FLUTICASONE PROPIONATE- fluticasone propionate spray, metered

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Direct_RX

Administracija rute:

NASAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

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 is contraindicated in patients with hypersensitivity to any of its ingredients [see Warnings and Precautions (5.3), Description (11)]. 8.1 Pregnancy 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 induc

Proizvod sažetak:

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 60505-0829-1) with a package insert (prescribing information and patient leaflet). 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°C and 30°C (39°F to 86°F). Shake gently before each use.

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

FLUTICASONE PROPIONATE- FLUTICASONE PROPIONATE SPRAY, METERED
DIRECT_RX
----------
FLUTICASONE PROPIONATE
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.
Administer Fluticasone propionate nasal spray by the intranasal route
only. Prime fluticasone propionate
nasal spray before using for the first time or after a period of
non-use (1 week or more) by shaking the
contents well and releasing 6 sprays into the air away from the face.
Shake fluticasone propionate nasal
spray gently before each use.
Patients should use fluticasone propionate nasal spray at regular
intervals since its effectiveness
depends on its regular use. Maximum effect may take several days and
individual patients will
experience a variable time to onset and different degree of symptom
relief.
2.1 Adults
The recommended starting dosage in adults is 2 sprays (50 mcg of
fluticasone propionate each) in each
nostril once daily (total daily dose, 200 mcg). The same total daily
dose, 1 spray in each nostril
administered twice daily (e.g., 8 a.m. and 8 p.m.) is also effective.
After the first few days, patients may
be able to reduce their dose to 1 spray in each nostril once daily for
maintenance therapy.
Maximum total daily doses should not exceed 2 sprays in each nostril
(total dose, 200 mcg/day). There
is no evidence that exceeding the recommended dose is more effective.
2.2 Adolescents and Children (Aged 4 Years and Older)
The recommended starting dosage in adolescents and children, aged 4
years and older is 1 spray in each
nostril once daily (total daily dose, 100 mcg). Patients not
adequately responding to 1 spray in each
nostril may use 2 sprays in each nostril once daily (total daily dose,
200 mcg). Once adequate control is
achieved, the dosage should be decreased to 1 spray in each nostril
once daily.
The maximum total daily dosage should not exceed 2 sprays in each
nostril (200 mcg/day). There is no
evidence tha