Rexulti 0.5mg film-coated tablets

国: マレーシア

言語: 英語

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

有効成分:

Brexpiprazole

から入手可能:

Lundbeck Malaysia Sdn. Bhd.

INN（国際名）:

Brexpiprazole

パッケージ内のユニット:

28 Tablets; 7 Tablets

製:

OTSUKA PHARMACEUTICAL CO., LTD

情報リーフレット

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
REXULTI
®
FILM-COATED TABLETS
_ _
Brexipiprazole (0.25mg, 0.5mg, 1mg, 2mg, 3mg, 4mg)
_ _
1
WHAT IS IN THIS LEAFLET
1.
What REXULTI is used for
2.
How REXULTI works
3.
Before you use REXULTI
4.
How to use REXULTI
5.
While you are using it
6.
Side Effects
7.
Storage and disposal of
REXULTI
8.
Product Description
9.
Manufacturer and
Product
Registration
Holder
10.
Date of revision
WHAT REXULTI IS USED FOR
REXULTI
film-coated
tablets
contain
the
active
substance
brexpiprazole.
REXULTI
is
a
prescription
medicine used to treat adults aged
18 and older who suffer from:
−
Major
depressive
disorder
(MDD): REXULTI is used in
addition
to
your
antidepressant
medicine,
when your doctor determines
that the antidepressant alone
did not adequately treat your
depression.
−
Schizophrenia:
REXULTI
is
used
to
treat
symptoms
of
schizophrenia.
Your
doctor
may
continue
to
prescribe
REXULTI even when you are
feeling
better
in
order
to
prevent
the
re-emergence
of
symptoms.
HOW REXULTI WORKS
REXULTI belongs to a group of
medicines
called
antipsychotic
agents. REXULTI helps to correct
a chemical imbalance in the brain
which
is
associated
with
schizophrenia.
In
Depression
REXULTI
is
used
as
adjunct
treatment to add to the action of
antidepressants
to
restore
the
chemical
imbalance
in
the
brain
that
is
thought
to
occur
in
depression.
You and your doctor have decided
on REXULTI to help relieve the
symptoms
of
your
condition.
Although
REXULTI
cannot cure schizophrenia, it can
help
to
keep
the
symptoms
of
schizophrenia
under
control
and
reduce the risk of relapse as you
continue treatment. In depression
REXULTI
can
help
to
reduce
symptoms in patients that do not
respond
optimally
to
current
treatment with antidepressants.
BEFORE YOU USE REXULTI
_When you must not use it _
Do not take REXULTI: if you are
allergic to brexpiprazole or any of
the
other
ingredients
of
this
medicine (listed in Section 8).
_Pregnancy and lactation _
If
you
are
pregnant
or
breast-
feeding,
think
you
may
be
pregnan

製品の特徴

PACKAGE LEAFLET
1
DESCRIPTION
Brexpiprazole is a serotonin-dopamine activity modulator that is
available as brexpiprazole film-coated
tablets.
1.1.1
NAME OF MEDICINAL PRODUCT
Rexulti 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg film-coated
tablets
1.2
QUALITATIVE AND QUANTITATIVE COMPOSITION
0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg film-coated tablets
contain 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3
mg, and 4 mg of brexpiprazole, respectively
1.3
PHYSICOCHEMISTRY
1.3.1
NON PROPRIETARY NAME
Brexpiprazole
1.3.2
CHEMICAL NAME
7-{4-[4-(1-Benzothiophen-4-yl)piperazin-1-yl]butyloxy}quinolin-2(1H)-one
1.3.3
MOLECULAR FORMULA
C
25
H
27
N
3
O
2
S
1.3.4
MOLECULAR WEIGHT
433.57
1.3.5
STRUCTURAL FORMULA
1.3.6
DRUG SUBSTANCE DESCRIPTION
Brexpiprazole occurs as white to off-white crystals or crystalline
powders.
1.4
PHARMACEUTICAL FORM
TABLE 1
REXULTI FILM-COATED TABLET
DOSE
SHAPE
COLOR
MARKING
0.25 mg
round
light brown
“BRX” and “0.25”
0.5 mg
round
light orange
”BRX” and ”0.5”
1 mg
round
light yellow
”BRX” and “1”
2 mg
round
light green
”BRX” and “2”
3 mg
round
light purple
”BRX” and “3”
4 mg
round
white
”BRX” and “4”
2
THERAPEUTIC INDICATIONS
Brexpiprazole is indicated in adult patients for:
•
Use as an adjunctive therapy to antidepressants for the treatment of
major depressive disorder
(MDD). Efficacy was demonstrated in 6-week trials in adults with MDD
who had an inadequate
response to antidepressant therapy during the current episode. The
long-term efficacy of
brexpiprazole as adjunctive treatment in MDD has not been established
•
Treatment of schizophrenia
3
POSOLOGY AND METHOD OF ADMINISTRATION
For oral use once daily with or without food
3.1
DOSAGE AND METHOD OF ADMINISTRATION
ADJUNCTIVE TREATMENT OF MAJOR DEPRESSIVE DISORDER
The recommended starting dose for REXULTI as adjunctive treatment is
0.5 mg or 1 mg once daily. Dose
titration to 1 mg/day and up to the target dose of 2 mg/day should
occur at intervals of up to 1 week based
on the patient’s clinical response and tole