Mometasone Sandoz

Mometasone Sandoz

mometasone

Manufacturer:

Lek Pharma

Distributor:

Zuellig Pharma

Marketer:

Sandoz
Concise Prescribing Info
Contents
Mometasone furoate
Indications/Uses
Symptomatic relief of seasonal or perennial allergic rhinitis in adults, adolescents & childn ≥2 yr. Nasal congestion associated w/ seasonal allergic rhinitis in adults & childn ≥2 yr. Symptomatic treatment of nasal polyps in adults ≥18 yr. Symptoms of acute rhinosinusitis in patients ≥12 yr w/o signs or symptoms of bacterial infection. Adjunctive treatment 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). Max: 4 actuations in each nostril once daily (total dose: 400 mcg). Childn 2-11 yr 1 actuation (50 mcg/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). Adult Nasal polyposis Initially 2 actuations in each nostril once daily (total daily dose: 200 mcg). Acute rhinosinusitis 2 actuations in each nostril bid (total daily dose: 400 mcg). Adult (including elderly) & adolescent ≥12 yr Adjunctive treatment of acute episodes of sinusitis 2 spray in each nostril bid (total daily dose: 400 mcg).
Contraindications
Hypersensitivity. Do not use in the presence of untreated localised infection involving the nasal mucosa eg, herpes simplex; patients who have experienced recent nasal surgery or trauma.
Special Precautions
Immunosuppressed patients. Patients w/ active or quiescent tuberculous infections of the resp tract, or in untreated fungal, bacterial, or systemic viral infections. Periodically examine for possible charges in nasal mucosa. Discontinue if localized fungal infection of nose or pharynx develops. Not recommended in case of nasal septum perforation. Systemic effects including Cushing's syndrome, adrenal suppression, growth retardation in childn & adolescents, cataract, glaucoma, & more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particulary in childn) may occur in prolonged use. Instances of IOP. Unilateral polyps, polyps associated w/ cystic fibrosis, or polyps that completely obstruct the nasal cavities. May produce positive results in doping controls. May cause nasal mucosa swelling due to benzalkonium Cl. Growth retardation in childn; regularly monitor height of childn receiving prolonged treatment. Visual disturbances eg, blurred vision or other visual disturbances. Pregnancy & lactation. Childn <12 yr w/ symptoms of rhinosinusitis & adolescent <18 yr w/ nasal polyps.
Adverse Reactions
Epistaxis. Pharyngitis, upper resp tract infection; headache; nasal burning, nasal irritation & ulceration, throat irritation.
Drug Interactions
Increased risk of systemic side-effects w/ CYP3A inhibitors including cobicistat-containing drugs.
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
120 metered dose x 1's
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