Nazione: Stati Uniti
Lingua: inglese
Fonte: NLM (National Library of Medicine)
FLUTICASONE PROPIONATE (UNII: O2GMZ0LF5W) (FLUTICASONE - UNII:CUT2W21N7U)
Unit Dose Services
FLUTICASONE PROPIONATE
FLUTICASONE PROPIONATE 50 ug
NASAL
PRESCRIPTION DRUG
Fluticasone Propionate Nasal Spray, USP 50 mcg per spray is indicated for the management of the nasal symptoms of perennial nonallergic rhinitis in adult and pediatric patients aged 4 years and older. Fluticasone Propionate Nasal Spray is contraindicated in patients with hypersensitivity to any of its ingredients [see Warnings and Precautions (5.3), Description (11)]. Teratogenic Effects Pregnancy Category C. There are no adequate and well-controlled trials with Fluticasone Propionate Nasal Spray in pregnant women. Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Because animal reproduction studies are not always predictive of human response, Fluticasone Propionate Nasal Spray should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Women should be advised to contact their physicians if they become pregnant while taking Fluticasone Propionate Nasal Spray. Mice and rats at flut
Product: 50436-2640 NDC: 50436-2640-1 120 SPRAY, METERED in a BOTTLE, SPRAY
Abbreviated New Drug Application
FLUTICASONE- FLUTICASONE PROPIONATE SPRAY, METERED UNIT DOSE SERVICES ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE FLUTICASONE PROPIONATE NASAL SPRAY SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FLUTICASONE PROPIONATE NASAL SPRAY. FLUTICASONE PROPIONATE NASAL SPRAY FOR INTRANASAL USE INITIAL U.S. APPROVAL: 1994 RECENT MAJOR CHANGES Indications and Usage (1) 01/2015 INDICATIONS AND USAGE Fluticasone Propionate Nasal Spray, USP 50 mcg per spray is a corticosteroid indicated for the management of the nasal symptoms of perennial nonallergic rhinitis in adult and pediatric patients aged 4 years and older. (1) DOSAGE AND ADMINISTRATION For intranasal use only. Recommended starting dosages: Adults: 2 sprays per nostril once daily (200 mcg per day). (2.1) Adolescents and children aged 4 years and older: 1 spray per nostril once daily (100 mcg per day). (2.2) DOSAGE FORMS AND STRENGTHS Nasal spray: 50 mcg of fluticasone propionate in each 100-mg spray. (3) CONTRAINDICATIONS Hypersensitivity to any ingredient. (4) WARNINGS AND PRECAUTIONS Epistaxis, nasal ulceration, _Candida albicans_ infection, nasal septal perforation, and impaired wound healing. Monitor patients periodically for signs of adverse effects on the nasal mucosa. Avoid use in patients with recent nasal ulcers, nasal surgery, or nasal trauma. (5.1) Close monitoring for glaucoma and cataracts is warranted. (5.2) Hypersensitivity reactions (e.g., anaphylaxis, angioedema, urticaria, contact dermatitis, and rash) have been reported after administration of Fluticasone Propionate Nasal Spray. Discontinue Fluticasone Propionate Nasal Spray if such reactions occur. (5.3) Potential worsening of infections (e.g., existing tuberculosis; fungal, bacterial, viral, or parasitic infection; ocular herpes simplex). Use with caution in patients with these infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients. (5.4) Hypercorticism and adrenal Leggi il documento completo