VALPROATE WINTHROP SYRUP sodium valproate 40mg/mL oral liquid bottle

Krajina: Austrália

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktívna zložka:

Sodium valproate

Dostupné z:

Sanofi-Aventis Australia Pty Ltd

INN (Medzinárodný Name):

Sodium valproate

Súhrn charakteristických

_ _ Page 1
valproate-winthrop-ccdsv21-piv13-07dec16
PRODUCT INFORMATION
VALPROATE WINTHROP
®
NAME OF THE MEDICINE
AUSTRALIAN APPROVED NAME
Sodium valproate
CHEMICAL NAME
Sodium di-n-propylacetic acid
CHEMICAL STRUCTURE
CAS REGISTRY NUMBER
1069-66-5
DESCRIPTION
_Active_:
Sodium valproate. Sodium valproate is a white, odourless, crystalline
powder with a saline taste.
It is highly soluble in water and alcohol. Its molecular weight is
166. It is quite dissimilar to other
established anticonvulsants such as barbiturates, hydantoins,
succinamides, oxazolidinediones
and acetylureas in that it has no nitrogen or aromatic moiety.
_Inactive_:
Crushable: includes maize starch, kaolin, silicon dioxide and
magnesium stearate.
Enteric-Coated: includes povidone, purified talc, magnesium stearate,
calcium silicate, citric acid
monohydrate, macrogol 6000, hypromellose, hyprolose, polyvinyl acetate
phthalate, diethyl
phthalate, stearic acid, amaranth aluminium lake, indigo carmine
aluminium lake, titanium dioxide.
Sugar-Free
Liquid:
includes
hyetellose,
saccharin
sodium,
sorbitol
solution
(70%)
(non-
crystallising), citric acid, brilliant scarlet 4R, purified water,
flavour imitation cherry 17.40.0740,
sodium methyl hydroxybenzoate and sodium propyl hydroxybenzoate.
Syrup: includes sucrose, sorbitol, saccharin sodium, brilliant scarlet
4R, purified water, flavour
imitation
cherry
17.40.0740,
sodium
methyl
hydroxybenzoate
and
sodium
propyl
hydroxybenzoate.
PHARMACOLOGY
CLASS: Anticonvulsant, antipsychotic.
SITE AND MODE OF ACTION: The mode of action of Valproate Winthrop has
not been fully
established. Its anticonvulsant effect is attributed to the blockade
of voltage dependent Na
+
channels and increased brain levels of

-aminobutyric acid (GABA). The GABA-ergic effect is also
believed to possibly contribute towards the antimanic properties of
sodium valproate.
In animals, Valproate Winthrop raises cerebral and cerebellar levels
of the inhibitory synaptic
transmitter,
GABA,
possibly
by
inhibiting
GABA
degradative
enzymes,
suc