GABAPENTIN- gabapentin tablet

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

Gabapentin (UNII: 6CW7F3G59X) (Gabapentin - UNII:6CW7F3G59X)

Disponível em:

Lake Erie Medica & Surgical Supply DBA Quality Care Products LLC

DCI (Denominação Comum Internacional):

Gabapentin

Composição:

Gabapentin 600 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Gabapentin tablets USP are indicated for the management of postherpetic neuralgia in adults. Gabapentin tablets USP are indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in patients over 12 years of age with epilepsy. Gabapentin tablets USP are also indicated as adjunctive therapy in the treatment of partial seizures in pediatric patients age 3 – 12 years. Gabapentin tablets are contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. The abuse and dependence potential of gabapentin has not been evaluated in human studies.

Resumo do produto:

Gabapentin tablets USP, 600 mg: White to off white film-coated, oval shaped, biconvex scored tablets debossed with “G” and “31” on one side. Available in : Bottles of 100: NDC # 68462-126-01 Bottles of 500: NDC # 68462-126-05 Gabapentin tablets USP, 800 mg: White to off white film-coated, oval shaped, biconvex scored tablets debossed with “G” and “13” on one side. Available in : Bottles of 100: NDC # 68462-127-01 Bottles of 500: NDC # 68462-127-05 Store at 25°C (77°F); excursions permitted to 15° - 30°C (59° - 86°F) [see USP Controlled Room Temperature].

Status de autorização:

Abbreviated New Drug Application

Folheto informativo - Bula

Lake Erie Medica & Surgical Supply DBA Quality Care Products LLC
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MEDICATION GUIDE
GABAPENTIN (GAB″ A PEN′ TIN) TABLETS USP
Read the Medication Guide before you start taking gabapentin and each
time you get a refill. There may
be new information. This information does not take the place of
talking to your healthcare provider about
your medical condition or treatment.
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT
GABAPENTIN?
Do not stop taking gabapentin without first talking to your healthcare
provider.
Stopping gabapentin suddenly can cause serious problems.
Gabapentin can cause serious side effects including:
1.
Like other antiepileptic drugs, gabapentin may cause suicidal thoughts
or actions in a very small
number of people, about 1 in 500.
Call a healthcare provider right away if you have any of these
symptoms, especially if they are new,
worse, or worry you:
•
thoughts about suicide or dying
•
attempts to commit suicide
•
new or worse depression
•
new or worse anxiety
•
feeling agitated or restless
•
panic attacks
•
trouble sleeping (insomnia)
•
new or worse irritability
•
acting aggressive, being angry, or violent
•
acting on dangerous impulses
•
an extreme increase in activity and talking (mania)
•
other unusual changes in behavior or mood
HOW CAN I WATCH FOR EARLY SYMPTOMS OF SUICIDAL THOUGHTS AND
ACTIONS?
•
Pay attention to any changes, especially sudden changes, in mood,
behaviors, thoughts, or
feelings.
•
Keep all follow-up visits with your healthcare provider as scheduled.
Call your healthcare provider between visits as needed, especially if
you are worried about symptoms.
Do not stop taking gabapentin without first talking to a healthcare
provider.
• Stopping gabapentin suddenly can cause serious problems. Stopping
a seizure medicine suddenly in a
patient who has epilepsy can cause seizures that will not stop (status
epilepticus).
Suicidal thoughts or actions can be caused by things other than
medicines. If you have suicidal thoughts
or actions

Características técnicas

GABAPENTIN- GABAPENTIN TABLET
LAKE ERIE MEDICA & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC
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GABAPENTIN TABLETS USP
DESCRIPTION
Gabapentin tablets USP are supplied as oval shaped, film-coated,
biconvex scored tablets containing
600 mg and 800 mg of gabapentin USP.
The inactive ingredients for the tablets are corn starch, copovidone,
poloxamer 407, magnesium
stearate, polyethylene glycol, hypromellose, titanium dioxide, talc,
macrogol, polysorbate 80 and
purified water.
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 USP 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 designed to detect anticonvulsant activity, gabapentin
prevents seizures as do