Xbira 250mg (Abiraterone Acetate Tablets USP 250mg)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Abiraterone Acetate

Boleh didapati daripada:

CIPLA MALAYSIA SDN BHD

INN (Nama Antarabangsa):

Abiraterone Acetate

Unit dalam pakej:

120 Tablets

Dikeluarkan oleh:

Aizant Drug Research Solutions Private Limited

Risalah maklumat

XBIRA 250MG
® TABLETS CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)
ABIRATERONE ACETATE USP (250 MG)
_________________________________________________________________________________
Page | 1
WHAT IS IN THIS LEAFLET
1.
What XBIRA 250 is used for
2.
How XBIRA 250 works
3.
Before you use XBIRA 250
4.
How to use XBIRA 250
5.
While you are using XBIRA 250
6.
Side effects
7.
Storage and Disposal of XBIRA 250
8.
Product Description
9.
Manufacturer
10.
Marketing Authorisation Holder
11.
Date of Revision
WHAT XBIRA 250 IS USED FOR
XBIRA 250 is indicated with prednisone or
prednisolone for the treatment of prostate
cancer that has spread to other parts of the
body.
HOW XBIRA 250 WORKS
XBIRA 250 contains a medicine called
abiraterone
acetate.
It
is
used
to
treat
prostate cancer in adult men that has spread
to other parts of the body. XBIRA 250
stops your body from making testosterone;
this can slow the growth of prostate cancer
BEFORE YOU USE XBIRA 250
_ _
_WHEN YOU MUST NOT USE IT _
_ _
_Do not take XBIRA 250 _
-
if
you
are
allergic
to
abiraterone
acetate or any of the other ingredients
of this medicine (listed in section 8).
-
if
you
are
a
woman,
especially
if
pregnant. XBIRA 250 is for use in
male patients only.
_Children and adolescents _
-
This medicine is not for use in children
and
adolescents.
If
XBIRA
250
is
accidentally
ingested by
a child
or
adolescent,
go
to
the
hospital
immediately
and
take
the
package
leaflet
with
you
to
show
to
the
emergency doctor.
_ _
_ _
_BEFORE YOU START TO USE IT _
_ _
XBIRA 250 can make high blood pressure
or heart failure or low blood potassium
worse. Taking prednisone or prednisolone
with XBIRA 250 helps to avoid worsening
of
these
conditions.
If
you
have
these
conditions, or other heart or blood vessel
problems, discuss them with your doctor.
Your blood pressure, serum potassium and
signs and symptoms of fluid retention will
be monitored clinically at least monthly.
If you are having sex with a pregnant
woman you need to use a condom. If you
are having sex with a woman who can
be

Ciri produk

_For the use of a Registered Medical Practitioner or a Hospital or a
Laboratory only OR _
_for Specialist Use only _
XBIRA 250 MG
ABIRATERONE ACETATE TABLET USP 250MG
COMPOSITION
Each tablet contains.
Abiraterone acetate USP………... 250 mg
Excipient with known effect: Lactose
DOSAGE FORM
Uncoated Tablet
PRODUCT DESCRIPTION
White to off-white oval shaped tablets, debossed with “A” on one
side and “250” on
other side
EXCIPIENTS
Povidone,
Sodium
Lauryl
Sulfate,
Microcrystalline
cellulose,
Lactose
monohydrate,
Croscarmellose sodium, Purified water, Colloidal silicon dioxide,
Magnesium stearate
PHARMACOLOGY
_PHARMACODYNAMICS _
Pharmacotherapeutic group: endocrine therapy, other hormone
antagonists and related
agents, ATC code: L02BX03
Mechanism of action
Abiraterone acetate is converted
_in vivo_
to abiraterone, an androgen biosynthesis inhibitor.
Specifically, abiraterone selectively inhibits the enzyme
17α-hydroxylase/C17,20-lyase
(CYP17). This enzyme is expressed in and is required for androgen
biosynthesis in
testicular, adrenal and prostatic tumour tissues. CYP17 catalyses the
conversion of
pregnenolone and progesterone into testosterone precursors, DHEA and
androstenedione,
respectively, by 17α-hydroxylation and cleavage of the C17,20 bond.
CYP17 inhibition
also results in increased mineralocorticoid production by the adrenals
(see
_Warnings and _
_Precautions_
).
Androgen-sensitive prostatic carcinoma responds to treatment that
decreases androgen
levels. Androgen deprivation therapies, such as treatment with LHRH
analogues or
orchiectomy, decrease androgen production in the testes but do not
affect androgen
production by the adrenals or in the tumour. Treatment with
abiraterone decreases serum
testosterone to undetectable levels (using commercial assays) when
given with LHRH
analogues (or orchiectomy).
Pharmacodynamic effects
Abiraterone decreases serum testosterone and other androgens to levels
lower than those
achieved by the use of LHRH analogues alone or by orchiectomy. This
results from the
s