DEPROPIN TABLET 25MG

Country: Malaysia

Language: English

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

Active ingredient:

DOTHIEPIN HCL

Available from:

DUOPHARMA (M) SDN. BHD.

INN (International Name):

DOTHIEPIN HCL

Units in package:

100 Tablets

Manufactured by:

DUOPHARMA (M) SDN. BHD.

Patient Information leaflet

_Patient Information Leaflet (PIL) _
1
DEPROPIN TABLET
Dothiepin hydrochloride 25mg
WHAT IS IN THE LEAFLET?
1.
What DEPROPIN is used
for
2.
How DEPROPIN works
3.
Before you use DEPROPIN
4.
How to use DEPROPIN
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
DEPROPIN
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT DEPROPIN IS USED FOR
DEPROPIN
is
used
to
treat
depression.
Your
doctor
may
have
prescribed
DEPROPIN
for
another
reason.
Ask
your
doctor
if
you
have
any
questions
about
why
DEPROPIN
has
been
prescribed for you.
HOW DEPROPIN WORKS
DEPROPIN contains dothiepin
hydrochloride. It belongs to a
group of medicines known as
tricyclic
antidepressants
(TCAs).
DEPROPIN
corrects
the
chemical
imbalance
and
may help relieve the symptoms
of depression.
BEFORE YOU USE DEPROPIN
-
_When you must not take it _
_ _
Do not use DEPROPIN if you
have liver failure.
Do not use DEPROPIN if you
have fits.
DEPROPIN
is
not
recommended
for
use
in
children under 16 years.
Do not take this medicine if
you are allergic to
•
dothiepin hydrochloride
•
any of the ingredients listed
at the end of this leaflet
•
any
other
tricyclic
antidepressants such as :
▪
amitriptyline
▪
clomipramine
▪
desipramine
▪
doxepin
▪
imipramine
▪
nortriptyline
▪
protriptyline
▪
trimipramine
Do not take DEPROPIN if you
are taking another medicine for
depression called a monoamine
oxidase inhibitor (MAOI) such
as
isocarboxazid,
nialamide,
phenelzine,
hydracarbazine.
Ask your doctor or pharmacist
if you are unsure as to whether
or not you are taking a MAOI.
Do not take DEPROPIN if you
are
recovering
from
a
recent
heart attack. It may make your
condition worse.
Do not use 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,
return it to your pharmacist for
disposal.
If you are not sure whether you
should start using this medicine,
talk to your doctor.
-
_Before you start to use it _
_ _

Summary of Product characteristics

DESCRIPTION:
DEPROPIN TABLET 25MG: A 7 mm diameter round shaped tablet, apple green
in colour with “DUOMA/DUOMA” and “DUO 861” markings.
COMPOSITION:
Each tablet contains Dothiepin Hydrochloride 25 mg.
PHARMACODYNAMICS:
ACTIONS: Tricyclic antidepressant
PHARMACOLOGY: Dothiepin is a thionalogue of amitriptyline. In
anti-reserpine activity, it is generally equivalent to amitriptyline
but less potent than imipramine.
SITE AND MODE OF ACTION: The site of action is thought to be in the
CNS, but the mechanism by which this drug and all tricyclic
antidepressants produce an
antidepressant effect is unknown. Dothiepin possesses anticholinergic,
antihistamine and central sedative properties. It is postulated that
the aetiology of
depression is associated with a functional abnormality of one or more
of the biogenic amines, particularly the cathecolamines, in the brain.
The tricyclics inhibit
uptake of noradrenaline and 5-hydroxytryptamine from the nerve endings
thus increasing their availability at central noradrenergic synapses.
PHARMACOKINETICS:
_ABSORPTION: _Well absorbed. Animal studies show dothiepin is absorbed
from the small intestine. After a single 50 mg oral dose in one
patient, a peak level of
20 nanogram / mL was achieved after 3 hours, falling to 10 nanograms /
mL at 6 hours. There are substantial inter-individual variations in
steady state concentra-
tions. In 10 patients takin 100 mg / day for two weeks, the serum
concentration ranged from 18-84 nanogram / mL (mean 41 ± 7 nanogram /
mL). After increasing
the dose to 175 mg / day for a further two weeks the concentration
ranged from 43 to 196 nanogram / mL (mean 96 ± 15 nanogram / mL).
Steady state
concentrations appear to be reached after 10 to 14 days.
_DISTRIBUTION:_ Dothiepin is present in low concentrations in breast
milk. It crosses the placental and blood brain barriers in animals.
Animal studies in the dog or
cat show maximal concentration after 24 hours in liver, uveal tract of
the eye, lung, kidney, pituitary and thyroid in descending order