Furthermore, an initial dose of 100 mg may reduce the need for dose titration and may prevent discouragement and treatment abandonment in men for whom a dose of 50 mg is insufficient. This suggests prescription of an initial dose of 100 mg, except in those for whom it is inappropriate. Correlations between increased erection hardness and improvements in emotional well-being and satisfaction outcomes in men treated with sildenafil citrate for erectile dysfunction. Steidle C, McCullough A, Kaminetsky J, Crowley A, Siegel R, Deriesthal H et al. Early sildenafil dose optimization and personalized instruction improves the frequency, flexibility, and success of sexual intercourse in men with erectile dysfunction. Lowy M, Collins S, Bloch MT, Gillman M, Lording DW, Sutherland P et al. Quality of erection questionnaire correlates: change in erection quality with erectile function, hardness, and psychosocial measures in men treated with sildenafil for erectile dysfunction. A prospective study of the beneficial effects of dose optimization and customized instructions on patient satisfaction with sildenafil citrate (VIAGRA) for erectile dysfunction. Sildenafil citrate 100 mg starting dose in men with erectile dysfunction in an international, double-blind, placebo-controlled study: effect on the sexual experience and reducing feelings of anxiety about the next intercourse attempt. Effect of sildenafil citrate on the male sexual experience assessed with the Sexual Experience Questionnaire; a multicenter, double-blind, placebo-controlled trial with open-label extension.
Validation of the Erection Hardness Score (EHS). Rosen RC, Riley A, Wagner G, Osterloh IH, Kirkpatrick J, Mishra A . The International Index of Erectile Function (IIEF): a multidimensional scale for assessment of erectile dysfunction. Development and validation of the Self-Esteem And Relationship (SEAR) questionnaire in erectile dysfunction.
Comparison between sildenafil-treated subjects with erectile dysfunction and control subjects on the Self-Esteem And Relationship Questionnaire. Sildenafil citrate improves self-esteem, confidence, and relationships in men with erectile dysfunction: results from an international, multi-center, double-blind, placebo-controlled trial.
Mulhall JP, King R, Kirby M, Hvidsten K, Symonds T, Bushmakin AG et al. Evaluating the sexual experience in men: validation of the Sexual Experience Questionnaire. Development and validation of the Quality of Erection Questionnaire. Althof SE, Corty EW, Levine SB, Levine F, Burnett AL, McVary K et al.
Furthermore, an initial dose of 100 mg may reduce the need for dose titration and may prevent discouragement and treatment abandonment in men for whom a dose of 50 mg is insufficient. This suggests prescription of an initial dose of 100 mg, except in those for whom it is inappropriate. Correlations between increased erection hardness and improvements in emotional well-being and satisfaction outcomes in men treated with sildenafil citrate for erectile dysfunction. Steidle C, McCullough A, Kaminetsky J, Crowley A, Siegel R, Deriesthal H et al. Early sildenafil dose optimization and personalized instruction improves the frequency, flexibility, and success of sexual intercourse in men with erectile dysfunction.
Lowy M, Collins S, Bloch MT, Gillman M, Lording DW, Sutherland P et al. Quality of erection questionnaire correlates: change in erection quality with erectile function, hardness, and psychosocial measures in men treated with sildenafil for erectile dysfunction. A prospective study of the beneficial effects of dose optimization and customized instructions on patient satisfaction with sildenafil citrate (VIAGRA) for erectile dysfunction. Sildenafil citrate 100 mg starting dose in men with erectile dysfunction in an international, double-blind, placebo-controlled study: effect on the sexual experience and reducing feelings of anxiety about the next intercourse attempt. Effect of sildenafil citrate on the male sexual experience assessed with the Sexual Experience Questionnaire; a multicenter, double-blind, placebo-controlled trial with open-label extension. EDITS: development of questionnaires for evaluating satisfaction with treatments for erectile dysfunction. O'Leary MP, Althof SE, Cappelleri JC, Crowley A, Sherman N, Duttagupta S . Self-esteem, confidence and relationship satisfaction of men with erectile dysfunction treated with sildenafil citrate: a multicenter, randomized, parallel group, double-blind, placebo controlled study in the United States. What to learn about sildenafil in the treatment of erectile dysfunction from 3-year clinical experience. Achieving treatment optimization with sildenafil citrate (Viagra) in patients with erectile dysfunction. Harrold LR, Gurwitz JH, Field TS, Andrade SE, Fish LS, Jarry PD et al.
