GABAPENTIN capsule

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Compra

Scarica Scheda tecnica (SPC)
13-05-2018

Principio attivo:

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

Commercializzato da:

St Marys Medical Park Pharmacy

INN (Nome Internazionale):

GABAPENTIN

Composizione:

GABAPENTIN 400 mg

Tipo di ricetta:

PRESCRIPTION DRUG

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

                                GABAPENTIN- GABAPENTIN CAPSULE
ST MARYS MEDICAL PARK PHARMACY
----------
GABAPENTIN CAPSULES
RX ONLY
DESCRIPTION
Gabapentin Capsules are supplied as imprinted hard shell capsules
containing 100 mg, 300 mg, and 400
mg of gabapentin.
The inactive ingredients are: black iron oxide, corn starch, D and C
Yellow 10 aluminum lake. FD&C
Blue No.1 aluminum lake, FD&C Blue No.2 aluminum lake,FD&C Red No.40
aluminum lake, gelatin,
mannitol, pharmaceutical glaze, propylene glycol, red iron oxide
T3469, silicon dioxide, sodium lauryl
sulfate, synthetic black iron oxide, talc, titanium dioxide, and
yellow iron oxide T3506.
Gabapentin 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 ac
                                
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