16 HOW SUPPLIED/STORAGE AND HANDLING

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 compared to placebo. On a global improvement question, 57% of sildenafil patients reported improved erections versus 10% on placebo. Diary data indicated that on sildenafil, 48% of intercourse attempts were successful versus 12% on placebo.

Contraindication	Reason	Alternative Action
Use of Nitrates	Severe hypotension risk	Avoid co-administration
Severe Cardiovascular Disease	Increased risk of adverse events	Medical consultation required
Hypersensitivity to Sildenafil or excipients	Allergic reaction	Discontinue use and notify healthcare provider
Concurrent use of Guanylate Cyclase Stimulators	Risk of significant hypotension	Seek medical advice before use

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.

• Men should not take sildenafil LP 100 mg if they have severe heart problems.
• Use caution if you have low blood pressure or a history of strokes.
• Always inform your doctor about current medications before use.

Diary data indicated that on sildenafil, 59% of attempts at sexual intercourse were successful compared to 13% on placebo.

6.2 Postmarketing Experience

Across all trials, sildenafil improved the erections of 43% of radical prostatectomy patients compared to 15% on placebo.

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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. A 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. For 100 mg - Pale blue to blue, caplet shaped film-coated tablets, debossed with ‘1A1’ on one side and plain on other side. Physicians 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 [ Physicians should discuss with patients the contraindication of sildenafil with use of guanylate cyclase stimulators such as riociguat [ Physicians should advise patients of the potential for sildenafil to augment the blood pressure lowering effect of alpha-blockers and anti-hypertensive medications.

Related Product

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 [ Physicians 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 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 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 [ Physicians 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 [ Physicians 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 are the serious side effects of sildenafil?

If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result [ Physicians should inform patients not to take sildenafil tablets with other PDE5 inhibitors including REVATIO or other pulmonary arterial hypertension (PAH) treatments containing sildenafil. The safety and efficacy of sildenafil tablets with other PDE5 inhibitors, including REVATIO, have not been studied [ The 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 [ Plot No.221, PB No.73, GIDC, II nd Phase, 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. Sildenafil tablets does not protect you or your partner from getting sexually transmitted diseases, including HIV-the virus that causes AIDS. •take medicines called nitrates (such as nitroglycerin) •use street drugs called “poppers” such as amyl nitrate or amyl nitrite, and butyl nitrate •take 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.

Does sildenafil interact with other medicines (drug interactions)?

•have or have had heart problems such as a heart attack, irregular heartbeat, angina, chest pain, narrowing of the aortic valve or heart failure •have had heart surgery within the last 6 months •have low blood pressure, or high blood pressure that is not controlled •have had an erection that lasted for more than 4 hours •have problems with your blood cells such as sickle cell anemia, multiple myeloma, or leukemia •have retinitis pigmentosa, a rare genetic (runs in families) eye disease •have ever had severe vision loss, including an eye problem called non-arteritic anterior ischemic optic neuropathy (NAION) •have kidney problems or are having kidney dialysis Sildenafil tablets may affect the way other medicines work, and other medicines may affect the way sildenafil tablets works causing side effects. Especially tell your healthcare provider if you take any of the following: •medicines called nitrates (see“What is the most important information I should know about sildenafil tablets?”) •medicines called guanylate cyclase stimulators, such as riociguat (Adempas) •medicines called alpha blockers such as Hytrin (terazosin HCl), Flomax (tamsulosin HCl), Cardura (doxazosin mesylate), Minipress (prazosin HCl), Uroxatral (alfuzosin HCl), Jalyn (dutasteride and tamsulosin HCl), or Rapaflo (silodosin). •medicines called HIV protease inhibitors, such as ritonavir (Norvir), indinavir sulfate (Crixivan), saquinavir (Fortovase or Invirase) or atazanavir sulfate (Reyataz) •some types of oral antifungal medicines, such as ketoconazole (Nizoral), and itraconazole (Sporanox) •some types of antibiotics, such as clarithromycin (Biaxin), telithromycin (Ketek), or erythromycin •other medicines that treat high blood pressure •Sildenafil tablets contains sildenafil, which is the same medicine found in another drug called REVATIO. •Take sildenafil tablets exactly as your healthcare provider tells you sildenafil 12 5 mg to take it. •Your healthcare provider will tell you how much sildenafil tablets to take and when to take it. Concomitant administration of sildenafil and an alpha - blocker may lead to symptomatic hypotension in some patients.

