Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
SILDENAFIL CITRATE (UNII: BW9B0ZE037) (SILDENAFIL - UNII:3M7OB98Y7H)
Amneal Pharmaceuticals LLC
SILDENAFIL CITRATE
SILDENAFIL 20 mg
ORAL
PRESCRIPTION DRUG
Adults Sildenafil tablets are 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. New Dosing Regimen in Adults with Pulmonary Arterial Hypertension (PAH) and treatment of PAH in Pediatric Patients (Ages 1 to 17) information are 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 these information. Sildenafil tablets are contraindicated in patients with: - Concomitant use of organic nitrates in any form, either regularly or intermittently, because of the greater risk of hypotension [see Warnings and Precautions (5.1)] . - Concomitant use of riociguat, a guanylate cyclase stimulator. Phosphodiesterase-5 (PDE-5) inhibitors, including sildenafil, may potentiate the hypotensive effects of riociguat. - Known hypersensitivity to sildenafil or any component of the tablet.
Sildenafil Tablets USP, 20 mg, are supplied as white to off-white, round shaped film-coated tablets with debossing ‘AN 351’ on one side and plain on the other side, containing sildenafil citrate, USP equivalent to the nominally indicated amount of sildenafil. They are available as follows: Bottles of 90: NDC 65162-351-09 Bottles of 1000: NDC 65162-351-11 Recommended Storage for Sildenafil Tablets, USP: Store at controlled room temperature 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
SILDENAFIL- SILDENAFIL TABLET AMNEAL PHARMACEUTICALS LLC ---------- 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 USE INITIAL U.S. APPROVAL: 1998 RECENT MAJOR CHANGES Indications and Usage (1) 01/2023 Dosage and Administration (2.1) 01/2023 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 Adults: 20 mg three times a day, 4 to 6 hours apart. (2.1) DOSAGE FORMS AND STRENGTHS Tablets: 20 mg (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 citrate 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 AMNEAL PHARMACEUTICALS AT 1-877-835- 5472 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) _New Dosing Regimen in Adults with Pulmonary Arterial Hypertension (PAH) and treatment of PAH in_ _Pediatric Patients (Ages 1 to 17) information are approved for Vi Olvassa el a teljes dokumentumot