Chemmart Moclobemide

Država: Australija

Jezik: engleski

Izvor: Department of Health (Therapeutic Goods Administration)

Aktivni sastojci:

Moclobemide

Dostupno od:

Apotex Pty Ltd

Razred:

Medicine Registered

Uputa o lijeku

CHEMMART
MOCLOBEMIDE

_Contains the active ingredient, moclobemide_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some common
questions about moclobemide.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. More recent information on
this medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet,
•
if you are worried about taking
your medicine, or
•
to obtain the most up-to-date
information.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
Pharmaceutical companies cannot
give you medical advice or an
individual diagnosis.
Keep this leaflet with your medicine.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is
Chemmart Moclobemide. It contains
the active ingredient moclobemide.
It is used to treat depression.
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you.
Your doctor may have prescribed
moclobemide for another reason.
This medicine is available only with
a doctor's prescription.
_HOW IT WORKS_
There are many different types of
medicines used to treat depression.
Moclobemide belongs to a group of
antidepressant medicines called
reversible inhibitors of monoamine
oxidase A (RIMA).
Antidepressants are used to treat
depression and work on the central
nervous system. They are thought to
work by their action on brain
chemicals called amines, which are
involved in controlling mood.
Depression is longer lasting and/or
more severe than the "low moods"
everyone has from time to time due
to the stress of everyday life. It is
thought to be caused by a chemical
imbalance in parts of the brain. This
imbalance affects your

Svojstava lijeka

Product Information – Australia 
Chemmart Moclobemide Tablets 
Page 1 
CHEMMART MOCLOBEMIDE TABLETS 

NAME OF THE MEDICINE 
Moclobemide. 

Chemical Name:  
p-chloro-N-(2-morpholinoethyl)benzamide. 

Structural Formula: 

H
O
N
CH
2
CH
2
N C
O
Cl

Molecular Formula:  
C
13
H
17
O
2
N
2
Cl  

Molecular Weight:  
268.74 

CAS Registry Number:  
71320-77-9 

DESCRIPTION 
Moclobemide is a white to slightly reddish crystalline powder. It contains no
crystal water and is not 
hygroscopic. It is soluble in water at 0.4 g/100 mL. The pKa is approximately 6.2. 

PHARMACOLOGY 
PHARMACOKINETICS 
Absorption 
After oral administration, moclobemide is completely absorbed from the gastrointestinal tract into the 
portal blood.  A hepatic first-pass effect reduces the
systemically available dose fraction 

(bioavailability:  F). This reduction is more pronounced
after single (F:  60%) than after multiple  (F: > 
80%) doses. 

Following the administration of a 300 mg single dose of moclobemide
to healthy subjects, peak 
plasma concentrations ranged from 1.0 to 3.4 
μg/mL (mean C
max
 2.2 
μg/mL) and were reached in 0.8 
to 4.0 hours (median T
max
 1.75 hours). Studies using other moclobemide-containing formulations have 
shown that during the second week of a 100mg t.i.d. dosing regimen in healthy subjects, the steady-
state trough concentrations of moclobemide ranged between 114 ng/mL and 517 ng/mL. An increase 
in the dose to 150 mg t.i.d.  resulted in a greater than
proportional increase in moclobemide steady-
state trough concentrations, namely to concentrations ranging between 346 ng/mL and 1,828 ng/mL. 

Distribution 
Due to its lipophilic nature, moclobemide
is extensively distributed in the body with an apparent 
volume of distribution (V
ss
) of about 1.2 L/kg. Bind