Drug Class or Name	Effect on Sildenafil	Possible Outcome
Nitrates	Potentiate vasodilation	Risk of severe hypotension
Alpha-blockers	Enhanced blood pressure lowering	Caution advised, dose adjustments needed
CYP3A4 inhibitors (e.g., Ketoconazole)	Decrease sildenafil metabolism	Increased risk of side effects
Blood pressure medications	Additive effects	Monitor blood pressure closely

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 [ Physicians 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 [ Physicians 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 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 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 [ Physicians 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.

Related/similar drugs

•Your healthcare provider may change your dose if needed. •Take sildenafil tablets about 1 hour before sexual activity. •Sildenafil tablets can be taken with or without food. If you take sildenafil tablets after a high fat meal (such as a cheeseburger and french fries), sildenafil tablets may take a little longer to start working •Do nottake sildenafil tablets more than 1 time a day. •If you accidentally take too much sildenafil, call your doctor or go to the nearest hospital emergency room right away.

Is this product currently listed with the FDA?

•an erection that will not go away (priapism).If you have an erection that lasts more than 4 hours, get medical help right away. •sudden vision loss in one or both eyes.Sudden vision loss in one or both eyes can be a sign of a serious eye problem called non-arteritic anterior ischemic optic neuropathy (NAION). •abnormal vision, such as changes in color vision (such as having a blue color tinge) and blurred vision Tell your healthcare provider if you have any side effect that bothers you or does not go away. You may report side effects to FDA at 1‑-800-FDA-1088. •Store sildenafil tablets at room temperature between 68°F to 77°F (20°C to 25°C).

Common Side Effects

For more information, call Nivagen Pharmaceuticals, Inc. at 1-877-977-0687. Plot No.221, PB No.73, GIDC, II nd Phase, *The other brands listed are trademarks of their respective owners and are not trademarks of Umedica Laboratories Pvt. The makers of these brands are not affiliated with and do not endorse Umedica Laboratories Pvt. Thought you might appreciate this item(s) I saw in Urological Science. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors [ Physicians 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.

• Do not exceed one dose of sildenafil LP 100 mg per day.
• Common side effects include headache, flushing, and nasal congestion.
• Consult a doctor if you experience chest pain or vision changes.

If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result [ Physicians should inform patients not to take sildenafil tablets with other PDE5 inhibitors including REVATIO or other pulmonary arterial hypertension (PAH) treatments containing sildenafil. The safety and efficacy of sildenafil tablets with other PDE5 inhibitors, including REVATIO, have not been studied [ The 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 [ Plot No.221, PB No.73, GIDC, II nd Phase, 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. Sildenafil tablets does not protect you or your partner from getting sexually transmitted diseases, including HIV-the virus that causes AIDS. •take medicines called nitrates (such as nitroglycerin) •use street drugs called “poppers” such as amyl nitrate or amyl nitrite, and butyl nitrate •take 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. •have or have had heart problems such as a heart attack, irregular heartbeat, angina, chest pain, narrowing of the aortic valve or heart failure •have had heart surgery within the last 6 months •have low blood pressure, or high blood pressure that is not controlled •have had an erection that lasted for more than 4 hours •have problems with your blood cells such as sickle cell anemia, multiple myeloma, or leukemia •have retinitis pigmentosa, a rare genetic (runs in families) eye disease •have ever had severe vision loss, including an eye problem called non-arteritic anterior ischemic optic neuropathy (NAION) •have kidney problems or are having kidney dialysis Sildenafil tablets may affect the way other medicines work, and other medicines may affect the way sildenafil tablets works causing side effects. Especially tell your healthcare provider if you take any of the following: •medicines called nitrates (see“What is the most important information I should know about sildenafil tablets?”) •medicines called guanylate cyclase stimulators, such as riociguat (Adempas) •medicines called alpha blockers such as Hytrin (terazosin HCl), Flomax (tamsulosin HCl), Cardura (doxazosin mesylate), Minipress (prazosin HCl), Uroxatral (alfuzosin HCl), Jalyn (dutasteride and tamsulosin HCl), or Rapaflo (silodosin). •medicines called HIV protease inhibitors, such as ritonavir (Norvir), indinavir sulfate (Crixivan), saquinavir (Fortovase or Invirase) or atazanavir sulfate (Reyataz) •some types of oral antifungal medicines, such as ketoconazole (Nizoral), and itraconazole (Sporanox) •some types of antibiotics, such as clarithromycin (Biaxin), telithromycin (Ketek), or erythromycin •other medicines that treat high blood pressure •Sildenafil tablets contains sildenafil, which is the same medicine found in another drug called REVATIO.

