LEVEXA

Pays: Indonésie

Langue: indonésien

Source: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Unités en paquet:

DUS, 1 VIAL @ 5 ML

Date de l'autorisation:

2023-01-25

Résumé des caractéristiques du produit

1
LEVEXA
LEVETIRACETAM
INJECTION
COMPOSITION :
LEVEXA Injection 100 mg/mL, each mL contains : Levetiracetam 100 mg.
DESCRIPTION OF THE DOSAGE FORM
LEVEXA Injection 100 mg/mL is a clear colorless solution in Type 1, 5
mL tubular glass vials
sealed with 20 mm grey serum rubber stoppers and blue color flip off
aluminum seal.
The excipients ingredients include sodium chloride, sodium acetate
trihydrate, glacial acetic
acid, water for injection.
PHARMACOLOGY :
MECHANISM OF ACTION
The active substance, Levetiracetam, is a pyrrolidone derivative
(S-enantiomer of alfa-ethyl-2-
oxo-1-pyrrolidine acetamide), chemically unrelated to existing
antiepileptic active substances.
The mechanism of action of Levetiracetam still remains to be fully
elucidated. In vitro and in
vivo experiments suggest that Levetiracetam does not alter basic cell
characteristic and normal
neurotransmission.
In vitro studies show that levetiracetam affects intraneuronal Ca2+
levels by partial inhibition of
N-type Ca2+ currents and by reducing the release of Ca2+ from
intraneuronal stores. In addition,
it partially reverses the reductions in GABA- and glycine-gated
currents induced by zinc and β-
carbolines. Furthermore, Levetiracetam has been shown in in vitro
studies to bind to a specific
site in rodent brain tissue. This binding site is the synaptic vesicle
protein 2A, believed to be
involved in vesicle fusion and neurotransmitter exocytosis.
Levetiracetam and related analogs
show a rank order of affinity for binding to the synaptic vesicle
protein 2A which correlates with
the potency of their anti -seizure protection in the mouse audiogenic
model of epilepsy. This
finding suggests that the interaction between levetiracetam and the
synaptic vesicle protein 2A
seems to contribute to the antiepileptic mechanism of action of the
medicinal product.
PHARMACOKINETICS (LEVETIRACETAM TABLET)
This study was designed as a randomized, single blind, two periods,
single dose, two-period,
two-treatment, two-sequence, cross-over study with one week washout
period