Ülke: Singapur
Dil: İngilizce
Kaynak: HSA (Health Sciences Authority)
Levetiracetam
GOLDPLUS UNIVERSAL PTE LTD
N03AX14
TABLET, FILM COATED
Levetiracetam 250mg
ORAL
Prescription Only
Jubilant Generics Limited
ACTIVE
2018-09-28
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 Belgenin tamamını okuyun