Nasospray

Nasospray

mometasone

Manufacturer:

Apotex

Distributor:

Berlin Pharm

Marketer:

Berlin Pharm
Concise Prescribing Info
Contents
Mometasone furoate
Indications/Uses
Nasal congestion associated w/ seasonal allergic rhinitis in adults & ped ≥2 yr. Nasal polyps & associated symptoms including congestion & loss of smell in adults ≥18 yr. Symptomatic treatment of seasonal or perennial rhinitis in adults, adolescents & childn 2-11 yr; acute rhinosinusitis in patients ≥12 yr w/o signs or symptoms of bacterial infection. Prophylaxis in patients w/ history of moderate to severe symptoms of seasonal allergic rhinitis. Adjunct to antibiotics for acute episodes of sinusitis in adults & adolescents ≥12 yr.
Dosage/Direction for Use
Nasal congestion associated w/ seasonal allergic rhinitis Adult & adolescent ≥12 yr 2 sprays in each nostril once daily (total dose: 200 mcg). Childn 2-11 yr 1 spray in each nostril once daily (total dose: 100 mcg). Nasal polyps Adult (including geriatric) & adolescent ≥18 yr 2 sprays in each nostril bid (total dose: 400 mcg). May be reduced to 2 sprays in each nostril once daily (total dose: 200 mcg) once symptoms are adequately controlled. Seasonal or perennial rhinitis Adult (including geriatric) & adolescent 2 sprays in each nostril once daily (total dose: 200 mcg). Maintenance dose: May be reduced to 1 spray in each nostril (total dose: 100 mcg) once symptoms are controlled. May be increased to a max of 4 sprays in each nostril once daily (total dose: 400 mcg) if symptoms are inadequately controlled. Childn 2-11 yr 1 spray in each nostril once daily (total dose: 100 mcg). Acute rhinosinusitis 2 sprays in each nostril bid (total dose: 400 mcg). Adjunctive treatment of acute episodes of sinusitis Adult (including geriatric) & adolescent ≥12 yr 2 sprays in each nostril bid (total dose: 400 mcg). May be increased to 4 sprays in each nostril bid (total dose: 800 mcg) if symptoms are inadequately controlled.
Contraindications
Hypersensitivity. Not to be used in presence of untreated localised infection involving nasal mucosa eg, herpes simplex. Patients who have experienced recent nasal surgery or trauma.
Special Precautions
Discontinue use if localised fungal infection of nose or pharynx develops; if persistent nasopharyngeal irritation occurs. Not recommended in case of nasal septum perforation. Not for use in treatment of unilateral polyps, polyps associated w/ cystic fibrosis, or polyps that completely obstruct nasal cavities. Active or quiescent tuberculous resp tract infections, or in untreated fungal, bacterial, or systemic viral infections. Epistaxis; irritation or swelling inside the nose, especially in long-time use due to benzalkonium Cl. Cataract, glaucoma, central serous chorioretinopathy; Cushing's syndrome, cushingoid features, adrenal suppression, psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in childn). Increased IOP; visual disturbance. Adrenal insufficiency in systemic corticosteroid w/drawal. May unmask preexisting allergic conditions eg, allergic conjunctivitis & eczema, previously suppressed by systemic corticosteroid therapy during transfer. Potentially immunosuppressed patients. Transferring from long-term administration of systemically active corticosteroids. Periodically examine patients in long-term use (several mth or longer) for possible nasal mucosal changes. Regularly monitor height of childn receiving prolonged treatment. Pregnancy & lactation. Carefully observe for hypoadrenalism those infants born of mothers who received corticosteroids during pregnancy. Growth retardation in childn & adolescents.
Adverse Reactions
Epistaxis. Pharyngitis, URTI; headache; nasal burning, irritation & ulceration; throat irritation. Blurred vision.
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
Nasospray nasal spray 50 mcg/actuation
Packing/Price
((140 doses)) 1's
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