AMISULPRIDE WINTHROP amisulpride 100mg/mL oral solution bottle

Ország: Ausztrália

Nyelv: angol

Forrás: Department of Health (Therapeutic Goods Administration)

Aktív összetevők:

Amisulpride

Beszerezhető a:

Sanofi-Aventis Australia Pty Ltd

INN (nemzetközi neve):

Amisulpride

Termékjellemzők

amisulpride-winthrop-ccdsv12-piv14-08aug17
PRODUCT INFORMATION
AMISULPRIDE WINTHROP
® TABLETS AND SOLUTION
NAME OF THE MEDICINE
AMISULPRIDE 50 WINTHROP
AMISULPRIDE 100 WINTHROP
AMISULPRIDE 200 WINTHROP
AMISULPRIDE 400 WINTHROP
AMISULPRIDE WINTHROP SOLUTION 100mg/mL
AUSTRALIAN APPROVED NAME
Amisulpride
CHEMICAL STRUCTURE
Chemical Name:
(R, S)-4-Amino-N-[(1-ethyl-2-pyrrolidinyl)methyl]-5-ethylsulfonyl-2-
methoxybenzamide
Molecular Weight:
369.48
Molecular Formula:
C
17
H
27
N
3
O
4
S
CAS NUMBER
71675-85-9
DESCRIPTION
Amisulpride is a white to off-white powder, which is practically
insoluble in water, sparingly
soluble in ethanol, soluble in methanol and freely soluble in
dichloromethane.
AMISULPRIDE WINTHROP Tablets contain amisulpride (50 mg, 100 mg, 200
mg and 400 mg)
and the following excipients:
50, 100 and 200 mg tablets:
sodium
starch
glycollate
type
A,
lactose
monohydrate,
microcrystalline
cellulose,
hypromellose,
magnesium
stearate.
400 mg tablets:
sodium
starch
glycollate
type
A,
lactose
monohydrate,
microcrystalline
cellulose,
hypromellose,
magnesium
stearate, PEG-40 stearate, titanium dioxide.
amisulpride-winthrop-ccdsv12-piv14-08aug17
AMISULPRIDE WINTHROP SOLUTION contains amisulpride 100mg/mL and the
following
excipients:
hydrochloric acid, methyl hydroxybenzoate, propyl
hydroxybenzoate, potassium sorbate and purified
water.
and the following proprietary ingredients:
Gesweet
®
2023
(ARTG No 10553)
and Caramel Flavour
E9422058 (ARTG No 10645)
PHARMACOLOGY
CLASS
Neuroleptic of the benzamide class.
PHARMACODYNAMICS
Amisulpride binds selectively to the human dopaminergic D
2
(Ki 2.8 nM) and D
3
(Ki 3.2 nM)
receptor subtypes without any affinity for D
1
, D
4
and D
5
receptor subtypes (Ki > 1

M). Unlike
classical and atypical neuroleptics, amisulpride displays low affinity
for serotonin,

-adrenergic,
histamine receptor subtypes, muscarinic receptors and sigma sites.
In the rodent, it preferentially blocks post-synaptic D
2
receptors located in the limbic structures as
compared to those in the stri