Ambrisentan Tablet, Film Coated
Product Images NDC 0591-2406

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Ambrisentan (NDC 0591-2406). 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.

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Figure 1 Ambrisentan Structural Formula (Image 1)

Chemical structure diagram of the active ingredient Ambrisentan, showing its molecular framework with aromatic rings, methyl groups, and carboxylic acid functionality.*

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Acceptable Birth Control Options (Image 10)

A drug facts panel showing four contraception method options. Each option lists types of birth control methods, including intrauterine devices, hormonal contraceptives like pills and patches, barrier methods such as male condoms, diaphragms with spermicide, cervical caps, and surgical options like sterilization and partner vasectomy.*

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5 mg (Image 11)

Label for Ambrisentan Tablets 5 mg film-coated tablets. The label indicates the package contains 30 tablets, manufactured by Watson Pharma Private Limited in India for Teva Pharmaceuticals USA, Inc. It advises to dispense the accompanying Medication Guide and not to split, crush, or chew the tablets. Storage temperature is 20° to 25°C (68° to 77°F).*

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10 mg (Image 12)

Label for Ambrisentan Tablets 10 mg, film-coated tablets supplied in a package of 30 tablets. The label includes storage instructions, manufacturer information (Watson Pharma Private Limited, manufactured for Teva Pharmaceuticals USA, Inc.), and a barcode. The label states the product is Rx only and cautions not to split, crush, or chew tablets.*

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Figure 2: Effects Of Other Drugs On Ambrisentan Pharmacokinetics (Image 2)

A forest plot chart depicting pharmacokinetic (PK) interactions of various drugs with ambrisentan, showing fold change and 90% confidence intervals for Cmax and AUC values relative to ambrisentan alone. The chart includes recommendations such as limiting ambrisentan to 5 mg once daily with cyclosporine, while no dose adjustments are recommended for other drugs like mycophenolate mofetil, ketoconazole, omeprazole, rifampin, ritonavir, sildenafil, tacrolimus, tadalafil, and warfarin.*

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Figure 3: Effects Of Ambrisentan On Other Drugs (Image 3)

A forest plot chart showing fold changes and 90% confidence intervals of pharmacokinetic parameters (Cmax, AUC) for various interacting drugs when administered with Ambrisentan tablets. The chart includes drugs such as Cyclosporine, Digoxin, Ethinylestradiol, Norethindrone, Mycophenolic acid, Ritonavir, Sildenafil, Tadalafil, and Warfarin, with all recommendations indicating no dose adjustment required.*

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Figure 4: Mean Change In 6-minute Walk Distance (aries-1 And Aries-2) (Image 4)

Two line graphs titled ARIES-1 and ARIES-2 depicting changes in meters walked over time at Baseline, Week 4, Week 8, and Week 12. The ARIES-1 graph compares placebo, 5 mg, and 10 mg doses, while ARIES-2 compares placebo, 2.5 mg, and 5 mg doses. Both show distance improvements over time for active doses compared to placebo.*

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Figure 5: Time To Clinical Worsening (aries-1 And Aries-2) (Image 5)

Two Kaplan-Meier survival curves labeled ARIES-1 and ARIES-2 show event-free percentages over a 12-week period comparing Ambrisentan and placebo. Both graphs plot event-free (%) on the Y-axis and time (weeks) on the X-axis, with Ambrisentan represented by solid lines and placebo by dotted lines. Each graph includes numbers at risk for both groups at four time points, with p-values indicating statistical significance.*

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Figure 6: Time To Primary Endpoint Event (ambition) (Image 6)

Two Kaplan-Meier survival curves comparing event-free percentages over time in weeks between combination therapy and monotherapies (Ambrisentan and Tadalafil) for a drug further processing Ambrisentan tablet, film coated. Each graph shows separate event-free survival analyses with corresponding hazard ratios and confidence intervals, including patient numbers at risk below the time axis.*

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Figure 7: Primary Endpoint Events And First Occurrences Of Each Component At Any Time (ambition) (Image 7)

A hazard ratio forest plot chart comparing combination therapy vs. ambrisentan and tadalafil monotherapies across multiple clinical endpoints, including any event, death, hospitalization for worsening PAH, short term clinical worsening, and inadequate long term clinical response. The chart displays event rates, hazard ratios with 95% confidence intervals, and p-values, visually showing comparative effectiveness favoring combination or monotherapy treatments.*

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Figure 8: Primary Endpoint By Subgroups (ambition) (Image 8)

A forest plot comparing hazard ratios and 95% confidence intervals for various subgroups, illustrating the effectiveness of a combination therapy versus ambrisentan monotherapy and tadalafil monotherapy. The x-axis shows hazard ratios with markers indicating whether the combination favors or monotherapy. Data categories include overall, sex, age, geographic region, WHO functional classes, types of pulmonary arterial hypertension, and 6-minute walk distance groups.*

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Figure 9: Median Change In 6-minute Walk Distance (meters) In Ambition (Image 9)

A line graph comparing distance in meters over time (Baseline to Week 24) for three treatments: Combination, Ambrisentan Monotherapy, and Tadalafil Monotherapy. The graph includes error bars representing 95% confidence intervals for each data point.*

* 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.