GABAPENTIN tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Proficient Rx LP

INN (International Name):

GABAPENTIN

Composition:

GABAPENTIN 800 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 are contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. Gabapentin is not a scheduled drug. 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 gabap

Product summary:

Gabapentin Tablets, USP are supplied as follows:   Gabapentin Tablets USP, 800 mg are white, biconvex, elliptical, film-coated tablets, with deep break line on both sides and debossed with ‘D’ and ‘25’ on either side of the break line on one side and plain on other side.            Bottles of 90                           NDC 63187-148-90           Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]   Maalox® is a registered trademark of Novartis Consumer Health, Inc.    Manufactured for: Aurobindo Pharma USA, Inc. 2400 Route 130 North Dayton, NJ 08810   Manufactured by: Aurobindo Pharma Limited Unit-VII (SEZ) Mahaboob Nagar (Dt) AP-509302, INDIA   Revised: 05/2013  Repackaged by: Proficient Rx LP Thousand Oaks, CA 91360

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

GABAPENTIN- GABAPENTIN TABLET, FILM COATED
Proficient Rx LP
----------
MEDICATION GUIDE
Gabapentin Tablets, USP
Rx only
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
medic

Summary of Product characteristics

GABAPENTIN- GABAPENTIN TABLET, FILM COATED
PROFICIENT RX LP
----------
GABAPENTIN TABLETS, USP
DESCRIPTION
Gabapentin tablets, USP are supplied as film-coated tablets containing
600 mg and 800 mg of gabapentin
USP.
The inactive ingredients for the tablets are copovidone, corn starch,
crospovidone, hydroxypropyl
cellulose, magnesium stearate, microcrystalline cellulose, and talc.
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 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 other marketed
anticonvulsants. Gabapentin exhibits antiseizure activity in mice and
rats in both the maxim