7 DRUG INTERACTIONS

4.3 Concomitant Guanylate Cyclase (GC) Stimulators
About Sildenafil Citrate Tablets 200mg
Warnings & Precautions
4.1 Nitrates
2.1 Dosage Information
What to avoid

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: 1998INDICATIONS AND USAGESildenafil citrate 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: 100 mg (3)CONTRAINDICATIONSAdministration of sildenafil tablets to patients using nitric oxide donors, such as organic nitrates or organic nitrites in any form. Sildenafil citrate 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 tablets if sexual activity is inadvisable due to cardiovascular status (5.1)Patients should seek emergency treatment if an erection lasts >4 hours. 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.

4.3 Concomitant Guanylate Cyclase (GC) Stimulators

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 sildenafil citrate tablets 150 mg loss of hearing (5.4)Caution is advised when sildenafil tablets is co-administered with alpha-blockers or anti-hypertensives.

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About Sildenafil Citrate Tablets 200mg

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Decrease in sildenafil citrate 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 Quallent Pharmaceuticals Health LLC at 1-877-605-7243 or FDA at 1-800-FDA-1088 or INTERACTIONSSildenafil citrate 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 citrate at 25 mg dose (2.3)CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, erythromycin): Increase sildenafil citrate exposure (2.4, 7.4, 12.3)USE IN SPECIFIC POPULATIONSSee 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.Revised: 11/2025 Sildenafil citrate 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) Administration of sildenafil tablets to patients using nitric oxide donors, such as organic nitrates or organic nitrites in any form.

Use Case	Patient Group	Typical Dosage	Onset Time	Duration of Effect
Erectile Dysfunction	Men aged 18-65	200mg	30-60 min	Up to 4-6 hours
Pulmonary Hypertension	Adults with PAH	200mg titrated	15-30 min	4-6 hours
Off-label for Altitude Sickness	High-altitude climbers	200mg	1-2 hours	Varies

Warnings & Precautions

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 is co-administered with alpha-blockers or anti-hypertensives.

The onset of action for sildenafil citrate is typically 30 minutes, but varies among individuals.
Sildenafil citrate can last 4-6 hours, depending on dosage and personal metabolism.
Use sildenafil citrate responsibly to prevent dependence or misuse.

Concomitant use may lead to hypotension (5.5) Decreased blood pressure, syncope, and prolonged erection may occur at higher sildenafil citrate exposures.

4.1 Nitrates

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). 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 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 citrate exposures. Decrease in sildenafil citrate 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) To report SUSPECTED ADVERSE REACTIONS, contact Quallent Pharmaceuticals Health LLC at 1-877-605-7243 or FDA at 1-800-FDA-1088 or Sildenafil citrate 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 citrate at 25 mg dose sildenafil chewable tablets (2.3) CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, erythromycin): Increase sildenafil citrate 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.

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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 citrate 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. 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)].

Drug Interactions

For most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour 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. Decrease in sildenafil citrate 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) To report SUSPECTED ADVERSE REACTIONS, contact Quallent Pharmaceuticals Health LLC at 1-877-605-7243 or FDA at 1-800-FDA-1088 or Sildenafil citrate 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 citrate at 25 mg dose sildenafil chewable tablets (2.3) CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, erythromycin): Increase sildenafil citrate 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.

Sildenafil citrate may interact with certain antifungals and antibiotics, increasing side effects.
Always review current medications with your healthcare provider before using sildenafil citrate.
Report any adverse reactions immediately to prevent worsening health conditions.

2.1 Dosage Information

Less common

How should I store sildenafil?

However, sildenafil tablets may be taken anywhere from 30 minutes to 4 hours before sexual activity.

At 200mg, visual side effects like blue-green tint are more pronounced.
This occurs because PDE6 in retinal rods is also inhibited at high doses.
Transient light sensitivity and blurred vision may last several hours.
Risk increases with dose; 200mg has higher incidence than 50mg or 100mg.
In most cases, visual changes are reversible upon drug elimination.
Patients with retinitis pigmentosa should avoid sildenafil altogether.
NAION (non-arteritic ischemic optic neuropathy) risk is dose-independent.
Annual eye exams may be advised for patients using high-dose sildenafil.
Report any sudden vision loss immediately; it may be permanent.

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 citrate 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. 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)].

What to avoid

QUALITATIVE AND QUANTITATIVE COMPOSITION:

Sildenafil citrate 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 tablets if sexual activity is inadvisable due to cardiovascular status (5.1)Patients should seek emergency treatment if an erection lasts >4 hours. 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 sildenafil citrate tablets 150 mg loss of hearing (5.4)Caution is advised when sildenafil tablets is co-administered with alpha-blockers or anti-hypertensives.

Does sildenafil interact with other medicines (drug interactions)?

Concomitant use may lead to hypotension (5.5)Decreased blood pressure, syncope, and prolonged erection may occur at higher sildenafil citrate exposures. In patients taking strong CYP inhibitors, such as ritonavir, sildenafil exposure is increased. Decrease in sildenafil citrate 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 Quallent Pharmaceuticals Health LLC at 1-877-605-7243 or FDA at 1-800-FDA-1088 or INTERACTIONSSildenafil citrate 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 citrate at 25 mg dose (2.3)CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, erythromycin): Increase sildenafil citrate exposure (2.4, 7.4, 12.3)USE IN SPECIFIC POPULATIONSSee 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.Revised: 11/2025 Sildenafil citrate 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) Administration of sildenafil tablets to patients using nitric oxide donors, such as organic nitrates or organic nitrites in any form. Sildenafil citrate 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 tablets if sexual activity is inadvisable due to cardiovascular status (5.1) Patients should seek emergency treatment if an erection lasts >4 hours. For most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity.

Sildenafil citrate 200mg may cause vision changes such as blue tinting.
Do not take sildenafil citrate if prone to cardiovascular issues without doctor approval.
Side effects can include dizziness, nasal congestion, and stomach upset.

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.