JUBLEVET FILM COATED TABLETS 250MG

국가: 싱가포르

언어: 영어

출처: HSA (Health Sciences Authority)

유효 성분:

Levetiracetam

제공처:

GOLDPLUS UNIVERSAL PTE LTD

ATC 코드:

N03AX14

약제 형태:

TABLET, FILM COATED

구성:

Levetiracetam 250mg

관리 경로:

ORAL

처방전 유형:

Prescription Only

Manufactured by:

Jubilant Generics Limited

승인 상태:

ACTIVE

승인 날짜:

2018-09-28

제품 특성 요약

Last modified: 4. August 2020, 5:22 PM
FOR THE USE OF A REGISTERED MEDICAL PRACTITIONER OR A HOSPITAL OR A
LABORATORY ONLY
JUBLEVET
LEVETIRACETAM TABLETS 250 MG AND 500 MG
1.
PRODUCT NAME:
Levetiracetam Tablets 250 mg
Levetiracetam Tablets 500 mg
2.
NAME AND STRENGTH OF ACTIVE INGREDIENT:
EACH FILM-COATED TABLET CONTAINS:
Levetiracetam Ph.Eur. 250 mg
Levetiracetam Ph.Eur. 500 mg
3.
PRODUCT DESCRIPTION:
LEVETIRACETAM TABLET 250 MG:
Blue coloured, oblong shaped, film coated tablets, with a scoreline on
one side and debossed with ‘250’ on the other side of the tablet.
LEVETIRACETAM TABLET 500 MG:
Yellow coloured, oblong shaped, film coated tablets, with a scoreline
on one side and debossed with ‘500’ on the other side of the
tablet.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
EXCIPIENTS:
Povidone, Croscarmellose sodium, Polyethylene glycol 6000 PF, Silica
colloidal anhydrous, Magnesium stearate, Opadry II Blue
85F20694 (for 250mg Tablets) & Opadry II Yellow 85F32004 (for 500mg
Tablets), Water purified
4.
PHARMACODYNAMICS / PHARMACOKINETICS:
PHARMACODYNAMIC PROPERTIES
Pharmacotherapeutic group: Antiepileptics, Other Antiepileptics
ATC code: N03AX14
Mechanism of action
The active substance, levetiracetam, is a pyrrolidone derivative
(S-enantiomer of
α
-ethyl-2-oxo-1-pyrrolidine acetamide), chemically
unrelated to existing anti-epileptic 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 characteristics and normal
neurotransmission.
_In vitro_ studies show that levetiracetam affects intraneuronal Ca
2+
levels by partial inhibition of N-type Ca
2+
currents and by reducing the
release of Ca
2+
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 spe