Country: Singapore
Language: English
Source: HSA (Health Sciences Authority)
Azelastine hydrochloride; Fluticasone propionate
PHARMLINE MARKETING PTE. LTD.
R01AD58
SPRAY, METERED
Azelastine hydrochloride 0.1 %w/w; Fluticasone propionate 0.0365 %w/w
NASAL
Prescription Only
Cipla Limited
ACTIVE
2017-06-05
PRODUCT INFORMATION DYMISTA ® NASAL SPRAY NAME OF THE MEDICINE Azelastine hydrochloride and fluticasone propionate DESCRIPTION DYMISTA is formulated as a white, homogeneous and redispersible suspension. It is available as a metered-spray suspension for intranasal administration. DYMISTA ® nasal spray is a fixed combination product containing the following active ingredients: azelastine hydrochloride and fluticasone propionate. Each g of suspension contains 1 mg azelastine hydrochloride and 0.365 mg fluticasone propionate. One spray contains 137 μ g of azelastine hydrochloride (equivalent to azelastine 125 μ g) and 50 μ g of fluticasone propionate. DYMISTA ® nasal spray contains the following inactive ingredients: disodium edetate, glycerol, microcrystalline cellulose, carmellose sodium, polysorbate 80, benzalkonium chloride, phenethyl alcohol and purified water. PHARMACOLOGY PHARMACODYNAMICS Pharmacotherapeutic group: Decongestants and other nasal preparations for topical use, corticosteroids/ fluticasone, combinations, ATC code: R01AD58. DYMISTA ® is a novel formulation of azelastine hydrochloride and fluticasone propionate. Therefore, the mechanisms of actions described below for the individual components apply to DYMISTA ® . Azelastine hydrochloride, a phthalazinone derivative, is classified as a potent long-acting anti-allergic compound with selective H1-antagonist, mast cell stabilizing and anti-inflammatory properties. Data from _in vivo _(preclinical) and _in vitro _ studies show that azelastine inhibits the synthesis or release of the chemical mediators known to be involved in early and late stage allergic reactions, e.g. leukotrienes, histamine, platelet-activating factor (PAF) and serotonin. The major metabolite, desmethylazelastine, also exhibits H1-receptor antagonist activity. DYMISTA ® is administered as a racemic mixture. The racemate, R- and S- enantiomers were equally potent at inhibiting eyelid histamine-induced oedema in rats, however the R-enantiomer was 2-fold less active at inhibiti Read the complete document