FLONASE ALLERGY RELIEF Aqueous nasal spray (2019)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Name of the medicinal product
Flonase Allergy Relief Fluticasone propionate aqueous nasal spray USP.
Summary product information
Route of Administration Dosage Form/Strength Nonmedicinal Ingredients Intranasal Nasal spray/50 mcg benzalkonium chloride, dextrose, microcrystalline cellulose and carboxymethylcellulose sodium, phenylethyl ...
Indications and clinical use
Flonase Allergy Relief (fluticasone propionate aqueous nasal spray) is indicated for: the treatment of the symptoms associated with seasonal allergic rhinitis including hay fever, and perennial rhinitis. ...
Contraindications
Flonase Allergy Relief (fluticasone propionate aqueous nasal spray) is contraindicated in: patients who are hypersensitive to fluticasone propionate, or to any ingredient in the formulation or component ...
Warnings and precautions
General Patients should be informed that the full effect of Flonase Allergy Relief (fluticasone propionate aqueous nasal spray) therapy is not achieved until 2 to 3 days of treatment have been completed. ...
Adverse reactions
Adverse Drug Reaction Overview Systemic and local corticosteroid use may result in the following: Epistaxis, nasal ulcerations, candida albicans infection, nasal septal perforation and impaired wound healing ...
Drug interactions
Overview Fluticasone propionate is cleared by extensive first-pass metabolism mediated by cytochrome P450 3A4 in the gut and liver. A drug interaction study of intranasal fluticasone propionate in healthy ...
Dosage and administration
Dosing Considerations Flonase Allergy Relief is available without a prescription for adults and adolescents 18 years of age and older. Flonase Allergy Relief is not recommended for children under 4 years ...
Overdosage
Like any other nasally administered corticosteroid, acute overdosing is unlikely in view of the total amount of active ingredient present. However, when used chronically in excessive doses or in conjunction ...
Action and clinical pharmacology
Mechanism of Action Fluticasone propionate is a synthetic trifluorinated corticosteroid with anti-inflammatory activity. Fluticasone propionate has been shown in vitro to exhibit a binding affinity for ...
Storage and stability
Store between 4° and 30°C. Shake gently before use.
Dosage forms, composition and packaging
Flonase Allergy Relief is an aqueous suspension of microfine fluticasone propionate (0.05% w/w) for topical administration to the nasal mucosa by means of a metering, atomising spray pump. Each 100 mg ...
Pharmaceutical information
Drug Substance Proper name: fluticasone propionate (BAN, INN, USAN). Chemical name: S-fluoromethyl 6α,9α-difluoro-11β-hydroxy-16α-methyl-3-oxo17α-propionyloxyandrosta-1,4-diene-17β-carbothioate Molecular ...
Clinical trials
The safety and efficacy of Flonase Allergy Relief (fluticasone propionate aqueous nasal spray) has been examined in Seasonal Allergic Rhinitis, Perennial Rhinitis, and Sinus Pain/Pressure of Allergic Rhinitis. ...
Toxicology
Acute Toxicity The results of the acute toxicity studies with fluticasone propionate administered by inhalation, orally, subcutaneously and intravenously, demonstrated a large margin of safety over the ...
Marketing authorization holder
GlaxoSmithKline Consumer Healthcare Inc., 7333 Mississauga Road, Mississauga, Ontario, L5N 6L4
Submission control number
226709
Date of revision
July 22, 2019
References
Dockhorn RJ et al. Once- versus twice-daily fluticasone propionate aqueous nasal spray for seasonal allergic rhinitis. Am J Rhinol. 1993;7:77-83. Esumi Y et al. Studies on the metabolic fate of fluticasone ...