Apo-Mometasone

Apo-Mometasone

mometasone

Manufacturer:

Apotex

Distributor:

Pharmaforte
Concise Prescribing Info
Contents
Mometasone furoate
Indications/Uses
Seasonal or perennial allergic rhinitis symptoms in adults & childn ≥3 yr; prophylaxis in patients who have a history of moderate to severe seasonal allergic rhinitis (recommended 2-4 wk prior to the anticipated start of the pollen season). Nasal polyps in patients ≥18 yr. Mild to moderate uncomplicated acute rhinosinusitis in patients ≥12 yr w/o signs & symptoms of severe bacterial infection.
Dosage/Direction for Use
Seasonal or perennial allergic rhinitis Adult (including elderly) & childn ≥12 yr 2 sprays into each nostril once daily. Once symptoms are controlled, reduce dose to 1 spray into each nostril as maintenance. Childn 3-11 yr 1 spray into each nostril once daily. Nasal polyposis Adult (including elderly) & adolescent ≥18 yr 2 sprays in each nostril once daily, may be increased to 2 sprays in each nostril bd if symptoms are inadequately controlled. Mild to moderate uncomplicated acute rhinosinusitis Adult (including elderly) & childn ≥12 yr 2 sprays into each nostril bd.
Special Precautions
Not to be used in the presence of untreated localized infection involving the nasal mucosa; those who have recent nasal surgery or trauma until healing has occurred. Discontinue use if localized fungal infection of the nose or pharynx develops. Patients w/ active or quiescent TB infections of resp tract or in untreated fungal, bacterial, systemic viral infections or ocular herpes simplex. Transfer from systemic corticosteroids to mometasone aqueous nasal spray may unmask pre-existing allergic conditions & w/drawal symptoms may occur. Patients who are potentially immunocompromised should be warned of the risk of exposure to certain infections (eg, chickenpox, measles). Very rarely, nasal septum perforation or increased IOP may occur. Systemic effects may occur at high doses for prolonged periods. Growth retardation in childn; regularly monitor height of childn receiving prolonged treatment. Higher than recommended doses may result in adrenal suppression; consider additional systemic corticosteroid during periods of stress or elective surgery if there is evidence of treatment w/ higher than recommended doses. Consider referral to an ophthalmologist if patient presents w/ symptoms eg, blurred vision or other visual disturbances. Consult a physician immediately if signs & symptoms of severe bacterial infection are observed. Pregnancy & lactation. Childn <12 yr (symptomatic treatment of acute rhinosinusitis). Childn & adolescent <18 yr (treatment of nasal polyposis).
Adverse Reactions
Headache, epistaxis, pharyngitis, nasal burning, irritation & ulceration; sneezing.
MIMS Class
Nasal Decongestants & Other Nasal Preparations
ATC Classification
R01AD09 - mometasone ; Belongs to the class of topical corticosteroids used for prophylaxis and treatment of allergic rhinitis.
Additional Information
Exemptions granted for limited sale and supply without prescription (with effect from 1 Dec 2016):
As an intranasal spray not exceeding 50 mcg/actuation
Indication: Prevention and treatment of allergic rhinitis
Maximum daily dose: 200 mcg
Maximum supply: 3 months
Minimum age: 18 years
Presentation/Packing
Form
Apo-Mometasone nasal spray 50 mcg/metered spray
Packing/Price
140 metered spray x 1's
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