Rx Item-Fluticasone 50MCG 16 GM Spray by Hikma Pharma USA , Clinical Information:
Generic Code And Description: 18368 Fluticasone Propionate Nasal Spray Susp 50 Mcg
Strength: 50 Mcg/Actuation
Dose Form: Spray Suspension
Product Category: : Rx Pharmaceuticals
Fine Line Class: 850085008510 All Rx Products
DEA Class: None Omp Family:
Drug Class: 52080800 Corticosteroids (Eent)
48100804 Nasal Preparations (Steroids)
Active Ingredients: 3593 Fluticasone Propionate 80474142
Inactive Ingredients: 3141 Benzalkonium Chloride 8001545
9865 Polysorbate 80 9005656 Drug Class: Drug Class: 52080800 Corticosteroids (Eent)
48100804 Nasal Preparations (Steroids, OMP Family: , Temparature Zone: 10 Room Temperature, Unit Dose Indicator: NO, Item Size: 16GM, Brand Label Flag: GENERIC , Storage Temperature Zone: 10 Room Temperature, Item Size Code:16GM, Item Strength Code:50MCG , Item Abbreviation: Fluticasone , Generic Form: SPY
These highlights do not include all the information needed to use FLUTICASONE PROPIONATE NASAL SPRAY safely and effectively. See full prescribing information for FLUTICASONE PROPIONATE NASAL SPRAY.
FLUTICASONE PROPIONATE nasal spray
Initial U.S. Approval: 1994
INDICATIONS AND USAGE
Fluticasone propionate nasal spray 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:
•
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)
DOSAGE FORMS AND STRENGTHS
Nasal spray: 50 mcg of fluticasone propionate, USP in each 100 mg spray. (3)
CONTRAINDICATIONS
Hypersensitivity to any ingredient. (4)
WARNINGS AND PRECAUTIONS
•
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 ulcers, nasal surgery, or nasal trauma. (5.1)
•
Glaucoma and cataracts: Consider referral to an ophthalmologist in patients who develop ocular symptoms or use fluticasone propionate nasal spray long-term. (5.2)
•
Hypersensitivity reactions (e.g., anaphylaxis, angioedema, urticaria, contact dermatitis, and rash) have been reported after administration of fluticasone propionate nasal spray. Discontinue fluticasone propionate nasal spray if such reactions occur. (5.3)
•
Potential worsening of infections (e.g., existing tuberculosis; fungal, bacterial, viral, or parasitic infection; ocular herpes simplex). Use with caution in patients with these infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients. (5.4)
•
Hypercorticism and adrenal suppression may occur with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue fluticasone propionate nasal spray slowly. (5.5)
•
Monitor growth of pediatric patients. (5.7)
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 Hikma Pharmaceuticals USA Inc. at 1-800-962-8364 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 PATIENT COUNSELING INFORMATION.
Revised: 2/2022
