FLUTICASONE PROPIONATE spray, metered

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

NuCare Pharmaceuticals,Inc.

Administreringssätt:

NASAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Fluticasone propionate nasal 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 decrea

Produktsammanfattning:

Fluticasone Propionate Nasal Spray USP, 50 mcg, is supplied in an amber glass bottle fitted with a silver metering nasal pump, white plastic actuator, and translucent cap in a box of 1 (NDC 68071-2582-5) with a package insert (prescribing information and patient leaflet). Each bottle contains a net fill weight of 16 g and will provide 120 actuations. Store between 4°C to 30°C (39°F to 86°F). Shake gently before each use.

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

FLUTICASONE PROPIONATE- 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, USP
INITIAL U.S. APPROVAL: 1994
RECENT MAJOR CHANGES
Warnings and Precautions, Glaucoma and Cataracts ( 5.2) 1/2019
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)
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 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 these
infections. More serious or even fatal
cou