FLUTICASONE PROPIONATE spray, metered

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Proficient Rx LP

Stjórnsýsluleið:

NASAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

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

Vörulýsing:

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 63187-638-16) 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.                                                               

Leyfisstaða:

Abbreviated New Drug Application

Upplýsingar fylgiseðill

FLUTICASONE PROPIONATE- FLUTICASONE PROPIONATE SPRAY, METERED
Proficient Rx LP
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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 a week. T

Vara einkenni

FLUTICASONE PROPIONATE- FLUTICASONE PROPIONATE SPRAY, METERED
PROFICIENT RX LP
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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. (ERROR! HYPERLINK REFERENCE NOT VALID.)
(6)
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. (6)
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: 6/2022
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
us