APO-LORAZEPAM TABLET 1MG

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

LORAZEPAM

Boleh didapati daripada:

PHARMAFORTE (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

LORAZEPAM

Unit dalam pakej:

100 Tablets

Dikeluarkan oleh:

APOTEX INC

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
APO-LORAZEPAM TABLET
_ _
Lorazepam (1mg)
1
WHAT IS IN THIS LEAFLET
1.
What Apo-Lorazepam is used for
2.
How Apo-Lorazepam works
3.
Before you use Apo-Lorazepam
4.
How to use Apo-Lorazepam
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Apo-
Lorazepam
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT APO-LORAZEPAM IS USED FOR
Apo-Lorazepam
is
useful
for
the
short-term relief of manifestations of
excessive
anxiety
in
people
with
anxiety disorder.
HOW APO-LORAZEPAM_ _WORKS
Apo-Lorazepam
contains
the
active
ingredient
lorazepam.
Apo-
Lorazepam
belongs
to
a
group
of
medicines
called
benzodiazepines.
They are thought to work by their
action on brain chemicals.
BEFORE YOU USE APO-LORAZEPAM
-
_When you must not use it _
You must not use this medication, if
you have any allergies to lorazepam,
any
other
benzodiazepines,
or
any
other ingredients in this medication.
(See section PRODUCT DESCRIPTION).
Do
not
take
Apo-Lorazepam
(lorazepam) if you have myasthenia
gravis (weakness and rapid fatigue of
muscles)
or
acute
narrow
angle
glaucoma (increased pressure in the
eye).
_ _
-
_Before you start to use it _
Before
you
start
to
use
this
medication, your doctor should know
if you have or have had any of the
following conditions:
•
any past drug abuse/ dependency
history
•
depression,
psychosis
(loss
of
contact with reality) or other mental
illness
•
suicidal attempts or thoughts
•
liver or kidney problems
•
elderly
This medication is not recommended
for children and adolescent under the
age
of
18.
Anaphylaxis
(severe
allergic
reaction)
and
angioedema
(severe facial swelling) might occur
as early as the first time the product is
taken.
_Pregnancy and lactation _
Do not take Apo-Lorazepam if you
are pregnant, trying to get pregnant or
think you may be pregnant. Do not
take
Apo-Lorazepam
if
you
are
breast-feeding.
Ask
your
doctor
or
pharmacist for advice before taking
any medicine.
-
_Taking other medi

Ciri produk

APO-LORAZEPAM
LORAZEPAM TABLETS USP 1MG
ANXIOLYTIC-SEDATIVE
PHARMACODYNAMICS: Apo-Lorazepam (lorazepam) is an active
benzodiazepine with a depressant action on the
central nervous system. It has anxiolytic and sedative properties
which are of value in the symptomatic relief of
pathologic anxiety in patients with anxiety disorders giving rise to
significant functional disability but is not considered
indicated in the management of trait anxiety.
PHARMACOKINETICS: Lorazepam is rapidly and completely absorbed after
oral administration, reaching mean peak
plasma levels at approximately 2 hours. Lorazepam is rapidly
conjugated to a glucuronide which has no demonstrable
psychopharmacological activity and is excreted mainly in the urine.
The serum half life of the conjugate varied
between 16 to 20 hours. Very small amounts of other metabolites and
their conjugates have been isolated from urine
and plasma. Most of the drug (88%) is excreted in the urine, with 75%
excreted as the glucuronide. At clinically
relevant concentrations, approximately 85% of lorazepam is bound to
plasma proteins. Anterograde amnesia, a lack
of recall of events during period of drug action, has been reported
and appears to be dose-related.
INDICATIONS: Apo-Lorazepam (lorazepam) is useful for the short-term
relief of manifestations of excessive anxiety in
patients with anxiety neurosis. Anxiety and tension associated with
the stresses of everyday life usually do not require
treatment with anxiolytic drugs.
CONTRAINDICATIONS: Apo-Lorazepam (lorazepam) is contraindicated in
patients with myasthenia gravis or acute
narrow angle glaucoma, and in those with known hypersensitivity to
benzodiazepines.
WARNINGS: Apo-Lorazepam (lorazepam) is not recommended for use in
depressive neurosis or in psychotic reactions.
Because of the lack of sufficient clinical experience, lorazepam is
not recommended for use in patients less than 18
years of age. It should not be used in children under 6 years age.
Since Apo-Lorazepam has a central nervous system
depressant ef