BLOOMS THE CHEMIST PREGABALIN pregabalin 100 mg capsule blister pack

Summary of Product characteristics

                                Product Information – Australia
Blooms The Chemist Pregabalin capsules
Page 1
BLOOMS THE CHEMIST PREGABALIN CAPSULES
NAME OF THE MEDICINE
Pregabalin.
Chemical Name:
(S)-3-(aminomethyl)-5-methylhexanoic acid
Structural Formula:
Molecular Formula:
C
8
H
17
NO
2
Molecular Weight:
159.23
CAS Registry Number:
148553-50-8
DESCRIPTION
Pregabalin is an analogue of the neurotransmitter gamma-aminobutyric
acid (GABA). It has analgesic
and anticonvulsant activity. Pregabalin is a white to off-white solid.
It is freely soluble in water and basic
and acidic aqueous solutions.
Each capsule contains 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225
mg or 300 mg of pregabalin,
as the active ingredient.
In addition, each capsule contains the following inactive ingredients:
lactose monohydrate, maize starch,
purified talc, gelatin, purified water, titanium dioxide, sodium
lauryl sulfate and TekPrint SW 9008 black
ink. The 75 mg, 100 mg, 200 mg, 225 mg and 300 mg capsules also
contain iron oxide red.
PHARMACOLOGY
PHARMACOLOGICAL ACTIONS
_In vitro_ studies show that pregabalin binds to an auxiliary subunit
(α2δ protein) of voltage-gated calcium
channels in the central nervous system, potently displacing
[3H]-gabapentin. Two lines of evidence
indicate that binding of pregabalin to the α2δ site is required for
analgesic and anticonvulsant activity in
animal models: (1) Studies with the inactive _R_-enantiomer and other
structural derivatives of pregabalin
and (2) Studies of pregabalin in mutant mice with defective drug
binding to the α2δ protein. In addition,
pregabalin reduces the release of several neurotransmitters, including
glutamate, noradrenaline and
substance P. The significance of these effects for the clinical
pharmacology of pregabalin is not known.
Pregabalin does not show affinity for receptor sites or alter
responses associated with the action of
several common drugs for treating seizures or pain. Pregabalin does
not interact with either GABA
A
or
GABA
B
receptors; it is not converted metabolically into GABA or a 
                                
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