FLUTICASONE PROPIONATE- fluticasone propionate spray, metered

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Lake Erie Medical DBA Quality Care Products LLC

INN (Algemene Internationale Benaming):

FLUTICASONE PROPIONATE

Samenstelling:

FLUTICASONE PROPIONATE 50 ug

Toedieningsweg:

NASAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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

Product samenvatting:

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 55700-460-16) 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).

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

FLUTICASONE PROPIONATE- FLUTICASONE PROPIONATE SPRAY, METERED
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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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, 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)
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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
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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.
REVISED: 2/2017
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 of adverse e