Valsts: Kanāda
Valoda: angļu
Klimata pārmaiņas: Health Canada
GABAPENTIN
RATIOPHARM INC DIVISION OF TEVA CANADA LIMITED
N02BF01
GABAPENTIN
300MG
CAPSULE
GABAPENTIN 300MG
ORAL
100/500
Prescription
MISCELLANEOUS ANTICONVULSANTS
Active ingredient group (AIG) number: 0125929003; AHFS:
CANCELLED POST MARKET
2014-09-19
PRODUCT MONOGRAPH PR RATIO-GABAPENTIN (Gabapentin Capsules 100 mg, 300 mg and 400 mg) and (Gabapentin Tablets 600 mg and 800 mg) ANTIEPILEPTIC AGENT ratiopharm inc. Date of Preparation: 17800 Rue Lapointe November 9, 2004 Mirabel PQ J7J 1P3 CONTROL #: 095105 PRODUCT MONOGRAPH PR RATIO-GABAPENTIN (Gabapentin Capsules 100 mg, 300 mg and 400 mg) and (Gabapentin Tablets 600 mg and 800 mg) THERAPEUTIC CLASSIFICATION Antiepileptic ACTION AND CLINICAL PHARMACOLOGY Gabapentin exhibits anti-seizure activity in mice and rats both in the maximal electroshock and in the pentylenetetrazol seizure models. Gabapentin is structurally related to the neurotransmitter GABA (gamma-aminobutyric acid) but does not interact with GABA receptors, it is not metabolized to GABA or to GABA agonists, and it is not an inhibitor of GABA uptake or degradation. Gabapentin at concentrations up to 100 _µ_ M did not demonstrate affinity for other receptor sites such as benzodiazepine, glutamate, glycine or N-methyl-D-aspartate receptors nor does it interact with neuronal sodium channels or L-type calcium channels. The mechanism of action of gabapentin has not yet been established, however, it is unlike that of the commonly used anticonvulsant drugs. In vitro studies with radiolabeled gabapentin have revealed a gabapentin binding site in rat brain tissues including neocortex and hippocampus. The identity and function of this binding site remain to be elucidated. P HARMACOKINETICS _ _ _ ADULTS:_ Following oral administration of gabapentin, peak plasma concentrations are observed within 2 to 3 hours. Absolute bioavailability of a 300 mg dose of gabapentin capsules is approximately 59%. At doses of 300 and 400 mg, gabapentin bioavailability is unchanged following multiple dose administration. 3 Gabapentin 600 mg and 800 mg tablets are bioequivalent to two 300 mg capsules and two 400 mg capsules, respectively. The results of a single-dose, two-way crossover, comparative bioavailability study in the fasted state comparing gabapentin 600 mg tablets and 2 Izlasiet visu dokumentu