Tracleer Tablet, Film Coated
Product Images NDC 66215-101

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Tracleer (NDC 66215-101). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Actelion Pharmaceuticals Us, 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 (Tracleer 01)

This text appears to be a list of interacting drugs including Cyclosporin A, Glyburide, Simvastatin, R-Hydroxy acid simvastatin, Norethindrone, and Ethinyl estradiol, and the corresponding Cmax and AUC values. The text also suggests a fold-change of the interacting drug and a recommendation for each drug interaction, including contraindication for Cyclosporin A and Glyburide, and monitoring cholesterol and using additional contraception for Simvastatin and Ethiny estradiol interactions.*

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Figure 2 (Tracleer 02)

This text describes the interactions of different drugs and their effects on various enzymes and transporters. Cyclosporin A inhibits OATP, Lopinavirfitonavir inhibits both OATP and CYP3A, while Rifampin induces CYP3A and CYP2C9 and inhibits OATP. The text also presents some pharmacokinetic parameters such as Ctrough, Cmax, and AUC. Finally, it suggests that bosentan should not be used in combination with these drugs or that a dose reduction may be required, and recommends monitoring AST/ALT weekly.*

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Chemical Structure (Tracleer 03)

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Figure 3 (Tracleer 04)

This text appears to be a list of drugs and their interactions with other drugs. It includes information about changes in plasma concentrations, as well as recommendations such as contraindications and dosage adjustments. However, the output contains several errors which may affect the accuracy of the information presented, and some information appears to be incomplete.*

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Figure 4 (Tracleer 05)

This is a table that shows various interactions between drugs and their effect on specific enzymes and transporters in the body. It also shows measurements of drug levels in the blood (Ctrough (ss), Cmax, Auc) and a recommended course of action for each interaction, such as dose reductions or contraindication.*

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Figure 5 (Tracleer 06)

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Figure 6 (Tracleer 07)

The text represents a graph that shows the event-free percentage of Bosentan E and Placebo over time in weeks. The graph shows vertical bars at 100, 75, 50, and 25%. The Bosentan E group shows a higher event-free percentage than the Placebo group, indicated by a solid line (Bosentan E) and a dotted line (Placebo). At week 12, Bosentan E shows an event-free percentage of 89%, while Placebo shows 63%. The p-value is 0.0015, indicating a significant difference between the two groups. The x-axis represents time in weeks, and the y-axis represents the event-free percentage.*

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Figure (Tracleer 08)

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Principal Display Panel (62.5 mg Tablet Bottle Carton)

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Principal Display Panel (125 mg Tablet Bottle Carton)

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Principal Display Panel (32 mg Tablet Blister Pack Carton)

Tracleer is a medication available in tablet form for oral suspension. It contains the active ingredient Bosentan and comes in a strength of 32mg. The National Drug Code (NDC) for this medication is 66215-103.56. The medication guide enclosed contains important information and caution should be exercised when dispensing. Each tablet contains 1.67mg for oral suspension. Store the medication out of reach of children. The manufacturer is located in South Francaca, CA 3402 05. No other information is available.*

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Tracleer 12

This is a medication containing Bosentan for oral suspension, which is dispensed with an enclosed medication guide. The medication is contained in a carton of 56 tablets with each blister strip containing 14 tablets. Each tablet contains 32mg of anhydrous bosentan, and the recommended dosage should be dispersed for oral suspension or as a tablet half immediately before administration. The medicine should be stored at controlled room temperature ranging from 20°C to 25°C (68°F to 77°F) and kept out of the reach of children. It is intended for use only on prescription and contains 1.87mg of Phenylalanine per tablet.*

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