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The diffusion of a novel therapy into clinical practice: the case of sildenafil. Muirhead GJ, Wilner K, Colburn W, Haug-Pihale G, Rouvieux B . The effects of age and renal and hepatic impairment on the pharmacokinetics of sildenafil citrate.
Stecher is an employee of Pfizer. This work is licensed under the Creative Commons Attribution-NonCommercial-No Derivative Works 3.0 Unported License. To view a copy of this license, visit Ströberg, P., Kaminetsky, J., Park, N. et al. Hardness, function, emotional well-being, satisfaction and the overall sexual experience in men using 100-mg fixed-dose or flexible-dose sildenafil citrate.
Enhanced understanding of the relationship between erection and satisfaction in ED treatment: application of a longitudinal mediation model International Journal of Impotence Research (2014) Changes in sexual inhibition and excitation during PDE5I therapy International Journal of Impotence Research (2014) NDC Code(s): 72789-406-15, 72789-406-30, 72789-406-90 If you are a consumer or patient please visit this version. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS.SILDENAFIL TABLETS, for oral useInitial U.S. Approval: 1998RECENT MAJOR CHANGESWarnings and Precautions, Effects on the Eye (5.3) 08/2017INDICATIONS AND USAGESildenafil is a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED) (1)DOSAGE AND ADMINISTRATIONFor most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity. However, sildenafil tablets may be taken anywhere from 30 minutes to 4 hours before sexual activity ( 2.1)Based on effectiveness and toleration, may increase to a maximum of 100 mg or decrease to 25 mg ( 2.1)Maximum recommended dosing frequency is once per day ( 2.1)DOSAGE FORMS AND STRENGTHSTablets: 25 mg, 50 mg and 100 mg (3)CONTRAINDICATIONSAdministration of sildenafil tablets to patients using nitric oxide donors, such as organic nitrates or organic nitrites in any form. Muirhead GJ, Faulkner S, Harness JA, Taubel J . The effects of steady-state erythromycin and azithromycin on the pharmacokinetics of sildenafil in healthy volunteers.
Pharmacokinetic pfizer sildenafil 100 interactions between sildenafil and saquinavir/ritonavir. Pharmacology and drug interaction effects of the phosphodiesterase 5 inhibitors: focus on alpha-blocker interactions. These studies were funded by Pfizer Inc. Editorial support was provided by Deborah M Campoli-Richards, BSPHA, RPh, at Complete Healthcare Communications, Inc and was funded by Pfizer. Peter Ströberg is a scientific study/trial investigator for Pfizer. Nam Cheol Park has nothing to declare. Dana L. Creanga was a paid consultant to Pfizer in connection with the statistical analyses performed in this study. Vera J. Stecher is an employee of Pfizer. This work is licensed under the Creative Commons Attribution-NonCommercial-No Derivative Works 3.0 Unported License.
EDITS: development of questionnaires for evaluating satisfaction with treatments for erectile dysfunction. O'Leary MP, Althof SE, Cappelleri JC, Crowley A, Sherman N, Duttagupta S . Self-esteem, confidence and relationship satisfaction of men with erectile dysfunction treated with sildenafil citrate: a multicenter, randomized, parallel group, double-blind, placebo controlled study in the United States. What to learn about sildenafil in the treatment of erectile dysfunction from 3-year clinical experience. Achieving treatment optimization with sildenafil citrate (Viagra) in patients with erectile dysfunction.
