WARNINGS AND PRECAUTIONS
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.
Sildenafil (Viagra) dosage
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.
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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 sildenafil film tablet 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. 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.
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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.
Other uses for this medicine
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.
Are you currently using Sildenafil (Viagra, Revatio)?
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. 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. 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 sildenafil citrate tablets 50 mg baseline that was characterized by median categorical scores of 2 (a few times) on principal IIEF questions.
5.1 Cardiovascular
Why it’s used
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 similar.Figure 7.
Sildenafil (Viagra) contraindications
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 sildenafil citrate tablets 50 mg 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.
How it works
In the titration studies (n=644) (with most patients eventually receiving 100 mg), results were similar.Figure 7. Percentage of Patients Reporting an Improvement in Erections.The patients sildenafil products over the counter 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. Percentage of Patients Reporting an Improvement in Erections.The patients sildenafil products over the counter 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 tablets are not intended for recreational use or performance enhancement.
- Always follow a healthcare provider’s instructions for safe use.
- Sildenafil’s effects last for a few hours, depending on individual factors.
- The medication is taken as needed, not as a daily supplement.
- Only use sildenafil under medical supervision if you have heart disease.
- Do not take sildenafil if you are allergic to sildenafil citrate.
- The drug helps improve quality of life for men with ED.
- Sildenafil may cause temporary visual disturbances, like a blue tint.
- Proper hydration can help minimize side effects.
- Certain genetic conditions may affect sildenafil's effectiveness.
- Regular medical reviews ensure safe long-term use of sildenafil.
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.
- Sildenafil tablets are available in various generic versions.
- White sildenafil tablets are often easier to swallow due to their shape.
- The cost of sildenafil varies depending on the brand and dosage.
- Using sildenafil responsibly can improve quality of life for users.
- Not all erectile issues require medication; consult a doctor for underlying causes.
- Sildenafil is not suitable for women or children.
- The drug works by blocking PDE5, enhancing natural erections.
- Physical activity after taking sildenafil can enhance its effectiveness.
- Sildenafil is sometimes used off-label for pulmonary hypertension.
- Proper hydration may help reduce side effects like headaches.
- Patients should report any persistent or severe side effects to a healthcare professional.
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). 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.
| Storage Condition | Details | Notes |
|---|---|---|
| Temperature | Keep below 30°C (86°F) | Avoid excessive heat |
| Light | Keep away from direct sunlight | Protect from UV rays |
| Humidity | Store in dry place | Prevent moisture from degrading the tablet |
| Out of reach | Keep out of children's reach | Safety precaution |
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. 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.
7.4 Ritonavir and other CYP3A4 inhibitors
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 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.
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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. 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 sildenafil film tablet 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. The studies that established benefit demonstrated improvements in success rates 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.
- Sildenafil tablets may have different appearances depending on manufacturer.
- Consult a healthcare professional if unsure about dosing or interactions.
- Sildenafil should be used responsibly to prevent dependence.
- Some users experience a slight tingling sensation after ingestion.
- Generic sildenafil is usually less expensive but equally effective.
- Always buy from trusted sources to avoid counterfeit medication.
- Sildenafil can be used in combination with other ED treatments if advised.
- Certain medical conditions may contraindicate sildenafil use.
- The tablets are commonly available in blister packs for safety.
- Avoid combining sildenafil with grapefruit juice, which can affect metabolism.
- Keep a record of all medications and their effects during treatment.
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. 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.