Effect of Sildenafil Citrate and Placebo on Maintenance of Erection by Baseline Score.The frequency of patients reporting improvement of erections in response to a global question in four of the randomized, double-blind, parallel, placebo-controlled fixed dose studies (1,797 patients) of 12 to 24 weeks duration is shown in Figure 7.
- Sildenafil tablets 125 mg are manufactured by various brands.
- Always verify the authenticity of medication sources.
- Use only FDA-approved or certified pharmacies.
- Cost can vary based on brand and location.
- Generic versions are typically more affordable.
- Beware of counterfeit sildenafil products.
- Read customer reviews before purchasing online.
- Consult your doctor about the best brand for you.
These patients had erectile dysfunction at baseline that was characterized by median categorical scores of 2 (a few times) on principal IIEF questions. Erectile dysfunction was attributed to organic (58%; generally not characterized, but including diabetes and excluding spinal cord injury), psychogenic (17%), or mixed (24%) etiologies.
- Always use the lowest effective dose of sildenafil.
- Follow your doctor’s instructions carefully.
- Do not alter the dosage without consulting your doctor.
- Keep track of your health conditions and medications.
- Use sildenafil responsibly to prevent dependency.
- Seek prompt medical attention for prolonged erections.
- Consider lifestyle changes to improve ED symptoms.
- Education about sildenafil can improve treatment outcomes.
Sixty-three percent, 74%, and 82% of the patients on 25 mg, 50 mg and 100 mg of sildenafil citrate, respectively, reported an improvement in their erections, compared to 24% on placebo. In the titration studies (n=644) (with most patients eventually receiving 100 mg), results were similar.Overall treatment p<0.0001Figure 7. Percentage of Patients Reporting an Improvement in ErectionsThe patients in studies had varying degrees of ED. One-third to one-half of the subjects in these studies reported successful intercourse at least once during a 4-week, treatment-free run-in period.In many of the studies, of both fixed dose and titration designs, daily diaries were kept by patients. In these studies, involving about 1,600 patients, analyses of patient diaries showed no effect of sildenafil citrate on rates of attempted intercourse (about 2 per week), but there was clear treatment-related improvement in sexual function: per patient weekly success rates averaged 1.3 on 50 to 100 mg of sildenafil citrate vs 0.4 on placebo; similarly, group mean success rates (total successes divided by total attempts) were about 66% on sildenafil citrate vs about 20% on placebo.During 3 to 6 months of double-blind treatment or longer-term (1 year), open-label studies, few patients withdrew from active treatment for any reason, including lack of effectiveness. At the end of the long-term study, 88% of patients reported that sildenafil citrate improved their erections.Men with untreated ED had relatively low baseline scores for all aspects of sexual function measured (again using a 5-point scale) in the IIEF.
- Sildenafil tablets are classified as phosphodiesterase inhibitors.
- They are quick-acting but effects vary by individual.
- Avoid taking with other erectile dysfunction medications.
- Liver or kidney impairment may require dose adjustments.
- Do not use sildenafil during sexual activity if unadvised.
- Safe sexual activity involves knowing your health status.
- Window for maximum effectiveness is around 1 hour before.
- Avoid excessive physical exertion after taking sildenafil.
Sildenafil citrate improved these aspects of sexual function: frequency, firmness and maintenance of erections; frequency of orgasm; frequency and level of desire; frequency, satisfaction and enjoyment of intercourse; and overall relationship satisfaction.One randomized, double-blind, flexible-dose, placebo-controlled study included only patients with erectile dysfunction attributed to complications of diabetes mellitus (n=268). As in the other titration studies, patients were started on 50 mg and allowed to adjust the dose up to 100 mg or down to 25 mg of sildenafil citrate; all patients, however, were receiving 50 mg or 100 mg at the end of the study. There were highly statistically significant improvements on the two principal IIEF questions (frequency of successful penetration during sexual activity and maintenance of erections after penetration) on sildenafil citrate compared to placebo. On a global improvement question, 57% of sildenafil citrate patients reported improved erections versus 10% on placebo. Diary data indicated that on sildenafil citrate, 48% of intercourse attempts were successful versus 12% on placebo.One randomized, double-blind, placebo-controlled, crossover, flexible-dose (up to 100 mg) study of patients with erectile dysfunction resulting from spinal cord injury (n=178) was conducted. The changes from baseline in scoring on the two end point questions (frequency of successful penetration during sexual activity and maintenance of erections after penetration) were highly statistically significantly in favor sildenafil 50mg tablet of sildenafil citrate. On a global improvement question, 83% of patients reported improved erections on sildenafil citrate versus 12% on placebo.
