APOMINE apomorphine hydrochloride hemihydrate 10mg/1mL injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

apomorphine hydrochloride hemihydrate

Available from:

Pfizer Australia Pty Ltd

Authorization status:

Registered

Patient Information leaflet

Apomine (Apomorphine) CMI.
Page 1
APOMINE
™
_ _INJECTION AND APOMINE™ PFS
Apomorphine _(a-poe-MOR-feen) _hydrochloride _ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about APOMINE_ _
Injection and APOMINE Pre-Filled
Syringe (PFS). It does not contain
all the available information. It
does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits
.
Your doctor has weighed
the risks of you using APOMINE
Injection or APOMINE PFS against
the benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET IN A SAFE PLACE.
You may need to read it again.
For further information on
APOMINE Injection or APOMINE
PFS please refer to “A guide to the
use of apomorphine in the
treatment of Parkinson’s Disease
for patients and carers” which is
available from Hospira Pty Ltd (ph:
1300 046 774).
WHAT APOMINE
INJECTION AND APOMINE
PFS ARE USED FOR
APOMINE Injection and APOMINE
PFS contain apomorphine which
belongs to a group of medicines
called dopaminergic compounds.
Apomorphine is used in the
treatment of Parkinson’s disease to
reduce the number and severity of
bouts of freezing and stiffness (or
“off” periods).
This medicine works by acting on
dopamine receptors. These
receptors help control movement
by the body.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED
FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
This medicine is available only with
a doctor’s prescription.
There is not enough information to
recommend the use of this
medicine in children under 18
years.
BEFORE YOU USE
APOMINE INJECTION OR
APOMINE PFS.
_WHEN YOU MUST NOT USE IT _
DO NOT USE APOMINE INJECTION OR
APOMINE PFS IF YOU HAVE AN
ALLERGY TO:

apomorphine

sodium metabisulfite

certain types of pain killers
such as morphine or other
opioid analgesics.
Some of the symptoms of an
a

Summary of Product characteristics

Version 8.0
Page 1
APOMINE
™ INJECTION
NAME OF THE MEDICINE
Apomorphine hydrochloride
The CAS registry number of apomorphine hydrochloride, anhydrous is
41372-20-7 and the chemical
structure is shown below:
DESCRIPTION
Apomine
™
Injection is a sterile solution containing 10 mg/mL of apomorphine
hydrochloride in Water
for Injections BP. Sodium metabisulfite 1 mg/mL is included in the
formulation as an antioxidant.
The pH of the injection is 3.0 to 4.0.
PHARMACOLOGY
Apomorphine is a directly acting dopamine receptor agonist,
structurally related to dopamine.
Apomorphine has high
_in vitro_
binding affinity for the dopamine D
4
and D
5
receptor (
_K_
_i_
:4 and 14 nM
respectively), moderate affinity (
_K_
_i_
: 26 to 130 nM) for the dopamine D
2
and D
3
, adrenergic

1D
,

2B
,

2C
receptors, serotonin 5HT
1A
, 5HT
2A
, 5HT
2B
, and 5HT
2C
receptors and low affinity for the
dopamine D
1
receptor (
_K_
_i_
: 370 nM). Apomorphine exhibits no affinity for the adrenergic ß
1
and ß
2
or
histamine H
1
receptors.
The effect of apomorphine as an antiparkinsonian agent is believed to
be the result of direct
stimulation of postsynaptic D
2
dopamine receptors, but stimulation of presynaptic D
2
dopamine
receptors and antagonism of

2
adrenergic receptors may also be important. Apomorphine reduces
the tremor, rigidity and bradykinesia in patients receiving levodopa.
Apomorphine induces vomiting
by direct stimulation of the medullary chemoreceptor trigger zone.
PHARMACOKINETICS
The peripheral pharmacokinetics of apomorphine have been studied
following subcutaneous injection,
subcutaneous infusion and intravenous infusion.
ABSORPTION
Following intramuscular or subcutaneous administration, apomorphine is
reported to be well
absorbed. Peak plasma concentration occurs as early as three minutes
following subcutaneous bolus
injection. The rapid and complete absorption from subcutaneous tissues
and rapid clearance is
believed to correlate with the rapid onset and brief duration of
action respectively. Antiparkinsonian