Trandate Tablets 100mg

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

LABETALOL HYDROCHLORIDE

Boleh didapati daripada:

Aspen Medical Products Malaysia Sdn Bhd

INN (Nama Antarabangsa):

LABETALOL HYDROCHLORIDE

Unit dalam pakej:

50 Tablet Tablets

Dikeluarkan oleh:

Aspen Bad Oldesloe GmbH

Risalah maklumat

_Consumer Medication Information Leaflet (RIMUP) _
1
TRANDATE TABLETS 100MG
Labetalol hydrochloride (100mg)
WHAT IS IN THE LEAFLET?
1.
What
Trandate
Tablet
is
used for
2.
How Trandate Tablet works
3.
Before
you
use
Trandate
Tablet
4.
How to use Trandate Tablet
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
Trandate Tablet
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT TRANDATE TABLET IS USED
FOR
Trandate Tablet is used for the
treatment
of
all
degrees
of
hypertension. Hypertension is a
condition marked by high blood
pressure.
HOW TRANDATE TABLET WORKS
Trandate
Tablet
contains
a
medicine
called
labetalol
hydrochloride. This belongs to
a
group
of
medicines
called
beta-blockers.
It
works
by
changing the body’s response to
some
nerve
impulses.
Therefore, it widens the blood
vessels in the body, causing the
blood pressure to fall.
Ask your doctor if you have any
questions
about
why
this
medicine has been prescribed
for you. Your doctor may have
prescribed it for another reason.
BEFORE
YOU
USE
TRANDATE
TABLET
-
_When you must not take it _
Do not take this medicine if you
have an allergy to:
•
labetalol hydrochloride, the
active ingredient
•
any of the other ingredients
listed
at
the
end
of
this
leaflet
Do not take Trandate Tablet if
•
you suffer from second or
third
degree
heart
block
(unless
pacemaker
is
in
situ), cardiogenic shock and
other
conditions
accompanied by severe and
prolonged
hypertension
or
bradycardia.
•
you suffer from asthma or
from airways obstruction.
•
you
suffer
from
uncompensated heart failure
•
you suffer from unstable /
uncontrolled
heart
insufficiency
•
you suffer from sick sinus
syndrome (including sinus
atrial
block)
unless
pacemaker is in situ.
•
you suffer from prinzmetal
angina.
•
you suffer from sinus node
dysfunction.
Do not take this medicine after
the expiry date printed on the
pack or if the packaging is torn
or shows signs of tampering. If
it has expired or is damaged,
retur

Ciri produk

1
TRANDATE
LABETALOL HYDROCHLORIDE
QUALITATIVE AND QUANTITATIVE COMPOSITION
TRANDATE Injection is a clear, colourless solution, practically free
from visible particles,
containing 5mg of Labetalol Hydrochloride per ml and supplied in 5ml
ampoule.
TRANDATE Tablets are orange, round, biconvex film-coated tablets,
engraved TT01 on one
face. Each tablet contains 100mg of Labetalol Hydrochloride.
PHARMACEUTICAL FORM
Solution for injection.
Film-coated tablets.
CLINICAL INFORMATION
INDICATIONS
_INJECTION IS INDICATED FOR: _
•
Severe hypertension, including severe hypertension of pregnancy, when
rapid control
of blood pressure is essential.
•
May be used to achieve controlled hypotension during anaesthesia.
_ _
_TABLET IS INDICATED FOR: _
•
Mild, moderate or severe hypertension.
•
Hypertensions in pregnancy.
•
Angina pectoris with coexisting hypertension.
DOSAGE AND ADMINISTRATION
_INJECTION: _
POSOLOGY
Labetalol injection is intended for i.v. use in hospitalised patients.
POPULATIONS
•
ADULTS
INDICATION
DOSE
SEVERE
HYPERTENSION
Bolus Injection:
If it is essential to reduce the blood pressure quickly a dose of 50
mg
should be given by I.V. injection (over a period of at least 1 min)
and, if
necessary, repeated at 5 min intervals until a satisfactory response
occurs. The total dose should not exceed 200 mg.
2
The maximum effect usually occurs within 5 min and the duration of
action
is usually about 6 h but may be as long as 18 h.
Intravenous Infusion:
_ _
A 1 mg/ml solution of labetalol should be used, i.e. the contents of
eight 5
ml ampoules (200 mg) diluted to 200 ml with Sodium Chloride and
Dextrose Injection BP or 5% Dextrose Intravenous Infusion BP.
The infusion rate should normally be about 160 mg/h but may be
adjusted
according to the response at the discretion of the physician. The
effective
dose is usually 50 to 200 mg but infusion should be continued
until a
satisfactory response is obtained and larger doses may be needed,
especially in patients with phaeochromocytoma.
In case of severe hypertension