Harrold LR, Gurwitz JH, Field TS, Andrade SE, Fish LS, Jarry PD et al. The diffusion of a novel therapy into clinical practice: the case of sildenafil. Muirhead GJ, Wilner K, Colburn W, Haug-Pihale G, Rouvieux B . The effects of age and renal and hepatic impairment on the pharmacokinetics of sildenafil citrate. Muirhead GJ, Faulkner S, Harness JA, Taubel J . To view a copy of this license, visit Ströberg, P., Kaminetsky, J., Park, N.
| Monitoring Aspect | Purpose | Key Metrics |
|---|---|---|
| Adverse Event Reporting | Track side effects and adverse reactions | Unexpected or severe reactions |
| Cardiac Function Monitoring | Patients with cardiovascular risk | ECG or other assessments |
| Liver and Kidney Function Tests | Patients on long-term therapy | Ensure no organ damage |
| Patient Education | Inform about common side effects and interaction risks | Enhance safe usage |
et al.
The effects of steady-state erythromycin and azithromycin on the pharmacokinetics of sildenafil in healthy volunteers. Pharmacokinetic pfizer sildenafil 100 interactions between sildenafil and saquinavir/ritonavir. Pharmacology and drug interaction effects of the phosphodiesterase 5 inhibitors: focus on alpha-blocker interactions. These studies were funded by Pfizer Inc. Editorial support was provided by Deborah M Campoli-Richards, BSPHA, RPh, at Complete Healthcare Communications, Inc and was funded by Pfizer.
Peter Ströberg is a scientific study/trial investigator for Pfizer. Nam Cheol Park has nothing to declare. Dana L. Creanga was a paid consultant to Pfizer in connection with the statistical analyses performed in this study. Vera J. Hardness, function, emotional well-being, satisfaction and the overall sexual experience in men using 100-mg fixed-dose or flexible-dose sildenafil citrate. Enhanced understanding of the relationship between erection and satisfaction in ED treatment: application of a longitudinal mediation model International Journal of Impotence Research (2014) Changes in sexual inhibition and excitation during PDE5I therapy International Journal of Impotence Research (2014) NDC Code(s): 72789-406-15, 72789-406-30, 72789-406-90 If you are a consumer or patient please visit this version. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively.
Validation of the Erection Hardness Score (EHS). Rosen RC, Riley A, Wagner G, Osterloh IH, Kirkpatrick J, Mishra A . The International Index of Erectile Function (IIEF): a multidimensional scale for assessment of erectile dysfunction. Development and validation of the Self-Esteem And Relationship (SEAR) questionnaire in erectile dysfunction. Comparison between sildenafil-treated subjects with erectile dysfunction and control subjects on the Self-Esteem And Relationship Questionnaire.
Sildenafil citrate improves self-esteem, confidence, and relationships in men with erectile dysfunction: results from an international, multi-center, double-blind, placebo-controlled trial. Mulhall JP, King R, Kirby M, Hvidsten K, Symonds T, Bushmakin AG et al. Evaluating the sexual experience in men: validation of the Sexual Experience Questionnaire. Development and validation of the Quality of Erection Questionnaire. Althof SE, Corty EW, Levine SB, Levine F, Burnett AL, McVary K et al. See full prescribing information for SILDENAFIL TABLETS.SILDENAFIL TABLETS, for oral useInitial U.S. Approval: 1998RECENT MAJOR CHANGESWarnings and Precautions, Effects on the Eye (5.3) 08/2017INDICATIONS AND USAGESildenafil is a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED) (1)DOSAGE AND ADMINISTRATIONFor most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity. However, sildenafil tablets may be taken anywhere from 30 minutes to 4 hours before sexual activity ( 2.1)Based on effectiveness and toleration, may increase to a maximum of 100 mg or decrease to 25 mg ( 2.1)Maximum recommended dosing frequency is once per day ( 2.1)DOSAGE FORMS AND STRENGTHSTablets: 25 mg, 50 mg and 100 mg (3)CONTRAINDICATIONSAdministration of sildenafil tablets to patients using nitric oxide donors, such as organic nitrates or organic nitrites in any form. Sildenafil tablets was shown to potentiate the hypotensive effect of nitrates ( 4.1, 7.1, 12.2)Known hypersensitivity to sildenafil or any component of tablet ( 4.2)Administration with guanylate cyclase (GC) stimulators, such as riociguat ( 4.3)WARNINGS AND PRECAUTIONSPatients should not use sildenafil if sexual activity is inadvisable due to cardiovascular status ( 5.1)Patients should seek emergency treatment if an erection lasts >4 hours.
