APO-AMITRIPTYLINE 25MG TABLET

Country: Malaysia

Language: English

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

Active ingredient:

AMITRIPTYLLINE HYDROCHLORIDE

Available from:

PHARMAFORTE (MALAYSIA) SDN. BHD.

INN (International Name):

AMITRIPTYLLINE HYDROCHLORIDE

Units in package:

500 Tablets

Manufactured by:

APOTEX INC

Patient Information leaflet

_Consumer Medication Information Leaflet (RiMUP) _
Page 1
APO-AMITRIPTYLINE TABLET
Amitriptyline Hydrochloride (10mg, 25mg)
WHAT IS IN THIS LEAFLET
1.
What Apo-Amitriptyline is
used for
2.
How Apo-Amitriptyline
works
3.
Before you use Apo-
Amitriptyline
4.
How to use Apo-
Amitriptyline
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Apo-
Amitriptyline
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT APO-AMITRIPTYLINE IS USED
FOR
APO-AMITRIPTYLINE is a
prescription medication
containing the active ingredient,
amitriptyline hydrochloride.
APO-AMITRIPTYLINE is
intended for the relief of
symptoms of depression.
Treatment with these types of
medications is mostly safe and
effective when you and your
doctor have good communication
about how you are feeling.
This medication can be used for
bedwetting as well for certain
cases.
HOW APO-AMITRIPTYLINE WORKS
APO-AMITRIPTYLINE is a
form of tricyclic antidepressant
(TCA). It works by increasing the
amounts of certain natural
substances in the brain that are
needed to maintain mental
balance.
BEFORE YOU USE
-
_When you must not use it _
Do not use this medicine if:
- you have any known
hypersensitivity to amitryptylline
or to any ingredients listed at the
end of this leaflet
- you have had heart attack
- you have acute congestive heart
failure
_ _
-
_Before you start to use it_
_ _
Your doctor needs to know:
•
Any other medical condition
that you may have including
heart, liver, or kidney
diseases, unusual eye
conditions, seizures,
difficulties in urinating ;
•
How much alcohol you
consume;
•
Whether you are planning to
get pregnant, are currently
pregnant or are nursing an
infant;
•
If you are going to undergo
any operation, including
dental surgery;
•
If you are a hyperthyroid (a
condition where you produce
too much thyroid hormone)
patient or are receiving
thyroid medication.
_ _
_- Taking other medicines _
Tell your doctor if you are taking
any other prescription or over-the-
counter medication

Summary of Product characteristics

APO-AMITRIPTYLINE
AMITRIPTYLINE HCL TABLETS USP 10MG AND 25MG
ANTIDEPRESSANT
PHARMACOLOGY:
Amitriptyline is structurally and pharmacologically related to
imipramine, desipramine and
nortriptyline. In experimental animals, amitriptyline exhibits a
disruptive action on the electroencephalogram and
on operant behavior, a fairly strong anticonvulsant action, a
peripheral atropine like action, antihistamine and
antiserotonin effects, some adrenergic blockage, and a gastric
antisecretory effect. Amitriptyline is not a MAO
inhibitor. The manner in which it exerts its clinical antidepressant
effect is uncertain. Amitriptyline is well
absorbed from gastrointestinal tract. Antidepressant effects may not
be apparent for 2 or more weeks. It is
metabolized by the liver to active (nortriptyline) and inactive
metabolites. Elimination half-life is 10 to 50 hours.
Amitriptyline
is
excreted
in
the
urine
and
bile
as
conjugates
of
the
cis
and
trans
isomers
of
10-
hydroxynortriptyline.
INDICATIONS:
The treatment of depression including that accompanied by anxiety.
Amitriptyline has been found
effective in reducing the incidence of enuresis in some cases where
organic pathology has been excluded.
CONTRAINDICATIONS:
Known
hypersensitivity.
Concomitant
administration
with
MAO
inhibitors
has
been
considered an absolute contraindication; however, patients with
refractory depression have received combination
therapy without significant adverse effects. If used in combination
therapy, give the drugs orally, avoid large doses
and monitor the patient closely. Not recommended during the acute
recovery phase following myocardial
infarction and in the presence of acute congestive heart failure.
PRECAUTIONS:
Amitriptyline should be used with caution in patients with a history
of seizures or urinary retention,
or with narrow angle glaucoma or increased intraocular pressure.
Arrhythmias, sinus tachycardia and prolongation
of the conduction time have been reported, particularly with high
doses. A few instances of unexpected death have
been reported