FLUTICASONE- fluticasone propionate spray, metered

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NuCare Pharmaceuticals,Inc.

INN (International Name):

FLUTICASONE PROPIONATE

Composition:

FLUTICASONE PROPIONATE 50 ug

Administration route:

NASAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Fluticasone Propionate Nasal Spray, USP 50 mcg per spray 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 is contraindicated in patients with hypersensitivity to any of its ingredients [see Warnings and Precautions (5.3), Description (11)]. Teratogenic Effects Pregnancy Category C. 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

Product summary:

Fluticasone Propionate Nasal Spray, 50 mcg is supplied in an amber glass bottle fitted with a white metering atomizing pump, white nasal adapter, and transparent dust cap in a box of 1 (NDC 68071-1638-5) 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).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FLUTICASONE- FLUTICASONE PROPIONATE SPRAY, METERED
NUCARE PHARMACEUTICALS,INC.
----------
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
RECENT MAJOR CHANGES
Indications and Usage ( 1)
01/2015
INDICATIONS AND USAGE
Fluticasone Propionate Nasal Spray, USP 50 mcg per 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)
DOSAGE AND ADMINISTRATION
For intranasal use only. Recommended starting dosages:
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)
CONTRAINDICATIONS
Hypersensitivity to any ingredient. ( 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)
Close monitoring for glaucoma and cataracts is warranted. ( 5.2)
Hypersensitivity reactions (e.g., anaphylaxis, angioedema, urticaria,
contact dermatitis, and rash) have been reported
after administration of Fluticasone Propionate Nasal Spray.
Discontinue Fluticasone Propionate Nasal Spray if such
reactions occur. ( 5.3)
Potential worsening of infections (e.g., existing tuberculosis;
fungal, bacterial, viral, or parasitic infection; ocular herpes
simplex). Use with caution in patients with these infections. More
serious or even fatal course of chickenpox or measles
can occur in susceptible patients. ( 5.4)
Hypercor