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.
| Aspect | Description | Cultural Note |
|---|---|---|
| Popularity | Widely used for ED in different countries | Often associated with masculinity |
| Marketing | Often marketed as a quick fix for ED | Emphasis on discreet packaging |
| Social Perception | Varies; some view as stigma, others as convenient | Changing attitudes towards ED treatment |
| Online Communities | Many forums discussing experiences & tips | Peer support and caution |
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 tablets were better than that seen in patients treated with placebo.
- The pink sildenafil pill is available in various countries worldwide.
- It is often packaged in blister packs for convenience.
- Some manufacturers claim it’s a natural or herbal supplement.
- Ensure medication authenticity before use.
- The pink pill is sometimes used by women for off-label reasons.
- Always follow the guidance from healthcare professionals.
At the same time, on-treatment function was better in treated patients who were less impaired at baseline.Effect of Sildenafil Tablets on Maintenance of Erection by Baseline ScoreEffect of Placebo on Maintenance of Erection by Baseline ScoreFigure 6.
8.7 Hepatic Impairment
Effect of Sildenafil Tablets and Placebo onMaintenance 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 (1797 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 tablets, 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 sildenafil 50 mg tab similar.Figure 7. 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. In these studies, involving about 1600 patients, analyses of patient diaries showed no effect of sildenafil tablets 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 tablets vs 0.4 on placebo; similarly, group mean success rates (total successes divided by total attempts) were about 66% on sildenafil tablets 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 tablets 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 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).
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Viagra Generic | 100mg | 270 + 10 Pills | 270.47€ 257.59€ | |
| Viagra Generic | 150mg | 120 + 8 Pills | 177.58€ 169.12€ | |
| Viagra Generic | 50mg | 180 + 8 Pills | 158.82€ 151.26€ | |
| Viagra Generic | 100mg | 10 Pills | 28.91€ 27.53€ | |
| Kamagra Oral Jelly | 100mg | 220 + 18 Sachets | 662.24€ 630.70€ | |
| Viagra Generic | 50mg | 20 Pills | 40.52€ 38.59€ | |
| Viagra Generic | 200mg | 120 + 8 Pills | 204.80€ 195.05€ | |
| Kamagra Polo | 100mg | 272 + 12 Pills | 622.94€ 593.28€ | |
| Viagra Generic | 25mg | 90 + 6 Pills | 105.03€ 100.03€ | |
| Viagra Generic | 25mg | 360 + 10 Pills | 213.68€ 203.50€ | |
| Kamagra Polo | 100mg | 32 Pills | 125.88€ 119.89€ | |
| Viagra Generic | 150mg | 20 Pills | 55.02€ 52.40€ | |
| Kamagra Oral Jelly | 100mg | 21 Sachets | 95.92€ 91.35€ | |
| Viagra Generic | 100mg | 90 + 6 Pills | 129.02€ 122.88€ | |
| Viagra Generic | 100mg | 180 + 8 Pills | 199.37€ 189.88€ | |
| Kamagra Soft Tabs | 100mg | 120 + 6 Pills | 311.78€ 296.93€ |
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 tablets; 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 tablets compared to placebo.
5.8 Effects on Bleeding
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. Figure 6 shows that regardless of the baseline levels of function, subsequent function in patients treated with sildenafil tablets were better than that seen in patients treated with placebo.
Erectile dysfunction
At the same time, on-treatment function was better in treated patients who were less impaired at baseline.Effect of Sildenafil Tablets on Maintenance of Erection by Baseline ScoreEffect of Placebo on Maintenance of Erection by Baseline ScoreFigure 6. Effect of Sildenafil Tablets and Placebo onMaintenance 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 (1797 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 tablets, respectively, reported an improvement in their erections, compared to 24% on placebo. On a global improvement question, 57% of sildenafil tablets patients reported improved erections versus 10% on placebo.
7.2 Alpha-blockers
Diary data indicated that on sildenafil tablets, 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 tablets. On a global improvement question, 83% of patients reported improved erections on sildenafil tablets versus 12% on placebo.
