DRUG INTERACTIONS

Tell your healthcare provider if you have any of the following. Heart problems, such as heart rhythm problems, chest pain, or heart failure Heart attack, stroke, or heart surgery within the past six months High blood pressure that is still too high despite taking medicines for it Peyronie's disease, or a penis with an abnormal curve or shape An erection lasting longer than four hours A blood disorder, such as sickle cell anemia An inherited eye disease called retinitis pigmentosa Vision loss, or a problem with the nerve between your eyes and brain (optic nerve) Health conditions or factors that raise the risk of optic nerve problems, such as diabetes, high cholesterol, smoking, being older than 50, or having a “crowded disc,” which is something an eye doctor may see in an eye exam Pulmonary veno-occlusive disease, a condition where blood vessels in the lungs are blocked It is not known if or how sildenafil could affect pregnancy or harm an unborn baby. Tell your healthcare provider if you are or plan to become pregnant. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Your healthcare provider will advise you if you should take sildenafil while breastfeeding.

If you take sildenafil after you eat a high-fat meal, such as a burger and fries, it may take longer to start working.

• Sildenafil LP 100 mg may interact with nitrate medications.
• Do not use sildenafil tablets LP 100 mg if allergic to sildenafil.
• Report any severe side effects such as prolonged erection immediately.

Your healthcare provider may recommend limiting or avoiding grapefruit while taking sildenafil.

2.1 Dosage Information

In particular, make sure that you discuss if you are using any of the following before taking sildenafil. Tell your healthcare provider about all medicines that you take or have recently taken. This may not be a complete list of medicines that can interact with sildenafil. If you or someone else has used too much sildenafil, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222. For this use, sildenafil is used only when needed.

How should I store sildenafil?

Take it as your healthcare provider recommends, which is usually between 30 minutes to four hours before planned sexual activity. Do not take double or extra doses. For this use, take sildenafil as your healthcare provider recommends, which is usually three times a day. If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and only take the next dose. Grapefruit or grapefruit juice can raise sildenafil levels in your body, which can increase the risk of side effects. There are no known interactions between sildenafil and alcohol. Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

• Avoid using sildenafil tablets LP 100 mg with recreational drugs.
• Seek immediate medical attention if you experience allergic reactions.
• Talk to your healthcare provider about any side effects experienced.

In particular, make sure that you discuss if you are using any of the following before taking sildenafil. Tell your healthcare provider about all medicines that you take or have recently taken. This may not be a complete list of medicines that can interact with sildenafil.

• Sildenafil LP 100 mg is a prescription medication; do not buy online without a script.
• Follow your doctor’s instructions for safe and effective use.
• Report any unusual symptoms or concerns during treatment promptly.

If you or someone else has used too much sildenafil, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222. For this use, sildenafil is used only when needed. Take it as your healthcare provider recommends, which is usually between 30 minutes to four hours before planned sexual activity.

Do not take double or extra doses.

• Sildenafil tablets LP 100 mg is approved by the FDA for ED treatment.
• The medication can improve erectile response in men with ED.
• Follow prescribed dosage instructions carefully for safety.

For this use, take sildenafil as your healthcare provider recommends, which is usually three times a day. If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and only take the next dose. Ask your healthcare provider if you are unsure what to do after a sildenafil 50 mg tab missed dose. This survey is being conducted by the WebMD marketing sciences department.

NDC Code(s): 71205-473-10, 71205-473-20, 71205-473-30, 71205-473-60, view more71205-473-90 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.

Drug Label Information

Tell your healthcare provider if you have any of the following. Heart problems, such as heart rhythm problems, chest pain, or heart failure Heart attack, stroke, or heart surgery within the past six months High blood pressure that is still too high despite taking medicines for it Peyronie's disease, or a penis with an abnormal curve or shape An erection lasting longer than four hours A blood disorder, such as sickle cell anemia An inherited eye disease called retinitis pigmentosa Vision loss, or a problem with the nerve between your eyes and brain (optic nerve) Health conditions or factors that raise the risk of optic nerve problems, such as diabetes, high cholesterol, smoking, being older than 50, or having a “crowded disc,” which is something an eye doctor may see in an eye exam Pulmonary veno-occlusive disease, a condition where blood vessels in the lungs are blocked It is not known if or how sildenafil could affect pregnancy or harm an unborn baby. Tell your healthcare provider if you are or plan to become pregnant. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Your healthcare provider will advise you if you should take sildenafil while breastfeeding.

What should I know about sildenafil before taking it?

