NASONEX

국가: 인도네시아

언어: 인도네시아어

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

유효 성분:

MOMETASONE FUROATE MONOHYDRATE

제공처:

ORGANON PHARMA INDONESIA TBK - Indonesia

INN (International Name):

MOMETASONE FUROATE MONOHYDRATE

복용량:

0.051 MG

약제 형태:

SEMPROT HIDUNG

패키지 단위:

DUS,1 BOTOL PLASTIK @ 60 DOSIS

Manufactured by:

SCHERING-PLOUGH LABO NV - Belgium

승인 날짜:

2021-07-17

제품 특성 요약

NASONEX

Aqueous Nasal Spray
Mometasone Furoate
COMPOSITION
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.
ACTIONS
Mometasone
furoate
is
a
topical
glucocorticosteroid
with
local
anti-inflammatory
properties at doses that are not systemically active.
It is likely that much of the mechanism for the anti-allergic and
anti-inflammatory effects
of mometasone furoate lies in its ability to inhibit the release of
mediators of allergic
reactions. Mometasone furoate significantly inhibits the release of
leukotrienes from
leucocytes
of
allergic
patients.
In
cell
culture,
mometasone
furoate
demonstrated
potency in inhibition of synthesis and release of IL-I, IL-5, IL-6 and
TNF
α
. It is also a
potent inhibitor of leukotriene production. In addition, it is an
inhibitor of the production of
the Th 2 cytokines IL-4 and IL-5, from human CD 4 + T-cells. In
studies utilizing nasal
antigen challenge, NASONEX

Aqueous Nasal Spray has shown anti-inflammatory
activity in both the early and late-phase allergic responses. This has
been demonstrated
by decreases (vs placebo) in histamine and eosinophil activity and
reductions (vs
baseline) in eosinophils, neutrophils and ephithelial cell adhesion
proteins. In patients
with
seasonal
allergic
rhinitis,
NASONEX

Aqueous
Nasal
Spray
demonstrated
a
clinically significant onset of action within 12 hours after the first
dose.
Pharmacokinetic Properties
Mometasone
furoate,
administered
as
an
aqueous
nasal
spray,
has
a
systemic
bioavailability of <1% in plasma, using sensitive assay with a lower
quantitation limit
(LLOQ) of 0.25 pg/ml. Mometasone furoate suspension is very poorly
absorbed from the
DISETUJUI OLEH BPOM : 09/06/2021
EREG100373VR12100074 - 75
gastrointestinal tract, and the small am