Sildenafil 50 mg Tablets — Generic for Viagra — Camber 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 tablet is a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED)

(1)

Dosage And Administration

(2.1)

(2.1)

(2.1)

Dosage Forms And Strengths

Tablets: 25 mg, 50 mg, 100 mg

(3)

Contraindications

4.1,

7.1,

12.2)

(4.2)

(4.3)

Warnings And Precautions

• 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. 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. In patients taking strong CYP inhibitors, such as ritonavir, sildenafil exposure is increased. Decrease in sildenafil tablets dosage is recommended (2.4, 5.6)

• 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. 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. In patients taking strong CYP inhibitors, such as ritonavir, sildenafil exposure is increased. Decrease in sildenafil tablets dosage is recommended (2.4, 5.6)

(5.1)

(5.2)

(5.3)

(5.4)

(5.5)

(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 Hetero Labs Limited at 866-495-1995 or FDA at 1-800-FDA-1088 or

www.fda.gov/medwatch.

Drug Interactions

4.1,

5.5,

7.1,

7.2,

7.3,

12.2)

(2.3)

(2.4,

7.4,

12.3)

2.4,

5.6)

(2.4,

7.4)

Use In Specific Populations

(2.5,

8.5)

2.5,

8.6)

2.5,

8.7)

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

Revised: 12/2025