Gabix 100mg Capsule
Country: Philippines
Language: English
Source: FDA (Food And Drug Administration)
Summary of Product characteristics
(SPC)
25-04-2024
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Active ingredient:
Gabapentin
Available from:
Getz Pharma (Phils.), Inc.
INN (International Name):
Gabapentin
Dosage:
100mg
Pharmaceutical form:
Capsule
Units in package:
Blister Pack x 10's (Box of 10's), Blister pack x 10's in a box
Manufactured by:
Getz Pharma (Pvt.) Ltd., Pakistan
Therapeutic area:
Anti-Convulsant
Therapeutic indications:
Various types of neuropathic pain in adults: Postherpetic neuralgia (PHN). Painful diabetic neuropathy. Trigeminal neuralgia. Central pain. Complex regional pain syndrome. Epilepsy: As adjunctive therapy in the treatment of partial seizures with and without secondary generalization in adults and children aged 6 years and above. As monotherapy in the treatment of partial seizures with and without secondary generalization in adults and adolescents aged 12 years and above.
Authorization date:
2022-09-28
Summary of Product characteristics
DESCRIPTION
Gabapentin (GABIX
®
) is a new antiepileptic drug that is structurally similar
to the neurotransmitter gamma aminobutyric acid (GABA) and the
endogenous amino acid L-leucine. Chemically gabapentin is
1-(aminomethyl)
cyclohexaneacetic acid. Its molecular formula is C
9
H
17
NO
2
.
The structural
formula is:
FORMULATION
Gabapentin (GABIX
®
) is available for oral administration as:
1.
Gabapentin (GABIX
®
) Capsules 100mg
Each capsule contains:
Gabapentin …100mg
2.
Gabapentin (GABIX
®
) Capsules 300mg
Each capsule contains:
Gabapentin …300mg
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Gabapentin has proven affinity for special site in brain tissues such
as
neocortex and hippocampus. Though exact mechanism of its CNS
depressant and anticonvulsant activity is not fully understood, it is
thought
to be activated through peptide binding sites (receptor).
PHARMACOKINETICS
_Absorption_
Gabapentin is absorbed from the gastrointestinal tract by means of
saturable
mechanism. Gabapentin bioavailability is not dose proportional i.e.,
as
dose is increased bioavailability is decreased. Absolute
bioavailability of
300mg oral dose is approximately 60%. At doses of 300mg and 400mg,
gabapentin bioavailability was unchanged following multiple-dose
administration. Food has no effect on the rate and extent of
absorption.
_Distribution_
Gabapentin circulates largely unbound (<3%) to plasma proteins.
Gabapentin
is distributed into breast milk.
_Metabolism and Elimination_
Gabapentin is not appreciably metabolised and is eliminated from the
systemic circulation by renal excretion as unchanged drug. Elimination
half-life (t
1
/
2
) ranges from 5 to 7 hours and is unaltered by dose or following
multiple dosing. Gabapentin elimination rate constant, plasma
clearance
and renal clearance are directly proportional to creatinine clearance.
SPECIAL POPULATIONS
_Renal Insufficiency_
The mean gabapentin half-life ranged from about 6.5 hours (patients
with
creatinine clearance (CL
cr
) >60mL/min) to 52 hours (CL
cr
<30mL/min) and
ga
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