FLUTICASONE PROPIONATE spray, metered

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

FLUTICASONE PROPIONATE (UNII: O2GMZ0LF5W) (FLUTICASONE - UNII:CUT2W21N7U)

제공처:

Preferred Pharmaceuticals, Inc.

관리 경로:

NASAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Fluticasone propionate nasal spray is indicated for the management of the nasal symptoms of perennial nonallergic rhinitis in adults 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)] . Risk Summary There are insufficient data on the use of fluticasone propionate nasal spray 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 teratogenici

제품 요약:

Fluticasone Propionate Nasal Spray USP, 50 mcg is supplied in an amber glass bottle fitted with a white metering atomizing pump, white nasal adapter fitted with a clear plastic dust cap, and a green safety clip, in a box of one (NDC 68788-7658-01) with FDA-approved Patient Labeling (see Patient Instructions for Use for proper actuation of the device). Each bottle contains a net fill weight of 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 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).

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

FLUTICASONE PROPIONATE- FLUTICASONE PROPIONATE SPRAY, METERED
PREFERRED PHARMACEUTICALS, INC.
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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
INITIAL U.S. APPROVAL: 1994
RECENT MAJOR CHANGES
INDICATIONS AND USAGE
Fluticasone propionate nasal 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:
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DOSAGE FORMS AND STRENGTHS
Nasal spray: 50 mcg of fluticasone propionate USP in each 100 mg
spray. (3)
CONTRAINDICATIONS
Hypersensitivity to any ingredient. (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 WEST-WARD
PHARMACEUTICALS CORP. AT 1-
800-962-8364 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)
USE IN SPECIFIC POPULATIONS
Hepatic impairment: Monitor patients for signs of increased drug
exposure. (8.6)
SEE 17 FOR PATIENT COUNSELING INFORMATION AND PATIENT COUNSELING
INFORMATION.
REVISED: 5/2021
Warnings and Precautions, Glaucoma and Cataracts (5.2) 1/2019
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 effects