FLUTICASONE PROPIONATE spray, metered

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Asclemed USA, Inc.

관리 경로:

NASAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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/m 2 basis, respectively. ( See Animal Data .) However, fluticasone propionate administered via

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, 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 16 gram size (NDC 76420-106-16 relabeled from NDC 50383-700-16). 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).

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

FLUTICASONE PROPIONATE- FLUTICASONE PROPIONATE SPRAY, METERED
ASCLEMED USA, INC.
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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)
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)
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
Epistaxis, nasal ulceration, Candida albicans infection, nasal septal
perforation, and impaired wound
healing. Monitor patients periodically for signs of adverse effects on
the nasal mucosa. Avoid use in
patients with recent nasal ulcers, nasal surgery, or nasal trauma.
(5.1)
Glaucoma and cataracts: Consider referral to an ophthalmologist in
patients who develop ocular
symptoms or use fluticasone propionate nasal spray, USP long-term.
(5.2)
Hypersensitivity reactions (e.g., anaphylaxis, angioedema, urticaria,
contact dermatitis, and rash) have
been reported after administration of fluticasone propionate nasal
spray, USP. Discontinue fluticasone
propionate nasal spray, USP if such reactions occur. (5.3)
Potential worsening of infections (e.g., existing tuberculosis;
fungal, bacterial, viral, or parasitic infection;
ocular herpes simplex). Use w