Fluticasone furoate
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Ammu Susheela, M.D. [2]
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Overview
Fluticasone furoate is {{{aOrAn}}} Anti-Allergic Agents that is FDA approved for the treatment of It is indicated for the treatment of the symptoms of seasonal and perennial allergic rhinitis in patients aged 2 years and older.. Common adverse reactions include {{{adverseReactions}}}.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
The recommended starting dosage is 110 mcg once daily administered as 2 sprays (27.5 mcg/spray) in each nostril. When the maximum benefit has been achieved and symptoms have been controlled, reducing the dosage to 55 mcg (1 spray in each nostril) once daily may be effective in maintaining control of allergic rhinitis symptoms.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Fluticasone furoate in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Fluticasone furoate in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
The recommended starting dosage in children is 55 mcg once daily administered as 1 spray (27.5 mcg/spray) in each nostril. Children not adequately responding to 55 mcg may use 110 mcg (2 sprays in each nostril) once daily. Once symptoms have been controlled, dosage reduction to 55 mcg once daily is recommended.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Fluticasone furoate in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Fluticasone furoate in pediatric patients.
Contraindications
Fluticasone furoate is contraindicated in patients with hypersensitivity to any of its ingredients
Warnings
5.1 Local Nasal Effects Epistaxis and Nasal Ulceration
In clinical trials of 2 to 52 weeks’ duration, epistaxis and nasal ulcerations were observed more frequently and some epistaxis events were more severe in patients treated with VERAMYST Nasal Spray than those who received placebo [see Adverse Reactions (6.1)].
Candida Infection
Evidence of localized infections of the nose with Candida albicans was seen on nasal exams in 7 of 2,745 patients treated with VERAMYST Nasal Spray during clinical trials and was reported as an adverse event in 3 patients. When such an infection develops, it may require treatment with appropriate local therapy and discontinuation of VERAMYST Nasal Spray. Therefore, patients using VERAMYST Nasal Spray over several months or longer should be examined periodically for evidence of Candida infection or other signs of adverse effects on the nasal mucosa.
Nasal Septal Perforation
Postmarketing cases of nasal septal perforation have been reported in patients following the intranasal application of VERAMYST Nasal Spray [see Adverse Reactions (6.2)].
Impaired Wound Healing
Because of the inhibitory effect of corticosteroids on wound healing, patients who have experienced recent nasal ulcers, nasal surgery, or nasal trauma should not use VERAMYST Nasal Spray until healing has occurred.
5.2 Glaucoma and Cataracts Nasal and inhaled corticosteroids may result in the development of glaucoma and/or cataracts. Therefore, close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure (IOP), glaucoma, and/or cataracts.
Glaucoma and cataract formation was evaluated with intraocular pressure measurements and slit lamp examinations in 1 controlled 12-month trial in 806 adolescent and adult patients aged 12 years and older and in 1 controlled 12-week trial in 558 children aged 2 to 11 years. The patients had perennial allergic rhinitis and were treated with either VERAMYST Nasal Spray (110 mcg once daily in adult and adolescent patients and 55 or 110 mcg once daily in pediatric patients) or placebo. Intraocular pressure remained within the normal range (<21 mmHg) in ≥98% of the patients in any treatment group in both trials. However, in the 12-month trial in adolescents and adults, 12 patients, all treated with VERAMYST Nasal Spray 110 mcg once daily, had intraocular pressure measurements that increased above normal levels (≥21 mmHg). In the same trial, 7 patients (6 treated with VERAMYST Nasal Spray 110 mcg once daily and 1 patient treated with placebo) had cataracts identified during the trial that were not present at baseline.
5.3 Hypersensitivity Reactions, Including Anaphylaxis Hypersensitivity reactions, including anaphylaxis, angioedema, rash, and urticaria, may occur after administration of VERAMYST Nasal Spray. Discontinue VERAMYST Nasal Spray if such reactions occur [see Contraindications (4)].
5.4 Immunosuppression Persons who are using drugs that suppress the immune system are more susceptible to infections than healthy individuals. Chickenpox and measles, for example, can have a more serious or even fatal course in susceptible children or adults using corticosteroids. In children or adults who have not had these diseases or have not been properly immunized, particular care should be taken to avoid exposure. How the dose, route, and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If a patient is exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If a patient is exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information.) If chickenpox or measles develops, treatment with antiviral agents may be considered.
Corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculous infections of the respiratory tract, untreated local or systemic fungal or bacterial infections, systemic viral or parasitic infections, or ocular herpes simplex because of the potential for worsening of these infections.
5.5 Hypothalamic-Pituitary-Adrenal Axis Effects Hypercorticism and Adrenal Suppression
When intranasal steroids are used at higher-than-recommended dosages or in susceptible individuals at recommended dosages, systemic corticosteroid effects such as hypercorticism and adrenal suppression may appear. If such changes occur, the dosage of VERAMYST Nasal Spray should be discontinued slowly, consistent with accepted procedures for discontinuing oral corticosteroid therapy.
The replacement of a systemic corticosteroid with a topical corticosteroid can be accompanied by signs of adrenal insufficiency. In addition, some patients may experience symptoms of corticosteroid withdrawal, e.g., joint and/or muscular pain, lassitude, depression. Patients previously treated for prolonged periods with systemic corticosteroids and transferred to topical corticosteroids should be carefully monitored for acute adrenal insufficiency in response to stress. In those patients who have asthma or other clinical conditions requiring long-term systemic corticosteroid treatment, rapid decreases in systemic corticosteroid dosages may cause a severe exacerbation of their symptoms.
5.6 Use of Cytochrome P450 3A4 Inhibitors Coadministration with ritonavir is not recommended because of the risk of systemic effects secondary to increased exposure to fluticasone furoate. Use caution with the coadministration of VERAMYST Nasal Spray and other potent cytochrome P450 3A4(CYP3A4) inhibitors, such as ketoconazole [see Drug Interactions (7)].
5.7 Effect on Growth Corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. Monitor the growth routinely of pediatric patients receiving VERAMYST Nasal Spray. To minimize the systemic effects of intranasal corticosteroids, including VERAMYST Nasal Spray, titrate each patient’s dose to the lowest dosage that effectively controls his/her symptoms [see Use in Specific Populations (8.4)].
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Fluticasone furoate Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Fluticasone furoate Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Fluticasone furoate Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Fluticasone furoate in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Fluticasone furoate in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Fluticasone furoate during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Fluticasone furoate in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Fluticasone furoate in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Fluticasone furoate in geriatric settings.
Gender
There is no FDA guidance on the use of Fluticasone furoate with respect to specific gender populations.
Race
There is no FDA guidance on the use of Fluticasone furoate with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Fluticasone furoate in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Fluticasone furoate in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Fluticasone furoate in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Fluticasone furoate in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Fluticasone furoate Administration in the drug label.
Monitoring
There is limited information regarding Fluticasone furoate Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Fluticasone furoate and IV administrations.
Overdosage
There is limited information regarding Fluticasone furoate overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Fluticasone furoate Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Fluticasone furoate Mechanism of Action in the drug label.
Structure
There is limited information regarding Fluticasone furoate Structure in the drug label.
Pharmacodynamics
There is limited information regarding Fluticasone furoate Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Fluticasone furoate Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Fluticasone furoate Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Fluticasone furoate Clinical Studies in the drug label.
How Supplied
There is limited information regarding Fluticasone furoate How Supplied in the drug label.
Storage
There is limited information regarding Fluticasone furoate Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Fluticasone furoate Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Fluticasone furoate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Fluticasone furoate Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Fluticasone furoate Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.