Erlocip 25mg Film Coated Tablet

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

ERLOTINIB HYDROCHLORIDE

Boleh didapati daripada:

CIPLA MALAYSIA SDN BHD

INN (Nama Antarabangsa):

ERLOTINIB HYDROCHLORIDE

Unit dalam pakej:

1 x 10 Tablets

Dikeluarkan oleh:

CIPLA LTD

Risalah maklumat

ERLOCIP FILM COATED TABLET
_CONSUMER MEDICATION INFORMATION (RIMUP)_
Erlotinib (25 mg, 100 mg and 150 mg)
____________________________________________________________________________________
1
WHAT IS IN THIS LEAFLET
1.
What Erlocip is used for
2.
How Erlocip works
3.
Before you take Erlocip
4.
How to take Erlocip
5.
While you are using Erlocip
6.
Side effects
7.
Storage and Disposal of Erlocip
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT ERLOCIP IS USED FOR
Erlocip
contains
the
active
ingredient
erlotinib.
Erlocip
is
indicated
for
adults.
This
medicine can be prescribed to you if you
have non-small cell lung cancer at an
advanced stage. It can be prescribed as
initial therapy if your cancer cells have
specific EGFR mutations. It can also be
prescribed if your disease remains largely
unchanged after initial chemotherapy, or
if previous chemotherapy has not helped
to stop your disease.
Erlocip is also used in combination with
gemcitabine
for
the
treatment
of
pancreatic cancer.
This medicine is available only with a
doctor's prescription.
HOW ERLOCIP WORKS
As a targeted cancer treatment, Erlocip
targets a specific protein on the surface of
the cancer cells called EGFR / HER1
(epidermal growth factor receptor 1). It
slows or blocks the activity of EGFR and
may cause the cancer cells to die, with
potentially less damage to normal cells.
However, the way Erlocip works to treat
cancer is not fully known.
BEFORE YOU TAKE ERLOCIP
-
_When you must not take it _
Do not take Erlocip if:
1.
you have had an allergic reaction to
Erlocip or any ingredients listed at
the end of this leaflet.
2.
the package is torn or shows signs of
tampering.
3.
the expiry date (EXP) printed on the
pack has passed.
If you take this medicine after the expiry
date has passed, it may not work as well.
If you are not sure if you should be taking
Erlocip, talk to your doctor.
Use in children
DO NOT GIVE ERLOCIP TO CHILDREN.
Safety and effectiveness in patients less
than
18
years
of

Ciri produk

_For the use of a Registered Medical Practitioner or a Hospital or a
Laboratory only OR for_
_Specialist Use only_
ERLOCIP
25 / 100 / 150 FILM COATED TABLET
ERLOTINIB HYDROCHLORIDE 25 / 100 / 150
COMPOSITION
Erlocip 25
Each film coated tablet contains
Erlotinib hydrochloride equivalent to Erlotinib……25 mg
Colour: Titanium dioxide
Erlocip 100
Each film coated tablet contains
Erlotinib hydrochloride equivalent to Erlotinib……100 mg
Colour: Titanium dioxide
Erlocip 150
Each film coated tablet contains
Erlotinib hydrochloride equivalent to Erlotinib……150 mg
Colour: Titanium dioxide
DOSAGE FORM
Film Coated Tablet
PRODUCT DESCRIPTION
Erlocip 25
White, round, biconvex, film coated tablet debossed with "C1" on one
side and plain on
the other side.
Erlocip 100
White, round, biconvex, film coated tablet debossed with "C2" on one
side and plain on
the other side.
Erlocip 150
White, round, biconvex, film coated tablet debossed with ‘C3’ on
one side and plain on
other side.
PHARMACOLOGY
_ _
_PHARMACODYNAMICS _
Mechanism of action
Erlotinib potently inhibits the intracellular phosphorylation of
HER1/EGFR receptor.
HER1/EGFR receptor is expressed on the cell surface of normal cells
and cancer cells. In non-
clinical models, inhibition of EGFR phosphotyrosine results in cell
stasis and/or death.
_PHARMACOKINETICS_
Exposure
Following a 150 mg oral dose of erlotinib, at steady state, the median
time to reach maximum
plasma concentrations is approximately 4 hours with median maximum
plasma concentrations
achieved of 1,995 ng/ml. Prior to the next dose at 24 hours, the
median minimum plasma
concentrations are 1,238 ng/ml. Median AUC achieved during the dosing
interval at steady
state are 41.300 mcg*hr/ml.
Absorption
Oral erlotinib is well absorbed and has an extended absorption phase,
with mean peak plasma
levels occurring at 4 hours after oral dosing,provided an estimate of
bioavailability of 59%. The
exposure after an oral dose may be increased by food.
Following absorption, erlotinib is highly bound in blood, with