LETRAM 500 (Levetiracetam Tablets 500mg)

Страна: Малайзия

Език: английски

Източник: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Активна съставка:

LEVETIRACETAM

Предлага се от:

UNIMED SDN BHD

INN (Международно Name):

LEVETIRACETAM

Броя в опаковка:

10 x 10 tablet Tablets; 10 x 10 tablet Tablets

Произведено от:

Hetero Labs Limited

Данни за продукта

LETRAM 250 (Levetiracetam Tablets 250 Mg)
LETRAM 500 (Levetiracetam Tablets 500 Mg)
DESCRIPTION AND COMPOSITION:
LETRAM 250 (Levetiracetam Tablets 250 Mg):
Blue coloured, oblong shaped, scored film coated tablets debossed with
‘H’ on one side
and ‘87’ on other side.
Each film-coated tablet contains 250 mg of Levetiracetam.
LETRAM 500 (Levetiracetam Tablets 500 Mg):
Yellow coloured, oblong shaped, scored, film coated tablets debossed
with ‘H’ on one
side and ‘88’ on other side.
Each film-coated tablet contains 500 mg of Levetiracetam.
PHARMACODYNAMICS
The active substance, Levetiracetam is a pyrrolidone derivative
(S-enantiomer of α-ethyl-
2-oxo-1- pyrrolidine acetamide), chemically unrelated to existing
antiepileptic active
substances.
_ _
_Mechanism of action _
The mechanism of action of Levetiracetam still remains to be fully
elucidated but appears
to be different from the mechanisms of current antiepileptic medicinal
products.
_ _
_Pharmacodynamics effects _
Levetiracetam induces seizure protection in a broad range of animal
models of partial and
primary
generalized
seizures
without
having
pro-convulsant
effect.
The
primary
metabolite is inactive.
In man, activity in both partial and generalized epilepsy conditions
(epileptiform
discharge/photoparoxysmal
response)
has
confirmed
the
broad
spectrum
of
the
preclinical pharmacological profile.
_ _
PHARMACOKINETICS
Levetiracetam is a highly soluble and permeable compound. The
pharmacokinetic profile
is linear and time-independent with low intra- and inter-subject
variability. There is no
modification of the clearance after repeated administration. There is
no evidence for any
relevant gender, race or circadian variability. The pharmacokinetic
profile is comparable
in healthy volunteers and in patients with epilepsy.
Due to its complete and linear absorption, plasma levels can be
predicted from the oral
dose of Levetiracetam expressed as mg/kg bodyweight. Therefore there
is no need for
plasma level monitoring of Levetiracetam.
A significant correlat