VERAMYST- fluticasone furoate spray, metered

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

FLUTICASONE FUROATE (UNII: JS86977WNV) (FLUTICASONE - UNII:CUT2W21N7U)

Tersedia dari:

GlaxoSmithKline LLC

INN (Nama Internasional):

FLUTICASONE FUROATE

Komposisi:

FLUTICASONE FUROATE 27.5 ug

Rute administrasi :

NASAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

VERAMYST® (fluticasone furoate) Nasal Spray is indicated for the treatment of the symptoms of seasonal and perennial allergic rhinitis in patients aged 2 years and older. VERAMYST Nasal Spray is contraindicated in patients with hypersensitivity to any of its ingredients [see Warnings and Precautions (5.3)] . Teratogenic Effects Pregnancy Category C. Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. There were no teratogenic effects in rats and rabbits at inhaled fluticasone furoate dosages of up to 91 and 8 mcg/kg/day, respectively (approximately 7 and 1 times, respectively, the maximum recommended daily intranasal dose in adults on a mcg/m2 basis). There was also no effect on pre- or post-natal development in rats treated with up to 27 mcg/kg/day by inhalation during gestation and lactation (approximately 2 times the maximum recommended daily intranasal dose in adults on a mcg/m2 basis). There are no adequate and well-co

Ringkasan produk:

VERAMYST Nasal Spray, 27.5 mcg per spray, is supplied in a brown glass bottle enclosed in a nasal device with a nozzle and a mist-release button to actuate the spray in a box of 1 (NDC 0173-0753-00) with FDA-Approved Patient Labeling (see Patient Instructions for Use for proper actuation of the device). Each bottle contains a net fill weight of 10 g of white, liquid suspension and will provide 120 metered sprays. After priming [see Dosage and Administration (2)] , each spray delivers a fine mist containing 27.5 mcg of fluticasone furoate in 50 microliters of formulation through the nozzle. The contents of the bottle can be viewed through an indicator window. Shake the contents well before each use. The correct amount of medication in each spray cannot be assured before the initial priming and after 120 sprays have been used, even though the bottle is not completely empty. The nasal device should be discarded after 120 sprays have been used. Store the device in the upright position with the cap in place between 15 ° and 30 °C (59 ° and 86 °F). Do not freeze or refrigerate.

Status otorisasi:

New Drug Application

Karakteristik produk

VERAMYST- FLUTICASONE FUROATE SPRAY, METERED
GLAXOSMITHKLINE LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VERAMYST SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR VERAMYST.
VERAMYST (FLUTICASONE FUROATE) NASAL SPRAY
INITIAL U.S. APPROVAL: 2007
INDICATIONS AND USAGE
VERAMYST Nasal Spray is a corticosteroid indicated for treatment of
symptoms of seasonal and perennial allergic rhinitis
in adults and children ≥2 years. (1.1)
DOSAGE AND ADMINISTRATION
For intranasal use only. Usual starting dosages:
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DOSAGE FORMS AND STRENGTHS
Nasal spray: 27.5 mcg of fluticasone furoate in each 50-microliter
spray. (3)
Supplied in 10-g bottle containing 120 sprays. (16)
CONTRAINDICATIONS
Hypersensitivity to ingredients. (4)
WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
The most common adverse reactions (>1% incidence) included headache,
epistaxis, pharyngolaryngeal pain, nasal
ulceration, back pain, pyrexia, and cough. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT GLAXOSMITHKLINE AT
1-888-825-5249 OR FDA AT 1-800-
FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Potent inhibitors of cytochrome P450 3A4 (CYP3A4) may increase
exposure to fluticasone furoate.
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USE IN SPECIFIC POPULATIONS
Hepatic impairment may increase exposure to fluticasone furoate. Use
with caution in patients with moderate or severe
hepatic impairment. (8.6)
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 7/2016
Adults and adolescents ≥12 years: 110 mcg (2 sprays per nostril)
once daily. (2.1)
Children 2-11 years: 55 mcg (1 spray per nostril) once daily. (2.2)
Priming information: Prime VERAMYST Nasal Spray before using for the
first time, when not used for more than 30
days, or if the cap has been left off the bottle for 5 days or longer.
(2)
Epistaxis, nasal ulceration, Candida albicans infection, nasal septal
perforation, impaired wound healing. Monitor
patients periodically for signs of