7 DRUG INTERACTIONS

In combination with sexual stimulation, sildenafil works by increasing blood flow to the penis to help a man get and keep an erection. Sildenafil does not protect against sexually transmitted diseases (such as HIV, hepatitis B, gonorrhea, syphilis).

• 20mg sildenafil provides a balance between effectiveness and safety.
• It is not a cure for ED but helps achieve and maintain an erection.
• Using sildenafil without medical advice can be risky.
• The medication may cause nasal congestion or stomach upset.
• Always follow the dosage instructions provided by your healthcare provider.

Practice "safe sex" such as using latex condoms.

Overdose/Missed Dose

Advise patients taking sildenafil tablets not to take VIAGRA or other PDE-5 inhibitors. • Advise patients to seek immediate medical attention for a sudden loss of vision in one or both eyes while taking sildenafil tablets. • Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking sildenafil tablets. TORRENT PHARMA INC., Basking Ridge, NJ 07920. Sildenafil is used to treat male sexual function problems (impotence or erectile dysfunction-ED). Consult your doctor or pharmacist for more details.

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Sildenafil is also available in other brands and strengths for treating high blood pressure in the lungs (pulmonary hypertension).

• 20mg sildenafil is a standard starting dose for many men.
• Its safety profile is well-established when used responsibly.
• The drug should be taken at least 30 minutes before sexual activity.
• Use caution if you experience dizziness or sudden vision loss.
• Always follow medical advice when using sildenafil for ED.

Do not take sildenafil with any other product that contains sildenafil or other similar medications for erectile dysfunction-ED or pulmonary hypertension (such as tadalafil, vardenafil).

What Are Warnings and Precautions for Sildenafil?

Kaplan-Meier estimates of survival at 3 years were 66%, 79%, and 85% in the 5-, 20-, and 80mg TID dose groups, respectively Clinical Worsening Sildenafil 80 mg was also superior to 5 mg for time to first event of clinical worsening with HR (99.7% CI) = 0.44 (0.22, 0.89). At baseline, the median of 6MWD for the intent-to-treat (ITT) population was 332 to 352 m. At Month 6, the median change from baseline was highest for sildenafil 80 mg TID with 28 m compared to 18 m and 19 m for sildenafil 5 mg TID and sildenafil 20 mg TID groups, respectively. The same was seen at Month 12, the median change from baseline for sildenafil 80 mg TID group was 33 m compared to 17 m for sildenafil 5 mg TID and 31 m in sildenafil 20 mg TID groups. Overall, the safety data for sildenafil 20 mg TID and for the higher sildenafil 80 mg TID dose were consistent with the established safety profile of sildenafil in previous adult PAH studies [see Adverse Reactions (6.1)]. Sildenafil is available under the following different brand names: Revatio, and Viagra.

14. Clinical Studies

Patients were naïve for specific PAH therapy and the use of prostacyclin, prostacyclin analogues and endothelin receptor antagonists were not permitted in the study, and neither were arginine supplementation, nitrates, alpha-blockers and potent CYP450 3A4 inhibitors. The primary objective of the study was to assess the effect of Sildenafil citrate on percent change from baseline in PVO2, normalized to body weight, from baseline to week 16 as measured by the Cardiopulmonary Exercise Test (CPET) (patients who were developmentally able to perform the test, n = 115). Secondary endpoints included hemodynamic monitoring, symptom assessment, WHO Functional Class, change in background treatment, and quality of life measurements (n = 234). Patients were allocated to one of three sildenafil treatment groups (low, medium, or high) or placebo. Actual doses administered were dependent on body weight (see Table 5).

What are the most common side effects of sildenafil?

Treatment Allocation by Dose and Body Weight in Pediatric Study The proportion of patients receiving supportive medicinal products at baseline (anticoagulants, digoxin, calcium channel blockers, diuretics and/or oxygen) was similar in the combined sildenafil treatment group (48%) and the placebo treatment group (42%). The primary endpoint was a percentage change in VO2peak from baseline to week 16 assessed by CPET. Mean baseline peak volume of oxygen consumed (VO2) values were similar across the sildenafil treatment groups (17 to 18 ml/kg/min), and slightly higher for the placebo treatment group (20 ml/kg/min). A total of 45% of patients were evaluable for CPET, which comprised those children ≥7 years old and developmentally able to perform the test. Children <7 years were evaluable only for the secondary endpoints. Dosage Considerations – Should be Given as Follows: 50 mg orally 1 hour before sexual activity may be increased to 100 mg or reduced to 25 mg, depending on effectiveness and tolerance Oral: 5 mg or 20 mg 3 times daily, administered 4-6 hours apart Intravenous (IV): 2.5-mg or 10-mg bolus 3 times daily if patient is temporarily unable to take orally Recommended oral/IV dose not to be exceeded Adding Revatio to bosentan does not have any beneficial effect on

