APO-LEVODOPA/CARBIDOPA 250/25 levodopa 250 mg and carbidopa (as monohydrate) 25 mg tablet blister pack

国: オーストラリア

言語: 英語

ソース: Department of Health (Therapeutic Goods Administration)

有効成分:

levodopa, Quantity: 250 mg; carbidopa monohydrate, Quantity: 27 mg (Equivalent: carbidopa, Qty 25 mg)

から入手可能:

Arrotex Pharmaceuticals Pty Ltd

医薬品形態:

Tablet, uncoated

構図:

Excipient Ingredients: magnesium stearate; microcrystalline cellulose; crospovidone; pregelatinised maize starch; indigo carmine aluminium lake

投与経路:

Oral

パッケージ内のユニット:

20 tablets, 10 tablets, 100 tablets

処方タイプ:

(S4) Prescription Only Medicine

適応症:

APO-LEVODOPA/CARBIDOPA is indicated for the treatment of Parkinson's disease and syndrome. It is useful in relieving many of the symptoms of parkinsonism, particularly rigidity and bradykinesia. APO-LEVODOPA/CARBIDOPA frequently is helpful in the management of tremor, dysphagia, sialorrhoea and postural instability associated with Parkinson's disease and syndrome.

製品概要:

Visual Identification: Round, light blue uncoated tablets with 'C' on one side and '20' on the other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

認証ステータス:

Registered

承認日:

2018-01-11

情報リーフレット

APO-LEVODOPA/CARBIDOPA
1
APO-
LEVODOPA/CARBIDOPA
_Levodopa/Carbidopa _
CONSUMER MEDICINE INFORMATION
FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about this medicine. 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 taking this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT THIS MEDICINE IS
USED FOR
Levodopa/Carbidopa is used to treat
some symptoms of Parkinson’s
disease. This is a disease of the
nervous system that mainly affects
body movement. The three main
symptoms are shaking (tremor),
muscle stiffness, and slow and
unsteady movement. People with
Parkinson's disease often walk with a
shuffle as they have difficulty in
initiating movement. If untreated,
Parkinson's disease can cause
difficulty in performing normal daily
activities.
Levodopa/Carbidopa is most helpful
in improving slow movement and
muscle stiffness. It is also frequently
helpful in treating shaking, difficulty
in swallowing and drooling.
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 muscle
movement. When too little dopamine
is produced, slowness of movement
results.
APO-Levodopa/Carbidopa contains
two active ingredients, levodopa and
carbidopa. Levodopa is a chemical
closely related to dopamine which
allows the body to make its own
dopamine. Carbidopa makes sure that
enough levodopa gets to the brain
where it is needed. In many patients,
levodopa/carbidopa reduces some of
the symptoms of Parkinson's disease.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.

製品の特徴

AUSTRALIAN PRODUCT INFORMATION – APO-LEVODOPA/CARBIDOPA
(LEVODOPA/CARBIDOPA)
1.
NAME OF THE MEDICINE
Levodopa and carbidopa
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Levodopa and carbidopa (as monohydrate) 250mg/25mg
Levodopa and carbidopa (as monohydrate) 100mg/25mg
_Carbidopa_
Carbidopa, an inhibitor of aromatic amino acid decarboxylase, is a
white, crystalline compound, slightly
soluble
in
water,
with
a
molecular
weight
of
244.3.
It
is
designated
chemically as (-) L-alpha-
hydrazino-alpha-methyl-beta-(3,4-dihydroxy-benzene) propanoic
acid monohydrate. Tablet content is
expressed in terms of anhydrous carbidopa, which has
a molecular weight of 226.3
_Levodopa_
Levodopa,
an
aromatic
amino
acid,
is
a
white,
crystalline
compound,
slightly
soluble
in
water,
with
a
molecular
weight
of
197.2.
It
is
designated
chemically
as
(-)
L-alpha-amino-
beta-(3,4-
dihydroxybenzene) propanoic acid.
For the full list of excipients, refer Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Levodopa/carbidopa is supplied as uncoated tablets for oral
administration.
250mg/25mg: Round, light blue uncoated tablets with ‘C’ on one
side and ‘20’ on the other side.
100mg/25mg: Round, light yellow uncoated tablets with ‘C’ on one
side and ‘19’ on the other side.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
APO-LEVODOPA/CARBIDOPA is indicated for the treatment of Parkinson's
disease and syndrome. It is
useful in
relieving many of the symptoms of parkinsonism, particularly rigidity
and bradykinesia. APO-
LEVODOPA/CARBIDOPA frequently is helpful in the management of tremor,
dysphagia, sialorrhoea
and
postural instability associated with Parkinson's disease and syndrome.
4.2.
DOSE AND METHOD OF ADMINISTRATION
The optimum daily dosage of levodopa/carbidopa must be determined by
careful titration in each
patient. APO-LEVODOPA/CARBIDOPA tablets are available in a 4:1 ratio
of levodopa to carbidopa
(Levodopa/carbidopa 100/25) as well as a 10:1 ratio
(Levodopa/carbidopa 250/25). Tablets of the two
ratios may be given