APO-PRAMIPEXOLE pramipexole dihydrochloride 1 mg tablets blister pack

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

유효 성분:

pramipexole dihydrochloride monohydrate

제공처:

Apotex Pty Ltd

INN (International Name):

pramipexole dihydrochloride monohydrate

환자 정보 전단

APO-PRAMIPEXOLE
TABLETS
_Contains the active ingredient pramipexole (as pramipexole
hydrochloride monohydrate)_
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 pramipexole. 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.
You can also download the most up
to date leaflet from
www.apotex.com.au.
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-
Pramipexole Tablets. It contains the
active ingredient pramipexole (as
pramipexole hydrochloride
monohydrate).
It is used to treat Parkinson's disease.
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.
_HOW IT WORKS_
It belongs to a group of medicines
known as "dopamine agonists".
Parkinson's disease is a disease of the
brain that affects body movement.
The symptoms of Parkinson's disease
are caused by a lack of dopamine, a
naturally occurring chemical
produced by certain brain cells.
Dopamine relays messages in the
part of the brain that controls
movement. Pramipexole works by
having a similar effect to dopamine
in the

제품 특성 요약

Product Information – Australia
APO-Pramipexole tablets
Page 1
APO-PRAMIPEXOLE TABLETS
NAME OF THE MEDICINE
Pramipexole Hydrochloride Monohydrate
Chemical Name:
(S)-2-amino-6-propylamino-4,5,6,7-tetrahydrobenzothiazole
dihydrochloride
monohydrate
Structural Formula:
Molecular Formula:
C
10
H
17
N
3
S
.
2HCl
.
H
2
O
Molecular Weight:
302.26 (monohydrate)
211.33 (free base)
284.25 (anhydrous)
CAS Registry Number:
191217-81-9
DESCRIPTION
Pramipexole Hydrochloride Monohydrate is a white to off-white
crystalline powder, freely soluble in
water (>20% w/v).
Each tablet contains 0.125 mg, 0.25mg or 1mg pramipexole hydrochloride
monohydrate as the active
ingredient. In addition, each tablet contains the following inactive
ingredients: mannitol, pregelatinised
maize starch, colloidal anhydrous silica, povidone and magnesium
stearate.
PHARMACOLOGY
PHARMACOLOGICAL ACTIONS
Pramipexole is a dopamine agonist that binds with high selectivity and
specificity to the dopamine D2
subfamily receptors and has a preferential affinity to D3 receptors.
It has full intrinsic activity.
Pramipexole alleviates Parkinsonian motor deficits by stimulation of
dopamine receptors in the
striatum. Animal studies have shown that pramipexole inhibits dopamine
synthesis, release and
turnover.
In human volunteers a dose-dependent decrease in prolactin was
observed.
PHARMACOKINETICS
Pramipexole displays linear pharmacokinetics over the clinical dosage
range with peak to trough
fluctuations (C
max
, C
min
) of approximately 55%.
Absorption
Pramipexole
is
rapidly
absorbed
following
oral
administration.
The
absolute
bioavailability
of
pramipexole is greater than 90%, indicating that it is well absorbed
and undergoes little presystemic
metabolism. Generally, concomitant administration with food does not
affect the bioavailability of
pramipexole.
Following administration of pramipexole tablets, maximum plasma
concentrations (C
max
) are reached
in approximately 2 hours. Food does not affect the extent of
pramipexole absorption, although the
time to maximum