Bosentan Tablet, Coated
Product Images NDC 68382-447

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Bosentan (NDC 68382-447). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Zydus Pharmaceuticals Usa 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

Cyp3a Induction-mediated Effect Of Bosentan On Other Drugscyp3a Induction-mediated Effect Of Bosentan On Other Drugs (71780a49 6db0 40ce 994b E34a834ca834 01)

A chart showing the fold-change of interacting drugs' concentrations (Cmax and AUC) when administered with Bosentan. The chart lists Cyclosporin A, Glyburide, Simvastatin, ß-Hydroxy acid simvastatin, Norethindrone, and Ethinyl estradiol with respective recommendations such as contraindicated, monitor cholesterol, or use additional contraception.*

FDA Label Image

Effect Of Other Drugs On Bosentan (71780a49 6db0 40ce 994b E34a834ca834 02)

A table showing the fold-change of bosentan when coadministered with interacting drugs Cyclosporin A, Lopinavir/ritonavir, and Rifampin. It includes pharmacokinetic parameters (Cmax, AUC, Ctrough) and corresponding clinical recommendations such as contraindication, dose reduction, and weekly AST/ALT monitoring.*

FDA Label Image

Bosentan Tablets (71780a49 6db0 40ce 994b E34a834ca834 03)

Chemical structure of Bosentan, the active ingredient shown with its molecular framework including aromatic rings, sulfonamide, and other functional groups.*

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Cyp Induction-mediated Effect Of Bosentan On Other Drugs (71780a49 6db0 40ce 994b E34a834ca834 04)

A chart showing fold-change of interacting drugs with Bosentan, including Cmax and AUC values, and corresponding clinical recommendations such as contraindications, monitoring cholesterol, no adjustment needed, or use of additional contraception. Drugs listed include Cyclosporin A, Glyburide, Simvastatin, ß-Hydroxy acid simvastatin, Digoxin, Sildenafil, S-Warfarin, R-Warfarin, Norethindrone, Ethinyl estradiol, Nimodipine, and Tadalafil.*

FDA Label Image

Effects Of Other Drugs On Bosentan (71780a49 6db0 40ce 994b E34a834ca834 05)

A chart showing the fold-change of bosentan exposure with various interacting drugs, including Cyclosporin A, Lopinavir/ritonavir, Rifampin, Ketoconazole, Losartan, Sildenafil, and Tadalafil. It presents Cmax and AUC values along with clinical recommendations such as dose reduction, contraindication, or no adjustment required for each interacting drug.*

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Mean Change In 6-min Walk Distance (breathe-1) (71780a49 6db0 40ce 994b E34a834ca834 06)

A line graph comparing the meters walked over time from baseline to week 16 between two groups: Bosentan (144 subjects) and placebo (69 subjects). The Bosentan group shows a steady increase reaching about 40 meters at weeks 8 and 16, while the placebo group shows minimal improvement and a decline after week 8. Error bars indicate variability at each time point.*

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Time To Clinical Worsening (breathe-1) (71780a49 6db0 40ce 994b E34a834ca834 07)

A Kaplan-Meier curve chart comparing event-free survival rates over 28 weeks between Bosentan and placebo groups. The Y-axis shows the percentage of event-free subjects, and the X-axis displays time in weeks. The Bosentan group remains at approximately 89% event-free, while the placebo group drops to about 63% event-free. Statistical significance (p-values) is noted at 16 and 28 weeks.*

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62.5 mg (71780a49 6db0 40ce 994b E34a834ca834 09)

Bosentan Tablets 62.5 mg tablet, coated oral dosage form labeled by Zydus Pharmaceuticals USA Inc. The label indicates a package of 60 tablets with prescription-only status. It includes a pharmacist instruction to dispense the Medication Guide, dosage and storage information, and cautions about child resistance and keeping out of reach of children. Manufacturer and distributor details are provided.*

FDA Label Image

125 mg (71780a49 6db0 40ce 994b E34a834ca834 10)

Bosentan Tablets 125 mg film-coated oral tablets label from Zydus Pharmaceuticals USA Inc. The label indicates a package containing 60 tablets for prescription use only. It includes dosage strength, instructions to dispense the Medication Guide with each patient, storage conditions, and manufacturer and distributor details.*

* 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.