Nasonex Special Precautions

Nasonex 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 Nasonex, 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 Nasonex 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 Nasonex or appropriate treatment may be required. Persistent nasopharyngeal irritation may be an indication for discontinuing Nasonex.
Nasonex 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 Nasonex. However, patients who are transferred from long-term administration of systemically active corticosteroids to Nasonex require careful attention. Systemic corticosteroid withdrawal in such patients may result in adrenal insufficiency for a number of months until recovery of HPA 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 should be instituted.
During transfer from systemic corticosteroids to Nasonex, some patients may experience withdrawal symptoms from systemically active corticosteroids (eg, joint and/or muscle pain, lassitude and depression initially) despite relief from nasal symptoms and will require encouragement to continue Nasonex therapy. Such transfer may also unmask preexisting allergic conditions eg, 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 (eg, 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.
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.
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.
Use in pregnancy & lactation: There are no adequate or well-controlled studies in pregnant women. Following intranasal administration of the maximal recommended clinical dose to patients, mometasone plasma concentrations are not measurable; thus, fetal exposure is expected to be negligible and the potential for reproductive toxicity is very low.
As with other nasal corticosteroid preparations, Nasonex should not be used in pregnant women, nursing mothers or women of childbearing age unless the potential benefit justifies the potential risk to the mother, fetus or infant. Infants born of mothers who received corticosteroids during pregnancy should be observed carefully for hypoadrenalism.
Use in children: It is recommended that the height of children receiving prolonged treatment with nasal corticosteroids be regularly monitored. If growth is slow, 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 pediatric specialist.