Axcel Mometasone Nasal Spray

Axcel Mometasone Nasal Spray Special Precautions



Kotra Pharma


Kotra Pharma
Full Prescribing Info
Special Precautions
Axcel Mometasone 0.05%w/w 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 Axcel Mometasone 0.05%w/w 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 Axcel Mometasone 0.05%w/w 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 Axcel Mometasone 0.05%w/w Nasal Spray or appropriate treatment may be required. Persistence of nasopharyngeal irritation may be an indication for discontinuing Axcel Mometasone 0.05%w/w Nasal Spray. Axcel Mometasone 0.05%w/w 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 Axcel Mometasone 0.05%w/w Nasal Spray. However, patients who are transferred from long-term administration of systemically active corticosteroids to Axcel Mometasone 0.05%w/w Nasal Spray 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 instituted. Treatment with higher than recommended doses may result in clinically significant adrenal suppression. If there is evidence for higher than recommended dose being used, then additional systemic corticosteroid cover should be considered during periods of stress or elective surgery. Safety and efficacy of Axcel Mometasone 0.05%w/w Nasal Spray for the treatment of nasal polyposis in children and adolescents less than 18 years of age have not been studied. During transfer from systemic corticosteroids to Axcel Mometasone 0.05%w/w Nasal Spray, some patients may experience symptoms of withdrawal from systemically active corcosteroids (e.g joint and/or muscular pain, lassitude, and depression initially) despite relief from nasal symptoms and will require encouragement to continue Axcel Mometasone 0.05%w/w 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.
Use in Pregnancy and 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, very low. As with other nasal corticosteroid preparations, Axcel Mometasone 0.05%w/w Nasal Spray should be used in pregnant women, nursing mother or women of childbearing age only if 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.
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