Diary data indicated that on sildenafil, 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.
- Sildenafil is often used off-label for pulmonary hypertension under medical supervision.
- The dosage for pulmonary use may differ from the 100mg standard.
- Always follow healthcare provider instructions for different conditions.
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. On a global improvement question, 83% of patients reported improved erections on sildenafil versus 12% on placebo.
5.1 Cardiovascular
Erectile dysfunction
Diary data indicated that on sildenafil, 59% of attempts at sexual intercourse were successful compared to 13% on placebo.Across all trials, sildenafil 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 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 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 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 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.
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Viagra Generic | 200mg | 360 + 10 Pills | 481.98€ 459.03€ | |
| Viagra Generic | 100mg | 180 + 8 Pills | 199.37€ 189.88€ | |
| Kamagra Soft Tabs | 100mg | 12 Pills | 57.55€ 54.81€ | |
| Kamagra Soft Tabs | 100mg | 180 + 8 Pills | 425.45€ 405.19€ | |
| Viagra Generic | 50mg | 10 Pills | 26.87€ 25.59€ | |
| Kamagra Oral Jelly | 100mg | 30 + 5 Sachets | 136.20€ 129.71€ | |
| Viagra Generic | 200mg | 270 + 10 Pills | 379.76€ 361.68€ | |
| Viagra Generic | 150mg | 360 + 10 Pills | 423.48€ 403.31€ | |
| Kamagra | 100mg | 32 Pills | 121.24€ 115.47€ | |
| Kamagra Polo | 100mg | 32 Pills | 125.88€ 119.89€ | |
| Kamagra Polo | 100mg | 272 + 12 Pills | 622.94€ 593.28€ | |
| Viagra Generic | 150mg | 120 + 8 Pills | 177.58€ 169.12€ | |
| Viagra Generic | 25mg | 360 + 10 Pills | 213.68€ 203.50€ | |
| Kamagra Polo | 100mg | 120 + 6 Pills | 327.15€ 311.57€ | |
| Kamagra | 100mg | 84 + 6 Pills | 264.44€ 251.85€ | |
| Viagra Generic | 100mg | 120 + 6 Pills | 149.50€ 142.38€ |
The studies that established benefit demonstrated improvements in success rates for sexual intercourse compared with placebo. Effect of sildenafil and Placebo on Maintenance of Erection by Baseline Score. 16 HOW SUPPLIED/STORAGE AND HANDLING Sildenafil tablets USP are supplied as pale blue to blue, caplet shaped film-coated tablets containing sildenafil citrate equivalent to the nominally indicated amount of sildenafil as follows:For 100 mg - Pale blue to blue, caplet shaped film-coated tablets, debossed with ‘1A1’ on one side and plain on other side.For 50 mg - Pale blue to blue, caplet shaped film-coated tablets, debossed with ‘1A2’ on one side and plain on other side.For 25 mg - Pale blue to blue, round film-coated tablets, debossed with “25” on one side and “SL” on other side.Recommended Storage:Store at 25°C (77°F); excursions permitted within 15-30°C (59-86°F) [see USP Controlled Room Temperature].
- The blue pill is part of a class of medications that include tadalafil and vardenafil.
- Each PDE5 inhibitor has different duration and onset times.
- Consult a doctor to choose the most appropriate medication.
Sildenafil tablets USP are supplied as pale blue to blue, caplet shaped film-coated tablets containing sildenafil citrate equivalent to the nominally indicated amount of sildenafil as follows: Recommended Storage:Store at 25°C (77°F); excursions permitted within 15-30°C (59-86°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 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 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 to augment the blood pressure lowering effect of alpha-blockers and anti-hypertensive medications. Concomitant administration of sildenafil and an alpha - blocker may lead to symptomatic hypotension in some patients. Therefore, when sildenafil is co-administered with alpha-blockers, patients should be stable on alpha-blocker therapy prior to initiating sildenafil treatment and sildenafil 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.
What is the difference between sildenafil and Viagra?
Such an event may be a sign of non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision canada sildenafil 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, 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, and seek prompt medical attention in the event of sudden decrease or loss of hearing. These events, which may be accompanied by tinnitus and dizziness, have been reported in temporal association to the intake of PDE5 inhibitors, including sildenafil. 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.
What should I know about sildenafil before taking it?
