50mg Sildenafil Citrate Tablet

Sildenafil should be used with caution, and only when the anticipated benefits outweigh the risks, in patients with a history of NAION.

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Patients with a “crowded” optic disc may also be at an increased risk of NAION. (5.3)Patients should stop sildenafil 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.

• Legally, sildenafil is classified as a prescription drug in many parts of India.
• Online purchasing should be from licensed pharmacies to avoid scams.
• Always read the patient information leaflet before use.
• Sildenafil 50 mg offers a quick and effective solution for ED.
• The medication has been shown to improve sexual satisfaction for many men.
• Use in combination with counseling can improve overall outcomes.
• Avoid operating machinery or driving after taking sildenafil until effects are known.
• Report any adverse reactions to a healthcare provider promptly.
• Keep track of dosage and response to determine the ideal use pattern.

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 Macleods PharmaUSA, Inc., at 1-888-943-3210 or 1-855-926-3384 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 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.Revised: 9/2025 Warnings and Precautions, Effects on the Eye (5.3) 08/2017 Sildenafil tablets are 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, 100 mg (3) Administration of sildenafil to patients using nitric oxide donors, such as organic nitrates or organic nitrites in any form.

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Sildenafil was shown to potentiate sildenafil citrate 200mg price 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 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).

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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 [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 1 hour before sexual activity. However, sildenafil tablets may be taken anywhere from 30 minutes to 4 hours before sexual activity. 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)]. Consider a starting dose of 25 mg in patients > 65 years, patients with hepatic impairment (e.g., cirrhosis), and patients sildenafil 100mg hexal with severe renal impairment (creatinine clearance <30 mL/minute) because administration of sildenafil tablets [see Use in Specific Populations (8.5, 8.6, 8.7) and Clinical Pharmacology (12.3)].

Additional Information

3 DOSAGE FORMS & STRENGTHS Sildenafil tablets, USP are supplied as white to off-white, diamond shaped film-coated tablets containing sildenafil citrate, USP equivalent to 25 mg, 50 mg, or 100 mg of sildenafil. Tablets are debossed with ‘CL35’, ‘CL36’ and ‘CL37’ on one side for 25 mg, 50 mg and 100 mg respectively and plain on the other side Sildenafil tablets, USP are supplied as white to off-white, diamond shaped film-coated tablets containing sildenafil citrate, USP equivalent to 25 mg, 50 mg, or 100 mg of sildenafil. Tablets are debossed with ‘CL35’, ‘CL36’ and ‘CL37’ on one side for 25 mg, 50 mg and 100 mg respectively and plain 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 was 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, 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 is contraindicated in patients with a known hypersensitivity to sildenafil, as contained in sildenafil and REVATIO, or any component of the tablet.

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Patients should stop sildenafil 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.

Myth	Fact	Source
Sildenafil is addictive	No, it is not addictive	Medical authorities
It cures ED permanently	No, it provides temporary relief during use	Health experts
It causes heart attacks	Not directly, but can affect heart in some cases	Clinical studies
Only older men use it	Used by men across various age groups	User surveys

Concomitant use may sildenafil 20 mg prescription lead to hypotension (5.5) Decreased blood pressure, syncope, and prolonged erection may occur at higher sildenafil exposures.

• Sildenafil 50 mg is a widely accessible medication in India's healthcare market.
• It is essential to understand potential drug interactions before use.
• Some patients may experience dizziness or lightheadedness when standing.
• Use caution when combining sildenafil with antihypertensive medications.
• Avoid excessive alcohol consumption while using sildenafil.
• Patients with a history of heart attacks should consult a doctor before use.
• The medication does not provide protection against pregnancy or STDs.
• Regular medical checkups help ensure safe and effective use of sildenafil.
• Proper storage and handling ensure medication potency and safety.

