FLUTICASONE PROPIONATE spray, metered

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

RPK Pharmaceuticals, Inc.

Spôsob podávania:

NASAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

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

Prehľad produktov:

Product: 53002-7692 NDC: 53002-7692-1 16 g in a BOTTLE, PUMP / 1 in a CARTON

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

FLUTICASONE PROPIONATE- FLUTICASONE PROPIONATE SPRAY, METERED
RPK PHARMACEUTICALS, INC.
----------
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: 12/2020
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 si