DYMISTA

Land: Indonesien

Sprache: Indonesisch

Quelle: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Einheiten im Paket:

DUS, 1 BOTOL @ 17 ML

Berechtigungsdatum:

2022-12-09

Fachinformation

DYMISTA
®
AZELASTINE HYDROCHLORIDE 137 ΜG
FLUTICASONE PROPIONATE 50 ΜG
NASAL SPRAY
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 µg of azelastine
hydrochloride (equivalent
to azelastine 125 µg) and 50 µg 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 HI-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
HI-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 inhibiting eyeball
histamine-induced