Ticagrelor Tablet, Film Coated
Product Images NDC 0378-2214

Product Visual Gallery

This gallery contains 21 technical images submitted to the FDA as part of the official labeling for Ticagrelor (NDC 0378-2214). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Mylan 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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Ticagrelor Tablets 90 mg Bottle Label (Export 00)

Ticagrelor 90 mg film-coated tablets label from Mylan Pharmaceuticals Inc. The label shows the tablet strength, NDC code 0378-2215-91, and marks the product as Rx only with 60 tablets per container. It includes storage instructions, manufacturer details, and a barcode. The label also highlights a medication guide for pharmacists to dispense.*

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Ticagrelor Tablets 60 mg Bottle Label (Export 01)

Ticagrelor 60 mg film-coated oral tablets label from Mylan Pharmaceuticals Inc., showing proprietary name, strength, dosage form, and tablet imprint. The label includes storage instructions, barcode, and manufacturer details, with a package size of 60 tablets and a child-resistant closure warning.*

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Figure 18: Subgroup Analyses Of Ticagrelor 90 mg (thales) (Export 02)

A forest plot comparing hazard ratios (HR) with 95% confidence intervals for ticagrelor versus placebo across various patient subgroups, including age, sex, race, weight, BMI, geographic region, diagnosis, time from event to randomisation, diabetes status, hypertension, prior ischemic stroke or TIA, prior ischaemic heart disease, prior ASA, prior statin treatment, and smoking status. The plot visually displays ticagrelor's relative performance compared to placebo in these groups.*

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Figure 17: Time To First Occurrence Of Stroke Or Death (thales) (Export 03)

A Kaplan-Meier curve chart comparing cumulative percentage event rates over time between Ticagrelor 90 mg twice daily and placebo groups. The x-axis shows days from randomization up to 34 days, and the y-axis represents cumulative percentage. Ticagrelor data is shown with a solid line, placebo with a dashed line, along with numbers at risk over time for each group below the graph.*

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Figure 16: Subgroup Analyses Of Ticagrelor (themis) (Export 04)

A forest plot chart showing hazard ratios (HR) with 95% confidence intervals (CI) for various patient characteristics comparing Ticagrelor versus Placebo treatment outcomes. Characteristics include age groups, sex, race, BMI, geographic region, aspirin use, baseline lab values, insulin use, medical history, time since procedures, smoking status, and duration of diabetes. The chart visually represents the relative effectiveness of Ticagrelor and placebo within these subgroups.*

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Figure 15: Time To First Occurrence Of Cv Death, Mi Or Stroke (themis) (Export 05)

A line chart showing cumulative percentage of events over months from randomization comparing Ticagrelor and Placebo. The graph includes data points up to 54 months with Ticagrelor represented by a solid line and Placebo by a dashed line. The chart shows patient numbers at risk below the x-axis over time. Ticagrelor had 736 events out of 9619 patients; Placebo had 818 events out of 9601 patients.*

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Figure 14: Subgroup Analyses Of Ticagrelor 60 mg (pegasus) (Export 06)

A forest plot chart comparing Ticagrelor versus placebo across various patient subgroups and characteristics including age, sex, race, weight, BMI, geographic region, medical history, and treatment factors. The chart presents hazard ratios (HR) with 95% confidence intervals, showing overall treatment effect and primary endpoint outcomes. Ticagrelor is generally favored as indicated by HR values less than 1 for most subgroups.*

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Figure 13: Time To First Occurrence Of Cv Death, Mi Or Stroke (pegasus) (Export 07)

A line graph showing the cumulative percentage of patients with events over days from randomization, comparing Ticagrelor 90 mg, Ticagrelor 60 mg, and placebo groups. The graph includes data points along the time axis up to approximately 1300 days and a legend summarizing event counts and hazard ratios for each group.*

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Figure 11: Subgroup Analyses Of (plato) (Export 08)

A forest plot graph comparing the hazard ratios (HR) and 95% confidence intervals (CI) of Ticagrelor versus Clopidogrel across multiple subgroups and characteristics, including geographic region, dose of ASA, treatment approach, early PCI, diabetes history, age group, sex, and race. The HR values and sample sizes for each subgroup are listed, with a vertical line at 1 indicating equal effectiveness. The plot visually shows where Ticagrelor or Clopidogrel is favored based on HR values.*

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Figure 10: Time To First Occurrence Of Cv Death, Mi, Or Stroke (plato) (Export 09)

A Kaplan-Meier cumulative incidence curve comparing Ticagrelor 90 mg and Clopidogrel over 360 days from randomization. The x-axis represents days, and the y-axis shows cumulative percentage of patients experiencing events. The graph includes a legend with patient numbers, percentages, hazard ratio, confidence interval, and p-value for the comparison between the two treatments.*

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Figure 12: Cv Death, Mi, Stroke By Maintenance Aspirin Dose In The U.s. And Outside The U.s. (plato) (Export 10)

