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Momeclir

Momeclir Special Precautions

mometasone

Manufacturer:

Hanlim Pharma

Distributor:

OEP Phils
Full Prescribing Info
Special Precautions
Immunosuppression: Mometasone furoate (Momeclir) Nasal spray suspension 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, or systemic viral infections.
Local nasal effects: Following 12 months of treatment with Mometasone furoate (Momeclir) Nasal spray suspension in a study of patients with perennial rhinitis, 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. Nevertheless, patients using Mometasone Furoate 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 furoate (Momeclir) Nasal spray suspension therapy or appropriate treatment may be required. Persistence of nasopharyngeal irritation may be an indication for discontinuing Mometasone furoate (Momeclir) Nasal spray suspension.
Non-nasal symptoms: Although Mometasone furoate (Momeclir) Nasal spray suspension will control the nasal symptoms in most patients, the concomitant use of appropriate additional therapy may provide additional relief of other symptoms particularly ocular symptoms.
There is no evidence of hypothalamic-pituitary-adrenal (HPA) axis suppression following prolonged treatment with Mometasone furoate (Momeclir) Nasal spray suspension. However, patients who are transferred from long-term administration of systemically active corticosteroids to Mometasone furoate (Momeclir) Nasal spray suspension 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 corticosteroids administration should be resumed and other modes of therapy and appropriate measures instituted.
During transfer from systemic corticosteroids to Mometasone furoate (Momeclir) Nasal spray suspension, 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 furoate (Momeclir) Nasal Spray suspension. Such transfer may also unmask pre-existing allergic conditions, such as allergic conjunctivitis and eczema, previously suppressed by systemic corticosteroid therapy.
The safety and efficacy of Mometasone furoate (Momeclir) Nasal spray suspension has not been studied for use in the treatment of unilateral polyps, polyps associated with cystic fibrosis, or polyps that completely obstruct the nasal cavities.
Unilateral polyps that are unusual or irregular in appearance, especially if ulcerating or bleeding should be further evaluated.
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 corticosteroids, instances of nasal septum perforation or increased intraocular pressure have been reported very rarely.
Safety 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 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 the patients to a pediatric 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 the additional systemic corticosteroid cover should be considered during periods of stress or elective surgery.
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