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:

Morton Grove 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)]. Risk Summary There are insufficient data on the use of Fluticasone Propionate Nasal Spray 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 i

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 60432-264-15) 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
MORTON GROVE PHARMACEUTICALS, INC.
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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
RECENT MAJOR CHANGES
Warnings and Precautions, Glaucoma and Cataracts (5.2)
01/2019
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)
Glaucoma and cataracts: Consider referral to an ophthalmologist in
patients who develop ocular symptoms or use
Fluticasone Propionate Nasal Spray 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.
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 t