GABAPENTIN tablet film coated

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

McKesson Packaging Services a business unit of McKesson Corporation

INN (International Nazwa):

GABAPENTIN

Skład:

GABAPENTIN 600 mg

Typ recepty:

PRESCRIPTION DRUG

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

GABAPENTIN- GABAPENTIN TABLET, FILM COATED
MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION
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GABAPENTIN
RX ONLY
DESCRIPTION
Gabapentin tablets, USP are supplied as elliptical film-coated tablets
containing 600 mg and 800 mg of
gabapentin, USP.
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, USP is described as 1-(aminomethyl) cyclohexaneacetic 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 pK of 3.7
and a pK 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