Vesicare Tablet 5mg

Land: Singapore

Sprog: engelsk

Kilde: HSA (Health Sciences Authority)

Aktiv bestanddel:

Solifenacin succinate

Tilgængelig fra:

ASTELLAS PHARMA SINGAPORE PTE. LTD.

ATC-kode:

G04BD08

Dosering:

5mg/tablet

Lægemiddelform:

TABLET, FILM COATED

Sammensætning:

Solifenacin succinate 5 mg

Indgivelsesvej:

ORAL

Recept type:

Prescription Only

Fremstillet af:

Astellas Pharma Europe B.V

Autorisation status:

ACTIVE

Autorisation dato:

2009-09-18

Indlægsseddel

VESICARE
®
 (SOLIFENACIN SUCCINATE 5 MG, 10 MG FILM-COATED TABLETS) 

NAME OF THE MEDICINE 

Vesicare 5 mg Tablet 
Vesicare 10 mg Tablet 

DESCRIPTION 

Vesicare 5 mg film-coated tablet: 
Each tablet contains 5 mg solifenacin
succinate, corresponding to 3.8 mg solifenacin. 
Vesicare 10 mg film-coated tablet: 
Each tablet contains 10 mg solifenacin succinate, corresponding
to 7.5 mg 
solifenacin. 

Solifenacin(3R)-1-azabicyclo[2.2.2]oct-3-yl(1S)-1-phenyl-3,4-dihydroisoquinoline-
2(1H)-carboxylate monosuccinate 

The empirical formula is C
23
H
26
N
2
O
2
.C
4
H
6
O
4

The molecular weight is 480.55 
The CAS number is 242478-38-2 

Molecular structure: 

PHARMACOLOGY 

Pharmacotherapeutic group: Urinary antispasmodics, ATC code: G04B D08. 

Mechanism of Action 

Solifenacin is a competitive
muscarinic receptor antagonist. Muscarinic receptors 
play an important role
in several major cholinergic mediated functions, including 
contractions of urinary bladder smooth muscle and stimulation
of the salivary 
secretion. 

Pharmacokinetics 

_Absorption _
_ _
After intake of Vesicare tablets, maximum solifenacin
plasma concentrations (C
max
) 
are reached after 3 to 8 hours and at steady state
ranged from 32.3 to 69.9 ng/ml for 
the 5 and 10 mg Vesicare tablets, respectively. The t
max 
is independent of the dose. 
The C
max
 and area under the curve (AUC) increase
in proportion to the dose between 
5
to 40 mg. Absolute bioavailability is approximately 90%. Food
intake does not 
affect the C
max 
and AUC of solifenacin. 

_Distribution _
_ _
The apparent volume
of distribution of solifenacin following intravenous 
administration is about 600 L. Solifenacin is to
a great extent (approximately 98%) 
bound to plasma proteins, primarily α
1
-acid glycoprotein. 

_Metabolism _

Solifenacin is exte

Produktets egenskaber

VESICARE
® (SOLIFENACIN SUCCINATE 5 MG, 10 MG FILM-COATED TABLETS
)
NAME OF THE MEDICINE
Vesicare 5 mg Tablet
Vesicare 10 mg Tablet
DESCRIPTION
Vesicare 5 mg film-coated tablet:
Each tablet contains 5 mg solifenacin succinate, corresponding to 3.8
mg solifenacin.
Vesicare 10 mg film-coated tablet:
Each tablet contains 10 mg solifenacin succinate, corresponding to 7.5
mg
solifenacin.
Solifenacin(3R)-1-azabicyclo[2.2.2]oct-3-yl(1S)-1-phenyl-3,4-dihydroisoquinoline-
2(1H)-carboxylate monosuccinate
The empirical formula is C
23
H
26
N
2
O
2
.C
4
H
6
O
4
The molecular weight is 480.55
The CAS number is 242478-38-2
Molecular structure:
PHARMACOLOGY
Pharmacotherapeutic group: Urinary antispasmodics, ATC code: G04B D08.
Mechanism of Action
Solifenacin is a competitive muscarinic receptor antagonist.
Muscarinic receptors
play an important role in several major cholinergic mediated
functions, including
contractions of urinary bladder smooth muscle and stimulation of the
salivary
secretion.
Pharmacokinetics
_Absorption _
_ _
After intake of Vesicare tablets, maximum solifenacin plasma
concentrations (C
max
)
are reached after 3 to 8 hours and at steady state ranged from 32.3 to
69.9 ng/ml for
the 5 and 10 mg Vesicare tablets, respectively. The t
max
is independent of the dose.
The C
max
and area under the curve (AUC) increase in proportion to the dose
between
5 to 40 mg. Absolute bioavailability is approximately 90%. Food intake
does not
affect the C
max
and AUC of solifenacin.
_Distribution _
_ _
The apparent volume of distribution of solifenacin following
intravenous
administration is about 600 L. Solifenacin is to a great extent
(approximately 98%)
bound to plasma proteins, primarily α
1
-acid glycoprotein.
_Metabolism _
Solifenacin is extensively metabolized in the liver. The primary
pathway for
elimination is by way of CYP3A4; however, alternate metabolic pathway
exist. The
primary metabolic routes of solifenacin are through _N_-oxidation of
the quinuclidin ring
and 4_R_-hydroxylation of tetrahydroisoquinoline ring.