Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
SILDENAFIL CITRATE (UNII: BW9B0ZE037) (SILDENAFIL - UNII:3M7OB98Y7H)
Unit Dose Services
ORAL
PRESCRIPTION DRUG
Sildenafil is indicated for the treatment of pulmonary arterial hypertension (WHO Group I) in adults to improve exercise ability and delay clinical worsening. The delay in clinical worsening was demonstrated when sildenafil was added to background epoprostenol therapy [see Clinical Studies (14)] . Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with New York Heart Association (NYHA) Functional Class II–III symptoms and idiopathic etiology (71%) or associated with connective tissue disease (CTD) (25%). Limitation of Use: Adding sildenafil to bosentan therapy does not result in any beneficial effect on exercise capacity [see Clinical Studies (14)] . Sildenafil is 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 (5.2)] . - Concomitant use of riociguat, a guanylate cyclase stimulator. PDE-5 inhibitors, including s
Product: 50436-0034 NDC: 50436-0034-1 1 TABLET, FILM COATED in a POUCH NDC: 50436-0034-2 2 TABLET, FILM COATED in a POUCH NDC: 50436-0034-3 3 TABLET, FILM COATED in a POUCH NDC: 50436-0034-4 4 TABLET, FILM COATED in a POUCH NDC: 50436-0034-5 5 TABLET, FILM COATED in a POUCH
New Drug Application Authorized Generic
SILDENAFIL- SILDENAFIL TABLET, FILM COATED UNIT DOSE SERVICES ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE SILDENAFIL SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SILDENAFIL. SILDENAFIL TABLETS, FOR ORAL USE SILDENAFIL FOR ORAL SUSPENSION INITIAL U.S. APPROVAL: 1998 INDICATIONS AND USAGE Sildenafil is a phosphodiesterase-5 (PDE-5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) in adults to improve exercise ability and delay clinical worsening. Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with NYHA Functional Class II–III symptoms. Etiologies were idiopathic (71%) or associated with connective tissue disease (25%). (1) Limitation of Use: Adding sildenafil to bosentan therapy does not result in any beneficial effect on exercise capacity. (1, 14) DOSAGE AND ADMINISTRATION Tablets and oral suspension: 5 mg or 20 mg three times a day, 4–6 hours apart; see full prescribing information for reconstitution instructions for the Powder for Oral Suspension (2.1, 2.2) DOSAGE FORMS AND STRENGTHS _Tablets:_ 20 mg (3) _For Oral Suspension:_ 10 mg/mL (when reconstituted) (3) CONTRAINDICATIONS Use with organic nitrates or riociguat. (4) History of hypersensitivity reaction to sildenafil or any component of the tablet or oral suspension. (4) WARNINGS AND PRECAUTIONS Increased mortality with increasing doses in pediatric patients. Not recommended for use in pediatric patients. (5.1) Vasodilation effects may be more common in patients with hypotension or on antihypertensive therapy. (5.2) Use in pulmonary veno-occlusive disease may cause pulmonary edema and is not recommended. (5.3) Hearing or visual impairment: Seek medical attention if sudden decrease or loss of vision or hearing occurs. (5.5, 5.6) Pulmonary hypertension secondary to sickle cell disease: sildenafil may cause serious vaso-occlusive crises. (5.9) ADVERSE REACTIONS Most commo Lire le document complet