GABAPENTIN tablet, film coated

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

DIRECT RX

INN (International Adı):

GABAPENTIN

Kompozisyon:

GABAPENTIN 800 mg

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

Controlled Substance Gabapentin is not a scheduled drug. Abuse Gabapentin does not exhibit affinity for benzodiazepine, opiate (mu, delta or kappa), or cannabinoid 1 receptor sites. A small number of postmarketing cases report gabapentin misuse and abuse. These individuals were taking higher than recommended doses of gabapentin for unapproved uses. Most of the individuals described in these reports had a history of poly-substance abuse or used gabapentin to relieve symptoms of withdrawal from other substances. When prescribing gabapentin carefully evaluate patients for a history of drug abuse and observe them for signs and symptoms of gabapentin misuse or abuse (e.g. development of tolerance, self-dose escalation, and drug-seeking behavior). Dependence There are rare postmarketing reports of individuals experiencing withdrawal symptoms shortly after discontinuing higher than recommended doses of gabapentin used to treat illnesses for which the drug is not approved. Such symptoms included agitation, disorienta

Ürün özeti:

Gabapentin Tablets, USP 600 mg are white to off-white having mottled spots, oval-shaped, biconvex, film-coated tablets debossed with 'ZE72' with bisect on one side and plain with bisect on other side and are supplied as follows: NDC 68382-204-01 in bottle of 100 tablets NDC 68382-204-05 in bottle of 500 tablets NDC 68382-204-10 in bottle of 1000 tablets Gabapentin Tablets, USP 800 mg are white to off-white having mottled spots, oval-shaped, bevelled-edge, biconvex, film-coated tablets debossed with 'ZE71' with bisect on one side and plain with bisect on other side and are supplied as follows: NDC 68382-205-01 in bottle of 100 tablets NDC 68382-205-05 in bottle of 500 tablets NDC 68382-205-10 in bottle of 1000 tablets NDC 68382-205-30 in unit-dose blister cartons of 100 (10 x 10) unit dose tablets

Yetkilendirme durumu:

Abbreviated New Drug Application

Bilgilendirme broşürü

DIRECT RX
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SPL MEDGUIDE SECTION
Gabapentin Tablets, USP
Read the Medication Guide before you start taking gabapentin tablets
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
Tablets? Do not stop taking
gabapentin tablets without first talking to your healthcare provider.
Stopping gabapentin tablets suddenly can cause serious problems.
Gabapentin tablets can cause serious side effects including:
1.
Like other antiepileptic drugs, gabapentin tablets 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 tablets without first talking to a
healthcare provider.
•
Stopping gabapentin tablets 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, your h

Ürün özellikleri

GABAPENTIN- GABAPENTIN TABLET, FILM COATED
DIRECT RX
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GABAPENTIN
DESCRIPTION SECTION
Gabapentin is described as 1-(aminomethyl)cyclohexaneacetic acid with
a molecular formula of
C9H17NO2 and a molecular weight of 171.24. The structural formula of
gabapentin is:
Gabapentin, USP is a white to off-white powder with a pKa1 of 3.7 and
a pKa2 of 10.7. It is freely
soluble in water, 0.1 N hydrochloric acid, 0.1 N sodium hydroxide and
glacial acetic acid; slightly
soluble in methanol, very slightly soluble in ethanol, 2-propanol;
insoluble in toluene. The log of the
partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is
–1.25.
Each gabapentin tablet, USP intended for oral administration contains
600 mg and 800 mg of gabapentin.
In addition each tablet contains following inactive ingredients:
copovidone, low substituted
hydroxypropyl cellulose, magnesium stearate, mannitol, poloxamer,
povidone and talc.
CLINICAL PHARMACOLOGY SECTION
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
prevent