Adverse effects
In the titration studies (n=644) (with most patients eventually receiving 100 mg), results were sildenafil 50 mg tab similar.Figure 7. 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. In these studies, involving about 1600 patients, analyses of patient diaries showed no effect of sildenafil tablets 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 tablets vs 0.4 on placebo; similarly, group mean success rates (total successes divided by total attempts) were about 66% on sildenafil tablets 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 tablets 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.
What is sildenafil used for?
Sildenafil tablets 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 tablets; 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 tablets compared to placebo. On a global improvement question, 57% of sildenafil tablets patients reported improved erections versus 10% on placebo. Diary data indicated that on sildenafil tablets, 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. Diary data indicated that on sildenafil tablets, 59% of attempts at sexual intercourse were successful compared to 13% on placebo.Across all trials, sildenafil tablets 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 tablets 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 tablets 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 tablets 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 tablets 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.
8.2 Lactation
They are available as follows:Bottles of 30 tablets NDC 31722-711-30Bottles of 100 tablets NDC 31722-711-01Bottles of 500 tablets NDC 31722-711-05Recommended Storage:Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Sildenafil Tablets USP, 25 mg are white colored, round-shaped, biconvex, film coated tablets debossed with ' I ' on one side and '35'on the other side. 17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information)NitratesPhysicians should discuss with patients the contraindication of sildenafil tablets with regular and/or intermittent use of nitric oxide donors, such as organic nitrates or organic nitrites in any form [see Contraindications(4.1)].Guanylate Cyclase (GC) StimulatorsPhysicians should discuss with patients the contraindication of sildenafil tablets with use of guanylate cyclase stimulators such as riociguat [see Contraindications (4.3)].Concomitant Use with Drugs Which Lower Blood PressurePhysicians should advise patients of the potential for sildenafil tablets to augment the blood pressure lowering effect of alpha-blockers and anti-hypertensive medications. Concomitant administration of sildenafil tablets and an alpha-blocker may lead to symptomatic hypotension in some patients. Therefore, when sildenafil tablets are co-administered with alpha-blockers, patients should be stable on alpha-blocker therapy prior to initiating sildenafil tablets treatment and sildenafil tablets should be initiated at the lowest dose [see Warnings and Precautions (5.5)].Cardiovascular ConsiderationsPhysicians should discuss with patients the potential cardiac risk of sexual activity in patients with preexisting cardiovascular risk factors.
Altitude sickness
Patients who experience symptoms (e.g., angina pectoris, dizziness, nausea) upon initiation of sexual activity should be advised to refrain from further activity and should discuss the episode with their physician [see Warnings and Precautions (5.1)].Sudden Loss of VisionPhysicians should advise patients to stop use of all PDE5 inhibitors, including sildenafil tablets, and seek medical attention in the event of a sudden loss of vision in one or both eyes. Such an event may be a sign of non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including possible permanent loss of vision, that has been reported rarely post-marketing in temporal association with the use of all PDE5 inhibitors. The studies that established benefit demonstrated improvements in success rates sildenafil products over the counter for sexual intercourse compared with placebo.
Detection in biological fluids
Effect of Placebo on Maintenance of Erection by Baseline Score Effect of Sildenafil Tablets and Placebo on 16 HOW SUPPLIED/STORAGE AND HANDLING Sildenafil Tablets USP, 25 mg are white colored, round-shaped, biconvex, film coated tablets debossed with ' I ' on one side and '35'on the other side.
- Sildenafil pink pills are often sold online and in pharmacies.
- They come in various dosages, usually 50mg or 100mg.
- The pill is designed to enhance blood flow to the penis.
- It helps men achieve and maintain an erection.
- The pink color makes it easy to identify.
- Not suitable for use with nitrate medications.
They are available as follows:Bottles of 30 tablets NDC 31722-709-30Bottles of 500 tablets NDC 31722-709-05Sildenafil Tablets USP, 50 mg are white colored, round-shaped, biconvex, film coated tablets debossed with ' I ' on one side and '36'on the other side. They are available as follows:Bottles of 30 tablets NDC 31722-710-30Bottles of 100 tablets NDC 31722-710-01Bottles of 500 tablets NDC 31722-710-05Sildenafil Tablets USP, 100 mg are white colored, round-shaped, biconvex, film coated tablets debossed with ' I ' on one side and '58' on the other side.
