GABAPENTIN capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

GABAPENTIN (UNII: 6CW7F3G59X) (GABAPENTIN - UNII:6CW7F3G59X)

Available from:

Lake Erie Medical DBA Quality Care Products LLC

INN (International Name):

GABAPENTIN

Composition:

GABAPENTIN 300 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

GABAPENTIN - GABAPENTIN CAPSULE
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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GABAPENTIN 300 MG
DESCRIPTION
Gabapentin Capsules, USP are supplied as imprinted hard shell capsules
containing 100 mg, 300 mg,
and 400 mg of gabapentin.
CLINICAL PHARMACOLOGY MECHANISM OF ACTION
The mechanism by which gabapentin exerts its analgesic action is
unknown, but in animal models of
analgesia, gabapentin prevents allodynia (pain-related behavior in
response to a normally innocuous
stimulus) and hyperalgesia (exaggerated response to painful stimuli).
In particular, gabapentin prevents
pain-related responses in several models of neuropathic pain in rats
or mice (e.g. spinal nerve ligation
models, streptozocin-induced diabetes model, spinal cord injury model,
acute herpes zoster infection
model). Gabapentin also decreases pain-related responses after
peripheral inflammation (carrageenan
footpad test, late phase of formalin test). Gabapentin did not alter
immediate pain-related behaviors (rat
tail flick test, formalin footpad acute phase, acetic acid abdominal
constriction test, footpad heat
irradiation test). The relevance of these models to human pain is not
known.
The mechanism by which gabapentin exerts its anticonvulsant action is
unknown, but in animal test
systems designed to detect anticonvulsant activity, gabapentin
prevents seizures as do other marketed
anticonvulsants. Gabapentin exhibits antiseizure activity in mice and
rats in both the maximal
electroshock and pentylenetetrazole seizure models and other
preclinical models (e.g., strains with
genetic epilepsy, etc.). The relevance of these models to human
epilepsy is not known.
Gabapentin is structurally related to the neurotransmitter GABA
(gamma-aminobutyric acid) but it does
not modify GABA or GABA radioligand binding, it is not converted
metabolically into GABA or a
GABA agonist, and it is not an inhibitor of GABA uptake or
degradation. Gabapentin was tested in
radioligand binding assays at concentrations up to 100 µM and did not
exhibit affinity for