Drug Label Information

Most patients were PAH treatment naïve (83%). For most patients the etiology of PAH was idiopathic (72%). The most common WHO Functional Class was Class III (58% of patients). Treatment groups were well balanced with respect to baseline demographics of strata history of PAH treatment and etiology of PAH, as well as the WHO Functional Class categories. The primary objective of the study was to compare sildenafil 80 mg TID versus 5 mg TID for mortality, with success defined by ruling out twice the mortality at 80 mg.

Are you currently using Sildenafil (Viagra, Revatio)?

The key secondary efficacy endpoint was time to first event of clinical worsening, defined as a composite endpoint of all-cause mortality, hospitalization for worsening PAH or disease progression. An additional secondary endpoint sildenafil 50mg tablet was 6MWD at Months 6 and 12. Overall Survival At the time of a planned interim analysis (50% deaths) it was identified that the primary efficacy objective of this protocol was met and therefore the study was stopped. Based on the primary efficacy endpoint (mortality), the non-inferiority of sildenafil 80 mg TID arm versus 5 mg TID arm was met using a 2-sided significance level of 0.003 for the interim analysis. Primary comparison of the 80 mg TID group to the 5-mg TID group yielded the HR (99.7% CI) = 0.51 (0.22, 1.21); i.e., non-inferiority was established. exercise capacity Hepatic impairment or severe renal impairment: Use initial dose of 25 mg Older than 65 years: 25 mg orally initially 1 hour before sexual activity Oral: 5 mg or 20 mg 3 times daily, administered 4-6 hours apart Intravenous (IV): 2.5-mg or 10-mg bolus 3 times daily if patient is temporarily unable to take orally Recommended oral/IV dose not to be exceeded Adding Revatio to bosentan does not have any beneficial effect on exercise capacity Clinical trials found

Patient Group	Recommended Dose	Frequency of Use	Notes
First-time users	20 mg	Once per day	Take 30-60 min before activity
Experienced users	May increase to 50 mg	As needed	Under medical supervision
Elderly patients	20 mg or lower	As needed	Start with lowest dose
Patients on other medications	Consult doctor	Varies	Adjust dose accordingly

no significant difference in response between elderly patients and younger adults; however, cautious dose selection should be considered in elderly because of greater frequency of decreased hepatic, renal, and cardiac function, as well as comorbid conditions and concomitant pharmacotherapy Compared

• The future of sildenafil includes research into new therapeutic areas.
• Investigations are ongoing for its use in heart failure with preserved ejection fraction.
• Studies examine its potential benefits in Alzheimer's disease and vascular dementia.
• Its application in jet lag and sleep cycle disorders is being explored.
• Research continues for its use in various forms of female sexual dysfunction.
• Novel delivery systems, like microneedle patches, are in preclinical development.
• Combination therapies with other agents for enhanced effect are being tested.
• The search for more selective PDE5 inhibitors with fewer side effects continues.
• Genetic factors influencing drug response are an area of pharmacogenomic research.
• Sildenafil remains a valuable tool for basic research in vascular biology.
• Its story is a continuing one of scientific discovery and application.

with healthy younger volunteers, healthy elderly volunteers (65 years and older) had reduced clearance of sildenafil, resulting in approximately 84% and 107% higher plasma concentrations of sildenafil and its active N-desmethyl metabolite, respectively Not to be prescribed to children (1-17

1. Indications and Usage for Sildenafil Tablets

Of the total 229 patients who received sildenafil, there were 55, 74, and 100 patients in the low, medium, and high dose groups, respectively. Across the short-term and long-term studies, the overall duration of treatment from start of double-blind for individual patients ranged from 3 to 3,129 days. By sildenafil treatment group, median duration of sildenafil treatment was 1,696 days (excluding the sildenafil 25 mg tablets 5 patients who received placebo in double-blind and were not treated in the long-term extension study). Peak VO2 was assessed 1 year after the start of the placebo-controlled study. Of sildenafil-treated patients developmentally able to perform the CPET 59/114 patients (52%) had not shown any deterioration in PVO2 from start of sildenafil.

