Fluticasone: uses, appearance and warnings

Fluticasone propionate nasal spray is indicated for the management of the nasal symptoms of perennial nonallergic rhinitis in adults and pediatric patients aged 4 years and older. 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 )

Fluticasone propionate nasal spray, USP is a white, opaque, uniform, aqueous suspension free from any visible foreign matter or agglomerates. Each 100 mg spray delivers 50 mcg of fluticasone propionate, USP. Nasal spray: 50 mcg of fluticasone propionate, USP in each 100 mg spray. ( 3 )

Fluticasone Propionate Nasal Spray USP, 50 mcg is supplied in an amber glass bottle fitted with a crimped metered pump fixed with white actuator and transparent dust cap and a white safety clip, in a box with FDA-approved Patient Labeling (see Patient Instructions for Use for proper actuation of the device). Each bottle contains a net fill weight of 10 g, 11 g, 16 g and 18 g and will provide 60, 72, 120 and 144 actuations respectively. 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 labeled number of sprays (60, 72, 120 and 144 sprays) even though the bottle is not completely empty. The bottle should be discarded when the labeled number of actuations has been used. 60 Metered Sprays 10 g net fill weight NDC 68462-918-60 72 Metered Sprays 11 g net fill weight NDC 68462-918-72 120 Metered Sprays 16 g net fill weight NDC 68462-918-20 144 Metered Sprays 18 g net fill weight NDC 68462-918-44 Store between 4°C and 30°C (39°F and 86°F).

Fluticasone propionate nasal spray is contraindicated in patients with hypersensitivity to any of its ingredients [see Warnings and Precautions ( 5.3 ) , Description ( 11 )] . Hypersensitivity to any ingredient. ( 4 )

• 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 ) 5.1 Local Nasal Effects Epistaxis : In clinical trials of 2 to 26 weeks’ duration, epistaxis was observed more frequently in subjects treated with fluticasone propionate nasal spray than those who received placebo [see Adverse Reactions ( 6.1 )] . Nasal Ulceration : Postmarketing cases of nasal ulceration have been reported in patients treated with fluticasone propionate nasal spray [see Adverse Reactions ( 6.2 )] . Candida Infection : In clinical trials with fluticasone propionate administered intranasally, the development of localized infections of the nose and pharynx with Candida albicans has occurred. When such an infection develops, it may require treatment with appropriate local therapy and discontinuation of fluticasone propionate nasal spray. Patients using fluticasone propionate 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 treated with fluticasone propionate 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 avoid using fluticasone propionate nasal spray until healing has occurred. 5.2 Glaucoma and Cataracts Use of intranasal 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, glaucoma, and/or cataracts. Consider referral to an ophthalmologist in patients who develop ocular symptoms or use fluticasone propionate nasal spray long-term. 5.3 Hypersensitivity Reactions including Anaphylaxis 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 [see Contraindications ( 4 )] . Rarely, immediate hypersensitivity reactions may occur after the administration of fluticasone propionate nasal spray. 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 such children or adults who have not had these diseases or 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 complete prescribing information for VZIG and IG.) If chickenpox develops, treatment with antiviral agents may be considered. Intranasal corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculous infections of the respiratory tract; systemic fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex. 5.5 Hypercorticism and Adrenal Suppression When intranasal corticosteroids 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 fluticasone propionate 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 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. …

Systemic and local corticosteroid use may result in the following: • Epistaxis, nasal ulceration, Candida albicans infection, nasal septal perforation, and impaired wound healing [see Warnings and Precautions ( 5.1 )] • Glaucoma and cataracts [see Warnings and Precautions ( 5.2 )] • Immunosuppression [see Warnings and Precautions ( 5.4 )] • Hypercorticism and adrenal suppression [see Warnings and Precautions ( 5.5 )] • Effect on growth [see Warnings and Precautions ( 5.7 )] 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 Glenmark Pharmaceuticals Inc., USA at 1 (888) 721-7115 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …

Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir, ketoconazole): Use not recommended. May increase risk of systemic corticosteroid effects. ( 7.1 ) 7.1 Inhibitors of Cytochrome P450 3A4 Fluticasone propionate is a substrate of CYP3A4. The use of strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin, conivaptan, lopinavir, nefazodone, voriconazole) with fluticasone propionate nasal spray is not recommended because increased systemic corticosteroid adverse effects may occur. …