A forest plot comparing hazard ratios (HR) with 95% confidence intervals (CI) for Ticagrelor versus Clopidogrel across different acetylsalicylic acid (ASA) dose groups in US and Non-US regions. The plot displays subgroup analyses for ASA dose categories (≥300 mg, >100 to <300 mg, ≤100 mg) and illustrates relative effectiveness between the two drugs with markers and confidence intervals along a logarithmic scale.*

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Figure 1: Kaplan-meier Estimate Of Time To First Non-cabg Plato-defined Major Bleeding Event (plato) (Image 01)

A line graph displaying cumulative percentage over time (days from first study drug dose) for Ticagrelor 90 mg and Clopidogrel groups. The solid line represents Ticagrelor 90 mg, and the dashed line represents Clopidogrel, showing event rates over 360 days in a patient study.*

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Figure 2: ‘major Fatal/life-threatening’ Cabg-related Bleeding By Days From Last Dose Of Study Drug To Cabg Procedure (plato) (Image 02)

A bar chart showing the percentage of patients who had an event following CABG over multiple days. The x-axis represents days (1 through 8 and beyond) and the y-axis shows the percentage of patients. Bars are labeled T and C for comparison groups, with numerical values below the chart indicating patient counts for each day and group.*

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Ticagrelor Structural Formula (Image 03)

Chemical structure diagram of ticagrelor, showing its molecular framework with various functional groups including fluorophenyl, thiophene, and hydroxy substitutions.*

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Figure 5: Mean Inhibition Of Platelet Aggregation (± Se) Following Single Oral Doses Of Placebo, 180 mg Ticagrelor Or 600 mg Clopidogrel (Image 04)

A line graph comparing the percentage of IPA induced by 20µM ADP over time (up to 8 hours) for Ticagrelor 180 mg, Clopidogrel 600 mg, and Placebo. The graph shows three distinct curves with Ticagrelor having the highest IPA response, Clopidogrel moderate, and Placebo the lowest.*

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Figure 6: Mean Inhibition Of Platelet Aggregation (ipa) Following 6 Weeks On Placebo, Ticagrelor 90 mg Twice Daily, Or Clopidogrel 75 mg Daily (Image 05)

A line graph comparing the percentage of IPA induced by 20µM ADP over time (days) for Ticagrelor, Clopidogrel, and Placebo. The main graph shows a 10-day timeline, while an inset graph displays data over 48 hours. Lines are marked with circles for Ticagrelor, triangles for Clopidogrel, and squares for Placebo.*

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Figure 7: Impact Of Intrinsic Factors On The Pharmacokinetics Of Ticagrelor (Image 06)

A scatter plot chart labeled 'Mean Effect and 90% CI' showing intrinsic factors such as age, gender, ethnicity, renal impairment, end stage renal disease on hemodialysis, and hepatic impairment. It depicts the change relative to reference for Ticagrelor, with markers and confidence intervals for three pharmacokinetic variables (PK): Cmax, AUC, displayed with recommendations indicating no dose adjustment is needed for these factors.*

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Figure 3: Time To First Timi Major Bleeding Event (themis) (Image 07)

A line graph comparing the cumulative percentage of events over time for Ticagrelor versus Placebo. The x-axis represents months from randomization up to 54 months, while the y-axis shows cumulative event percentage. Ticagrelor shows a higher cumulative event percentage than Placebo throughout the time period. Patient numbers at risk are tabulated below the graph at multiple time points.*

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Figure 9: Impact Of Ticagrelor Tablets On The Pharmacokinetics Of Co-administered Drugs (Image 08)

A chart illustrating the interaction effects of various drugs with Ticagrelor at specific doses. It shows mean effect and 90% confidence intervals for drug concentrations (Cmax) and exposure (AUC) relative to drug alone, alongside recommendations for dose adjustments. Drugs include Simvastatin, Atorvastatin, Levonorgestrel, Ethinyl Estradiol, Tolbutamide, Digoxin, and Cyclosporine with corresponding Ticagrelor doses.*

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Figure 4: Time Course Of Gusto Severe Bleeding Events (Image 09)

A Kaplan-Meier cumulative incidence curve graph comparing Ticagrelor 90 mg twice daily to placebo over approximately 30 days post-randomization. The y-axis shows cumulative percentage, and the x-axis shows days from randomization. The graph includes event counts and risk at various time points for both groups.*

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Figure 7: Effect Of Co-administered Drugs On The Pharmacokinetics Of Ticagrelor (Image 16)

A chart displaying the mean effect and 90% confidence intervals of various interacting drugs on Ticagrelor and AR-C124910XX pharmacokinetics. The x-axis shows change relative to reference, with pharmacokinetic measures Cmax and AUC indicated by squares and triangles, respectively. The chart includes recommendations for dose adjustment or avoiding concomitant use for each interacting drug listed.*

* 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.