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.
| Tip | Explanation | Goal |
|---|---|---|
| Follow dosage instructions | Take exactly as prescribed | Prevent side effects or interactions |
| Be aware of side effects | Recognize common side effects and when to seek help | Ensure safety |
| Avoid alcohol and heavy meals | May decrease effectiveness or increase side effects | Maximize efficacy |
| Report health issues | Communicate with doctor about any adverse reactions or concerns | Maintain safety and treatment efficacy |
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.
Product Overview
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 sildenafil film tablet 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.
Marketing and sales
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. Diary data indicated that on sildenafil citrate, 59% of attempts at sexual intercourse were successful compared to 13% on placebo.
Sildenafil Oral Suspension Dosage and Administration
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]. 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.
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Kamagra Soft Tabs | 100mg | 20 Pills | 79.79€ 75.99€ | |
| Viagra Generic | 150mg | 180 + 10 Pills | 236.46€ 225.20€ | |
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| Kamagra Polo | 100mg | 12 Pills | 60.21€ 57.34€ | |
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| Kamagra Soft Tabs | 100mg | 120 + 6 Pills | 311.78€ 296.93€ | |
| Viagra Generic | 150mg | 360 + 10 Pills | 423.48€ 403.31€ | |
| Kamagra Oral Jelly | 100mg | 10 Sachets | 54.55€ 51.95€ | |
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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 sildenafil oral solution on Maintenance of Erection by Baseline Score.
Side Effects
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. 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 sildenafil film tablet 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. 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.
Overdose/Missed Dose
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 68071-3862-1 Bottles of 15 NDC 68071-3862-5 Bottles of 90 NDC 68071-3862-9 Recommended 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]. 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 citrate 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 citrate 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 citrate to augment the blood pressure lowering effect of alpha-blockers and anti-hypertensive medications. Concomitant administration of sildenafil citrate and an alpha-blocker may lead to symptomatic hypotension in some patients. Therefore, when sildenafil citrate is co-administered with alpha-blockers, patients should be stable on alpha-blocker therapy prior to initiating sildenafil citrate treatment and sildenafil citrate should be initiated at the lowest dose [ see Warnings and Precautions (5.5)].Cardiovascular ConsiderationsPhysicians should discuss with patients the potential cardiac risk of sildenafil 25mg tablets sexual activity in patients with preexisting cardiovascular risk factors.
Dosage for erectile dysfunction (ED)
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 citrate, 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. Physicians should discuss with patients the increased risk of NAION in individuals who have already experienced NAION in one eye. Physicians should also discuss with patients the increased risk of NAION among the general population in patients with a “crowded” optic disc, although evidence is insufficient to support screening of prospective users of PDE5 inhibitor, including sildenafil citrate, for this uncommon condition [ see Warnings and Precautions (5.3)and Adverse Reactions (6.2)].Sudden Hearing LossPhysicians should advise patients to stop taking PDE5 inhibitors, including sildenafil citrate, and seek prompt medical attention in the event of sudden decrease or loss of hearing. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors [ see Warnings and Precautions (5.4)and Adverse Reactions (6.2)].PriapismPhysicians should warn patients that prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) have been reported infrequently since market approval of sildenafil citrate.
Clinical monitoring
If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result [ see Warnings and Precautions (5.2)].Avoid Use with other PDE5 InhibitorsPhysicians should inform patients not to take sildenafil tablets, 25 mg, 50 mg and 100 mg with other PDE5 inhibitors including sildenafil tablets, 20 mg or other pulmonary arterial hypertension (PAH) treatments containing sildenafil. Diary data indicated that on sildenafil citrate, 59% of attempts at sexual intercourse were successful compared to 13% on placebo.
- Sildenafil tablets 125 mg are used to treat erectile dysfunction.
- The medication enhances blood flow to the penis.
- It’s important to follow prescribed dosages for safety.
- Sildenafil can cause side effects like headache or dizziness.
- Do not take sildenafil if you’re on nitrate medications.
- Store tablets in a cool, dry place away from children.
