups.*

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Table 03

This table shows the percentage of subjects who experienced selected adverse reactions during a comparative PCP treatment trial of Atovaquone Tablets and TMP-SMX. The adverse reactions listed include rash, nausea, diarrhea, headache, vomiting, fever, and insomnia. The number of subjects who experienced each reaction is indicated, along with the corresponding percentage.*

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Table 04

Table 4 shows the percentage of subjects with selected adverse reactions in the Pentamidine Comparative PCP Treatment Trial (Primary Therapy Group). The table compares the adverse reactions in subjects who were treated with Atovaquone Tablets and Pentamidine. The adverse reactions reported include fever, nausea, rash, diarrhea, insomnia, headache, vomiting, cough, sweat, and monilia (oral thrush).*

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Table 05

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Table 06

The text describes a table titled "Relationship between Plasma Treatment Outcome", which displays Atovaquone Concentrations and Successful Treatment. It shows the number of successes and the total number in each group, represented as a percentage for each concentration range (in meg/mL), ranging from less than 5 to equal to or greater than 20.*

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Table 07

Table 7 shows the confirmed or presumed/probable PCP events in three different trials related to the treatment of PCP. The trials used three drugs: Atoxavone, Dapsone, and Pentamidine. The table indicates daily dosages and the number of PCP events recorded during assessments. Additionally, the table records the relative risk of each drug's treatment.*

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Table 08

Table 8 shows the outcome of treatment for PCP-positive subjects enrolled in a comparative trial between Atovaquone Tablets and TMP-SMX. The table includes the number of subjects enrolled in each group, the percentage of therapy success and failure due to various reasons such as lack of response or adverse reactions. The table also mentions a required alternate PCP therapy during the trial. More information can be found in the trial description protocol.*

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Table 09

This is a table presenting the outcome of treatment for subjects enrolled in the Pentamidine Comparative Trial to treat PCP. The table compares the success rate of primary treatment and salvage treatment for Atovaquone, Pentamidine, Afovaquone and Pentamidine. The success rates are displayed in percentage, and the reasons for treatment failure, which include lack of response and adverse reaction, are also listed. The table contains five columns and ten rows.*

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.