When and How to Take Sildenafil for Best Results

Similarly, 191 of 229 patients (83%) who had received sildenafil had either maintained or improved their WHO Functional Class at 1 year assessment. Kaplan-Meier estimates of survival at 3 years in patients >20 kg in weight at baseline were 94%, 93%, and 85% in the low, medium, and high dose groups, respectively; for patients ≤20 kg in weight at baseline, the survival estimates were 94% and 93% for patients in the medium and high dose groups, respectively [see Use in Specific Populations (8.4) and Adverse Reactions (6.1)]. Study A1481324 (NCT02060487) - Study to Assess the Effects of Sildenafil citrate on Mortality in Adults with PAH A study to assess the effects of multiple doses of sildenafil on mortality in adults with PAH was conducted following the observation of a higher risk of mortality in pediatric patients taking a high dose of Sildenafil citrate TID, based on body weight, compared to those taking a lower dose of Sildenafil citrate in the long-term extension of the pediatric clinical trial. The study was a randomized, double-blind, parallel-group study in 385 adults with PAH. Patients were randomly assigned 1:1:1 to one of three treatment groups (5, 20, and 80 mg TID). years) for pulmonary arterial hypertension (PAH); this recommendation against use is based on long-term clinical pediatric trial showing that children taking high doses had higher risk of death than children taking low doses and that low doses were not effective

8.7 Patients with Renal Impairment

Sildenafil 20 mg tablets USP are white to off-white, round biconvex film coated tablets debossed with '85' on one side and plain on other side. Bottles of 30 Tablets NDC: 80425-0304-01 Bottles of 60 Tablets NDC: 80425-0304-02 Bottles of 90 Tablets NDC: 80425-0304-03 Bottles of 50 Tablets NDC: 80425-0304-04 Recommended Storage for Sildenafil Tablets USP: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Advise the patient to read the FDA-approved patient labeling (Patient Information). • Inform patients of contraindication of sildenafil tablets with regular and/or intermittent use of organic nitrates. • Inform patients that sildenafil is also marketed as VIAGRA for erectile dysfunction. in improving exercise ability Side effects associated with use of Sildenafil, include the following: Postmarketing side effects of sildenafil reported include: Vaso-occlusive crisis (PAH secondary to sickle-cell anemia) This document does not contain all possible side effects and others may occur.

Brand names

Mean increases in VO2peak percentage change from baseline at Week 16, were observed with all 3 sildenafil doses (range of 6% to 13%, Figure 6), with little change with placebo (0.5%). Percentage Change from Baseline in VO2Peak: Mean (95% Confidence Intervals) The estimated difference between the combined sildenafil doses and placebo was 8% (95% CI: 0.2 to 16). The results of the main analysis (combined dose groups versus placebo) were not statistically significant (p=0.056). The estimated difference between the sildenafil medium dose group and placebo was 11±5% (95% CI: 2 to 21). Impact on Hemodynamic Parameters Dose related improvements were observed with PVRI and mPAP.

5.5 Hypotension when Co-administered with Alpha-blockers or Anti-hypertensives

Statistically significant PVRI reductions compared to placebo were seen with the sildenafil medium and high dose groups (18% [95% CI: -32% to -2%] and 27% [95% CI: -39% to -14%], respectively) but not the low dose group (2% (95% CI: -20%, 20%). The sildenafil medium and high dose groups displayed mPAP changes from baseline compared to placebo, of -3.5 mmHg (95% CI: -8.9, 1.9) and -7.3 mmHg (95% CI: -12.4, -2.1), respectively; while the low dose group showed little difference from placebo (difference of 1.6 mmHg [95% CI: -4.5, 7.6]). Improvements were observed with cardiac index with all three sildenafil groups over placebo, 10%, 4%, and 15% for the low, medium, and high dose groups, respectively [see Clinical Pharmacology (12.2)]. STARTS-2 (NCT00159874) - Long-Term Survival with Oral Sildenafil Monotherapy in Treatment-Naïve Pediatric Pulmonary Arterial Hypertension Of the 234 pediatric patients treated in the short-term, placebo-controlled study, 220 patients entered the long-term extension study. Patients who had been in the placebo group in the short-term study were randomly reassigned to sildenafil treatment; patients weighing ≤20 kg entered the medium or high dose groups (1:2), while patients weighing >20 kg entered the low, medium, or high dose groups (1:1:1).