6. ADVERSE REACTIONS
Two of the questions from the IIEF served as primary study endpoints; categorical responses were elicited to questions about (1) the ability to achieve erections sufficient for sexual intercourse and (2) the maintenance of erections after penetration. The patient addressed both questions at the final visit for the last 4 weeks of the study.
- Sildenafil citrate 120 mg can cause prolonged erections if misused.
- This dose may increase the risk of cardiovascular side effects.
- Always consult a healthcare provider before taking high doses of sildenafil.
- Combining sildenafil with nitrates can cause dangerous blood pressure drops.
- Side effects may include flushing, nasal congestion, and dizziness.
- Sildenafil is metabolized in the liver and excreted via feces and urine.
The possible categorical responses to these questions were (0) no attempted intercourse, (1) never or almost never, (2) a few times, (3) sometimes, (4) most times, and (5) almost always or always. Also collected as part of the IIEF was information about other aspects of sexual function, including information on erectile function, orgasm, desire, satisfaction with intercourse, and overall sexual satisfaction. 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.Efficacy Results from Controlled Clinical StudiesThe 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. Results with all doses have been pooled, but scores showed greater improvement at the 50 and 100 mg doses than at 25 mg. The pattern of responses was similar for the other principal question, the ability to achieve an erection sufficient for intercourse. The titration studies, in which most patients received 100 mg, showed similar results.
- Sildenafil 120 mg is not approved by all regulatory agencies for general use.
- The maximum recommended dose for most individuals is 100 mg.
- Using high doses can lead to increased cardiovascular strain.
- Always inform your doctor of all medications to prevent interactions.
- Sildenafil may cause a sudden drop in blood pressure, especially with certain drugs.
- The medication can be used as part of a treatment plan for erectile dysfunction.
Figure 6 shows that regardless of the baseline levels of function, subsequent function in patients treated with sildenafil citrate was better than that seen in patients treated with placebo. 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 ScoreEffect of Placebo on Maintenance of Erection by Baseline ScoreFigure 6.
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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).
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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 of sildenafil citrate.
Drugs you should not use with sildenafil
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. 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.
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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) sildenafil citrate 100mg tablets (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 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.
What other information should I know?
Two of the questions from the IIEF served as primary study endpoints; categorical responses were elicited to questions about (1) the ability to achieve erections sufficient for sexual intercourse and (2) the maintenance of erections after penetration. The patient addressed both questions at the final visit for the last 4 weeks of the study. The possible categorical responses to these questions were (0) no attempted intercourse, (1) never or almost never, (2) a few times, (3) sometimes, (4) most times, and (5) almost always or always. Also collected as part of the IIEF was information about other aspects of sexual function, including information on erectile function, orgasm, desire, satisfaction with intercourse, and overall sexual satisfaction. 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.Efficacy Results from Controlled Clinical StudiesThe 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.
Pulmonary hypertension
Results with all doses have been pooled, but scores showed greater improvement at the 50 and 100 mg doses than at 25 mg. The pattern of responses was similar for the other principal question, the ability to achieve an erection sufficient for intercourse. The titration studies, in which most patients received 100 mg, showed similar results. Figure 6 shows that regardless of the baseline levels of function, subsequent function in patients treated with sildenafil citrate was better than that seen in patients treated with placebo. 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 ScoreEffect of Placebo on Maintenance of Erection by Baseline ScoreFigure 6.
Who should not take sildenafil?
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) sildenafil citrate 100mg tablets (with most patients eventually receiving 100 mg), results were similar.Overall treatment p<0.0001Figure 7. 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 of sildenafil citrate. 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.
- Sildenafil citrate 120 mg is often used illicitly, which increases health risks.
- Long-term safety data for high doses are limited; risks are not fully understood.
- Use should be personalized based on medical history and current health status.
- Do not crush or chew sildenafil tablets; take them whole with water.
- Combining sildenafil with other vasodilators can lead to dangerous blood pressure drops.
- Always seek professional guidance before initiating or adjusting sildenafil dosage.
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.
How should this medicine be used?
Binding Characteristics
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.
| Property | Description | Typical Dose | Onset of Action | Duration of Effect | Mechanism of Action |
|---|---|---|---|---|---|
| Bioavailability | Approximately 40% | 120 mg | 30-60 minutes | Up to 6 hours | Inhibits PDE5 enzyme in smooth muscle |
| Half-life | Approximately 4 hours | N/A | N/A | N/A | Enhances nitric oxide signaling |
| Metabolism | Liver via CYP3A4 and CYP2C9 | N/A | N/A | N/A | Prevents cGMP breakdown |
| Excretion | Mainly via feces (80%), urine (13%) | N/A | N/A | N/A | Eliminates unchanged drug |
| Peak Plasma Levels | Achieved within 30-120 minutes | 120 mg | 30 minutes | N/A | Related to dose and absorption rate |
In addition, patients were sildenafil 50 mg india 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.
Route of administration
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.
What other drugs will affect sildenafil?
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 sildenafil 50 mg india 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.
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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.
CYP3A4 Inhibitors
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. Percentage of Patients Reporting an Improvement in Erections The 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.
- Sildenafil citrate is primarily used to treat erectile dysfunction.
- 120 mg is a high dosing level and should only be used under medical supervision.
- The typical starting dose for sildenafil is 50 mg; 120 mg exceeds standard recommendations.
- High doses can increase the risk of side effects such as headaches and low blood pressure.
- Sildenafil works by relaxing blood vessels in the penis to facilitate an erection.
- Overdose of sildenafil citrate can cause severe hypotension and vision disturbances.
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.