FLUTICASONE PROPIONATE spray, metered

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Akorn

INN (الاسم الدولي):

FLUTICASONE PROPIONATE

تركيب:

FLUTICASONE PROPIONATE 50 ug in 0.1 g

طريقة التعاطي:

NASAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

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

ملخص المنتج:

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).

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

FLUTICASONE PROPIONATE- FLUTICASONE PROPIONATE SPRAY, METERED
AKORN
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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