| Brand Name | Manufacturer | Country of Origin | Description |
|---|---|---|---|
| Viagra | Pfizer | USA | Most well-known brand |
| Revatio | Pfizer | USA | Used for pulmonary hypertension |
| Sildenafil ZYDUS | Zydus Cadila | India | Generic alternative |
| Sildenafil Mylan | Mylan Pharmaceuticals | USA | Generic options |
Diary data indicated that on sildenafil citrate, 59% of attempts at sexual intercourse were successful compared to 13% on placebo.Across all trials, sildenafil citrate improved the erections of 43% of radical prostatectomy patients compared to 15% on placebo.Subgroup analyses of responses to a global improvement question in patients with psychogenic etiology in two fixed-dose studies (total n=179) and two titration studies (total n=149) showed 84% of sildenafil citrate patients reported improvement in erections compared with 26% of placebo.
8.2 Lactation
As in the other titration studies, patients were started on 50 mg and allowed to adjust the dose up to 100 mg or down to 25 mg of sildenafil citrate; all patients, however, were receiving 50 mg or 100 mg at the end of the study. There were highly statistically significant improvements on the two principal IIEF questions (frequency of successful penetration during sexual activity and maintenance of erections after penetration) on sildenafil citrate compared to placebo. On a global improvement question, 57% of sildenafil citrate patients reported improved erections versus 10% on placebo. Diary data indicated that on sildenafil citrate, 48% of intercourse attempts were successful versus 12% on placebo.One randomized, double-blind, placebo-controlled, crossover, flexible-dose (up to 100 mg) study of patients with erectile dysfunction resulting from spinal cord injury (n=178) was conducted. The changes from baseline in scoring on the two end point questions (frequency of successful penetration during sexual activity and maintenance of erections after penetration) were highly statistically significantly in favor sildenafil 50mg tablet of sildenafil citrate.
Less common
On a global improvement question, 83% of patients reported improved erections on sildenafil citrate versus 12% on placebo. Diary data indicated that on sildenafil citrate, 59% of attempts at sexual intercourse were successful compared to 13% on placebo.Across all trials, sildenafil citrate improved the erections of 43% of radical prostatectomy patients compared to 15% on placebo.Subgroup analyses of responses to a global improvement question in patients with psychogenic etiology in two fixed-dose studies (total n=179) and two titration studies (total n=149) showed 84% of sildenafil citrate patients reported improvement in erections compared with 26% of placebo. Diary data in two of the studies (n=178) showed rates of successful intercourse per attempt of 70% for sildenafil citrate and 29% for placebo.Efficacy Results in Subpopulations in Controlled Clinical StudiesA review of population subgroups demonstrated efficacy regardless of baseline severity, etiology, race and age. Sildenafil citrate was effective in a broad range of ED patients, including those with a history of coronary artery disease, hypertension, other cardiac disease, peripheral vascular disease, diabetes mellitus, depression, coronary artery bypass graft (CABG), radical prostatectomy, transurethral resection of the prostate (TURP) and spinal cord injury, and in patients taking antidepressants/antipsychotics and anti-hypertensives/diuretics. In clinical studies, sildenafil citrate was assessed for its effect on the ability of men with erectile dysfunction (ED) to engage in sexual activity and in many cases specifically on the ability to achieve and maintain an erection sufficient for satisfactory sexual activity. Diary data in two of the studies (n=178) showed rates of successful intercourse per attempt of 70% for sildenafil citrate and 29% for placebo.Efficacy Results in Subpopulations in Controlled Clinical StudiesA review of population subgroups demonstrated efficacy regardless of baseline severity, etiology, race and age. Sildenafil citrate was effective in a broad range of ED patients, including those with a history of coronary artery disease, hypertension, other cardiac disease, peripheral vascular disease, diabetes mellitus, depression, coronary artery bypass graft (CABG), radical prostatectomy, transurethral resection of the prostate (TURP) and spinal cord injury, and in patients taking antidepressants/antipsychotics and anti-hypertensives/diuretics. In clinical studies, sildenafil citrate was assessed for its effect on the ability of men with erectile dysfunction (ED) to engage in sexual activity and in many cases specifically on the ability to achieve and maintain an erection sufficient for satisfactory sexual activity. The studies that established benefit demonstrated improvements in success rates for sexual intercourse compared with placebo. The effectiveness of sildenafil citrate was evaluated in most studies using several assessment instruments. Sexual function data were also recorded by patients in a daily diary.
