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Momate Az

Momate Az

Manufacturer:

Glenmark Pharmaceuticals

Distributor:

Glenmark
Concise Prescribing Info
Contents
Per 50 mcg/140 mcg Mometasone furoate 50 mcg, azelastine HCl 140 mcg
Indications/Uses
Symptomatic relief of seasonal allergic rhinitis in patients ≥12 yr.
Dosage/Direction for Use
2 sprays in each nostril once daily or 1 spray in each nostril bid.
Contraindications
Hypersensitivity. Do not use in the presence of untreated localised infection involving nasal mucosa. Do not use in patients who have experienced recent nasal surgery or trauma until healing has occurred.
Special Precautions
Should be used during pregnancy only if potential benefits justify potential risk to the fetus. Caution when administered to nursing women. Mometasone furoate: Discontinue therapy if hypersensitivity reactions occur. Discontinue therapy & institute appropriate local or systemic therapy, if needed, when Candida infection develops. Risk of epistaxis; localized nose & pharynx infections w/ Candida albicans; impaired wound healing; glaucoma &/or cataracts. Reports of nasal septum perforation. Periodically examine for possible changes in nasal mucosa in patients using nasal spray over several mth or longer. Patients w/immunosuppression; active or quiescent tuberculous infection of the resp tract; untreated fungal, bacterial, systemic viral infections; ocular herpes simplex. May cause reduction in growth velocity when administered to ped patients. Azelastine HCl: Occurrence of somnolence. Caution against engaging in hazardous occupations requiring complete mental alertness & motor coordination (eg, operating machinery or driving motor vehicle). Safety & effectiveness in ped patients <12 yr have not been established.
Adverse Reactions
Epistaxis, headache. Mometasone furoate: Pharyngitis, nasal burning/irritation/ulceration. Azelastine HCl: Bitter taste, nasal discomfort, fatigue, somnolence, nasopharyngitis, sinusitis & sneezing.
Drug Interactions
Mometasone furoate: Increased plasma conc w/ ketoconazole (potent CYP3A4 inhibitor). Azelastine HCl: Reductions in alertness & impairment of CNS performance may occur w/ alcohol or other CNS depressants; concurrent use should be avoided. Increased mean Cmax & AUC of orally administered azelastine HCl w/ cimetidine.
MIMS Class
Nasal Decongestants & Other Nasal Preparations
ATC Classification
R01AD59 - mometasone, combinations ; Belongs to the class of topical corticosteroids used for prophylaxis and treatment of allergic rhinitis.
Presentation/Packing
Form
Momate Az 50 mcg/140 mcg nasal spray
Packing/Price
(150 actuations) 1's (P819/bottle)
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