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Use sildenafil tablets 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.

8.1 Pregnancy: Teratogenic Effects

Professional resources

Patients with a ”crowded” optic disc may also be at an increased risk of NAION.

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(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 tablets are 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 tablets 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 Hetero Labs Limited at 866-495-1995 or FDA at 1-800-FDA-1088 or 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)• With concomitant use of alpha blockers, initiate sildenafil tablets at 25 mg dose (2.3)• CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, erythromycin): Increase sildenafil tablets exposure (2.4, 7.4, 12.3)• Ritonavir: Do not exceed a maximum single dose of 25 mg in a 48 hour 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 and FDA-approved patient labeling.Revised: 12/2025 Sildenafil tablet 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) 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.

2.3 Dosage Adjustments in Specific Situations

3 DOSAGE FORMS AND STRENGTHS Sildenafil Tablets USP, 25 mg are white colored, round-shaped, biconvex, film coated tablets debossed with 'I' on one side and '35' on the other side.Sildenafil Tablets USP, 50 mg are white colored, round-shaped, biconvex, film coated tablets debossed with 'I' on one side and '36' on the other side.Sildenafil Tablets USP, 100 mg are white colored, round-shaped, biconvex, film coated tablets debossed with 'I' on one side and '58' on the other side. Sildenafil Tablets USP, 25 mg are white colored, round-shaped, biconvex, film coated tablets debossed with 'I' on one side and '35' on the other side. 4 CONTRAINDICATIONS 4.1 NitratesConsistent with its known effects on the nitric oxide/cGMP pathway [ see Clinical Pharmacology ( 12.1, 12.2)] , sildenafil tablets were shown to potentiate the hypotensive effects of nitrates, and its administration to patients who are using nitric oxide donors such as organic nitrates or organic nitrites in any form either regularly and/or intermittently is therefore contraindicated.After patients have taken sildenafil tablets, it is unknown when nitrates, if necessary, can be safely administered. Although plasma levels of sildenafil at 24 hours post dose are much lower than at peak concentration, it is unknown whether nitrates can be safely co-administered at this time point [ see Dosage and Administration (2.3),Drug Interactions (7.1),and Clinical Pharmacology (12.2)].4.2 Hypersensitivity ReactionsSildenafil tablets are contraindicated in patients with a known hypersensitivity to sildenafil, as contained in sildenafil tablets and REVATIO, or any component of the tablet. Hypersensitivity reactions have been reported, including rash and urticaria [ see Adverse Reactions (6.1)].

Drugs you should not use with sildenafil

Sildenafil tablets were shown to potentiate the hypotensive effect of nitrates ( 4.1, 7.1, 12.2) • Patients should not use sildenafil tablets if sexual activity is inadvisable due to cardiovascular status (5.1) Most common adverse reactions (≥ 2%) include headache, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, myalgia, nausea, dizziness and rash (6.1) • 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) 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 Pregnancy: Teratogenic Effects8.2 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 are often stored in their original packaging to avoid contamination.
  • Use only the amount prescribed; more does not mean better results.
  • Sildenafil helps improve erectile function but doesn’t increase libido.
  • The tablets are designed for rapid and effective absorption.
  • Always inform your doctor about existing health conditions before use.
  • Some brands of sildenafil are marketed as "white tablets" for easy recognition.
  • The medication can cause a mild increase in blood flow to other body parts.
  • Avoid caffeine or heavy meals before taking sildenafil for better results.
  • The safety and efficacy of sildenafil are supported by numerous clinical trials.
  • Never take expired sildenafil tablets, as their safety can’t be guaranteed.
  • Regular blood pressure checks are recommended when using sildenafil long-term.

Sections or subsections omitted from the full prescribing information are not listed.

Storage Condition Details Notes
Temperature Keep below 30°C (86°F) Avoid excessive heat
Light Keep away from direct sunlight Protect from UV rays
Humidity Store in dry place Prevent moisture from degrading the tablet
Out of reach Keep out of children's reach Safety precaution

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 were 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.

  • Sildenafil tablets are sometimes prescribed for conditions other than ED.
  • The active ingredient aids in relaxing blood vessels in the body.
  • White sildenafil tablets are often associated with certain pharmaceutical brands.
  • Some countries have strict regulations on sildenafil distribution and sale.
  • Sildenafil is typically not recommended for men with severe eyesight diseases.
  • Adherence to prescribed guidelines optimizes treatment outcomes.
  • The tablets are manufactured with quality control practices to ensure safety.
  • Patients should avoid sudden changes in medication or dosage.
  • Reactions to sildenafil can be immediate or delayed; monitor closely.
  • Lifestyle factors like smoking can influence sildenafil’s effectiveness.
  • Educate yourself on proper storage to maintain medication integrity.

Clinical data have shown that co-administration with saquinavir or erythromycin increased plasma levels of sildenafil by about 3 fold [see Drug Interactions (7.4)and Clinical Pharmacology (12.3)].2.5 Dosage Adjustments in Special PopulationsConsider a starting dose of 25 mg in patients > 65 years, patients with hepatic impairment (e.g., cirrhosis), and patients with severe renal impairment (creatinine clearance <30 mL/minute) because administration of sildenafil tablets in these patients resulted in higher plasma levels of sildenafil [see Use in Specific Populations ( 8.5, 8.6, 8.7)and Clinical Pharmacology ( 12.3)]. For most patients, the recommended dose is 50 mg taken, as needed, approximately sildenafil citrate tables 1 hour before sexual activity. The maximum recommended dosing frequency is once per day.