If you take sildenafil after you eat a high-fat meal, such as a burger and fries, it may take longer to start working. Your healthcare provider may recommend limiting or avoiding grapefruit while taking sildenafil. Grapefruit or grapefruit juice can raise sildenafil levels in your body, which can increase the risk of side effects. There are no known interactions between sildenafil and alcohol. Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. Approval: 1998RECENT MAJOR CHANGESWarnings and Precautions, Effects on the Eye (5.3) 08/2017INDICATIONS AND USAGESildenafil tablets is a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED) (1)DOSAGE AND ADMINISTRATION• 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) (2)• Based on effectiveness and toleration, may increase to a maximum of 100 mg or decrease to 25 mg (2.1) (2)• Maximum recommended dosing frequency is once per day (2.1) (2)DOSAGE FORMS AND STRENGTHSTablets: 25 mg, 50 mg, 100 mg (3)CONTRAINDICATIONS• Administration of sildenafil tablets to patients using nitric oxide donors, such as organic nitrates or organic nitrites in any form. Sildenafil tablets were shown to potentiate the hypotensive effect of nitrates (4.1, 7.1, 12.2) (4)• Known hypersensitivity to sildenafil or any component of tablet (4.2) (4)• Administration with guanylate cyclase (GC) stimulators, such as riociguat (4.3) (4)WARNINGS AND PRECAUTIONS• Patients should not use sildenafil tablets if sexual activity is inadvisable due to cardiovascular status (5.1) (5)• Patients should seek emergency treatment if an erection lasts >4 hours. Use sildenafil tablets with caution in patients predisposed to priapism (5.2) (5)• 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).

The bottom line

Decrease in sildenafil tablets dosage is recommended (2.4, 5.6) (5) • Sildenafil tablets can potentiate the hypotensive effects of nitrates, alpha blockers, and anti-hypertensives (4.1, 5.5, 7.1, 7.2, 7.3, 12.2) (7) • With concomitant use of alpha blockers, initiate sildenafil tablets at 25 mg dose (2.3) (7) • CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, erythromycin): Increase sildenafil tablets exposure (2.4, 7.4, 12.3) (7) Ritonavir: Do not exceed a maximum single dose of 25 mg in a 48hour period (2.4, 5.6) Erythromycin or strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, saquinavir): Consider a starting dose of 25 mg (2.4, 7.4) 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. 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) (5)• Patients should stop sildenafil tablets and seek prompt medical attention in the event of sudden decrease or loss of hearing (5.4) (5)• Caution is advised when sildenafil tablets is co-administered with alpha-blockers or anti-hypertensives. Concomitant use may lead to hypotension (5.5) (5)• Decreased blood pressure, syncope, and prolonged erection may occur at higher sildenafil exposures.

7.2 Alpha-blockers

In patients taking strong CYP inhibitors, such as ritonavir, sildenafil exposure is increased.

5.7 Combination with other PDE-5 inhibitors

Ask your healthcare provider if you are unsure what to do after a sildenafil 50 mg tab missed dose. This survey is being conducted by the WebMD marketing sciences department. NDC Code(s): 71205-473-10, 71205-473-20, 71205-473-30, 71205-473-60, view more71205-473-90 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.

What is sildenafil used for?

Approval: 1998RECENT MAJOR CHANGESWarnings and Precautions, Effects on the Eye (5.3) 08/2017INDICATIONS AND USAGESildenafil tablets is a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED) (1)DOSAGE AND ADMINISTRATION• 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) (2)• Based on effectiveness and toleration, may increase to a maximum of 100 mg or decrease to 25 mg (2.1) (2)• Maximum recommended dosing frequency is once per day (2.1) (2)DOSAGE FORMS AND STRENGTHSTablets: 25 mg, 50 mg, 100 mg (3)CONTRAINDICATIONS• Administration of sildenafil tablets to patients using nitric oxide donors, such as organic nitrates or organic nitrites in any form. Sildenafil tablets were shown to potentiate the hypotensive effect of nitrates (4.1, 7.1, 12.2) (4)• Known hypersensitivity to sildenafil or any component of tablet (4.2) (4)• Administration with guanylate cyclase (GC) stimulators, such as riociguat (4.3) (4)WARNINGS AND PRECAUTIONS• Patients should not use sildenafil tablets if sexual activity is inadvisable due to cardiovascular status (5.1) (5)• Patients should seek emergency treatment if an erection lasts >4 hours. Use sildenafil tablets with caution in patients predisposed to priapism (5.2) (5)• 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. Decrease in sildenafil tablets dosage is recommended (2.4, 5.6) (5)ADVERSE REACTIONSDRUG INTERACTIONS• Sildenafil tablets can potentiate the hypotensive effects of nitrates, alpha blockers, and anti-hypertensives (4.1, 5.5, 7.1, 7.2, 7.3, 12.2) (7)• With concomitant use of alpha blockers, initiate sildenafil tablets at 25 mg dose (2.3) (7)• CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, erythromycin): Increase sildenafil tablets exposure (2.4, 7.4, 12.3) (7)•Ritonavir: Do not exceed a maximum single dose of 25 mg in a 48hour period (2.4, 5.6)•Erythromycin or strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, saquinavir): Consider a starting dose of 25 mg (2.4, 7.4)USE IN SPECIFIC POPULATIONSSee 17 for PATIENT COUNSELING INFORMATION.Revised: 3/2021 Warnings and Precautions, Effects on the Eye (5.3) 08/2017 Sildenafil tablets 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) (2) • Based on effectiveness and toleration, may increase to a maximum of 100 mg or decrease to 25 mg (2.1) (2) • Maximum recommended dosing frequency is once per day (2.1) (2) Tablets: 25 mg, 50 mg, 100 mg (3) • Administration of sildenafil tablets to patients using nitric oxide donors, such as organic nitrates or organic nitrites in any form.

