Mometasone Sandoz

Mometasone Sandoz

mometasone

Manufacturer:

Lek Pharma

Distributor:

Zuellig Pharma

Marketer:

Sandoz
Concise Prescribing Info
Contents
Mometasone furoate
Indications/Uses
Symptomatic treatment of seasonal or perennial allergic rhinitis in adults, adolescents & childn ≥2 yr; nasal polyps in adults ≥18 yr; acute rhinosinusitis in patients ≥12 yr w/o signs or symptoms of bacterial infection. Relief of nasal congestion associated w/ seasonal allergic rhinitis in adults & childn ≥2 yr. Adjunct to antibiotics for acute episodes of sinusitis in adults & adolescents ≥12 yr. Prophylaxis in patients w/ history of moderate to severe symptoms of seasonal allergic rhinitis.
Dosage/Direction for Use
Seasonal or perennial allergic rhinitis Adult 2 actuations in each nostril once daily (total dose: 200 mcg). Maintenance: Reduce dose to 1 actuation in each nose (total dose: 100 mcg). Max: 4 actuations in each nostril once daily (total dose: 400 mcg). Childn 2-11 yr 1 actuation in each nostril once daily (total dose: 100 mcg). Nasal congestion associated w/ seasonal allergic rhinitis Adult & adolescent ≥12 yr 2 sprays in each nostril once daily (total daily dose of 200 mcg). Childn 2-11 yr 1 spray in each nostril once daily (total daily dose: 100 mcg). Nasal polyposis Adult Initially 2 actuations in each nostril once daily (total daily dose: 200 mcg). May be increased to 2 sprays in each nostril bid (total dose: 400 mcg) after 5-6 wk. Acute rhinosinusitis 2 actuations in each nostril bid (total daily dose: 400 mcg). Adjunctive treatment of acute episodes of sinusitis Adult (including elderly) & adolescent ≥12 yr 2 sprays in each nostril bid (total daily dose: 400 mcg). May be increased to 4 sprays in each nostril bid (total dose: 800 mcg).
Contraindications
Hypersensitivity. Not to be used in the presence of untreated localised infection involving the nasal mucosa eg, herpes simplex; in patients who have experienced recent nasal surgery or trauma.
Special Precautions
Discontinue if localised fungal infection of nose or pharynx develops. Not recommended in case of nasal septum perforation. Active or quiescent tuberculous resp tract infections, or in untreated fungal, bacterial, or systemic viral infections. Systemic effects eg, Cushing's syndrome, Cushingoid features, adrenal suppression, cataract, glaucoma & range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in childn) at high doses for prolonged periods. Increased IOP; visual disturbance eg, blurred vision or other visual disturbances. May produce positive results in doping controls. May unmask pre-existing allergic conditions eg, allergic conjunctivitis & eczema. Further evaluate for unilateral polyps (unusual or irregular in appearance), especially if ulcerating or bleeding. Periodically examine for possible nasal mucosa changes in patients receiving treatment over several mth or longer. Transferring from long-term administration of systemically active corticosteroids. Not to be used during pregnancy. Lactation. Childn & adolescents <18 yr. Growth retardation in childn. Regularly monitor height of childn receiving prolonged treatment.
Adverse Reactions
Epistaxis. Pharyngitis, URTI; headache; nasal burning, irritation & ulceration; throat irritation.
Drug Interactions
Increased risk of systemic side effects w/ CYP3A inhibitors including cobicistat-containing products.
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.
Presentation/Packing
Form
Mometasone Sandoz nasal spray 50 mcg
Packing/Price
140 metered dose x 1's
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