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

Pharmacokinetic interactions between sildenafil and saquinavir/ritonavir.

5.5 Hypotension when 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). 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. Decrease in sildenafil dosage is recommended ( 2.4, 5.6) Most common adverse reactions (≥ 2%) include headache, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, myalgia, nausea, dizziness and rash ( 6.1) Sildenafil 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) See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Table of Contents FULL PRESCRIBING INFORMATION: CONTENTS*1 INDICATIONS AND USAGE2 DOSAGE AND ADMINISTRATION2.1 Dosage Information2.2 Use with Food2.3 Dosage Adjustments in Specific Situations2.4 Dosage Adjustments Due to Drug Interactions2.5 Dosage Adjustments in Special Populations3 DOSAGE FORMS AND STRENGTHS4 CONTRAINDICATIONS4.1 Nitrates4.2 Hypersensitivity Reactions4.3 Concomitant Guanylate Cyclase (GC) Stimulators5 WARNINGS AND PRECAUTIONS5.1 Cardiovascular5.2 Prolonged Erection and Priapism5.3 Effects on the Eye5.4 Hearing Loss5.5 Hypotension when Co-administered with Alpha-blockers or Anti-hypertensives5.6 Adverse Reactions with the Concomitant Use of Ritonavir5.7 Combination with other PDE5 Inhibitors or Other Erectile Dysfunction Therapies5.8 Effects on Bleeding5.9 Counseling Patients About Sexually Transmitted Diseases6 ADVERSE REACTIONS6.1 Clinical Trials Experience6.2 Postmarketing Experience7 DRUG INTERACTIONS7.1 Nitrates7.2 Alpha-blockers7.3 Amlodipine7.4 Ritonavir and other CYP3A4 inhibitors7.5 Alcohol8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy8.2 Lactation8.4 Pediatric Use8.5 Geriatric Use8.6 Renal Impairment8.7 Hepatic Impairment10 OVERDOSAGE11 DESCRIPTION12 CLINICAL PHARMACOLOGY12.1 Mechanism of Action12.2 Pharmacodynamics12.3 Pharmacokinetics13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility14 CLINICAL STUDIES16 HOW SUPPLIED/STORAGE AND HANDLING17 PATIENT COUNSELING INFORMATION*Sections or subsections omitted from the full prescribing information are not listed.

Drugs Affecting or Metabolized by Hepatic Microsomal Enzymes

Sections or subsections omitted from the full prescribing information are not listed. 2 DOSAGE AND ADMINISTRATION 2.1 Dosage InformationFor 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. The maximum recommended dosing frequency is once per day.Based on effectiveness and toleration, the dose may be increased to a maximum recommended dose of 100 mg or decreased to 25 mg.2.3 Dosage Adjustments in Specific SituationsSildenafil tablets was shown to potentiate the hypotensive effects of nitrates and its administration in patients who use nitric oxide donors such as organic nitrates or organic nitrites in any form is therefore contraindicated [ see Contraindications (4.1), Drug Interactions (7.1), and Clinical Pharmacology (12.2)].When sildenafil tablets are co-administered with an alpha-blocker, patients should be stable on alpha-blocker therapy prior to initiating sildenafil tablets treatment and sildenafil tablets should be initiated at 25 mg [ see Warnings and Precautions (5.5), Drug Interactions (7.2), and Clinical Pharmacology (12.2)].2.4 Dosage Adjustments Due to Drug InteractionsRitonavirThe recommended dose for ritonavir-treated patients is 25 mg prior to sexual activity and the recommended maximum dose is 25 mg within a 48 hour period because concomitant administration increased the blood levels of sildenafil by 11-fold [ see Warnings and Precautions (5.6), Drug Interactions (7.4), and Clinical Pharmacology (12.3)].CYP3A4 InhibitorsConsider a starting dose of 25 mg in patients treated with strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, or saquinavir) or erythromycin. 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.

Society and culture

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. 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.

• People with heart problems should consult a doctor before using sildenafil 100 mg.
• Sildenafil is contraindicated in patients with severe liver or kidney impairment.
• Allergic reactions, though rare, may include rash, itching, or swelling.

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 chew sildenafil SILDENAFIL TABLETS.SILDENAFIL TABLETS, for oral useInitial U.S.

Author information

Pharmacokinetic 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.

