GANTIN gabapentin 100mg capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

gabapentin

Available from:

Upjohn Australia Pty Ltd

Authorization status:

Registered

Summary of Product characteristics

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PRODUCT INFORMATION
GANTIN
® (GABAPENTIN)
NAME OF THE MEDICINE
GANTIN (gabapentin) 100 mg, 300 mg and 400 mg capsules.
GANTIN (gabapentin) 800 mg tablets.
GANTIN contains the active ingredient gabapentin. The structural
formula of gabapentin is shown
below:
CH
2
NH
2
CH
2
C O
2
H
Chemical name:
1-(aminomethyl) cyclohexaneacetic acid
Molecular formula:
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 solid. It is freely
soluble in water and both basic and
acidic aqueous solutions.
GANTIN capsules also contain the following inactive ingredients:
lactose monohydrate, purified
talc, maize starch, gelatin and titanium dioxide. The 300 mg capsule
also contains iron oxide yellow
and the 400 mg capsule also contains both iron oxide yellow and iron
oxide red.
GANTIN tablets also contain the following inactive ingredients:
poloxamer, copovidone, maize
starch, magnesium stearate, candelilla wax and Opadry white
YS-1-18111.
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
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the brain