Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
SILDENAFIL CITRATE (UNII: BW9B0ZE037) (SILDENAFIL - UNII:3M7OB98Y7H)
Tris Pharma Inc
ORAL
PRESCRIPTION DRUG
Sildenafil for oral suspension 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 for oral suspension 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 for oral suspension 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
Sildenafil powder for oral suspension is supplied in amber glass bottles. Each bottle contains white to off-white powders containing 1.57 g of sildenafil citrate (equivalent to 1.12 g sildenafil). Following reconstitution, the volume of the oral suspension is 112 mL (10 mg sildenafil/mL). A 2 mL oral dosing syringe (with 0.5 mL and 2 mL dose markings) and a press-in bottle adaptor are also provided. Recommended storage for Sildenafil for oral suspension: Store below 30°C (86°F) in the original package in order to protect from moisture. Reconstituted Oral Suspension Store below 30°C (86°F) or in refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze. The shelf-life of the reconstituted oral suspension is 60 days. Any remaining oral suspension should be discarded 60 days after reconstitution.
Abbreviated New Drug Application
SILDENAFIL- SILDENAFIL CITRATE POWDER, FOR SUSPENSION TRIS PHARMA INC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE SILDENAFIL FOR ORAL SUSPENSION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SILDENAFIL FOR ORAL SUSPENSION. SILDENAFIL FOR ORAL SUSPENSION INITIAL U.S. APPROVAL: 1998 INDICATIONS AND USAGE Sildenafil for oral suspension 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 Oral suspension: 5 mg or 20 mg three times a day, 4 to 6 hours apart; see full prescribing information for reconstitution instructions for the Powder for Oral Suspension. ( 2.1) DOSAGE FORMS AND STRENGTHS _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 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 common Citiți documentul complet