Corresponding author

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. 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. 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.

Before Using

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.

More common

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 sildenafil online ireland (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. ( 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.

Viagra et environnement

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.

Recreational use

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 chew sildenafil 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. 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.

• The onset of action for sildenafil citrate 100 mg is typically within 30 minutes.
• Effects can last for up to 4-6 hours, providing a window for sexual activity.
• Individual response to the drug varies based on health and dosage.

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 sildenafil online ireland (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. Concomitant use may lead to hypotension ( 5.5) Decreased blood pressure, syncope, and prolonged erection may occur at higher sildenafil exposures. Decrease in sildenafil dosage is recommended ( 2.4, 5.6) Most common adverse reactions (≥ 2%) include headache, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, myalgia, nausea, dizziness and rash ( 6.1) Sildenafil 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) See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Table of Contents FULL PRESCRIBING INFORMATION: CONTENTS*1 INDICATIONS AND USAGE2 DOSAGE AND ADMINISTRATION2.1 Dosage Information2.2 Use with Food2.3 Dosage Adjustments in Specific Situations2.4 Dosage Adjustments Due to Drug Interactions2.5 Dosage Adjustments in Special Populations3 DOSAGE FORMS AND STRENGTHS4 CONTRAINDICATIONS4.1 Nitrates4.2 Hypersensitivity Reactions4.3 Concomitant Guanylate Cyclase (GC) Stimulators5 WARNINGS AND PRECAUTIONS5.1 Cardiovascular5.2 Prolonged Erection and Priapism5.3 Effects on the Eye5.4 Hearing Loss5.5 Hypotension when Co-administered with Alpha-blockers or Anti-hypertensives5.6 Adverse Reactions with the Concomitant Use of Ritonavir5.7 Combination with other PDE5 Inhibitors or Other Erectile Dysfunction Therapies5.8 Effects on Bleeding5.9 Counseling Patients About Sexually Transmitted Diseases6 ADVERSE REACTIONS6.1 Clinical Trials Experience6.2 Postmarketing Experience7 DRUG INTERACTIONS7.1 Nitrates7.2 Alpha-blockers7.3 Amlodipine7.4 Ritonavir and other CYP3A4 inhibitors7.5 Alcohol8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy8.2 Lactation8.4 Pediatric Use8.5 Geriatric Use8.6 Renal Impairment8.7 Hepatic Impairment10 OVERDOSAGE11 DESCRIPTION12 CLINICAL PHARMACOLOGY12.1 Mechanism of Action12.2 Pharmacodynamics12.3 Pharmacokinetics13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility14 CLINICAL STUDIES16 HOW SUPPLIED/STORAGE AND HANDLING17 PATIENT COUNSELING INFORMATION*Sections or subsections omitted from the full prescribing information are not listed. Sections or subsections omitted from the full prescribing information are not listed.

2.5 Dosage Adjustments in Special Populations

2 DOSAGE AND ADMINISTRATION 2.1 Dosage InformationFor 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.

The maximum recommended dosing frequency is once per day.Based on effectiveness and toleration, the dose may be increased to a maximum recommended dose of 100 mg or decreased to 25 mg.2.3 Dosage Adjustments in Specific SituationsSildenafil tablets was shown to potentiate the hypotensive effects of nitrates and its administration in patients who use nitric oxide donors such as organic nitrates or organic nitrites in any form is therefore contraindicated [ see Contraindications (4.1), Drug Interactions (7.1), and Clinical Pharmacology (12.2)].When sildenafil tablets are co-administered with an alpha-blocker, patients should be stable on alpha-blocker therapy prior to initiating sildenafil tablets treatment and sildenafil tablets should be initiated at 25 mg [ see Warnings and Precautions (5.5), Drug Interactions (7.2), and Clinical Pharmacology (12.2)].2.4 Dosage Adjustments Due to Drug InteractionsRitonavirThe recommended dose for ritonavir-treated patients is 25 mg prior to sexual activity and the recommended maximum dose is 25 mg within a 48 hour period because concomitant administration increased the blood levels of sildenafil by 11-fold [ see Warnings and Precautions (5.6), Drug Interactions (7.4), and Clinical Pharmacology (12.3)].CYP3A4 InhibitorsConsider a starting dose of 25 mg in patients treated with strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, or saquinavir) or erythromycin.