T.O.-Mometasone Aqueous Nasal Spray

T.O.-Mometasone Aqueous Nasal Spray

mometasone

Manufacturer:

Apotex Inc

Distributor:

T O Med

Marketer:

T. O. Chemicals
Concise Prescribing Info
Contents
Mometasone furoate
Indications/Uses
Nasal congestion associated w/ seasonal allergic rhinitis. Nasal polyposis. Symptomatic treatment of seasonal or perennial rhinitis & acute rhinosinusitis. Adjunctive treatment of acute episodes of sinusitis.
Dosage/Direction for Use
Seasonal or perennial rhinitis Patients w/ history of moderate to severe symptoms of seasonal allergic rhinitis Prophylaxis: Administer 2-4 wk prior to start of pollen season. Adult (including elderly) & adolescent Prophylaxis & treatment: 2 sprays in each nostril once daily (total dose: 200 mcg). Maintenance dose: Reduce to 1 spray in each nostril (total dose: 100 mcg) once symptoms are controlled. May be increased to max daily dose 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). 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). Adjunctive treatment of acute episodes of sinusitis Adult (including elderly) & 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. Nasal polyposis Adult (including elderly) & adolescent; ≥18 yr 2 sprays in each nostril bid (total dose: 400 mcg). Reduce dose to 2 sprays in each nostril once daily (total dose: 200 mcg) once symptoms are adequately controlled. Acute rhinosinusitis Childn; ≥12 yr w/o signs & symptoms of bacterial infection 2 actuations in each nostril bid (total dose: 400 mcg).
Contraindications
Hypersensitivity. Active or quiescent TB infections of the resp tract, or untreated fungal, bacterial, systemic viral infections or ocular herpes simplex.
Special Precautions
Rare, immediate hypersensitivity reactions eg, wheezing. Discontinue therapy if localized fungal infection of the nose & pharynx develops; nasaopharyngeal irritation persists. Do not use in patients w/ gastric or duodenal ulcer disease, diabetes, TB, viral infections; in untreated localized infection involving the nasal mucosa; patients w/ recent nasal surgery or trauma. Transfer from systemic corticosteroids may cause w/drawal symptoms (eg, joint & muscular pain, lassitude & depression) & unmask preexisting allergic conditions especially in patients who have asthma or other conditions where too rapid decrease in systemic corticosteroids may cause severe exacerbation of symptoms. Carefully monitor patients for adrenal sufficiency. Resume corticosteroid administration & other modes of therapy & institute appropriate measures if signs 7 symptoms of adrenal insufficiency develops. Hypercorticism especially in patients who are particularly sensitive or predisposed to corticosteroid effect. Increased susceptibility to infections in immunosuppressed patients. Periodically examine patients on treatment for over several months or longer for possible changes in the nasal mucosa. Nasal septum perforation; epistaxis. Avoid use in patients w/ active or quiescent TB, untreated fungal, bacterial, systemic viral infections or ocular herpes simplex infections. Increased IOP. Pregnancy & lactation. Infants born of mothers who received corticosteroids during pregnancy should be monitored for hypoadrenalism. Adolescents <18 yr, ped patients for the treatment of nasal polyps. Ped <2 yr for the treatment of seasonal & perennial allergic rhinitis. Ped <12 yr for the prophylaxis of nasal symptoms of seasonal & perennial allergic rhinitis.
Adverse Reactions
Headache, viral infection, pharyngitis, epistaxis/blood-tinged mucus, coughing, upper resp tract infection; dysmenorrhea, musculoskeletal pain, sinusitis; vomiting. Chest pain; diarrhea, allergic rhinitis, indigestion, nausea; arthralgia, myalgia; sinus headache; conjunctivitis; otalgia, otitis media; asthma, bronchitis, nasal irritation, wheezing; influenza-like symptoms. Anaphylaxis, angioedema, nasal burning & irritation, disturbances in smell, nasal septal perforation, asthma exacerbation (including cough, dyspnea, wheezing & bronchospasm).
Drug Interactions
May increase plasma conc w/ ketoconazole, atazanavir, clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir & telithromycin.
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
T.O.-Mometasone Aqueous Nasal Spray 0.05 mg
Packing/Price
((140 metered dose)) 1's
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