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 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) Table of Contents FULL PRESCRIBING INFORMATION: CONTENTS*1 INDICATIONS & USAGE2 DOSAGE & 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 & 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 Antihypertensives5.6 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.

5.5 Hypotension when Co-administered with Alpha-blockers or Antihypertensives

Sildenafil 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 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.

Recreational use

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 Macleods PharmaUSA, Inc., at 1-888-943-3210 or 1-855-926-3384 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 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.Revised: 9/2025 Warnings and Precautions, Effects on the Eye (5.3) 08/2017 Sildenafil tablets are 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, 100 mg (3) Administration of sildenafil to patients using nitric oxide donors, such as organic nitrates or organic nitrites in any form. Sildenafil was shown to potentiate sildenafil citrate 200mg price 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 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 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.

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Concomitant use may sildenafil 20 mg prescription 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 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) Table of Contents FULL PRESCRIBING INFORMATION: CONTENTS*1 INDICATIONS & USAGE2 DOSAGE & 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 & 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 Antihypertensives5.6 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 DOSAGE & 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 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. Sections or subsections omitted from the full prescribing information are not listed.

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2 DOSAGE & 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 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 [see Use in Specific Populations (8.5, 8.6, 8.7) and Clinical Pharmacology (12.3)].

Parameter	Description	Value
Absorption Time	Time to reach peak plasma concentration	30-120 minutes
Bioavailability	Percentage of dose reaching systemic circulation	~40%
Distribution Volume	Space in body for drug distribution	105 L
Half-life	Time for plasma concentration to reduce by half	4-5 hours
Metabolism	Mainly liver via CYP3A4 enzyme	Liver

For most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity.

Drug Type	Interaction Detail	Risk Level	Notes
Nitrates	Dangerous hypotension risk	High	Contraindicated
Alpha-blockers	Increased hypotension risk	Moderate	Use under medical supervision
CYP3A4 inhibitors	Increased sildenafil levels, side effects	Moderate	Adjust dosage accordingly
Antibiotics (e.g., erythromycin)	Possible increased plasma concentration	Moderate	Monitor for side effects

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

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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)].

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Consider a starting dose of 25 mg in patients > 65 years, patients with hepatic impairment (e.g., cirrhosis), and patients sildenafil 100mg hexal with severe renal impairment (creatinine clearance <30 mL/minute) because administration of sildenafil tablets [see Use in Specific Populations (8.5, 8.6, 8.7) and Clinical Pharmacology (12.3)]. 3 DOSAGE FORMS & STRENGTHS Sildenafil tablets, USP are supplied as white to off-white, diamond shaped film-coated tablets containing sildenafil citrate, USP equivalent to 25 mg, 50 mg, or 100 mg of sildenafil. Tablets are debossed with ‘CL35’, ‘CL36’ and ‘CL37’ on one side for 25 mg, 50 mg and 100 mg respectively and plain on the other side Sildenafil tablets, USP are supplied as white to off-white, diamond shaped film-coated tablets containing sildenafil citrate, USP equivalent to 25 mg, 50 mg, or 100 mg of sildenafil.

• Sildenafil 50 mg is a popular erectile dysfunction medication available in India.
• It is used to treat male impotence by increasing blood flow to the penis.
• Sildenafil 50 mg is typically taken about 30-60 minutes before sexual activity.
• The medication's effects can last for up to 4-6 hours.
• It is available at many Indian pharmacies both online and offline.
• Sildenafil 50 mg is often prescribed for men with ED aged 40-70.
• The drug should be taken on an empty stomach for better absorption.
• Possible side effects include headache, dizziness, and flushing.
• Correct dosage and usage should be advised by a healthcare professional.

Tablets are debossed with ‘CL35’, ‘CL36’ and ‘CL37’ on one side for 25 mg, 50 mg and 100 mg respectively and plain 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 was 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, 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 is contraindicated in patients with a known hypersensitivity to sildenafil, as contained in sildenafil and REVATIO, or any component of the tablet.