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 with other PDE5 inhibitors including REVATIO or other pulmonary arterial hypertension (PAH) treatments containing sildenafil. Sildenafil is also marketed as REVATIO for the treatment of PAH. The safety and efficacy of sildenafil tablets with other PDE5 inhibitors, including REVATIO, have not been studied [ see Warnings and Precautions (5.7)].Sexually Transmitted DiseaseThe use of sildenafil offers no protection against sexually transmitted diseases. Counseling of patients about the protective measures necessary to guard against sexually transmitted diseases, including the Human Immunodeficiency Virus (HIV), may be considered [ see Warnings and Precautions (5.9)].Manufactured by:Umedica Laboratories Pvt. 221 and 221/1, GIDC, II ndPhase,Vapi, Gujarat 396195, India (IND)Manufactured for:Nivagen Pharmaceuticals, Inc.Sacramento, CA 95827, USAToll free number: 1-877-977-0687Revised: June 2023, V-03Patient InformationSildenafil (sil den' a fil ) Tablets USPWhat is the most important information I should know about sildenafil ?Sildenafil tablets can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines.
Does sildenafil interact with foods or drinks?
Do not take sildenafil tablets if you take any other medicines called “nitrates.” Nitrates are used to treat chest pain (angina). A sudden drop in blood pressure can cause you to feel dizzy, faint, or have a heart attack or stroke.Do not take sildenafil tablets if you take medicines called guanylate cyclase stimulators which include:• Riociguat (Adempas ®) a medicine that treats pulmonary arterial hypertension and chronic-thromboembolic pulmonary hypertension.Tell all your healthcare providers that you take sildenafil tablets.If you need emergency medical care for a heart problem, it will be important for your healthcare provider to know when you last took sildenafil tablets.Stop sexual activity and get medical help right away if you get symptoms such as chest pain, dizziness, or nausea during sex.Sexual activity can put an extra strain on your heart, especially if your heart is already weak from a heart attack or heart disease. Ask your doctor if your heart is healthy enough to handle the extra strain of having sex.Sildenafil tablets does not protect you or your partner from getting sexually transmitted diseases, including HIV-the virus that causes AIDS.What are sildenafil tablets?Sildenafil tablets are a prescription medicine used to treat erectile dysfunction (ED). You will not get an erection just by taking this medicine. Sildenafil tablets helps a man with erectile dysfunction get and keep an erection only when he is sexually excited (stimulated).Sildenafil tablets are not for use in women or children.It is not known if sildenafil tablets are safe and effective in women or children under 18 years of age.Who should not take sildenafil tablets?Do not take sildenafil tablets if you:take medicines called nitrates (such as nitroglycerin)use street drugs called “poppers” such as amyl nitrate or amyl nitrite, and butyl nitratetake any medicines called guanylate cyclase stimulators such as riociguat (Adempas)are allergic to sildenafil, as contained in sildenafil tablets and REVATIO, or any of the ingredients in sildenafil tablets. 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 [ seeWarnings and Precautions (5.1)].Sudden Loss of VisionPhysicians should advise patients to stop use of all PDE5 inhibitors, including sildenafil, and seek medical attention in the event of a sudden loss of vision in one or both eyes.
5.5 Hypotension when Co-administered with Alpha-blockers or Anti-hypertensives
Diary data indicated that on sildenafil, 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. On a global improvement question, 83% of patients reported improved erections on sildenafil versus 12% on placebo. Diary data indicated that on sildenafil, 59% of attempts at sexual intercourse were successful compared to 13% on placebo.Across all trials, sildenafil 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 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 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.
Related treatment guides
Sildenafil 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 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 sildenafil and Placebo on Maintenance of Erection by Baseline Score. 16 HOW SUPPLIED/STORAGE AND HANDLING Sildenafil tablets USP are supplied as pale blue to blue, caplet shaped film-coated tablets containing sildenafil citrate equivalent to the nominally indicated amount of sildenafil as follows:For 100 mg - Pale blue to blue, caplet shaped film-coated tablets, debossed with ‘1A1’ on one side and plain on other side.For 50 mg - Pale blue to blue, caplet shaped film-coated tablets, debossed with ‘1A2’ on one side and plain on other side.For 25 mg - Pale blue to blue, round film-coated tablets, debossed with “25” on one side and “SL” on other side.Recommended Storage:Store at 25°C (77°F); excursions permitted within 15-30°C (59-86°F) [see USP Controlled Room Temperature].
How does sildenafil work (mechanism of action)?
