Sildenafil
Product Images NDC 53217-293

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Sildenafil (NDC 53217-293). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aidarex Pharmaceuticals Llc, 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 6: Kaplan-meier Plot Of Mortality By Sildenafil Dose (Sildenafil 20mg 1)

This text appears to be a chart or graph showing estimated cumulative mortality rates for different doses of some substance or treatment over a period of time in years. However, without further context or additional information, it is difficult to provide a more specific or useful description.*

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Chemical Structure (Sildenafil 20mg 2)

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Figure 7. Effects Of Other Drugs On Sildenafil Pharmacokinetics (Sildenafil 20mg 3)

This text provides information on the drug interactions and recommended dose adjustments for Aorvastatin, Aithromycin, Bosentan, Cimetidine, Enthromycin, Maalox, Oral Contraceptives, Ritonavir, and Saquinavir when used with Sildenatil. The table shows the fold change in interactions and the 90% C1 recommendation for each drug. The text also includes a horizontal line graph for the changes relative to Sildenatil alone. Further, it mentions that there is no benefit on exercise capacity when sildenafil is added to bosentan therapy, as seen in clinical studies.*

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Figure 8 Effects Of Sildenafil On Other Drugs (Sildenafil 20mg 4)

This is a drug interaction chart that shows how acenocoumarol interacts with other drugs. The list includes aspirin, atorvastatin, bosentan, doxazosin 1-3, ethinyloestradiol, levonorgestrel, phenprocoumon, ritonavir, saquinavir, and tolbutamide. The chart depicts the Impact on INR AUC, INR Cmax, BT, AU, Cmax, and AUC for each drug. The fold change and 90% CI are also shown. It appears that no dose adjustment is needed for most drugs but co-administration with bosentan and ritonavir is not recommended for some drugs.*

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Figure 9. Change From Baseline In 6-minute Walk Distance (meters) At Weeks 4, 8, And 12 In Study 1: Mean (95% Confidence Interval) (Sildenafil 20mg 5)

The text appears to be a figure from a study showing the change in 6-minute walk distance in meters at different time points for a placebo group and groups taking different doses of sildenafil. The doses of sildenafil were 40mg TID and 80mg TID. A confidence interval is also included.*

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Figure 10. Placebo-corrected Change From Baseline In 6-minute Walk Distance (meters) At Week 12 By Study Subpopulation In Study 1: Mean (95% Confidence Interval) (Sildenafil 20mg 6)

The text describes a figure labeled as Figure 10, which displays the placebo-corrected change from baseline in 6-minute walk distance, measured in meters, at week 12 by a study subpopulation in Study 1. The data is presented as mean and 95% confidence interval. The study subpopulations are classified according to their etiology, including Idiopathic PAH, Etiology PHCD, PAH-surgical repair, PH etiteia for functional capacity and therapeutic class. The subpopulations receive different treatments, including placebo, Sidenaf 20 mg TID or Sildenafil. The figure also includes additional data such as baseline walk distance, median age, median mean PAP, and PR dedn.*

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Figure 11. Kaplan-meier Plot Of Time (in Days) To Clinical Worsening Of Pah In Study 2 (Sildenafil 20mg 7)

The text describes a Kaplan-Meier plot that shows the time (in days) it takes for pulmonary arterial hypertension (PAH) patients to experience clinical worsening. The plot compares the percentage of patients who did not experience clinically worsening events between a placebo group and a group that received sildenafil. The x-axis measures time in days while the y-axis displays the percentage of patients who remain clinically stable.*

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Figure 12. Mean Change From Baseline In Six Minute Walk (meters) By Visit To Week 12 – Itt Population Sildenafil Protocol A1481244 (Sildenafil 20mg 8)

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Image Description (Sildenafil 20mg 9)

This is a package of generic tablets of 20mg Sildenafil Citrate, the active ingredient found in Viagra. The tablets come in a white round film-coated form with "T" on one side and "27" on the reverse. The label provides a warning, dosage instructions, and storage recommendations. It cautions that federal law prohibits dispensing this medication without a prescription. The label also includes information about the manufacturer, lot number and expiration date.*

* 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.