Mometasone furoate (NASONEX) Aqueous Nasal Spray should be used with caution, if at all, in patients with active or quiescent tuberculous infections of the respiratory tract, or in untreated fungal, bacterial, systemic viral infections or ocular herpes simplex.
Following 12 months of treatment with Mometasone furoate (NASONEX) Aqueous Nasal Spray, there was no evidence of atrophy of the nasal mucosa; also, mometasone furoate tended to reverse the nasal mucosa closer to a normal histologic phenotype. As with any long-term treatment, patients using Mometasone furoate (NASONEX) Aqueous Nasal Spray over several months or longer should be examined periodically for possible changes in the nasal mucosa, including the development of nasal ulcerations. If localized fungal infection of the nose or pharynx develops, discontinuance of Mometasone furoate (NASONEX) Aqueous Nasal Spray or appropriate treatment may be required.
There is no evidence of hypothalamic-pituitary-adrenal (HPA) axis suppression following prolonged treatment with Mometasone furoate (NASONEX) Aqueous Nasal Spray. However, as with other corticosteroids, patients who are transferred from long-term administration of systemically active corticosteroids to Mometasone furoate (NASONEX) Aqueous Nasal Spray require careful attention. Systemic corticosteroid withdrawal in such patients may result in adrenal insufficiency. If these patients exhibit signs and symptoms of adrenal insufficiency or symptoms of withdrawal (e.g., joint and/or muscular pain, lassitude, and depression initially), appropriate measures should be instituted.
Patients receiving corticosteroids who are potentially immunosuppressed should be warned of the risk of exposure to certain infections (e.g., chickenpox, measles) and of the importance of obtaining medical advice if such exposure occurs.
Following the use of intranasal aerosolized corticosteroids, instances of nasal septum perforation or increased intraocular pressure have been reported very rarely.
Visual disturbances may be reported with systemic and topical (including, intranasal, inhaled and intraocular) corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes of visual disturbances which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
Because of the inhibitory effect of corticosteroids on wound healing, patients who have experienced recent nasal surgery, or trauma should not use a nasal corticosteroid until healing has occurred.
Rarely, immediate hypersensitivity reactions may occur after intranasal administration of mometasone furoate monohydrate. Very rarely, anaphylaxis and angioedema have been reported for Mometasone furoate (NASONEX) Aqueous Nasal Spray. Disturbances of taste and smell have been reported very rarely.
Acute Rhinosinusitis: If signs or symptoms of severe bacterial infection are observed (such as fever, persistent severe unilateral facial/tooth pain, orbital or peri-orbital facial swelling, or worsening of symptoms after an initial improvement), the patient should be advised to consult their physician immediately.
Safety and efficacy of Mometasone furoate (NASONEX) Aqueous Nasal Spray for the treatment of symptoms of rhinosinusitis in children under 12 years of age have not been studied.
Safety and efficacy of Mometasone furoate (NASONEX) Aqueous Nasal Spray for the treatment of nasal polyposis in children and adolescents less than 18 years of age have not been studied.
Drug Abuse and Dependence: There is no information to indicate that abuse or dependency occurs with mometasone furoate.
Interference with Laboratory Tests: None identified.
Any Other Relevant Safety Information: None.
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