NASONEX AQUEOUS NASAL SPRAY

국가: 말레이시아

언어: 영어

출처: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

유효 성분:

MOMETASONE FUROATE

제공처:

ORGANON MALAYSIA SDN. BHD.

INN (International Name):

MOMETASONE FUROATE

패키지 단위:

40Units Units; 60Units Units; 120Units Units; 140Units Units; 40 Units; 60 Units; 120 Units; 140 Units

Manufactured by:

Organon Heist bv

제품 특성 요약

Copyright 2023 Organon group of companies. All rights reserved.
NASONEX
®
Aqueous Nasal Spray
LPC-OG0887-NS-082017
Brand of mometasone furoate monohydrate
FOR INTRANASAL ADMINISTRATION
DESCRIPTION: NASONEX Aqueous Nasal Spray is a metered-dose, manual
pump spray
unit containing a suspension of mometasone furoate.
Each metered-dose pump actuation
of NASONEX Aqueous Nasal Spray delivers approximately 100 mg of
mometasone furoate
suspension, containing mometasone furoate monohydrate equivalent to 50
micrograms
mometasone furoate.
Inactive ingredients: Cellulose, glycerol, citric acid monohydrate,
sodium citrate dihydrate,
polysorbate 80, benzalkonium chloride and purified water.
Preservatives: benzalkonium
chloride 0.2 mg/g.
ACTIONS: Mometasone furoate is a topical glucocorticosteroid with
local anti-inflammatory
properties at doses that are not systemically active.
PRECLINICAL PHARMACOLOGY AND TOXICOLOGY: Preclinical studies
demonstrate
that
mometasone
furoate
is
devoid
of
androgenic,
antiandrogenic,
estrogenic
or
antiestrogenic activity but, like other glucocorticoids, it possesses
some antiuterotrophic
activity and delays vaginal opening in animal models at high oral
doses of 56 mg/kg/day and
280 mg/kg/day.
In cell culture, mometasone furoate was shown to be at least ten times
more potent than
other
steroids,
including
beclomethasone
dipropionate
(BDP),
betamethasone,
hydrocortisone and dexamethasone, at inhibiting the synthesis/release
of IL-1, IL-6 and
TNF
α
. Mometasone furoate (IC
50
= 0.12 Nm) was also at least six times more potent than
BDP and betamethasone at inhibiting IL-5 production.
Also, in mixed leukocytes from
atopic patients, mometasone was a more potent leukotriene production
inhibitor than BDP.
In a preclinical model, the compound has been shown to reduce the
accumulation of
eosinophils markedly at the site of an allergic reaction. For example,
in allergic mice with
IgE-mediated allergy, inhaled mometasone furoate at doses as low as 13
micrograms/kg
inhibited eosinophil infiltration into bronc