Dabigatran Etexilate Capsule
Product Images NDC 72865-273

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Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Dabigatran Etexilate (NDC 72865-273). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Xlcare 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.

FDA Label Image

150-60 (150 60)

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2.4 (2.4)

2.4 (2.4)
Description: This information pertains to pediatric patients who have renal impairment. It is crucial to understand the impact of kidney issues on children to provide appropriate medical care and treatment.*
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2.7 (2.7)

2.7 (2.7)
This text provides important information on the timing for starting dabigatran etexilate capsules in adult patients who are already receiving parenteral anticoagulant therapy. It suggests initiating dabigatran etexilate capsules either 0 to 2 hours before the next scheduled dose of the parenteral drug or at the time of discontinuation of the parenteral drug if it is continuously administered, such as intravenous unfractionated heparin. This guideline aims to ensure a smooth transition between anticoagulant therapies for optimal patient care.*
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75-60 (75 60)

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Figure3.1 (Figure3.1)

Figure3.1 (Figure3.1)
This text provides information about interacting drugs with different dosages and time intervals for pharmacokinetics evaluation. It includes details on various drugs such as Dronedarone, Ketoconazole, Amiodarone, Clarithromycin, Quinidine, Ticagrelor, Verapamil, and Rifampicin. The text also mentions Pegp Inhibitors and Pegp Inducers, potentially used for studying drug interactions and their effects on pharmacokinetics. Additionally, there is a section on Fold Change and 90% Confidence Interval for evaluation purposes.*
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Figure3.2 (Figure3.2)

Figure3.2 (Figure3.2)
This text provides a list of interacting drugs along with their dosages and timings. It includes drugs like Atorvastatin, Clopidogrel, Diclofenac, Digoxin, Enoxaparin, Pantoprazole, and Ranitidine. The text also mentions fold change and 90% confidence intervals, suggesting a study or analysis related to drug interactions and efficacy.*
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Mg1 (Mg1)

Mg1 (Mg1)
Reduce the risk of stroke and blood clots related to atrial fibrillation or deep vein thrombosis, with this medication that helps prevent blood clots in the heart and veins.*
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Figure1 (Figure1)

Figure1 (Figure1)
The provided text seems to contain data related to major bleeding events and the comparison between patients treated with Dabigatran 150 vs. Warfarin. The data includes subgroups based on various factors such as VKA use, age, gender, weight, history of stroke/TIA, diabetes at baseline, CHADS2 score, and CrCL (mL/min). Hazard ratios with confidence intervals are provided for each subgroup, allowing for an assessment of the differences in major bleeding events between the two treatment groups. Additional information includes patient numbers, percentages per year, and hazard ratios with their corresponding confidence intervals. This data can be used to evaluate the safety profile of Dabigatran 150 compared to Warfarin in terms of major bleeding events across different patient subgroups.*
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Figure2 (Figure2)

Figure2 (Figure2)
This text provides information about the time course of aPTT (activated partial thromboplastin time) for different dosages of Dabigatran etexilate capsules based on the patient's creatinine clearance rate (CrCl). The dosage is 150 mg BID when CrCl is greater than 30 mL/min and 75 mg BID when CrCl is less than 30 mL/min. The graph shows the aPTT time course over 96 hours.*
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Figure4 (Figure4)

Figure4 (Figure4)
Not available.*
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Figure5 (Figure5)

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Structural (Structural)

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