מדינה: ארצות הברית
שפה: אנגלית
מקור: NLM (National Library of Medicine)
SILDENAFIL CITRATE (UNII: BW9B0ZE037) (SILDENAFIL - UNII:3M7OB98Y7H)
Mylan Pharmaceuticals Inc.
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 [see Clinical Studies (14)] . Pediatric Patients (1 to 17 Years old) Sildenafil tablets are indicated in pediatric patients 1 to 17 years old for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) to improve exercise ability and, in pediatric patients too young to perform standardized exercise testing, pulmonary hemodynamics thought to underly improvements in exercise [see Clinical Studies (14)] . Sildenafil tablets are contraindicated in patients with: Click here to enter Use in Specific Populations 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 during pregnancy. There are risks to the mo
Sildenafil Tablets, USP are available containing sildenafil citrate, USP equivalent to 20 mg of sildenafil. The 20 mg tablets are blue, film-coated, oval, unscored tablets debossed with M on one side of the tablet and SL 20 on the other side. They are available as follows: NDC 0378-1657-77 bottles of 90 tablets Recommended Storage for Sildenafil Tablets: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
Abbreviated New Drug Application
SILDENAFIL- SILDINAFIL TABLET, FILM COATED MYLAN PHARMACEUTICALS INC. ---------- 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) 1/2023 Dosage and Administration (2.1, 2.2) 1/2023 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) Pediatric Patients (1 to 17 years old) Sildenafil tablets are indicated in pediatric patients 1 to 17 years old for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) to improve exercise ability and, in pediatric patients too young to perform standard exercise testing, pulmonary hemodynamics thought to underly improvements in exercise (1, 14) DOSAGE AND ADMINISTRATION • • DOSAGE FORMS AND STRENGTHS • CONTRAINDICATIONS • • WARNINGS AND PRECAUTIONS • • • • ADVERSE REACTIONS Adults: Headache, dyspepsia, flushing, pain in limb, myalgia, back pain and diarrhea. (6.1, 6.2) Children: Priapism. (6.1) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT MYLAN AT 1-877-446-3679 (1-877-4-INFO-RX) OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. DRUG INTERACTIONS • • Adults: 20 mg three times a day. Dose may be increased based on symptoms and tolerability. (2.1) Pediatric patients (2.2) o o o ≤20 kg: 10 mg three times a day 20 kg to 45 kg: 20 mg three times a day >45 kg: 20 mg three times a day. Dose may be increased based on symptoms and tolerability. Tablets: 20 mg (3) Use with organic nitrates or riociguat. (4) History of hypersensitivity reaction to sildenafil or any component of the tablet. (4) Vasodilation effects may be more common in patients with hypotension or on antihypert קרא את המסמך השלם