Quetiapine Fumarate Tablet, Extended Release
Product Images NDC 50742-635

Product Visual Gallery

This gallery contains 31 technical images submitted to the FDA as part of the official labeling for Quetiapine Fumarate (NDC 50742-635). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Ingenus Pharmaceuticals, Llc, 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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Table 3 provides data on the proportion of patients shifting to a fasting glucose level of over 126 mg/dL in short-term placebo-controlled studies. The table includes information on the laboratory category change, treatment arm, number of patients, and percentage of patients who shifted from normal to high, and borderline to high glucose levels. The data presented is for both quetiapine fumarate immediate-release and extended-release formulations.*

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This is a table showing the percentage of patients in MDD adjunct therapy trials with shifts from normal baseline in blood glucose to equal or greater than 126 mg/dL (assumed fasting) by dose. The data includes three laboratory treatment arms, Quetiapine fumarate extended-release tablets of 150 mg and 300 mg, and Placebo. The number of patients and the percentage of those patients who experienced a shift in blood glucose are also included.*

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Table 5 shows the percentage of adult patients with shifts in total cholesterol, triglycerides, LDL-cholesterol, and HDL-cholesterol from baseline to a clinically significant level by indication. The table includes various indications such as Schizophrenia, Major Depressive Disorder, Bipolar Depression, and Bipolar Mania. It also shows the treatment arms, N, n, and percentages for patients receiving Quetiapine fumarate and Placebo. The study duration varies between 3 to 8 weeks.*

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The table presents the percentages of patients with shifts in total cholesterol, triglycerides, LDL-cholesterol, and HDL-cholesterol from baseline to clinically significant levels in MDD adjunctive therapy trials by dose for Quetiapine fumarate extended-release tablets 150 mg, Quetiapine fumarate extended-release tablets 300 mg, and Placebo over a 6-week duration.*

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Table 7 shows the percentage of children and adolescents with shifts in total cholesterol, triglycerides, LDL-cholesterol, and HDL-cholesterol from baseline to clinically significant levels. It provides data by indication and treatment arm. Age range is 1-13 years with a 6-week duration and 10-17 years with a 3-week duration.*

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The table shows the percentage of adult patients with weight gain greater than 7% of body weight for different indications and treatments. The indications are schizophrenia, bipolar mania, and bipolar depression. The treatments are quetiapine fumarate extended-release tablets and placebo. The duration of the treatments ranged from 3 weeks to 8 weeks. The results indicate that weight gain was higher in patients treated with quetiapine fumarate extended-release tablets than those treated with placebo for all indications. However, the percentage of weight gain varied depending on the indication and duration of treatment.*

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This is a table that shows the percentage of patients who experienced a weight gain of at least 7% of their body weight in MDD adjunctive therapy trials by dose for adults. The table lists three treatment arms: Quetiapine fumarate extended-release tablets 150mg, Quetiapine fumarate extended-release tablets 300mg, and Placebo. Alongside, the table gives information about the vital signs and the number of patients in each arm.*

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Table 10 provides data on the percentage of children and adolescents with weight gain >7% of body weight following treatment with quetiapine fumarate tablets for schizophrenia and bipolar mania. The table indicates that 21% of patients (23 out of 111) with schizophrenia experienced weight gain, while only 12% of patients (18 out of 157) with bipolar mania experienced weight gain after 6 weeks of treatment. The table also indicates that placebo treatment resulted in significantly fewer patients experiencing weight gain. The duration for schizophrenia treatment was 16 weeks, while bipolar mania treatment was 3 weeks.*

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This is a table showing the incidence of shifts in thyroid hormone levels and TSH in short-term placebo-controlled clinical trials for quetiapine. The table provides data on total T, free T, total T, free T, and TSH levels for both quetiapine and placebo. The shifts in hormone levels are defined as being potentially clinically important, with specific threshold levels provided. The data includes information on both quetiapine fumarate tablets and extended-release tablets.*

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The table shows the adverse reactions associated with extrapyramidal symptoms in a clinical trial for bipolar mania where Quetiapine fumarate and Placebo was used. The adverse reactions included dystonic event, Parkinsonism, Akathisia, and other extrapyramidal event. The number and percentage of patients experiencing each reaction are provided in the table. There were no adverse reactions with the preferred term of dyskinetic event.*

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This is a table containing information on adverse reactions associated with extrapyramidal symptoms in a placebo-controlled clinical trial for bipolar depression. The table compares the percentages of these reactions between two groups: those treated with quetiapine fumarate tablets and those treated with a placebo. The adverse reactions listed include dystonia, parkinsonism, akathisia, and other extrapyramidal side effects. It is noted that there were no adverse reactions for dyskinetic events with quetiapine fumarate.*

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This is a presentation of adverse effects in clinical trials which evaluated the adjunctive therapy of Quetiapine Fumarate for Major Depressive Disorder (MDD) over a 6-week period. The table shows the occurrence of extrapyramidal symptoms (EPS) such as dystonic event, Parkinsonism, Akathisia, Dyskinefic event and other EPS by dose, and compares them to a placebo group. The frequency of EPS was higher with Quetiapine Fumarate in comparison to the control group.*