Sildenafil tablets was shown to potentiate the hypotensive effect of nitrates ( 4.1, 7.1, 12.2) Known hypersensitivity to sildenafil or any component of tablet ( 4.2) Administration with guanylate cyclase (GC) stimulators, such as riociguat ( 4.3) Patients should not use sildenafil if sexual activity is inadvisable due to cardiovascular status ( 5.1) Patients should seek emergency treatment if an erection lasts >4 hours. Use sildenafil with caution in patients predisposed to priapism ( 5.2) Patients should stop sildenafil tablets and seek medical care if a sudden loss of vision occurs in one or both eyes, which could be a sign of non arteritic anterior ischemic optic neuropathy (NAION). Patients should stop sildenafil tablets and seek prompt medical attention in the event of sudden decrease or loss of hearing ( 5.4) Caution is advised when sildenafil is co-administered with alpha-blockers or anti-hypertensives.
Use sildenafil with caution in patients predisposed to priapism ( 5.2)Patients should stop sildenafil tablets and seek medical care if a sudden loss of vision occurs in one or both eyes, which could be a sign of non arteritic anterior ischemic optic neuropathy (NAION). Sildenafil tablets should be used with caution, and only when the anticipated benefits outweigh the risks, in patients with a history of NAION. Patients with a "crowded" optic disc may also be at an increased risk of NAION. ( 5.3)Patients should stop sildenafil tablets and seek prompt medical attention in the event of sudden decrease or loss of hearing ( 5.4)Caution is advised when sildenafil is co-administered with alpha-blockers or anti-hypertensives. Concomitant use may lead to hypotension ( 5.5)Decreased blood pressure, syncope, and prolonged erection may occur at higher sildenafil exposures. In patients taking strong CYP inhibitors, such as ritonavir, sildenafil exposure is increased. Decrease in sildenafil dosage is recommended ( 2.4, 5.6)ADVERSE REACTIONSMost common adverse reactions (≥ 2%) include headache, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, myalgia, nausea, dizziness and rash ( 6.1)To report SUSPECTED ADVERSE REACTIONS, contact Nivagen Pharmaceuticals, Inc. at 1-877-977-0687 or FDA at 1-800-FDA-1088 or INTERACTIONSSildenafil can potentiate the hypotensive effects of nitrates, alpha blockers, and anti-hypertensives ( 4.1, 5.5, 7.1, 7.2, 7.3, 12.2)With concomitant use of alpha blockers, initiate sildenafil at 25 mg dose ( 2.3)CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, erythromycin): Increase sildenafil exposure ( 2.4, 7.4, 12.3) USE IN SPECIFIC POPULATIONSSee 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.Revised: 6/2023 Warnings and Precautions, Effects on the Eye (5.3) 08/2017 Sildenafil is a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED) (1) For most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity. However, sildenafil tablets may be taken anywhere from 30 minutes to 4 hours before sexual activity ( 2.1) Based on effectiveness and toleration, may increase to a maximum of 100 mg or decrease to 25 mg ( 2.1) Maximum recommended dosing frequency is once per day ( 2.1) Tablets: 25 mg, 50 mg and 100 mg (3) Administration of sildenafil tablets to patients using nitric oxide donors, such as organic nitrates or organic nitrites in any form. Sildenafil tablets was shown to potentiate the hypotensive effect of nitrates ( 4.1, 7.1, 12.2) Known hypersensitivity to sildenafil or any component of tablet ( 4.2) Administration with guanylate cyclase (GC) stimulators, such as riociguat ( 4.3) Patients should not use sildenafil if sexual activity is inadvisable due to cardiovascular status ( 5.1) Patients should seek emergency treatment if an erection lasts >4 hours. Use sildenafil with caution in patients predisposed to priapism ( 5.2) Patients should stop sildenafil tablets and seek medical care if a sudden loss of vision occurs in one or both eyes, which could be a sign of non arteritic anterior ischemic optic neuropathy (NAION). Patients should stop sildenafil tablets and seek prompt medical attention in the event of sudden decrease or loss of hearing ( 5.4) Caution is advised when sildenafil is co-administered with alpha-blockers or anti-hypertensives.
