מדינה: אוסטרליה
שפה: אנגלית
מקור: Department of Health (Therapeutic Goods Administration)
gabapentin, Quantity: 600 mg
Micro Labs Pty Ltd
Tablet, film coated
Excipient Ingredients: magnesium stearate; hyprolose; purified talc
Oral
10, 20, 30, 45, 50, 60, 84, 90 or 100 tablets.
(S4) Prescription Only Medicine
GABAPENTIN MLABS is indicated for the treatment of partial seizures, including secondarily generalised tonic-clonic seizures, initially as add-on therapy in adults and children age 3 years and above who have not achieved adequate control with standard anti-epileptic drugs.,GABAPENTIN MLABS is indicated for the treatment of neuropathic pain.
Visual Identification: White to off white, oval, biconvex, film coated tablets approx.18.00 mm long and 9.20 mm wide, engraved with '600' on one face and plain on the other; Container Type: Blister Pack; Container Material: Other composite material; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Registered
2017-12-05
PRODUCT INFORMATION GABAPENTIN MLABS 600 MG /800 MG TABLETS NAME OF THE MEDICINE Gabapentin MLabs (gabapentin) 600 mg and 800 mg Tablets Gabapentin MLabs contains the active ingredient gabapentin. The structural formula of gabapentin is shown below: Chemical name : 1-(aminomethyl) cyclohexaneacetic acid Molecular formu1a : C 9 H 17 NO 2 Molecular weight : 171.24 CAS Registry Number : 60142-96-3 DESCRIPTION Gabapentin is a white to off-white crystalline powder. It is freely soluble in water and both basic and acidic aqueous solutions. It has values for LogP of -1.10, and values for pKa of 3.68 and 10.70. Gabapentin MLabs tablets also contain the following inactive ingredients: hyprolose, magnesium stearate and Opadry white YS-1-18111 (ARPING No. 3289). PHARMACOLOGY PHARMACODYNAMICS The mechanism by which gabapentin exerts its anticonvulsant action is unknown. Gabapentin is structurally related to the neurotransmitter GABA (gamma-aminobutyric acid) but its mechanism of action is different from that of several other drugs that interact with GABA synapses including valproate, barbiturates, benzodiazepines, GABA transaminase inhibitors, GABA uptake inhibitors, GABA agonists, and GABA prodrugs. _In vitro _ studies with radiolabelled gabapentin have characterised a novel peptide binding site in rat brain tissues including neocortex and hippocampus that may relate to anticonvulsant activity of gabapentin and its structural derivatives. However, the identification and function of the gabapentin binding site remains to be elucidated. Gabapentin at relevant clinical concentrations does not bind to other common drug or neurotransmitter receptors of the brain including GABA A , GABA B , 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. Several test systems ordinarily used to assess activity at the NMDA receptor complex have been examined. Results are contradictory. Accordingly no general stateme קרא את המסמך השלם