Apo-Mometasone

Apo-Mometasone Special Precautions

mometasone

Manufacturer:

Apotex

Distributor:

Pharmaforte
Full Prescribing Info
Special Precautions
Mometasone Aqueous Nasal Spray should not be used in the presence of untreated localized infection involving the nasal mucosa.
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.
Following 12 months of treatment with Mometasone 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 Aqueous Nasal Spray over several months or longer should be examined periodically for possible changes in the nasal mucosa. If localized fungal infection of the nose or pharynx develops, discontinuance of Mometasone Aqueous Nasal Spray therapy or appropriate treatment may be required. Persistence of nasopharyngeal irritation may be an indication for discontinuing Mometasone Aqueous Nasal Spray.
Mometasone 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.
There is no evidence of hypothalamic-pituitary-adrenal (HPA) axis suppression following prolonged treatment with Mometasone Aqueous Nasal Spray. However, patients who are transferred from long-term administration of systemically active corticosteroids to Mometasone Aqueous Nasal Spray require careful attention. Systemic corticosteroid withdrawal in such patients may result in adrenal insufficiency for a number of months until recovery of HA axis function. If these patients exhibit signs and symptoms of adrenal insufficiency, systemic corticosteroid administration should be resumed and other modes of therapy and appropriate measures instituted.
During transfer from systemic corticosteroids to Mometasone Aqueous Nasal Spray, some patients may experience symptoms of withdrawal from systemically active corticosteroids (e.g., joint and/or muscular pain, lassitude, and depression initially) despite relief from nasal symptoms and will require encouragement to continue Mometasone Aqueous Nasal Spray therapy. Such transfer may also unmask pre-existing allergic conditions such as allergic conjunctivitis and eczema, previously suppressed by systemic corticosteroid therapy.
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.
General Nasal Corticosteroid Warning: Systemic effects of nasal corticosteroids may occur, particularly at high doses prescribed for prolonged periods. Growth retardation has been reported in children receiving nasal corticosteroids at licensed doses.
It is recommended that the height of children receiving prolonged treatment with nasal corticosteroids is regularly monitored. If growth is slowed, therapy should be reviewed with the aim of reducing the dose of nasal corticosteroid, if possible, to the lowest dose at which effective control of symptoms is maintained. In addition, consideration should be given to referring patient to a paediatric specialist.
Treatment with higher than recommended doses may result in clinically significant adrenal suppression. If there is evidence for higher than recommended doses being used, then additional systemic corticosteroid cover should be considered during periods of stress or elective surgery.
In a placebo-controlled clinical trial in which paediatric patients were administered Mometasone 100 micrograms daily for one year, no reduction in growth velocity was observed.
Visual disturbance may be reported with systemic and topical 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 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.
Safety and efficacy of Mometasone Aqueous Nasal Spray for the treatment of nasal polyposis in children and adolescents less than 18 years of age have not been studied.
Use in acute rhinosinusitis: If signs and symptoms of severe bacterial infection are observed (such as fever, persistent severe unilateral facial/tooth pain, orbital or periorbital facial swelling, or worsening of symptoms after an initial improvement), the patient should be advised to consult their physician immediately. If these signs and symptoms are present at the time of diagnosis, treatment with Mometasone Aqueous Nasal Spray should not be initiated.
Safety and efficacy of Mometasone Aqueous Nasal Spray for the treatment of symptoms of acute rhinosinusitis in children under 12 years of age have not been studied.
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