Sildenafil tablets was shown to potentiate the hypotensive effect of nitrates ( 4.1, 7.1, 12.2)Known hypersensitivity to sildenafil or any component of tablet ( 4.2)Administration with guanylate cyclase (GC) stimulators, such as riociguat ( 4.3)WARNINGS AND PRECAUTIONSPatients should not use sildenafil if sexual activity is inadvisable due to cardiovascular status ( 5.1)Patients should seek emergency treatment if an erection lasts >4 hours. Use sildenafil with caution in patients predisposed to priapism ( 5.2)Patients should stop sildenafil tablets and seek medical care if a sudden loss of vision occurs in one or both eyes, which could be a sign of non arteritic anterior ischemic optic neuropathy (NAION). Sildenafil tablets should be used with caution, and only when the anticipated benefits outweigh the risks, in patients with a history of NAION. Patients with a "crowded" optic disc may also be at an increased risk of NAION. ( 5.3)Patients should stop sildenafil tablets and seek prompt medical attention in the event of sudden decrease or loss of hearing ( 5.4)Caution is advised when sildenafil is co-administered with alpha-blockers or anti-hypertensives.
Concomitant use may lead to hypotension ( 5.5)Decreased blood pressure, syncope, and prolonged erection may occur at higher sildenafil exposures. In patients taking strong CYP inhibitors, such as ritonavir, sildenafil exposure is increased. Decrease in sildenafil dosage is recommended ( 2.4, 5.6)ADVERSE REACTIONSMost common adverse reactions (≥ 2%) include headache, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, myalgia, nausea, dizziness and rash ( 6.1)To report SUSPECTED ADVERSE REACTIONS, contact Nivagen Pharmaceuticals, Inc. at 1-877-977-0687 or FDA at 1-800-FDA-1088 or INTERACTIONSSildenafil can potentiate the hypotensive effects of nitrates, alpha blockers, and anti-hypertensives ( 4.1, 5.5, 7.1, 7.2, 7.3, 12.2)With concomitant use of alpha blockers, initiate sildenafil at 25 mg dose ( 2.3)CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, erythromycin): Increase sildenafil exposure ( 2.4, 7.4, 12.3) USE IN SPECIFIC POPULATIONSSee 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.Revised: 6/2023 Warnings and Precautions, Effects on the Eye (5.3) 08/2017 Sildenafil is a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED) (1) For most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity. However, sildenafil tablets may be taken anywhere from 30 minutes to 4 hours before sexual activity ( 2.1) Based on effectiveness and toleration, may increase to a maximum of 100 mg or decrease to 25 mg ( 2.1) Maximum recommended dosing frequency is once per day ( 2.1) Tablets: 25 mg, 50 mg and 100 mg (3) Administration of sildenafil tablets to patients using nitric oxide donors, such as organic nitrates or organic nitrites in any form.