Children's Flonase Allergy Relief

>10%

Headache (17%)

URI (15%)

Epistaxis, Xhance 186 mcg (11.9%)

1-10%

Nasal congestion (8%)

Pharyngitis (6-8%)

Asthma symptoms (3-7%)

Fever (1-5%)

Dysphonia (4%)

Cough (3-4%)

Nasal discharge (1-3%)

Aches and pains (1-3%)

Flu-like syndrome (1-3%)

Bronchitis (1-3%)

Diarrhea (1-3%)

Abdominal pain (1-3%)

Nasal ulcer (1%)

Xhance 186 mcg

• Nasal septal ulceration (6.9%)
• Nasal mucosal erythema (5.6%)
• Headache (5%)
• Nasal congestion (4.4%)
• Acute sinusitis (4.4%)
• Nasal mucosal ulceration (3.8%)
• Nasal septal erythema (3.8%)
• Nasopharyngitis (1.9%)
• Pharyngitis (1.3%)

Xhance 372 mcg

• Epistaxis (9.9%)
• Nasopharyngitis (7.5%)
• Nasal septal ulceration (7.5%)
• Nasal congestion (5.6%)
• Acute sinusitis (5%)
• Nasal mucosal erythema (5%)
• Nasal septal erythema (4.3%)
• Headache (3.7%)
• Pharyngitis (3.1%)
• Nasal mucosal ulceration (2.5%)
• Nasal dryness (≥1%)
• Sinusitis (≥1%)
• Oropharyngeal pain (≥1%)
• Toothache (≥1%)
• Intraocular pressure increase (≥1%)

Frequency Not Defined

Loss of taste

Postmarketing Reports

Respiratory, thoracic, and mediastinal disorders: Rhinalgia, nasal discomfort (including nasal burning, nasal irritation, and nasal soreness), nasal dryness, and nasal septal perforation

Contraindications

Hypersensitivity

Cautions

May mask acute infection, including fungal infection, exacerbate viral infections or limit response to vaccines; not for use in untreated localized infection involving nasal mucosa; administer antimicrobial therapy if bacterial infection of sinuses suspected or confirmed; respiratory tract fungal or bacterial infections, parasitic infections, ocular herpes simplex may occur

Chickenpox and measles: Serious or fatal course in susceptible individuals; unvaccinated or immunologically unexposed children or adults should avoid exposure

Delays wound healing of nasal septal ulcers, trauma, or surgery; best to administer after healing has occurred

May increase risk of hypercorticism or hypothalamic-pituitary adrenal (HPA) axis suppression, especially in younger patients receiving high doses for prolonged periods; HPA suppression may lead to adrenal crisis; withdraw or discontinue slowly; pediatric patients may be more susceptible to systemic toxicity

Nasal corticosteroids, including fluticasone propionate, may result in the development of glaucoma and/or cataracts; closely monitor vision changes or patients with a history of increased intraocular pressure (IOP), glaucoma, and/or cataracts

Intranasal corticosteroids may cause a reduction in growth velocity in children and adolescents; safety and efficacy has not been established in pediatric patients

Decreases in bone mineral density (BMD) have been observed with long-term oral inhalation of products containing corticosteroids into lungs; monitor and appropriately treat patients with major risk factors for decreased bone mineral content (eg, prolonged immobilization, family history of osteoporosis, postmenopausal status, tobacco use, advanced age, poor nutrition, or chronic use of drugs that can reduce bone mass [eg, anticonvulsants, oral corticosteroids])

Avoid in patients with known hypersensitivity to fluticasone propionate or any ingredient of Xhance; see Contraindications

Avoid concomitant use with strong CYP3A4 (eg, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin, conivaptan, lopinavir, voriconazole)

Local nasal effects

• Epistaxis, nasal erosions, and nasal ulcerations were reported
• Nasal septal perforations have been reported; patients treated over several months or longer should be examined periodically for possible changes in the nasal mucosa
• If a septal perforation is noted, discontinue treatment; avoid spraying directly on septum
• Localized Candida albicans infections have been observed; if such an infection develops, consider appropriate local therapy and discontinuation treatment; periodically examine for evidence of candidal infection in the nasal and oropharyngeal mucosa
• Avoid use in patients who have experienced recent nasal ulcerations, nasal surgery, or nasal trauma

Pregnancy

Available data on inhaled or intranasal fluticasone propionate use in pregnant women have not reported a clear association with adverse developmental outcomes

Fluticasone propionate crossed the placenta following subcutaneous administration to mice and rats and oral administration to rabbits

Lactation

There are no available data on fluticasone propionate in human milk, effects on breastfed child, or effects on milk production

Developmental and health benefits of breastfeeding should be considered and adverse effects on breastfed child from treatment or from an underlying maternal condition

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

Mechanism of Action

Potent anti-inflammatory corticosteroid with vasoconstrictive properties

Available in 2 salt forms, fluticasone propionate (Flonase, Xhance) and fluticasone furoate (Veramyst)

Absorption

Peak plasma concentration, 186 mcg dose: 17.2 pg/mL

Peak plasma concentration, 372 mcg dose: 25.3 pg/mL

AUC, 186 mcg dose: 111.7 pg·h/mL

AUC, 372 mcg dose: 171.7 pg·h/mL

Bioavailability: ≤2%

Onset of action: May take several days to achieve optimum benefit

Distribution

Vd: 4.2 L/kg

Protein binding: 99%

Metabolism

Metabolized by CYP3A4 pathway; only circulating metabolite detected in humans is 17β-carboxylic acid derivative of fluticasone propionate

Elimination

Half-life: 7.8 hr

Clearance: 1093 mL/min

Renal clearance: <0.02% of total clearance

Excretion: Urine (<5%); feces (remaining amount excreted as parent drug and metabolites)