50mg Sildenafil Citrate Tablet

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Top 20 FAQs
4.3 Concomitant Guanylate Cyclase (GC) Stimulators
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8.6 Renal Impairment
Other Options for the Treatment of Erectile Dysfunction
8.1 Pregnancy

Use Case	Description	Typical Dosage	Duration of Effect	Suitable For
Erectile Dysfunction	Helps attain and maintain erections	50 mg	Up to 4-6 hours	Men with ED
Pulmonary Hypertension	Improves blood flow in lungs	50 mg	About 4 hours	Patients with PAH
Off-label Uses	Alternative treatments beyond primary uses	Varies	Varies	Under doctor supervision

HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively.

In-depth Details for Importers, Exporters, and Buyers

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See full prescribing information for 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 tablets are 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.

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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, 100 mg (3)CONTRAINDICATIONSAdministration of sildenafil to patients using nitric oxide donors, such as organic nitrates or organic nitrites in any form. Sildenafil 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.

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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 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 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 sildenafil tablet manforce 50 mg lasts >4 hours.

Erectile dysfunction

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. 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 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. 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). 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” sildenafil citrate chewable tablets 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.

4.3 Concomitant Guanylate Cyclase (GC) Stimulators

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)].

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

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.

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

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Who Should NOT Take Sildenafil

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.

8.6 Renal Impairment

Approval: 1998 Drug-Drug Interactions in the Management of Patients With Pulmonary Arterial Hypertension NDC Code(s): 33342-041-07, 33342-041-11, 33342-041-44, 33342-041-98, view more33342-042-07, 33342-042-11, 33342-042-44, 33342-042-98, 33342-043-07, 33342-043-11, 33342-043-44, 33342-043-98 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: 1998RECENT MAJOR CHANGESWarnings and Precautions, Effects on the Eye (5.3) 08/2017INDICATIONS AND USAGESildenafil tablets are 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, 100 mg (3)CONTRAINDICATIONSAdministration of sildenafil to patients using nitric oxide donors, such as organic nitrates or organic nitrites in any form.

Other warnings

Sildenafil 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 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 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” sildenafil citrate chewable tablets 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. 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 50 mg is available in India in various brands and formulations.
Purchase from licensed sources to ensure product safety and efficacy.
Long-term use should be monitored by a healthcare professional.
Sildenafil can cause vision changes, such as blurred or blue-tinted vision.
Avoid taking sildenafil if you experience sudden loss of vision or hearing.
The medication may cause low blood pressure in some users.
Not recommended for use by women or children.
Sildenafil 50 mg is sometimes used off-label for other conditions.
Proper hydration and a healthy lifestyle may improve treatment outcomes.

Other Options for the Treatment of Erectile Dysfunction

19. Is discreet packaging available?

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. 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.

8.1 Pregnancy

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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. 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)].