EMEND 125MG CAPSULE

Land: Malaysia

Sprache: Englisch

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

Wirkstoff:

APREPITANT

Verfügbar ab:

MERCK SHARP & DOHME (MALAYSIA) SDN BHD

INN (Internationale Bezeichnung):

APREPITANT

Einheiten im Paket:

3 (1x125mg & 2x80mg)capsule Capsules

Hergestellt von:

Alkermes Pharma Ireland Limited

Gebrauchsinformation

CONSUMER MEDICATION INFORMATION LE
AFLET (RIMUP)
EMEND
®
CAPSULE
Aprepitant (80 mg, 125 mg)
_____________________________________________________________________________________________
_____________________________________________________________________________________________
1
WHAT IS IN THIS LEAFLET
1.
What EMEND is
taken for
2.
How EMEND works
3.
Before you take EMEND
4.
How to take EMEND
5.
While you are taking EMEND
6.
Side effects
7.
Storage and Disposal of
EMEND
8.
Product description
9.
Manufacturer and product
registration holder
10.
Date of revision
WHAT EMEND IS
TAKEN FOR
EMEND is taken ALONG WITH
OTHER MEDICINES to prevent
and control nausea (sick feeling
)
and vomiting caused by your
cancer chemotherapy treatment.
HOW
EMEND WORKS
EMEND
is a member of a class of
medicines called neurokinin 1
(NK
1
) receptor antagonists
works
by blocking signals to the area of
the brain that controls nausea and
vomiting.
BEFORE YOU TAKE EMEND
-
When you must not take it

Do not take
EMEND if you are
allergic to any of its
ingredients.
-
Before you start to take it
Tell your doctor about any of the
following that apply to you:

any past or present medical
problems.

any allergies.

all medicines that you are
taking or plan to take, even
those you can get without a
prescription or herbal
products.

Any intolerance to some
sugars as this medicine
contains sucrose.
USE IN CHILDREN
Usage of
EMEND has not been
adequately studied in childr
en.
Therefore, EMEND should not be
given to children
under 18 years
old.
USE IN THE ELDERLY
EMEND works equally well in and
is equally well
-
tolerated by older
and younger adult
s. No dosage
adjustment is necessary in the
elderly.
- Taking other medicines
Do not take EMEND with
medicines containing
pimozide
(used to treat psychiatric illness)
,
terfenadine, astemizole
(used for
hay fever and other allergic
conditions), or cisapride (used for
treating digestive problems)
.
Taking EMEND with these
me
dications could result in
SERIOUS
OR LIFE-
THREATENING PROBLEMS
.
Your d

Fachinformation

LPC-MK0869-C-042021b-Malaysia
LOCAL PRODUCT CIRCULAR
Capsules
EMEND
®
(aprepitant, MSD)
I. THERAPEUTIC CLASS
EMEND
®
(aprepitant, MSD), is a substance P neurokinin 1 (NK
1
) receptor antagonist.
II. CLINICAL PHARMACOLOGY
IIa. Mechanism of Action
Aprepitant has a unique mode of action; it is a selective high
affinity antagonist at human
substance P neurokinin 1 (NK
1
) receptors. Counter-screening assays showed that aprepitant
was at least 3,000-fold selective for the NK
1
receptor over other enzyme, transporter, ion
channel and receptor sites including the dopamine and serotonin
receptors that are targets
for existing chemotherapy induced nausea and vomiting (CINV).
NK
1
-receptor antagonists have been shown pre-clinically to inhibit emesis
induced by
cytotoxic chemotherapeutic agents, such as cisplatin, via central
actions. Preclinical and
human Positron Emission Tomography (PET) studies with aprepitant have
shown that it is
brain penetrant and occupies brain NK
1
receptors. Preclinical studies show that aprepitant
has a long duration of central activity, inhibits both the acute and
delayed phases of
cisplatin-induced emesis, and augments the antiemetic activity of the
5-HT
3
-receptor
antagonist ondansetron and the corticosteroid dexamethasone against
cisplatin-induced
emesis.
IIb. Pharmacokinetics
IIb-1. Absorption
The mean absolute oral bioavailability of aprepitant is approximately
60 to 65% and the
mean peak plasma concentration (C
max
) of aprepitant occurred at approximately 4 hours
(T
max
). Oral administration of the capsule with a standard breakfast had no
clinically
meaningful effect on the bioavailability of aprepitant.
The pharmacokinetics of aprepitant are non-linear across the clinical
dose range. In healthy
young adults, the increase in AUC
0-∞
was 26% greater than dose proportional between 80-
mg and 125-mg single doses administered in the fed state. A separate
clinical study in
healthy young adults demonstrated that there is no clinically
important effect of food on
the pharmacokinetics of