- The effect typically lasts for about 4-6 hours.
- Consult your doctor before starting sildenafil treatment.
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.
| Region | Average Cost per Pack | Pack Quantity | Notes |
|---|---|---|---|
| USA | $30 - $50 | 30 tablets | Generic versions available |
| UK | £15 - £25 | 30 tablets | Prescribed or OTC in some areas |
| India | ₹150 - ₹300 | 10-30 tablets | Widely available, generic options |
| Australia | AUD 40 - AUD 70 | 30 tablets | Prescription required |
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.
2.3 Dosage Adjustments in Specific Situations
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. The studies that established benefit demonstrated improvements in success rates for sexual intercourse compared with placebo.
Risk Summary
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. At the same time, on-treatment function was better in treated patients who were less impaired at baseline.
8.7 Patients with Renal Impairment
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 sildenafil oral solution 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. 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. Efficacy Results in Subpopulations in Controlled Clinical Studies A review of population subgroups demonstrated efficacy regardless of baseline severity, etiology, race and age.
| Storage Condition | Details | Recommended Temperature |
|---|---|---|
| Temperature | Store in a cool, dry place | 20-25°C |
| Container | Keep in original packaging to prevent moisture | Airtight container |
| Light Exposure | Protect from direct sunlight | Yes |
| Expiry Date | Check before use | Typically 2-3 years |
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].
2. Sildenafil Oral Suspension Dosage and Administration
What’s the difference between sildenafil and Viagra?
Sildenafil 100 mg tablets USP are blue, round biconvex, film coated tablets debossed with '88' on one side and plain on other side.
- Recreational use of sildenafil without prescription is risky.
- The drug is not intended for daily use unless directed.
- Overuse can increase the risk of adverse effects.
- Always discuss health concerns with a healthcare professional.
- Managing stress and anxiety can improve ED symptoms.
- Patients should report persistent side effects promptly.
- Combining sildenafil with certain medications can be dangerous.
- Education on proper use enhances safety and effectiveness.
Bottles of 10 NDC 68071-3862-1 Bottles of 15 NDC 68071-3862-5 Bottles of 90 NDC 68071-3862-9 Recommended 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]. 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 citrate 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 citrate 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 citrate to augment the blood pressure lowering effect of alpha-blockers and anti-hypertensive medications. Concomitant administration of sildenafil citrate and an alpha-blocker may lead to symptomatic hypotension in some patients. Therefore, when sildenafil citrate is co-administered with alpha-blockers, patients should be stable on alpha-blocker therapy prior to initiating sildenafil citrate treatment and sildenafil citrate should be initiated at the lowest dose [ see Warnings and Precautions (5.5)].Cardiovascular ConsiderationsPhysicians should discuss with patients the potential cardiac risk of sildenafil 25mg tablets 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 citrate, 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. Physicians should discuss with patients the increased risk of NAION in individuals who have already experienced NAION in one eye. Physicians should also discuss with patients the increased risk of NAION among the general population in patients with a “crowded” optic disc, although evidence is insufficient to support screening of prospective users of PDE5 inhibitor, including sildenafil citrate, for this uncommon condition [ see Warnings and Precautions (5.3)and Adverse Reactions (6.2)].Sudden Hearing LossPhysicians should advise patients to stop taking PDE5 inhibitors, including sildenafil citrate, and seek prompt medical attention in the event of sudden decrease or loss of hearing.
- 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.
It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors [ see Warnings and Precautions (5.4)and Adverse Reactions (6.2)].PriapismPhysicians should warn patients that prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) have been reported infrequently since market approval of sildenafil citrate.
12.3 Pharmacokinetics
If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result [ see Warnings and Precautions (5.2)].Avoid Use with other PDE5 InhibitorsPhysicians should inform patients not to take sildenafil tablets, 25 mg, 50 mg and 100 mg with other PDE5 inhibitors including sildenafil tablets, 20 mg or other pulmonary arterial hypertension (PAH) treatments containing sildenafil.
- 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.
- INDICATIONS AND USAGE
- ADVERSE REACTIONS
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