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Table 20: Adverse reactions observed during a 6-week clinical trial for treating schizophrenia in adolescent patients. The trial involved 73 patients on 400mg Quetiapine Fumarate, 75 patients on 800mg Quetiapine Fumarate and 74 patients on Placebo. The most common adverse reactions observed were Somnolence, Dizziness, Dry mouth, Tachycardia, Irritability, Arthralgia, Asthenia, Back pain, and Abdominal pain. Some rare adverse reactions observed included tooth abscess, dyskinesia, epistaxis, and muscle rigidity.*

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The table provides a comparison of adverse reactions among Quetiapine Fumarate tablets and Placebo used for the treatment of bipolar mania in children and adolescent patients. It shows the percentage of commonly occurring adverse reactions, with a preferred term, such as Somnolence, Dizziness, Nausea, Fatigue, Tachycardia, and others. The reactions have been compared at different dosages of 400mg and 600mg. Somnolence and fatigue have been the most commonly occurring adverse reactions, and Tachycardia has had the highest percentage among cardiac-related reactions.*

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This table shows the adverse reactions associated with extrapyramidal symptoms in the Placenta-Controlled Trial in Adolescent Patients with Schizophrenia. It compares the results for three different doses of Quetiapine (400mg/day, 800mg/day and fumarate tablets) and a placebo. The adverse reactions listed include Dystonic Event, Parkinsonism, Akathisia, Dyskinetic Event, and Other Extrapyramidal Event. The table shows the number and percentage of patients who experienced each adverse reaction during the 6-week duration of the trial.*

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This is a table displaying adverse reactions associated with extrapyramidal symptoms in a placebo-controlled trial in children and adolescent patients with bipolar mania. The trial evaluated the effects of Quetiapine fumarate tablets at doses of 400 mg/day and 600 mg/day, Quetiapine tablets, and placebo. The adverse reaction terms listed are Parkinsonism and Akathisia. The table shows the number and percentage of patients who experienced these reactions for each medication. There were no adverse reactions with the preferred terms of dystonic or dyskinetic events.*

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Table 24 shows the effect of various drugs on the pharmacokinetics of Quetiapine. It provides information on the dosage schedules, co-administered drugs, and the effect of these drugs on the oral clearance, absorption, and AUC of Quetiapine. Some drugs, such as Phenytoin, Thioridazine, and Ketoconazole, significantly impact the oral clearance and AUC of Quetiapine, while others, like Fluoxetine, Imipramine, Haloperidol, and Risperidone, do not show any change in the steady state PK of Quetiapine.*

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This appears to be a table showing the results of short-term trials for treating schizophrenia using different dosages of Quetiapine fumarate extended-release tablets and a placebo. The primary efficacy endpoint is PANSS Total. The table includes data such as LS mean, baseline score, mean change, and difference between the treatment group and the placebo group. The doses of Quetiapine fumarate extended-release tablets with statistically significant superiority to the placebo are also highlighted. The table provides standard deviation, standard error, unadjusted confidence interval, and other related information as well.*

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The text describes a figure showing Kaplan-Meier curves of time to schizophrenic relapse from study 3. The figure includes the proportion of patients with relapse and time in months. The results are from an interim analysis and include PLA (placebo), QTP (quetiapine), and XR (extended-release).*

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The table presents data from five studies that evaluated the effectiveness of Quetiapine fumarate extended-release tablets or tablets with doses ranging from 200-800mg/day as a treatment for Mania. The primary efficacy measure used was the Young Mania Rating Scale (YMRS) total score. The table shows the mean baseline scores, LS mean score, standard deviation, and the difference from the placebo group for each trial. The mood stabilizer used was lithium or divalproex. The table also lists additional details about the trials, including the standard error, unadjusted confidence interval, and the types of patients included in the trial.*

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The text appears to be a table presenting data on the efficacy of different treatments for depressive episodes associated with bipolar disorder. The primary efficacy measure seems to be the MADRS total. The table includes different treatment groups, mean values, standard errors, standard deviations, and confidence intervals. It seems to suggest that some doses of the medication are statistically superior to placebos.*

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This appears to be a table showing the efficacy of adjunctive therapy in the form of Quetiapine fumarate for Major Depressive Disorder with Antidepressants. The primary efficacy measure is the change in MADRS total score. The table presents the LS Mean and standard deviation (SD) scores for baseline and change from baseline for the treatment group and placebo group in two studies. There are some statistically significant differences indicating that the drug is superior to the placebo.*

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This is information about quetiapine fumarate extended-release tablets, which contains 58mg of the active ingredient quetiapine fumarate, equivalent to 50mg of quetiapine. It is taken orally once a day and comes in a package of 60 tablets. The usual recommended dosage is 50-300mg per day. The text also includes a National Drug Code number (NDC 50742-635-60), an expiration date (09/2020) and storage instructions to keep it at 25°C with excursions permitted to 15-30°C. Other than that, the text contains some gibberish characters and is not readable.*

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This is the label of a medication called Quetiapine Fumarate Extended-Release Tablets, which is usually taken once a day. Each bottle contains 60 tablets, and each tablet has 173mg of fumarate US> and 150mg of Quetiapine. There are some warnings, and the dosage should be taken as directed. The rest of the text is not relevant or not understandable.*

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This is a description of a medication called Quetiapine Fumarate Extended-Release Tablets, which is taken once a day. The text also includes some identifying information about the pills, such as their dosage (in milligrams) and an expiration date.*

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