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:

Quality Care Products, LLC

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)] . 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 propionate nasal spray. Mice and rats at fluticasone propiona

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 55700-714-16) 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 at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature]. Shake gently before each use.

Status autorizacije:

Abbreviated New Drug Application

Uputa o lijeku

FLUTICASONE PROPIONATE- FLUTICASONE PROPIONATE SPRAY, METERED
Quality Care Products, LLC
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MEDICATION GUIDE
HOW TO USE YOUR NASAL SPRAY
Read the complete instructions carefully and use only as directed.
BEFORE USING
Shake the bottle gently and then remove the translucent cap (Fig. 1).
It is necessary to prime the pump into the air the first time it is
used, or when you have not used it for a
week or more. To prime the pump, hold the bottle as shown with the
nasal applicator pointing away from
you and with your forefinger and middle finger on either side of the
nasal applicator and your thumb
underneath the bottle. When you prime the pump for the first time,
press down and release the pump 6
times. (Fig. 2).
The pump is now ready for use. If the pump is not used for 7 days,
prime until a fine spray appears.
USING THE SPRAY
Step 1. Blow your nose to clear your nostrils.
Step 2. Close one nostril. Tilt your head forward slightly and,
keeping the bottle upright, carefully insert
the nasal applicator into the other nostril (Fig. 3).
Step 3. Start to breathe in through your nose, and WHILE BREATHING IN
press firmly and quickly
down once on the applicator to release the spray. To get a full
actuation, use your forefinger and middle
finger to spray while supporting the base of the bottle with your
thumb. Avoid spraying in eyes. Breathe
gently inwards through the nostril (Fig. 4).
Step 4. Breathe out through your mouth.
Step 5. If a second spray is required in that nostril, repeat steps 2
through 4.
Step 6. Repeat steps 2 through 5 in the other nostril.
Step 7. Wipe the nasal applicator with a clean tissue and replace the
translucent cap (Fig. 5).
Do not use this bottle for more than the labeled number of sprays even
though the bottle is not completely
empty. Before you throw the bottle away, you should consult your
doctor to see if a refill is needed. Do
not take extra doses or stop taking fluticasone propionate nasal spray
without consulting your doctor.
CLEANING
Your nasal spray should be cleaned at least once

Svojstava lijeka

FLUTICASONE PROPIONATE- FLUTICASONE PROPIONATE SPRAY, METERED
QUALITY CARE PRODUCTS, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLUTICASONE PROPIONATE
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
FLUTICASONE PROPIONATE.
FLUTICASONE PROPIONATE NASAL SPRAY, USP, 50 MCG
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 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:
3.
4.
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
7.
8.
9.
10.
11.
12.
ADVERSE REACTIONS
The most common adverse reactions (>3%) are headache, pharyngitis,
epistaxis, nasal burning/nasal
irritation, nausea/vomiting, asthma symptoms, and cough. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT APOTEX CORP. AT
1-800-706-5575 OR FDA
AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir, ketoconazole):
Use not recommended. May
increase risk of systemic corticosteroid effects. (7.1)
USE IN SPECIFIC POPULATIONS
Hepatic impairment: Monitor patients for signs of increased drug
exposure. (8.6)
SEE 17 FOR PATIENT COUNSELING INFORMATION AND MEDICATION GUIDE.
REVISED: 10/2023
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)
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