7.1 Nitrates

Your message has been successfully sent to your colleague. Some error has occurred while processing your request. Sildenafil Citrate Effects on Seminal Parameters in Male Participants with Idiopathic Infertility; A Randomized, Double-blind, Controlled Cross-over Clinical Trial Study Mokhtari, Gholamreza; Madani, Ali Hamidi; Leyli, Ehsan Kazemnezhad; Jafari, Alireza,* Urology Research Center, Razi Hospital, School of Medicine, Guilan University of Medical Sciences, Rasht, Iran Address for correspondence: Dr.

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What are the most common side effects of sildenafil?

•Take sildenafil tablets exactly as your healthcare provider tells you sildenafil 12 5 mg to take it. •Your healthcare provider will tell you how much sildenafil tablets to take and when to take it. •Your healthcare provider may change your dose if needed.

• This medication can interact with certain antibiotics and antifungals.
• Never change dosage or frequency without medical advice.
• Continuous use should be monitored by a healthcare professional for safety.

•Take sildenafil tablets about 1 hour before sexual activity. •Sildenafil tablets can be taken with or without food. If you take sildenafil tablets after a high fat meal (such as a cheeseburger and french fries), sildenafil tablets may take a little longer to start working •Do nottake sildenafil tablets more than 1 time a day. •If you accidentally take too much sildenafil, call your doctor or go to the nearest hospital emergency room right away. •an erection that will not go away (priapism).If you have an erection that lasts more than 4 hours, get medical help right away. •sudden vision loss in one or both eyes.Sudden vision loss in one or both eyes can be a sign of a serious eye problem called non-arteritic anterior ischemic optic neuropathy (NAION).

7.5 Alcohol

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 compared to placebo. On a global improvement question, 57% of sildenafil patients reported improved erections versus 10% on placebo. Diary data indicated that on sildenafil, 48% of intercourse attempts were successful versus 12% on placebo. 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.

What should I tell my healthcare provider before taking sildenafil?

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. A review of population subgroups demonstrated efficacy regardless of baseline severity, etiology, race and age.

Sildenafil Oral Film for ED

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. For 100 mg - Pale blue to blue, caplet shaped film-coated tablets, debossed with ‘1A1’ on one side and plain on other side. Physicians 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 [ Physicians should discuss with patients the contraindication of sildenafil with use of guanylate cyclase stimulators such as riociguat [ Physicians 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 [ Physicians should discuss with patients the potential cardiac risk of sexual activity in patients with preexisting cardiovascular risk factors. •abnormal vision, such as changes in color vision (such as having a blue color tinge) and blurred vision Tell your healthcare provider if you have any side effect that bothers you or does not go away. You may report side effects to FDA at 1‑-800-FDA-1088. •Store sildenafil tablets at room temperature between 68°F to 77°F (20°C to 25°C). For more information, call Nivagen Pharmaceuticals, Inc. at 1-877-977-0687. Plot No.221, PB No.73, GIDC, II nd Phase, *The other brands listed are trademarks of their respective owners and are not trademarks of Umedica Laboratories Pvt. The makers of these brands are not affiliated with and do not endorse Umedica Laboratories Pvt. Thought you might appreciate this item(s) I saw in Urological Science. Your message has been successfully sent to your colleague. Some error has occurred while processing your request. Sildenafil Citrate Effects on Seminal Parameters in Male Participants with Idiopathic Infertility; A Randomized, Double-blind, Controlled Cross-over Clinical Trial Study Mokhtari, Gholamreza; Madani, Ali Hamidi; Leyli, Ehsan Kazemnezhad; Jafari, Alireza,* Urology Research Center, Razi Hospital, School of Medicine, Guilan University of Medical Sciences, Rasht, Iran Address for correspondence: Dr.