FLUTICASONE PROPIONATE- fluticasone propionate spray, metered

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

A-S Medication Solutions

Uygulama yolu:

NASAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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)] . 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 fluticasone propionate doses approximately 1 and 4 times, respect

Ürün özeti:

Product: 50090-2879 NDC: 50090-2879-0 120 SPRAY, METERED in a BOTTLE, GLASS

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

FLUTICASONE PROPIONATE- FLUTICASONE PROPIONATE SPRAY, METERED
A-S MEDICATION SOLUTIONS
----------
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
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) (1)
DOSAGE AND ADMINISTRATION
For intranasal use only. Recommended starting dosages: (2)
•
•
DOSAGE FORMS AND STRENGTHS
Nasal spray: 50 mcg of fluticasone propionate USP 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 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) (7)
USE IN SPECIFIC POPULATIONS
Hepatic impairment: Monitor patients for signs of increased drug
exposure. (8.6) (8)
SEE 17 FOR PATIENT COUNSELING INFORMATION AND PATIENT COUNSELING
INFORMATION.
REVISED: 2/2018
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
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