Paroxetine Suspension
Product Images NDC 70954-319

Product Visual Gallery

This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Paroxetine (NDC 70954-319). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Ani Pharmaceuticals, 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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Figure-1 (Figure 1)

A forest plot chart depicting the fold change and 90% confidence interval for pharmacokinetic parameters (Cmax and AUC) of various interacting drugs (Pimozide, Desipramine, Propranolol, Digoxin, Phenytoin) relative to a reference. The x-axis represents change relative to reference on a logarithmic scale from 0.1 to 10.0.*

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Figure-2 (Figure 2)

A forest plot chart depicting the pharmacokinetic interaction effects of various interacting drugs with Paroxetine. The chart displays fold change with 90% confidence intervals in Cmax and AUC values for drugs including Cimetidine, Phenobarbital, Phenytoin, Digoxin, and Diazepam relative to reference values.*

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Figure-3 (Figure 3)

A scatter plot with horizontal error bars showing fold change and 90% confidence intervals of pharmacokinetic parameters (Cmax, AUC, Cmin) for Paroxetine suspension. The variables are compared relative to reference populations considering renal impairment (mild, moderate, severe), hepatic impairment, age groups with doses 20, 30, and 40 mg once daily, and gender (males). The x-axis is labeled 'Change relative to reference' with a logarithmic scale from 0.5 to 50, and the y-axis lists the population descriptions and PK parameters.*

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Paroxetine (Paroxetine Label)

Paroxetine HCl Oral Suspension 10 mg/5 mL in a 250 mL bottle. The label includes dosage information, storage instructions, and a warning to keep the medication out of reach of children. Manufactured by Novitium Pharma LLC with an NDC 70954-319-10.*

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Spl-table (Spl Table)

A data table comparing the incidence percentages of various adverse events reported in patients with Generalized Anxiety Disorder and Posttraumatic Stress Disorder treated with Paroxetine versus placebo. The table is categorized by body system or preferred term, listing rates of symptoms such as headache, nausea, insomnia, and abnormal ejaculation among others, across the two conditions and treatment groups.*

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Structure (Structure)

Chemical structure diagram of Paroxetine hydrochloride showing its molecular configuration with fluorophenyl and methylenedioxy groups.*

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Table-1 (Table 1)

A data table displaying adverse event rates (%) for Paroxetine versus placebo across various conditions: Major Depressive Disorder (MDD), Obsessive Compulsive Disorder (OCD), Panic Disorder (PD), Social Anxiety Disorder (SAD), Generalized Anxiety Disorder (GAD), and Post-Traumatic Stress Disorder (PTSD). The table categorizes events by system (CNS, Gastrointestinal, Other) with specific symptoms such as somnolence, insomnia, nausea, and abnormal ejaculation noted per condition.*

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Table-2 (Table 2)

A data table comparing the percentage of adverse reactions by body system between Paroxetine (n=421) and placebo (n=421). It lists various reactions such as headache, cardiovascular effects, gastrointestinal issues, nervous system symptoms, and urogenital disorders, showing higher percentages reported with Paroxetine across many categories.*

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Table-3-2 (Table 3 2)

A data table presenting frequencies of various adverse effects related to vision, taste, and urogenital system, including categories such as abnormal vision, taste perversion, abnormal ejaculation, dysmenorrhea, female genital disorder, impotence, urinary frequency, urination impaired, and urinary tract infection.*

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Table-3 (Table 3)

A table showing the frequency (%) of various adverse events reported in clinical trials of Paroxetine compared to placebo in patients with Obsessive Compulsive Disorder, Panic Disorder, and Social Anxiety Disorder. Categories include body systems such as Gastrointestinal, Nervous, Musculoskeletal, Respiratory, Dermatologic, and more, with specific events like Nausea, Insomnia, Dizziness, and Palpitation detailed by treatment groups.*

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Table-5 (Table 5)

This data table presents the incidence rates (percentages) of various adverse effects categorized by body system for Paroxetine at doses of 10 mg, 20 mg, 30 mg, and 40 mg, compared to placebo. Reported side effects include asthenia, sweating, gastrointestinal symptoms, nervous system effects like anxiety and dizziness, blurred vision, and urogenital disorders, with incidence generally increasing with higher Paroxetine doses.*

* 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.