Generic Name and Formulations:
Fluticasone propionate 93mcg/spray; aqueous nasal spray.
OptiNose US, Inc.
Indications for XHANCE:
≥18yrs: 1 spray in each nostril twice daily. Also, 2 sprays in each nostril twice daily may be effective in some patients. Max total daily doses: 2 sprays in each nostril twice daily (744mcg/day).
<18yrs: not established.
Maintain regular regimen. Do not exceed recommended dose. Respiratory tract tuberculosis. Systemic infections. Ocular herpes simplex. Immunosuppression. If exposed to measles or chickenpox, consider anti-infective prophylactic therapy. If adrenal insufficiency exists following systemic corticosteroid therapy, replacement with topical corticosteroids may exacerbate symptoms of adrenal insufficiency (eg, lassitude, depression). Recent nasal ulceration, surgery, trauma; avoid until healing has occurred. Change in vision, history of increased intraocular pressure, glaucoma, and/or cataracts; monitor closely. Monitor for hypercorticism and HPA axis suppression (if occur discontinue gradually), and candida infection or other nasal mucosal changes. Discontinue if septal perforation occurs. Discontinue if hypersensitivity reactions occur. Prolonged immobilization, family history of osteoporosis, postmenopausal, tobacco use, advanced age, poor nutrition: monitor bone mineral density. Hepatic impairment: monitor. Pregnancy. Nursing mothers.
Concomitant strong CYP3A4 inhibitors (eg, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin, conivaptan, lopinavir, voriconazole): not recommended. Additive effects with chronic use of drugs that can reduce bone mineral density (eg, anticonvulsants, oral corticosteroids): monitor.
Epistaxis, nasal septal ulceration/erythema, nasopharyngitis, nasal mucosal erythema/ulcerations, nasal congestion, acute sinusitis, headache, pharyngitis; impaired wound healing, reduced bone mineral density, HPA axis effects, reduced growth velocity in children.
Spray—16mL (120 sprays)
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