GABAPENTIN tablet film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

St Marys Medical Park Pharmacy

INN (International Name):

GABAPENTIN

Composition:

GABAPENTIN 800 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

GABAPENTIN- GABAPENTIN TABLET, FILM COATED
ST MARYS MEDICAL PARK PHARMACY
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GABAPENTIN TABLETS, USP
DESCRIPTION
Gabapentin Tablets, USP are supplied as elliptical film-coated tablets
containing 600 mg and 800 mg of
gabapentin.
The inactive ingredients are: calcium stearate, crospovidone,
hydroxypropyl cellulose, hypromellose,
polyethylene glycol and titanium dioxide. The 600 mg tablet also
contains FD&C blue #2 aluminum lake
and synthetic yellow iron oxide. The 800 mg tablet also contains
synthetic black iron oxide.
Gabapentin is described as 1-(aminomethyl) cyclohexane-acetic acid
with a molecular formula of C
H
NO
and a molecular weight of 171.24. The structural formula of gabapentin
is:
Gabapentin is a white to off-white crystalline solid with a pKa
of 3.7 and a pKa
of 10.7. It is freely
soluble in water and both basic and acidic aqueous solutions. The log
of the partition coefficient (n-
octanol/0.05M phosphate buffer) at pH 7.4 is -1.25.
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 activi