País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
SILDENAFIL CITRATE (UNII: BW9B0ZE037) (SILDENAFIL - UNII:3M7OB98Y7H)
Greenstone LLC
SILDENAFIL CITRATE
SILDENAFIL 20 mg
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: Risk Summary Limited published data from randomized controlled trials, case-controlled trials, and case series do not report a clear association with sildenafil and major birth defects, miscarriage, or adverse maternal or fetal outcomes when sildenafil is used d
Sildenafil tablets are supplied as white, film-coated, round tablets containing sildenafil citrate equivalent to the nominally indicated amount of sildenafil as follows: Bottle of 90 Tablets 20 mg 59762-0033-1 SDF20 Bottle of 300 Tablets 20 mg 59762-0033-3 SDF20 Recommended Storage for Sildenafil Tablets: Store at controlled room temperature 20°C – 25°C (68°F – 77°F); excursions permitted to 15°C – 30°C (59°F – 86°F) [see USP Controlled Room Temperature]. 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. Powder for oral suspension – bottle 10 mg/mL (when reconstituted) 59762-2058-1 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 – 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.
New Drug Application Authorized Generic
SILDENAFIL- SILDENAFIL TABLET, FILM COATED SILDENAFIL- SILDENAFIL POWDER, FOR SUSPENSION GREENSTONE LLC ---------- 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 Leia o documento completo