DYMISTA NASAL SPRAY

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Azelastine hydrochloride; Fluticasone propionate

Available from:

PHARMLINE MARKETING PTE. LTD.

ATC code:

R01AD58

Pharmaceutical form:

SPRAY, METERED

Composition:

Azelastine hydrochloride 0.1 %w/w; Fluticasone propionate 0.0365 %w/w

Administration route:

NASAL

Prescription type:

Prescription Only

Manufactured by:

Cipla Limited

Authorization status:

ACTIVE

Authorization date:

2017-06-05

Summary of Product characteristics

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