GABAPENTIN tablet, film coated 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:

Allied Pharma Inc

INN (International Name):

gabapentin

Composition:

gabapentin 600 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Postherpetic Neuralgia Gabapentin is indicated for the management of postherpetic neuralgia in adults. Epilepsy Gabapentin is 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 is also indicated as adjunctive therapy in the treatment of partial seizures in pediatric patients age 3 to 12 years. Gabapentin is 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. 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 po

Product summary:

Gabapentin tablets, USP 600 mg are available for oral administration as white to off -White, film-coated, oval-shaped tablets, deep scoring on both the sides and debossed with "NT"and “150” on one side supplied in bottles of 100 (NDC – 76267-150-02). Gabapentin tablets, USP 800 mg are available for oral administration as white to off -White, film-coated, oval-shaped tablets, deep scoring on both the sides and debossed with "NT"and “151” on one side supplied in bottles of 100 (NDC – 76267-151-02) Storage Store at 20° to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Made in India by:  Par Formulations Pvt Ltd,  1/58, Pudupakkam, Kelambakkam 603 103    Manufactured for Allied Pharma Inc 20 Corrielle Street Fords, NJ 08863 I08/13

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

GABAPENTIN - GABAPENTIN TABLET, FILM COATED
GABAPENTIN - GABAPENTIN TABLET, FILM COATED
Allied Pharma Inc
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SPL MEDGUIDE SECTION
GABAPENTIN TABLETS, USP 600 mg and 800 mg
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 act

Summary of Product characteristics

GABAPENTIN - GABAPENTIN TABLET, FILM COATED
GABAPENTIN - GABAPENTIN TABLET, FILM COATED
ALLIED PHARMA INC
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GABAPENTIN TABLETS, USP 600 MG AND 800 MG
ALLIED PHARMA INC
DESCRIPTION
Gabapentin tablets are supplied as oval-shaped film-coated tablets
containing 600 mg and 800 mg of
gabapentin USP.
The inactive ingredients are copovidone, hydroxyl propyl cellulose,
magnesium stearate mannitol,
poloxamer, polyethylene glycol, polyvinyl alcohol, talc and titanium
dioxide
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.
Gabapentin tablets meets 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, 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.
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17
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The mechanism by which gabapentin exerts its anticonvulsant action is
unknown, but in animal test
systems designed to detect anticonvulsant