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In addition, patients were asked a global efficacy question and an optional partner questionnaire was administered.
5.8 Vaso-occlusive Crisis in Patients with Pulmonary Hypertension Secondary to Sickle Cell Disease
Full Text Sources
The effect on one of the major end points, maintenance of erections after penetration, is shown in Figure 6, for the pooled results of 5 fixed-dose, dose-response studies of greater than one month duration, showing response according to baseline function. At the same time, on-treatment function was better in treated patients who were less impaired at baseline. Effect of Sildenafil citrate on Maintenance of Erection by Baseline Score Effect of Placebo on Maintenance of Erection by Baseline Score Effect of Sildenafil Citrate and Placebo on Maintenance of Erection by Baseline Score. The frequency of patients reporting improvement of erections in response to a global question in four of the randomized, double-blind, parallel, placebo-controlled fixed dose studies (1,797 patients) of 12 to 24 weeks duration is shown in Figure 7. In the titration studies (n=644) (with most patients eventually receiving 100 mg), results were similar. Percentage of Patients Reporting an Improvement in Erections The patients in studies had varying degrees of ED.
- Common side effects include headaches and facial flushing.
- Less common effects may include nasal congestion or upset stomach.
- Do not use sildenafil if allergic to it or similar drugs.
- Pregnant women should consult a healthcare provider before use.
- Be aware of the signs of allergic reactions.
- Sildenafil may also be indicated for certain heart conditions.
- Emergency services should be contacted if adverse reactions occur.
- Keep a record of any side effects experienced.
One-third to one-half of the subjects in these studies reported successful sildenafil 25mg tablets intercourse at least once during a 4-week, treatment-free run-in period.
Medical uses
One-third to one-half of the subjects in these studies reported successful sildenafil 25mg tablets intercourse at least once during a 4-week, treatment-free run-in period. In many of the studies, of both fixed dose and titration designs, daily diaries were kept by patients. In these studies, involving about 1,600 patients, analyses of patient diaries showed no effect of sildenafil citrate on rates of attempted intercourse (about 2 per week), but there was clear treatment-related improvement in sexual function: per patient weekly success rates averaged 1.3 on 50 to 100 mg of sildenafil citrate vs 0.4 on placebo; similarly, group mean success rates (total successes divided by total attempts) were about 66% on sildenafil citrate vs about 20% on placebo. During 3 to 6 months of double-blind treatment or longer-term (1 year), open-label studies, few patients withdrew from active treatment for any reason, including lack of effectiveness. At the end of the long-term study, 88% of patients reported that sildenafil citrate improved their erections.
