RATIO-GABAPENTIN TABLET

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

GABAPENTIN

Disponibbli minn:

RATIOPHARM INC DIVISION OF TEVA CANADA LIMITED

Kodiċi ATC:

N02BF01

INN (Isem Internazzjonali):

GABAPENTIN

Dożaġġ:

800MG

Għamla farmaċewtika:

TABLET

Kompożizzjoni:

GABAPENTIN 800MG

Rotta amministrattiva:

ORAL

Unitajiet fil-pakkett:

100/500

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

MISCELLANEOUS ANTICONVULSANTS

Sommarju tal-prodott:

Active ingredient group (AIG) number: 0125929005; AHFS:

L-istatus ta 'awtorizzazzjoni:

CANCELLED POST MARKET

Data ta 'l-awtorizzazzjoni:

2014-09-19

Karatteristiċi tal-prodott

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