Sildenafil tablets USP are supplied as pale blue to blue, caplet shaped film-coated tablets containing sildenafil citrate equivalent to the nominally indicated amount of sildenafil as follows: Recommended Storage:Store at 25°C (77°F); excursions permitted within 15-30°C (59-86°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 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 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 to augment the blood pressure lowering effect of alpha-blockers and anti-hypertensive medications. Concomitant administration of sildenafil and an alpha - blocker may lead to symptomatic hypotension in some patients. Therefore, when sildenafil is co-administered with alpha-blockers, patients should be stable on alpha-blocker therapy prior to initiating sildenafil treatment and sildenafil 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 [ seeWarnings and Precautions (5.1)].Sudden Loss of VisionPhysicians should advise patients to stop use of all PDE5 inhibitors, including sildenafil, 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 canada sildenafil 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, 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, and seek prompt medical attention in the event of sudden decrease or loss of hearing.
| Side Effect | Severity | Notes |
|---|---|---|
| Headache | Common | Usually mild |
| Flushing | Common | Facial redness |
| Nasal Congestion | Common | Feeling of stuffiness |
| Dizziness | Possible | Especially when standing up quickly |
| Vision Changes | Rare | Blurred or blue-tinted vision |
These events, which may be accompanied by tinnitus and dizziness, have been reported in temporal association to the intake of PDE5 inhibitors, including sildenafil. 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. 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 with other PDE5 inhibitors including REVATIO or other pulmonary arterial hypertension (PAH) treatments containing sildenafil. Sildenafil is also marketed as REVATIO for the treatment of PAH. The safety and efficacy of sildenafil tablets with other PDE5 inhibitors, including REVATIO, have not been studied [ see Warnings and Precautions (5.7)].Sexually Transmitted DiseaseThe use of sildenafil offers no protection against sexually transmitted diseases. Counseling of patients about the protective measures necessary to guard against sexually transmitted diseases, including the Human Immunodeficiency Virus (HIV), may be considered [ see Warnings and Precautions (5.9)].Manufactured by:Umedica Laboratories Pvt. 221 and 221/1, GIDC, II ndPhase,Vapi, Gujarat 396195, India (IND)Manufactured for:Nivagen Pharmaceuticals, Inc.Sacramento, CA 95827, USAToll free number: 1-877-977-0687Revised: June 2023, V-03Patient InformationSildenafil (sil den' a fil ) Tablets USPWhat is the most important information I should know about sildenafil ?Sildenafil tablets can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines. Do not take sildenafil tablets if you take any other medicines called “nitrates.” Nitrates are used to treat chest pain (angina).
Start your treatment journey
A sudden drop in blood pressure can cause you to feel dizzy, faint, or have a heart attack or stroke.Do not take sildenafil tablets if you take medicines called guanylate cyclase stimulators which include:• Riociguat (Adempas ®) a medicine that treats pulmonary arterial hypertension and chronic-thromboembolic pulmonary hypertension.Tell all your healthcare providers that you take sildenafil tablets.If you need emergency medical care for a heart problem, it will be important for your healthcare provider to know when you last took sildenafil tablets.Stop sexual activity and get medical help right away if you get symptoms such as chest pain, dizziness, or nausea during sex.Sexual activity can put an extra strain on your heart, especially if your heart is already weak from a heart attack or heart disease.
| Aspect | Details |
|---|---|
| Prescription Abuse | Risk of misuse and dependence |
| Accessibility | Widely available, but under strict regulation |
| Stigma | Some negative perceptions about ED medication use |
| Education Needed | Proper understanding of safe use |
| Cultural Attitudes | Vary by region, influence medication acceptance |
Ask your doctor if your heart is healthy enough to handle the extra strain of having sex.Sildenafil tablets does not protect you or your partner from getting sexually transmitted diseases, including HIV-the virus that causes AIDS.What are sildenafil tablets?Sildenafil tablets are a prescription medicine used to treat erectile dysfunction (ED). You will not get an erection just by taking this medicine. Sildenafil tablets helps a man with erectile dysfunction get and keep an erection only when he is sexually excited (stimulated).Sildenafil tablets are not for use in women or children.It is not known if sildenafil tablets are safe and effective in women or children under 18 years of age.Who should not take sildenafil tablets?Do not take sildenafil tablets if you:take medicines called nitrates (such as nitroglycerin)use street drugs called “poppers” such as amyl nitrate or amyl nitrite, and butyl nitratetake any medicines called guanylate cyclase stimulators such as riociguat (Adempas)are allergic to sildenafil, as contained in sildenafil tablets and REVATIO, or any of the ingredients in sildenafil tablets.