Bosentan Tablet, Film Coated
Product Images NDC 0591-2511

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Bosentan (NDC 0591-2511). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Actavis Pharma, 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

1 (Image 1)

A data table presenting drug interaction recommendations for bosentan with various interacting drugs. It includes fold-change graphs of Cmax and AUC values for Cyclosporin A, Glyburide, Simvastatin, ß-Hydroxy acid simvastatin, Norethindrone, and Ethinyl estradiol alongside corresponding recommendations such as contraindicated, monitor cholesterol, and use additional contraception.*

FDA Label Image

1 (Image 10)

Label for bosentan 125 mg film-coated tablets by Actavis Pharma, Inc. The label includes the NDC 0591-2512-60 and states the product contains 60 tablets for oral use by prescription only. It provides detailed information on the active ingredient amount, storage conditions, manufacturer (Watson Pharma Private Ltd., India), and distributor details. A barcode and space for lot and expiration dates are also visible.*

FDA Label Image

2 (Image 2)

A horizontal bar chart illustrating the fold-change effect of interacting drugs on bosentan levels. The drugs Cyclosporin A, Lopinavir/ritonavir, and Rifampin are shown with their impact on different pharmacokinetic parameters such as Cmax and AUC. Recommendations for each interaction are provided, including contraindication and dose adjustment guidance.*

FDA Label Image

1 (Image 3)

Chemical structure of bosentan, the active ingredient in the pharmaceutical product labeled bosentan. The diagram includes aromatic rings, sulfonamide, pyrimidine, and ether functional groups, illustrating the molecular configuration. A water molecule is also indicated in the structure.*

FDA Label Image

1 (Image 4)

A data table presenting drug interaction recommendations for bosentan. It lists interacting drugs, their effect on pharmacokinetic parameters (Cmax, AUC, plasma concentrations), and corresponding recommendations such as contraindications, monitoring cholesterol, no adjustment needed, or using additional contraception.*

FDA Label Image

1 (Image 5)

A chart illustrating the fold-change of bosentan levels in the presence of various interacting drugs, including Cyclosporin A, Lopinavir/ritonavir, Rifampin, Ketoconazole, Losartan, Sildenafil, and Tadalafil. It shows changes in Cmax and AUC with corresponding recommendations for dose adjustment or monitoring, such as contraindication, dose reduction, AST/ALT weekly monitoring, or no adjustment needed.*

FDA Label Image

5 (Image 6)

A line graph comparing the distance walked in meters over time (Baseline, Week 4, Week 8, Week 16) between Bosentan and Placebo groups. The Bosentan group shows an increase and maintenance of distance walked, while the Placebo group shows a smaller increase followed by a decline. Error bars indicate variability in measurements.*

FDA Label Image

6 (Image 7)

A Kaplan-Meier event-free survival curve comparing bosentan and placebo over a 28-week period. The y-axis shows the percentage of event-free participants, and the x-axis shows time in weeks. Bosentan displays higher event-free survival (89%) compared to placebo (63%), with p-values indicating statistical significance at 16 and 28 weeks.*

FDA Label Image

1 (Image 8)

A table titled Acceptable birth control options presenting four options for contraception methods. Each option lists different methods such as intrauterine devices, estrogen and progesterone contraceptives, diaphragms with spermicide, condoms, and partner's vasectomy with additional methods. The text is organized in columns with headings and includes contraceptive methods combining one or more listed options.*

FDA Label Image

1 (Image 9)

Label for Bosentan Tablets 62.5 mg from Actavis Pharma, Inc. The label specifies each film-coated tablet contains 64.541 mg of bosentan monohydrate, equivalent to 62.5 mg bosentan base. It is packaged as 60 tablets, prescription only, with handling and storage instructions, manufacturer details, and a barcode on the label.*

* 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.