APO-Amisulpride

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Amisulpride

Patient Information leaflet

APO-AMISULPRIDE

_Contains the active ingredient: amisulpride_
CONSUMER MEDICINE INFORMATION

_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_

WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some common
questions about amisulpride. 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 APO-
Amisulpride. It contains the active
ingredient amisulpride. It is used to
treat:
•
symptoms of schizophrenia
Schizophrenia is a condition which
affects the way you think, feel and/or
act. Schizophrenia may cause
symptoms such as hallucinations
(e.g. hearing, seeing or sensing things
which are not there), delusions,
unusual suspiciousness, emotional
and social withdrawal. People with
schizophrenia may also feel
depressed, anxious or tense.
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you. Your
doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
There is no evidence that this
medicine is addictive.
_USE IN CHILDREN_
This medicine must not be taken by
children up to the age of puberty.
There is limited information on the
use of amisulpride in adolescents,
therefore the use of ami

Summary of Product characteristics

Product Information – Australia 
APO-Amisulpride tablets  
Page 1 
APO-AMISULPRIDE TABLETS 

NAME OF THE MEDICINE 
Amisulpride. 

Chemical Name:  
(R, S)-4-Amino-N-[1-ethyl-2-pyrrolidinyl)methyl]-5-ethylsulfonyl-2-methoxybenxamide 

Structural Formula: 

Molecular Formula: 
C
17
H
27
N
3
O
4
S 

Molecular Weight: 
369.48 

CAS Registry Number:  71675-85-9 

DESCRIPTION 
Amisulpride is a white or almost white crystalline powder which
is practically insoluble in water, freely 
soluble in methylene chloride, and sparingly soluble in
anhydrous ethanol. 

PHARMACOLOGY 
CLASS 
Neuroleptic of the benzamide class 

PHARMACOKINETICS 
In man, amisulpride shows two absorption peaks: one
which is attained rapidly, one hour post- dose 
and a second between 3
and 4 hours after administration. Corresponding plasma 
concentrations are 39±3 and 54±4 ng/mL after a 50 mg dose. The volume of distribution is 5.8 L/kg. 
As plasma
protein binding is low (16%), drug interactions due to
displacement are unlikely. 
The absolute bioavailability of amisulpride
tablets is 48%. Amisulpride tablets are not interchangeable 
with amisulpride solution. 
Amisulpride is weakly metabolised: two inactive metabolites, accounting for approximately 4% of the 
dose, have been identified. The elimination half-life of amisulpride is approximately 12 hours after an 
oral dose. 
Fifty percent of an intravenous dose is excreted via the
urine, the majority as unchanged drug. Ninety 
percent of the intravenous dose is eliminated in the first 24 hours. Renal clearance is in the order of 
20 L/h or 330 mL/min. 
Following a single intravenous dose, about 20% of the dose was recovered from the
faeces, about 
70% of which was as unchanged amisulpride. Hepatic metabolism has a limited role in healthy 
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