Sildenafil 20 mg Tablets *** — Generic For Revatio — Camber

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

Recent Major Changes

Indications and Usage (

1) 1/2023

Dosage and Administration (

2.1) 1/2023

Indications And Usage

Adults

Sildenafil tablets are a phosphodiesterase-5 (PDE-5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening. (

1)

Dosage And Administration

2.1)

Dosage Forms And Strengths

3)

Contraindications

Use with organic nitrates or riociguat. (

4)

History of hypersensitivity reaction to sildenafil or any component of the tablet. (

4)

Warnings And Precautions

• Vasodilation effects may be more common in patients with hypotension or on antihypertensive therapy. ( 5.1)
• Use in pulmonary veno-occlusive disease (PVOD) may cause pulmonary edema and is not recommended. ( 5.2)
• Hearing or visual impairment: Seek medical attention if sudden decrease or loss of vision or hearing occurs. ( 5.4, 5.5)
• Pulmonary hypertension (PH) secondary to sickle cell disease: Sildenafil may cause serious vaso-occlusive crises. ( 5.8)

• Vasodilation effects may be more common in patients with hypotension or on antihypertensive therapy. ( 5.1)
• Use in pulmonary veno-occlusive disease (PVOD) may cause pulmonary edema and is not recommended. ( 5.2)
• Hearing or visual impairment: Seek medical attention if sudden decrease or loss of vision or hearing occurs. ( 5.4, 5.5)
• Pulmonary hypertension (PH) secondary to sickle cell disease: Sildenafil may cause serious vaso-occlusive crises. ( 5.8)

Vasodilation effects may be more common in patients with hypotension or on antihypertensive therapy. (

5.1)

Use in pulmonary veno-occlusive disease (PVOD) may cause pulmonary edema and is not recommended. (

5.2)

Hearing or visual impairment: Seek medical attention if sudden decrease or loss of vision or hearing occurs. (

5.4,

5.5)

Pulmonary hypertension (PH) secondary to sickle cell disease: Sildenafil may cause serious vaso-occlusive crises. (

5.8)

Adverse Reactions

Adults: Headache, dyspepsia, flushing, pain in limb, myalgia, back pain and diarrhea. (

6.1,

6.2)

To report SUSPECTED ADVERSE REACTIONS, contact Hetero Labs Limited at 1-866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug Interactions

Use with strong CYP3A inhibitors: Not recommended. (

7,

12.3)

Concomitant PDE-5 inhibitors: Avoid use with Viagra

®or other PDE-5 inhibitors. (

5.6)

Pediatric use information is approved for Viatris Specialty LLC’s, REVATIO (sildenafil) tablets. However, due to Viatris Specialty LLC’s marketing exclusivity rights, this drug product is not labeled with that information.

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 2/2024