  • Sildenafil tablets are classified as phosphodiesterase inhibitors.
  • White sildenafil tablets are available by prescription only.
  • They should not be used with nitrates due to risk of dangerous drops in blood pressure.
  • Certain medications may interact with sildenafil, including antibiotics and antifungals.
  • The tablets are designed to last approximately 4-6 hours.
  • Overuse can lead to adverse effects like dizziness or vision changes.
  • Sildenafil helps men with erectile dysfunction achieve and maintain erections.
  • The medicine is not an aphrodisiac and requires sexual stimulation.
  • The tablets should be stored in a cool, dry place away from children.
  • Beware of counterfeit sildenafil tablets sold online.
  • Always verify the legitimacy of the medication before use.

Sildenafil tablets were 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)].

Images for AN 351

Use sildenafil tablets 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 tablets are 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.

Dosage forms

In patients taking strong CYP inhibitors, such as ritonavir, sildenafil exposure is increased. Decrease in sildenafil tablets 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 Hetero Labs Limited at 866-495-1995 or FDA at 1-800-FDA-1088 or 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)• With concomitant use of alpha blockers, initiate sildenafil tablets at 25 mg dose (2.3)• CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, erythromycin): Increase sildenafil tablets exposure (2.4, 7.4, 12.3)• Ritonavir: Do not exceed a maximum single dose of 25 mg in a 48 hour 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 and FDA-approved patient labeling.Revised: 12/2025 Sildenafil tablet 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) 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) • Patients should not use sildenafil tablets if sexual activity is inadvisable due to cardiovascular status (5.1) Most common adverse reactions (≥ 2%) include headache, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, myalgia, nausea, dizziness and rash (6.1) • 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) 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 Pregnancy: Teratogenic Effects8.2 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. Consider a starting dose of 25 mg in patients > 65 years, patients with hepatic impairment (e.g., cirrhosis), and patients with severe renal impairment (creatinine clearance <30 mL/minute) because administration of sildenafil tablets in these patients resulted in higher plasma levels of sildenafil [see Use in Specific Populations ( 8.5, 8.6, 8.7)and Clinical Pharmacology ( 12.3)].

How it works

3 DOSAGE FORMS AND STRENGTHS Sildenafil Tablets USP, 25 mg are white colored, round-shaped, biconvex, film coated tablets debossed with 'I' on one side and '35' on the other side.Sildenafil Tablets USP, 50 mg are white colored, round-shaped, biconvex, film coated tablets debossed with 'I' on one side and '36' on the other side.Sildenafil Tablets USP, 100 mg are white colored, round-shaped, biconvex, film coated tablets debossed with 'I' on one side and '58' on the other side. Sildenafil Tablets USP, 25 mg are white colored, round-shaped, biconvex, film coated tablets debossed with 'I' on one side and '35' on the other side. 4 CONTRAINDICATIONS 4.1 NitratesConsistent with its known effects on the nitric oxide/cGMP pathway [ see Clinical Pharmacology ( 12.1, 12.2)] , sildenafil tablets were shown to potentiate the hypotensive effects of nitrates, and its administration to patients who are using nitric oxide donors such as organic nitrates or organic nitrites in any form either regularly and/or intermittently is therefore contraindicated.After patients have taken sildenafil tablets, it is unknown when nitrates, if necessary, can be safely administered. Although plasma levels of sildenafil at 24 hours post dose are much lower than at peak concentration, it is unknown whether nitrates can be safely co-administered at this time point [ see Dosage and Administration (2.3),Drug Interactions (7.1),and Clinical Pharmacology (12.2)].4.2 Hypersensitivity ReactionsSildenafil tablets are contraindicated in patients with a known hypersensitivity to sildenafil, as contained in sildenafil tablets and REVATIO, or any component of the tablet. Hypersensitivity reactions have been reported, including rash and urticaria [ see Adverse Reactions (6.1)].

Overdose/Missed Dose

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 were 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. Clinical data have shown that co-administration with saquinavir or erythromycin increased plasma levels of sildenafil by about 3 fold [see Drug Interactions (7.4)and Clinical Pharmacology (12.3)].2.5 Dosage Adjustments in Special PopulationsConsider a starting dose of 25 mg in patients > 65 years, patients with hepatic impairment (e.g., cirrhosis), and patients with severe renal impairment (creatinine clearance <30 mL/minute) because administration of sildenafil tablets in these patients resulted in higher plasma levels of sildenafil [see Use in Specific Populations ( 8.5, 8.6, 8.7)and Clinical Pharmacology ( 12.3)].

Sildenafil side effects

For most patients, the recommended dose is 50 mg taken, as needed, approximately sildenafil citrate tables 1 hour before sexual activity. The maximum recommended dosing frequency is once per day. Sildenafil tablets were 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)]. Consider a starting dose of 25 mg in patients > 65 years, patients with hepatic impairment (e.g., cirrhosis), and patients with severe renal impairment (creatinine clearance <30 mL/minute) because administration of sildenafil tablets in these patients resulted in higher plasma levels of sildenafil [see Use in Specific Populations ( 8.5, 8.6, 8.7)and Clinical Pharmacology ( 12.3)].

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