国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
SILDENAFIL CITRATE (UNII: BW9B0ZE037) (SILDENAFIL - UNII:3M7OB98Y7H)
ATLANTIC BIOLOGICALS CORP.
ORAL
PRESCRIPTION DRUG
Sildenafil tablets are 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 tablets were 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 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
Sildenafil Tablets, USP 20 mg are supplied as white round, biconvex film coated tablets debossed with "R" on one side and "20" on the other side, containing sildenafil citrate equivalent to the nominally indicated amount of sildenafil as follows: Recommended Storage for Sildenafil Tablets, USP: 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].
Abbreviated New Drug Application
SILDENAFIL CITRATE- SILDENAFIL TABLET, FILM COATED ATLANTIC BIOLOGICALS CORP. ---------- 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 Warnings and Precautions, Visual Loss ( 5.5) 7/2017 INDICATIONS AND USAGE Sildenafil tablets are 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: 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 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 adverse reactions greater than or equal to 3% and more frequent than placebo were epistaxis, headache, dyspepsia, flus 阅读完整的文件