ASMANEX TWISTHALER 400 MCG/INHALATION

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

MOMETASONE FUROATE

Boleh didapati daripada:

MERCK SHARP & DOHME (MALAYSIA) SDN BHD

INN (Nama Antarabangsa):

MOMETASONE FUROATE

Unit dalam pakej:

1Units Units

Dikeluarkan oleh:

MSD International GmbH (Singapore Branch)

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
ASMANEX
® TWISTHALER
®
Mometasone furoate (200mcg, 400mcg for oral inhalation)
1
WHAT IS IN THIS LEAFLET
1.
What ASMANEX is used for
2.
How ASMANEX works
3.
Before you use ASMANEX
4.
How to use ASMANEX
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
ASMANEX
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT ASMANEX IS USED FOR
ASMANEX is used as preventive
treatment in people with persistent
asthma.
HOW ASMANEX WORKS
ASMANEX contains the active
substance mometasone furoate which is a
steroid. ASMANEX works by their anti-
inflammatory effects (reduce swelling
and irritation in the walls of the small air
passages in the lungs), easing breathing
problems.
BEFORE YOU USE ASMANEX
_- When you must not use it _
Do not take ASMANEX:

If you are allergic (hypersensitive)
to mometasone furoate or to lactose
(which contains trace amount of
milk proteins).
_ _
_- Pregnancy and lactation _
Ask your doctor for advice if you are
pregnant, planning to become pregnant,
or if you are breastfeeding.
_ _
-
_Before you start using it _
Tell your doctor or pharmacist if you:

Have an infection (fungal, bacterial
or viral) or tuberculosis infection of
the respiratory tract.
_ASMANEX CONTAINS LACTOSE. _
_This medicine contains a small amount _
_of lactose (4.64mg per day is the _
_maximum recommended daily dose). This _
_amount does not normally cause _
_problems in lactose intolerant people. _
-
_Taking other medicines _
Tell your doctor or pharmacist if you are
taking, have recently taken, or might take
any other medicines, including medicines
obtained without a prescription.
Medicines that may interact with
ASMANEX include:

Antifungal medication
(ketoconazole, itraconazole)

Anti-HIV or other antiviral
medication (ritonavir, cobicistat-
containing products)

Antibiotics medication
(clarithromycin)
It is also important to tell your doctor
before you start to use ASMANEX if
you are taking other steroids

Ciri produk

1
LPC -MK0887 -PwIH -082017
AS MANEX® TW IST HALER ®
Brand of mometasone furoa te
FOR ORAL INH AL ATION
DES CR IPTION: Ea ch inha lation contains either 200 micrograms or 400 mi crograms of mometasone
furoate anh ydrou s. Inactive ingredients: Lac tose (which contain s trace amount of milk proteins).
ACTIONS: Mometason e furoate is a top ical glucocorticos teroid with local anti-inflammatory prop erties.
It is likely that much of the mechani sm for the anti-allergic and anti-inflammatory effec ts of
mometasone furoa te lies in its ability to inhibit the relea se of mediators of the inflammatory cascade. In
vitro, mometason e furoate sign ificantly inhibits the release of leu ko triene s from leukocytes of allergic
pa tients. In cell culture, mometasone furoate demons trated hig h potency in inh ibition of synthesis and
release of IL-1, IL-5, IL-6, an d TNF a; it is also a potent inh ibitor of LT prod uc tion 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 sho wn in vitro to exh ibit a bind ing a ffinity for the hu man
glucoco rtico id rece ptor, which is app rox imately 12 times that of dex amethasone, 7 times that of
triamcino lone ac eton ide, 5 times that of budeson ide, and 1.5 times that of fluticasone. Doub le-blind
placeb o-con trolled trials of 12- weeks du ration have sho wn that treatment wi th AS MANE X at
de live red doses wi thin the range of 20 0-800 microg rams per day resu lted in improved lung func tion
as meas ured by FEV 1 and peak exp iratory flow, improved as thma sy mptom co ntrol, and de creas ed
need for inha led be ta-2 agon ist. Improved lung func tion was obse rved wi thin 24 hou rs of the start of
treatm ent in so me pa tients, although max imum bene fit was not ach ieved be fore 1 to 2 weeks or
longe r. Im proved lung func tion was maintained for the duration of treatment.
Cli nical trials in hea lthy vo lun tee rs de monstrated a low rate of sys temic bioava ilab ility