Asmanex Twisthaler 100mcginhalation

Krajina: Singapur

Jazyk: angličtina

Zdroj: HSA (Health Sciences Authority)

Aktívna zložka:

mometasone furoate anhydrous

Dostupné z:

ORGANON SINGAPORE PTE. LTD.

ATC kód:

R03BA07

Dávkovanie:

100mcg/inhalation

Forma lieku:

POWDER, METERED

Zloženie:

mometasone furoate anhydrous 100mcg/inhalation

Spôsob podávania:

RESPIRATORY (INHALATION)

Typ predpisu:

Prescription Only

Výrobca:

MSD INTERNATIONAL GMBH (SINGAPORE BRANCH)

Stav Autorizácia:

ACTIVE

Dátum Autorizácia:

2009-04-15

Súhrn charakteristických

S-CCDS-MK0887-PwIH-052020
ASMANEX* TWISTHALER* Dry Powder Inhaler
Brand of mometasone furoate
FOR ORAL INHALATION
DESCRIPTION:
Each
inhalation
contains
either
100 micrograms,
200 micrograms
or
400 micrograms
of
mometasone
furoate
anhydrous.
Inactive
ingredients:
Lactose
(which
contains trace amount of milk proteins).
ACTIONS: Mometasone furoate is a topical glucocorticosteroid with
local anti-inflammatory
properties.
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 the inflammatory
cascade.
In vitro
, mometasone furoate significantly inhibits the release of
leukotrienes from
leukocytes of allergic patients. In cell culture, mometasone furoate
demonstrated high potency
in inhibition of synthesis and release of IL-1, IL-5, IL-6, and TNFα;
it is also a potent inhibitor of
LT production and in addition it is an extremely potent inhibitor of
the production of the TH
2
cytokines, IL-4 and IL-5, from human CD4+ T-cells.
Mometasone furoate has been shown
in vitro
to exhibit a binding affinity for the human
glucocorticoid receptor, which is approximately 12 times that of
dexamethasone, 7 times that of
triamcinolone acetonide, 5 times that of budesonide, and 1.5 times
that of fluticasone.
Double-blind placebo-controlled trials of 12 weeks duration in
patients ≥ 12 years of age have
shown that treatment with ASMANEX* TWISTHALER* at delivered doses
within the range of
200-800 micrograms per day resulted in improved lung function as
measured by FEV
1
and peak
expiratory flow, improved asthma symptom control, and decreased need
for inhaled beta
2
agonist. Improved lung function was observed within 24 hours of the
start of treatment in some
patients, although maximum benefit was not achieved before 1 to 2
weeks or longer. Improved
lung function was maintained for the duration of treatment.
A 12-week, placebo-controlled trial of 296 patients 4- to 11- years of
age with asthma of at least
6
months
duratio