4.2 Hypersensitivity Reactions
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 tablets. On a global improvement question, 83% of patients reported improved erections on sildenafil tablets versus 12% on placebo. Diary data indicated that on sildenafil tablets, 59% of attempts at sexual intercourse were successful compared to 13% on placebo.Across all trials, sildenafil tablets 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 tablets 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 tablets 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 tablets 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.
Does sildenafil interact with other medicines (drug interactions)?
In clinical studies, sildenafil tablets 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 sildenafil products over the counter for sexual intercourse compared with placebo. Effect of Placebo on Maintenance of Erection by Baseline Score Effect of Sildenafil Tablets and Placebo on 16 HOW SUPPLIED/STORAGE AND HANDLING Sildenafil Tablets USP, 25 mg are white colored, round-shaped, biconvex, film coated tablets debossed with ' I ' on one side and '35'on the other side. They are available as follows:Bottles of 30 tablets NDC 31722-709-30Bottles of 500 tablets NDC 31722-709-05Sildenafil Tablets USP, 50 mg are white colored, round-shaped, biconvex, film coated tablets debossed with ' I ' on one side and '36'on the other side. They are available as follows:Bottles of 30 tablets NDC 31722-710-30Bottles of 100 tablets NDC 31722-710-01Bottles of 500 tablets NDC 31722-710-05Sildenafil Tablets USP, 100 mg are white colored, round-shaped, biconvex, film coated tablets debossed with ' I ' on one side and '58' on the other side. They are available as follows:Bottles of 30 tablets NDC 31722-711-30Bottles of 100 tablets NDC 31722-711-01Bottles of 500 tablets NDC 31722-711-05Recommended Storage:Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Sildenafil Tablets USP, 25 mg are white colored, round-shaped, biconvex, film coated tablets debossed with ' I ' on one side and '35'on the other side. 17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information)NitratesPhysicians should discuss with patients the contraindication of sildenafil tablets with regular and/or intermittent use of nitric oxide donors, such as organic nitrates or organic nitrites in any form [see Contraindications(4.1)].Guanylate Cyclase (GC) StimulatorsPhysicians should discuss with patients the contraindication of sildenafil tablets with use of guanylate cyclase stimulators such as riociguat [see Contraindications (4.3)].Concomitant Use with Drugs Which Lower Blood PressurePhysicians should advise patients of the potential for sildenafil tablets to augment the blood pressure lowering effect of alpha-blockers and anti-hypertensive medications.
- Sildenafil pink pill may be contraindicated for some health conditions.
- Always inform your doctor of current medications before use.
- It can cause side effects like dizziness or stomach upset.
- Combining it with other ED medications is dangerous.
- Sildenafil should be taken on an empty stomach for best results.
- The medication is not a hormone and does not alter testosterone.
Concomitant administration of sildenafil tablets and an alpha-blocker may lead to symptomatic hypotension in some patients. Therefore, when sildenafil tablets are co-administered with alpha-blockers, patients should be stable on alpha-blocker therapy prior to initiating sildenafil tablets treatment and sildenafil tablets should be initiated at the lowest dose [see Warnings and Precautions (5.5)].Cardiovascular ConsiderationsPhysicians should discuss with patients the potential cardiac risk of sexual activity in patients with preexisting cardiovascular risk factors. Patients who experience symptoms (e.g., angina pectoris, dizziness, nausea) upon initiation of sexual activity should be advised to refrain from further activity and should discuss the episode with their physician [see Warnings and Precautions (5.1)].Sudden Loss of VisionPhysicians should advise patients to stop use of all PDE5 inhibitors, including sildenafil tablets, and seek medical attention in the event of a sudden loss of vision in one or both eyes. Such an event may be a sign of non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including possible permanent loss of vision, that has been reported rarely post-marketing in temporal association with the use of all PDE5 inhibitors.
| Aspect | Effect | Time to Max Effect | Reports of Increased Blood Flow | Notes |
|---|---|---|---|---|
| Vasodilation | Relaxes blood vessel muscles | 1 hour | Commonly observed | Leads to erection |
| Penile Blood Flow | Increased in response to stimulation | 30-60 minutes | Consistently reported | Enhances erectile function |
| Duration of increased blood flow | Up to 6 hours | Varies | Depends on dosage and individual |