Страна: США
мова: англійська
Джерело: NLM (National Library of Medicine)
FLUTICASONE PROPIONATE (UNII: O2GMZ0LF5W) (FLUTICASONE - UNII:CUT2W21N7U)
Akorn
FLUTICASONE PROPIONATE
FLUTICASONE PROPIONATE 50 ug in 0.1 g
NASAL
PRESCRIPTION DRUG
Fluticasone propionate nasal spray, USP 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, USP is contraindicated in patients with hypersensitivity to any of its ingredients [see Warnings and Precautions (5.3), Description (11) ]. Risk Summary There are insufficient data on the use of fluticasone propionate in pregnant women to inform a drug-associated risk. In animals, teratogenicity characteristic of corticosteroids, decreased fetal body weight and/or skeletal variations, were observed in rats, mice, and rabbits with subcutaneously administered maternal toxic doses of fluticasone propionate 5 times, equivalent to, and less than the maximum recommended human daily intranasal dose (MRHDID) on a mcg/m2 basis, respectively. (See Animal Data .) However, fluticasone propionate administered via nose-only inhalation to rats decreased fetal body weight, but did not induce teratogenicit
Fluticasone Propionate Nasal Spray, USP 50 mcg is supplied in an amber glass bottle fitted with a white metering atomizing pump, white nasal adapter, in a box of 1 with FDA-approved Patient Labeling (see Patient Instructions for Use for proper actuation of the device). Fluticasone Propionate Nasal Spray, USP 50 mcg comes in two (2) sizes; a 9 gram and 16 gram. The 9 gram fill contains a net fill weight of 9 g and will provide 50 actuations and the 16 gram fill contains 16 g and will provide 120 actuations. Each actuation delivers 50 mcg of fluticasone propionate in 100 mg of formulation through the nasal adapter. The correct amount of medication in each spray cannot be assured after 50/120 sprays even though the bottle is not completely empty. The bottle should be discarded when the labeled number of actuations has been used. Store between 4° and 30°C (39° and 86°F).
Abbreviated New Drug Application
FLUTICASONE PROPIONATE- FLUTICASONE PROPIONATE SPRAY, METERED AKORN ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE FLUTICASONE PROPIONATE NASAL SPRAY, USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FLUTICASONE PROPIONATE NASAL SPRAY, USP. FLUTICASONE PROPIONATE NASAL SPRAY, USP, 50 MCG FOR INTRANASAL USE INITIAL U.S. APPROVAL: 1994 RECENT MAJOR CHANGES Warnings and Precautions, Glaucoma and Cataracts (5.2) 01/2019 INDICATIONS AND USAGE Fluticasone propionate nasal spray, USP 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) (1) DOSAGE AND ADMINISTRATION For intranasal use only. Recommended starting dosages: (2) • • DOSAGE FORMS AND STRENGTHS Nasal spray: 50 mcg of fluticasone propionate in each 100-mg spray. (3) (3) CONTRAINDICATIONS Hypersensitivity to any ingredient. (4) (4) WARNINGS AND PRECAUTIONS • • • • • • ADVERSE REACTIONS The most common adverse reactions (>3%) are headache, pharyngitis, epistaxis, nasal burning/nasal irritation, nausea/vomiting, asthma symptoms, and cough. (6.1) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT HI-TECH PHARMACAL CO., INC. AT 1-800- 262-9010 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. DRUG INTERACTIONS Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir, ketoconazole): Use not recommended. May increase risk of systemic corticosteroid effects. (7.1) (7) USE IN SPECIFIC POPULATIONS Hepatic impairment: Monitor patients for signs of increased drug exposure. (8.6) (8) SEE 17 FOR PATIENT COUNSELING INFORMATION. REVISED: 3/2022 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) Epistaxis, nasal ulceration, Candida albicans infection, nasal septal perforation, and impaired wound healing. Monitor patients periodically for signs of adverse effec Прочитайте повний документ