5.2 Hypotension

Sildenafil tablets were shown to potentiate the hypotensive effect of nitrates (4.1, 7.1, 12.2) (4) • Known hypersensitivity to sildenafil or any component of tablet (4.2) (4) • Administration with guanylate cyclase (GC) stimulators, such as riociguat (4.3) (4) • Patients should not use sildenafil tablets if sexual activity is inadvisable due to cardiovascular status (5.1) (5) • Patients should seek emergency treatment if an erection lasts >4 hours. Use sildenafil tablets with caution in patients predisposed to priapism (5.2) (5) • 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) (5) • Caution is advised when sildenafil tablets is co-administered with alpha-blockers or anti-hypertensives. Concomitant use may lead to hypotension (5.5) (5) • Decreased blood pressure, syncope, and prolonged erection may occur at higher sildenafil exposures. Decrease in sildenafil tablets dosage is recommended (2.4, 5.6) (5) • Sildenafil tablets can potentiate the hypotensive effects of nitrates, alpha blockers, and anti-hypertensives (4.1, 5.5, 7.1, 7.2, 7.3, 12.2) (7) • With concomitant use of alpha blockers, initiate sildenafil tablets at 25 mg dose (2.3) (7) • CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, erythromycin): Increase sildenafil tablets exposure (2.4, 7.4, 12.3) (7) Ritonavir: Do not exceed a maximum single dose of 25 mg in a 48hour period (2.4, 5.6) Erythromycin or strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, saquinavir): Consider a starting dose of 25 mg (2.4, 7.4) 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.

What to avoid

Patients with a “crowded” optic disc may also be at an increased risk of NAION. (5.3) (5)• Patients should stop sildenafil tablets and seek prompt medical attention in the event of sudden decrease or loss of hearing (5.4) (5)• Caution is advised when sildenafil tablets is co-administered with alpha-blockers or anti-hypertensives. Concomitant use may lead to hypotension (5.5) (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 tablets dosage is recommended (2.4, 5.6) (5)ADVERSE REACTIONSDRUG INTERACTIONS• Sildenafil tablets can potentiate the hypotensive effects of nitrates, alpha blockers, and anti-hypertensives (4.1, 5.5, 7.1, 7.2, 7.3, 12.2) (7)• With concomitant use of alpha blockers, initiate sildenafil tablets at 25 mg dose (2.3) (7)• CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, erythromycin): Increase sildenafil tablets exposure (2.4, 7.4, 12.3) (7)•Ritonavir: Do not exceed a maximum single dose of 25 mg in a 48hour period (2.4, 5.6)•Erythromycin or strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, saquinavir): Consider a starting dose of 25 mg (2.4, 7.4)USE IN SPECIFIC POPULATIONSSee 17 for PATIENT COUNSELING INFORMATION.Revised: 3/2021 Warnings and Precautions, Effects on the Eye (5.3) 08/2017 Sildenafil tablets 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.

Sildenafil Tablets for ED

However, sildenafil tablets may be taken anywhere from 30 minutes to 4 hours before sexual activity (2.1) (2) • Based on effectiveness and toleration, may increase to a maximum of 100 mg or decrease to 25 mg (2.1) (2) • Maximum recommended dosing frequency is once per day (2.1) (2) Tablets: 25 mg, 50 mg, 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 were shown to potentiate the hypotensive effect of nitrates (4.1, 7.1, 12.2) (4) • Known hypersensitivity to sildenafil or any component of tablet (4.2) (4) • Administration with guanylate cyclase (GC) stimulators, such as riociguat (4.3) (4) • Patients should not use sildenafil tablets if sexual activity is inadvisable due to cardiovascular status (5.1) (5) • Patients should seek emergency treatment if an erection lasts >4 hours. Use sildenafil tablets with caution in patients predisposed to priapism (5.2) (5) • 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) (5) • Caution is advised when sildenafil tablets is co-administered with alpha-blockers or anti-hypertensives. Concomitant use may lead to hypotension (5.5) (5) • Decreased blood pressure, syncope, and prolonged erection may occur at higher sildenafil exposures.