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Local Nasal Effects: Epistaxis: In clinical studies, epistaxis was observed more frequently in patients with allergic rhinitis with Mometasone furoate monohydrate Nasal Spray than those who received placebo.
Candida infection: In clinical studies with Mometasone furoate monohydrate Nasal Spray 50 mcg the development of localized infections of the nose and pharynx with Candida albicans has occurred. When such an infection develops, use of Mometasone furoate monohydrate Nasal Spray 50 mcg should be discontinued and appropriate local or systemic therapy instituted, if needed.
Nasal Septum Perforation: Instances of nasal septum perforation have been reported following the intranasal application of corticosteroids. As with any long term topical treatment of the nasal cavity, patients using Mometasone furoate monohydrate Nasal Spray 50 mcg over several months or longer should be examined periodically for possible changes in the nasal mucosa.
Impaired Wound Healing: Because of the inhibitory effect of corticosteroids on wound healing patients who have experienced recent nasal septum ulcers, nasal surgery, or nasal trauma should not use a nasal corticosteroid until healing has occurred.
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, glaucoma, and/or cataracts.
Hypersensitivity Reactions: Hypersensitivity reactions including instances of wheezing may occur after the intranasal administration of mometasone furoate monohydrate. Discontinue Mometasone Nasal Spray if such reactions occur.
Immunosuppression: Persons who are on drugs which 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 non-immune children or adults on corticosteroids in such children or adults who have not had these diseases, 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 corticosteroid treatment so the risk is also not known. If exposed to chickenpox, prophylaxis with varicella zoster immunoglobulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. If chickenpox develops, treatment with antiviral agents may be considered.
Corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculosis infection of the respiratory tract, or in untreated fungal, bacterial, systemic viral infections, or ocular herpes simplex because of the potential for worsening of these infections.
Hypothalamic-Pituitary-Adrenal Axis Effect: Hypercoticism and Adrenal Suppression: When intranasal 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 Mometasone furoate monohydrate Nasal Spray should be discontinued slowly, consistent with accepted procedures for discontinuing oral corticosteroid therapy.
Effect on Growth: Corticosteroids may cause a reduction in growth velocity when administered in pediatric patients. Monitor the growth routinely of pediatric patients receiving Mometasone furoate monohydrate Nasal Spray. To minimize the systemic effects of intranasal corticosteroids including Mometasone furoate monohydrate Nasal Spray, titrate each patient's dose to the lowest dosage that effectively controls his/her symptoms.
Use in Specific Populations: Hepatic Impairment: Concentrations of mometasone furoate appear to increase with severity of hepatic impairment.
Use in Children: The safety and effectiveness of Mometasone furoate monohydrate Nasal Spray for the treatment of nasal polyps in children less than 18 years of age have not been established. Controlled clinical studies have shown intranasal corticosteroids may cause a reduction in growth velocity in pediatric patients.
The potential of Mometasone furoate monohydrate Nasal Spray 50 mcg to cause growth suppression in susceptible patients or when given at higher dose cannot be ruled out.
Use in Elderly: The adverse reactions reported in geriatric population were similar in type and incidence to those reported by younger patients.