When and How to Take Sildenafil for Best Results
Men with untreated ED had relatively low baseline scores for all aspects of sexual function measured (again using a 5-point scale) in the IIEF. Sildenafil citrate improved these aspects of sexual function: frequency, firmness and maintenance of erections; frequency of orgasm; frequency and level of desire; frequency, satisfaction and enjoyment of intercourse; and overall relationship satisfaction. One randomized, double-blind, flexible-dose, placebo-controlled study included only patients with erectile dysfunction attributed to complications of diabetes mellitus (n=268). Diary data indicated that on sildenafil citrate, 48% of intercourse attempts were successful versus 12% on placebo. One randomized, double-blind, placebo-controlled, crossover, flexible-dose (up to 100 mg) study of patients with erectile dysfunction resulting from spinal cord injury (n=178) was conducted. In many of the studies, of both fixed dose and titration designs, daily diaries were kept by patients. In these studies, involving about 1,600 patients, analyses of patient diaries showed no effect of sildenafil citrate on rates of attempted intercourse (about 2 per week), but there was clear treatment-related improvement in sexual function: per patient weekly success rates averaged 1.3 on 50 to 100 mg of sildenafil citrate vs 0.4 on placebo; similarly, group mean success rates (total successes divided by total attempts) were about 66% on sildenafil citrate vs about 20% on placebo.
| Step | Description | Notes |
|---|---|---|
| Consult a healthcare provider | Discuss suitability and health conditions | Important before use |
| Dose administration | Take with a glass of water, 30-60 min before activity | Avoid heavy or fatty meals |
| Frequency | Do not exceed once per day | Follow prescribed instructions |
| Food interactions | Fatty meals may delay absorption | Better taken on an empty stomach or light meal |
During 3 to 6 months of double-blind treatment or longer-term (1 year), open-label studies, few patients withdrew from active treatment for any reason, including lack of effectiveness. At the end of the long-term study, 88% of patients reported that sildenafil citrate improved their erections. Men with untreated ED had relatively low baseline scores for all aspects of sexual function measured (again using a 5-point scale) in the IIEF. Sildenafil citrate improved these aspects of sexual function: frequency, firmness and maintenance of erections; frequency of orgasm; frequency and level of desire; frequency, satisfaction and enjoyment of intercourse; and overall relationship satisfaction. One randomized, double-blind, flexible-dose, placebo-controlled study included only patients with erectile dysfunction attributed to complications of diabetes mellitus (n=268). Diary data indicated that on sildenafil citrate, 48% of intercourse attempts were successful versus 12% on placebo.
Drug Label Information
Effect of Sildenafil Citrate and Placebo on Maintenance of Erection by Baseline Score.The frequency of patients reporting improvement of erections in response to a global question in four of the randomized, double-blind, parallel, placebo-controlled fixed dose studies (1,797 patients) of 12 to 24 weeks duration is shown in Figure 7. These patients had erectile dysfunction at baseline that was characterized by median categorical scores of 2 (a few times) on principal IIEF questions. Erectile dysfunction was attributed to organic (58%; generally not characterized, but including diabetes and excluding spinal cord injury), psychogenic (17%), or mixed (24%) etiologies. Sixty-three percent, 74%, and 82% of the patients on 25 mg, 50 mg and 100 mg of sildenafil citrate, respectively, reported an improvement in their erections, compared to 24% on placebo. In the titration studies (n=644) (with most patients eventually receiving 100 mg), results were similar.Overall treatment p<0.0001Figure 7.
Altitude sickness
Percentage of Patients Reporting an Improvement in ErectionsThe patients in studies had varying degrees of ED. One-third to one-half of the subjects in these studies reported successful intercourse at least once during a 4-week, treatment-free run-in period.In many of the studies, of both fixed dose and titration designs, daily diaries were kept by patients. In these studies, involving about 1,600 patients, analyses of patient diaries showed no effect of sildenafil citrate on rates of attempted intercourse (about 2 per week), but there was clear treatment-related improvement in sexual function: per patient weekly success rates averaged 1.3 on 50 to 100 mg of sildenafil citrate vs 0.4 on placebo; similarly, group mean success rates (total successes divided by total attempts) were about 66% on sildenafil citrate vs about 20% on placebo.During 3 to 6 months of double-blind treatment or longer-term (1 year), open-label studies, few patients withdrew from active treatment for any reason, including lack of effectiveness. At the end of the long-term study, 88% of patients reported that sildenafil citrate improved their erections.Men with untreated ED had relatively low baseline scores for all aspects of sexual function measured (again using a 5-point scale) in the IIEF. Sildenafil citrate improved these aspects of sexual function: frequency, firmness and maintenance of erections; frequency of orgasm; frequency and level of desire; frequency, satisfaction and enjoyment of intercourse; and overall relationship satisfaction.One randomized, double-blind, flexible-dose, placebo-controlled study included only patients with erectile dysfunction attributed to complications of diabetes mellitus (n=268). One randomized, double-blind, placebo-controlled, crossover, flexible-dose (up to 100 mg) study of patients with erectile dysfunction resulting from spinal cord injury (n=178) was conducted.
