REQUIP TABLET 1 mg

Quốc gia: Singapore

Ngôn ngữ: Tiếng Anh

Nguồn: HSA (Health Sciences Authority)

Thành phần hoạt chất:

ROPINIROLE HCl EQV ROPINIROLE

Sẵn có từ:

GLAXOSMITHKLINE PTE LTD

Mã ATC:

N04BC04

Liều dùng:

1 mg

Dạng dược phẩm:

TABLET, FILM COATED

Thành phần:

ROPINIROLE HCl EQV ROPINIROLE 1 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

Prescription Only

Sản xuất bởi:

Glaxo Wellcome S.A.

Tình trạng ủy quyền:

ACTIVE

Ngày ủy quyền:

1999-07-13

Tờ rơi thông tin

 
1 
REQUIP™ 
ROPINIROLE

QUALITATIVE AND QUANTITATIVE COMPOSITION 
Ropinirole hydrochloride equivalent to 0.25 mg, 1.0 mg,
2.0 mg or 5.0 mg ropinirole free 
base. 
PHARMACEUTICAL FORM 
Film-coated, pentagonal-shaped tablets for oral administration.
The tablet strengths are 
distinguished by colour and debossing;  
0.25 mg: white, pentagonal-shaped, film-coated
tablets marked "SB" on one side and 
"4890" on the other.  
1.0 mg: green, pentagonal-shaped, film-coated
tablets marked "SB" on one side and 
"4892" on the other.  
2.0 mg: pink, pentagonal-shaped, film-coated
tablets marked "SB" on one side and 
"4893" on the other.  
5.0 mg: blue, pentagonal-shaped, film-coated
tablets marked "SB" on one side and 
"4894" on the other.  
CLINICAL PARTICULARS 
INDICATIONS 
REQUIP is indicated for the treatment of idiopathic Parkinson's disease: 
• 
REQUIP may be used alone (without levodopa [L-Dopa]) in
the treatment of 
idiopathic Parkinson's disease. 
• 
Addition of REQUIP to levodopa may be used to
control "on-off" fluctuations and 
permit a reduction in the total daily dose of L-Dopa. 
REQUIP is indicated for the treatment of moderate to severe

primary Restless Legs 
Syndrome (RLS). 

DOSAGE AND ADMINISTRATION 
When
switching treatment from another dopamine agonist to REQUIP,
the 
manufacturer's guidance on discontinuation should be followed
before initiating 
REQUIP. 

2 
Individual dose titration against efficacy and
tolerability is recommended. 
Patients should
be down-titrated if they experience disabling somnolence at any dose 
level.  For other adverse events, down-titration followed
by more gradual up-titration has 
been shown to be beneficial. 
_PARKINSON'S DISEASE _
•  ADULTS 
REQUIP should be taken three times a day and may be taken with
or without food (_see _
_Pharmacokinetics_). 
_TREATMENT INITIATION:�

Đặc tính sản phẩm

1
REQUIP
ROPINIROLE
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ropinirole hydrochloride equivalent to 0.25 mg, 1.0 mg or 2.0 mg
ropinirole free base.
CLINICAL INFORMATION
INDICATIONS
REQUIP is indicated for the treatment of idiopathic Parkinson's
disease:
•
REQUIP may be used alone (without levodopa [L-Dopa]) in the treatment
of
idiopathic Parkinson's disease.
•
Addition of REQUIP to levodopa may be used to control "on-off"
fluctuations and
permit a reduction in the total daily dose of L-Dopa.
REQUIP is indicated for the treatment of moderate to severe primary
Restless Legs
Syndrome (RLS).
DOSAGE AND ADMINISTRATION
Pharmaceutical form:
Film-coated, pentagonal-shaped tablets for oral administration. The
tablet strengths are
distinguished by colour and debossing;
0.25 mg: white, pentagonal-shaped, film-coated tablets marked "SB" on
one side and
"4890" on the other.
1.0 mg: green, pentagonal-shaped, film-coated tablets marked "SB" on
one side and
"4892" on the other.
2.0 mg: pink, pentagonal-shaped, film-coated tablets marked "SB" on
one side and
"4893" on the other.
When switching treatment from another dopamine agonist to REQUIP, the
manufacturer's guidance on discontinuation should be followed before
initiating
REQUIP.
Individual dose titration against efficacy and tolerability is
recommended.
Patients should be down-titrated if they experience disabling
somnolence at any dose
level. For other adverse events, down-titration followed by more
gradual up-titration has
been shown to be beneficial.
2
_PARKINSON'S DISEASE _
•
ADULTS
REQUIP should be taken three times a day and may be taken with or
without food (see
_ _
_Pharmacokinetics_
).
_TREATMENT INITIATION: _
The initial dose should be 0.25 mg t.i.d (three times a day). A guide
for the titration regimen for the first four weeks of treatment is
given in the table below:
Week
1
2
3
4
Unit dose (mg)
0.25
0.5
0.75
1.0
Total daily dose (mg)
0.75
1.5
2.25
3.0
_THERAPEUTIC REGIMEN_
: After the initial titration, weekly increments of up to 3 mg/day
may be given. REQU