GABAPENTIN tablet

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Proficient Rx LP

INN (Tarptautinis Pavadinimas):

GABAPENTIN

Sudėtis:

GABAPENTIN 600 mg

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

Postherpetic Neuralgia Gabapentin tablets USP are indicated for the management of postherpetic neuralgia in adults. Epilepsy 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 to 12 years. Gabapentin tablets USP are contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. 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 u

Produkto santrauka:

Gabapentin Tablets, USP 600 mg: White colored film coated, Modified Capsule shaped, biconvex tablets de-bossed with '1' on the left side of the bisect and '2' on the right side of the bisect on one side and bisect on other; supplied in bottles of 30, 60, 90 and 120. Bottles of 30’s count (NDC 63187-149-30) Bottles of 60’s count (NDC 63187-149-60) Bottles of 90’s count (NDC 63187-149-90) Bottles of 120’s count (NDC 63187-149-72) Store at 20° to 25°C (68° to 77°F). [See USP controlled room temperature]. Rev: 08/13

Autorizacija statusas:

Abbreviated New Drug Application

Pakuotės lapelis

GABAPENTIN- GABAPENTIN TABLET
Proficient Rx LP
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MEDICATION GUIDE
Gabapentin 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, your healthcare provider may check fo

Prekės savybės

GABAPENTIN- GABAPENTIN TABLET
PROFICIENT RX LP
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GABAPENTIN TABLETS, USP
RX ONLY
DESCRIPTION
Gabapentin tablets, USP are white colored film coated, modified
capsule shaped
biconvex tablets containing 600 mg and 800 mg of gabapentin, USP.
Each tablet for oral administration contains the following inactive
ingredients: Mannitol,
Hydroxypropyl Cellulose, Crospovidone, Talc, Magnesium Stearate and
Aquarius
BP18114 Cool Vanilla.
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 pKa1 of
3.7 and a pKa2 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.
This product (Gabapentin Tablets, USP 600 mg and 800 mg) meets the USP
Dissolution
Test 1.
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,
®
9
17
2
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 anticonvulsa