Sildenafil 50 mg Tablets — Generic for Viagra — TEVA Pharma

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 use

Initial U.S. Approval: 1998

Indications And Usage

Sildenafil tablets are 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)

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 Strengths

Tablets: 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)

Known hypersensitivity to sildenafil or any component of tablet (4.2)

Administration with guanylate cyclase (GC) stimulators, such as riociguat (4.3)

Warnings And Precautions

• 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). 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 coadministered 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 dosage is recommended (2.4, 5.6)

• 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). 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 coadministered 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 dosage is recommended (2.4, 5.6)

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). 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 coadministered 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 dosage is recommended (2.4, 5.6)

Adverse Reactions

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 Teva at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug Interactions

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 at 25 mg dose (2.3)

CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, erythromycin): Increase sildenafil 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 Populations

Geriatric use: Consider a starting dose of 25 mg (2.5, 8.5)

Severe renal impairment: Consider a starting dose of 25 mg (2.5, 8.6)

Hepatic impairment: Consider a starting dose of 25 mg (2.5, 8.7)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 7/2024