国家: 马来西亚
语言: 英文
来源: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
GABAPENTIN
UNIMED SDN BHD
GABAPENTIN
30tablet Tablets; 30tablet Tablets; 30tablet Tablets; 30tablet Tablets
Aurobindo Pharma Limited, Unit-VII (SEZ)
ONEGABA 600 GABAPENTIN TABLETS 600 MG QUALITATIVE AND QUANTITATIVE COMPOSITIONS: E a c h f i l m - c o a t e d t a b l e t contain s Gabapentin 600 mg Excipients: Maize starch, Crospovidone, Copovidone, Isopropyl Alcohol, Cellulose, microcrystalline (Avicel PH102 & Ceolus KG1000), Magnesium stearate, Opadry White YS-1-18111 and Methylene Chloride. PRODUCT DESCRIPTION: White, biconvex, elliptical, film-coated tablets, with deep break line on both sides and debossed with ‘D’ and ‘24’ on either side of the break line on one side and plain on other side. PHARMACOLOGICAL PROPERTIES: PHARMACODYNAMICS PROPERTIES: Gabapentin is structurally related to the neurotransmitter GABA (gamma-aminobutyric acid) but its mechanism of action is different from that of several other active substances that interact with GABA synapses including valproate, barbiturates, benzodiazepines, GABA transaminase inhibitors, GABA uptake inhibitors, GABA agonists, and GABA prodrugs. In vitro studies with radiolabeled gabapentin have characterized a novel peptide binding site in rat brain tissues including neocortex and hippocampus that may relate to anticonvulsant and analgesic activity of gabapentin and its structural derivatives. The binding site for gabapentin has been identified as the alpha 2-delta subunit of voltagegated calcium channels. Gabapentin at relevant concentrations does not bind to other common drug or neurotransmitter receptors of the brain including GABAA, GABAB, benzodiazepine, glutamate, glycine or N-methyl-d-aspartate receptors. Gabapentin does not interact with sodium channels in vitro and so differs from phenytoin and carbamazepine. Gabapentin partially reduces responses to the glutamate agonist Nmethyl-D-aspartate (NMDA) in some test systems in vitro, but only at concentrations greater than 100 μm, which are not achieved in vivo. Gabapentin slightly reduces the release of monoamine neurotransmitters in vitro. PHARMACOKINETIC PROPERTIES: _ABSORPTION_ Following oral administration, peak plasma gabapentin concentrati 阅读完整的文件