Uses for Viagra
Diary data indicated that on sildenafil citrate, 59% of attempts at sexual intercourse were successful compared to 13% on placebo. Across all trials, sildenafil citrate improved the erections of 43% of radical prostatectomy patients compared to 15% on placebo. Subgroup analyses of responses to a global improvement question in patients with psychogenic etiology in two fixed-dose studies (total n=179) and two titration studies (total n=149) showed 84% of sildenafil citrate patients reported improvement in erections compared with 26% of placebo. Diary data in two of the studies (n=178) showed rates of successful intercourse per attempt of 70% for sildenafil citrate and 29% for placebo. Efficacy Results in Subpopulations in Controlled Clinical Studies A review of population subgroups demonstrated efficacy regardless of baseline severity, etiology, race and age.
Warnings for people with certain health conditions
16 HOW SUPPLIED/STORAGE AND HANDLING Sildenafil 100 mg tablets USP are blue, round biconvex, film coated tablets debossed with '88' on one side and plain on other side.Bottles of 10 NDC 68071-3862-1Bottles of 15 NDC 68071-3862-5Bottles of 90 NDC 68071-3862-9Recommended Storage: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]. Diary data indicated that on sildenafil citrate, 59% of attempts at sexual intercourse were successful compared to 13% on placebo. Across all trials, sildenafil citrate improved the erections of 43% of radical prostatectomy patients compared to 15% on placebo. Subgroup analyses of responses to a global improvement question in patients with psychogenic etiology in two fixed-dose studies (total n=179) and two titration studies (total n=149) showed 84% of sildenafil citrate patients reported improvement in erections compared with 26% of placebo. Diary data in two of the studies (n=178) showed rates of successful intercourse per attempt of 70% for sildenafil citrate and 29% for placebo. Efficacy Results in Subpopulations in Controlled Clinical Studies A review of population subgroups demonstrated efficacy regardless of baseline severity, etiology, race and age. 16 HOW SUPPLIED/STORAGE AND HANDLING Sildenafil 100 mg tablets USP are blue, round biconvex, film coated tablets debossed with '88' on one side and plain on other side.Bottles of 10 NDC 68071-3862-1Bottles of 15 NDC 68071-3862-5Bottles of 90 NDC 68071-3862-9Recommended Storage: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].
5.3 Epistaxis
The studies that established benefit demonstrated improvements in success rates for sexual intercourse compared with placebo. The effectiveness of sildenafil citrate was evaluated in most studies using several assessment instruments. Sexual function data were also recorded by patients in a daily diary. In addition, patients were asked a global efficacy question and an optional partner questionnaire was administered. The effect on one of the major end points, maintenance of erections after penetration, is shown in Figure 6, for the pooled results of 5 fixed-dose, dose-response studies of greater than one month duration, showing response according to baseline function.
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
At the same time, on-treatment function was better in treated patients who were less impaired at baseline. Effect of Sildenafil citrate on Maintenance of Erection by Baseline Score Effect of Placebo on Maintenance of Erection by Baseline Score Effect of Sildenafil Citrate and Placebo on Maintenance of Erection by Baseline Score. The frequency of patients reporting improvement of erections in response to a global question in four of the randomized, double-blind, parallel, placebo-controlled fixed dose studies (1,797 patients) of 12 to 24 weeks duration is shown in Figure 7. In the titration studies (n=644) (with most patients eventually receiving 100 mg), results were similar. Percentage of Patients Reporting an Improvement in Erections The patients in studies had varying degrees of ED.