GABAPENTIN- gabapentin capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

West-ward Pharmaceutical Corp

INN (International Name):

GABAPENTIN

Composition:

GABAPENTIN 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Gabapentin Capsules are indicated for the management of postherpetic neuralgia in adults. Gabapentin Capsules 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 is also indicated as adjunctive therapy in the treatment of partial seizures in pediatric patients age 3 - 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.

Product summary:

Gabapentin Capsules, USP are supplied as follows: 100 mg capsules; Gray cap/gray body size 3 capsules imprinted with "West-ward 991"; available in: Bottles of 100's, 500's and 1,000s 300 mg capsules; Yellow cap/yellow body size 1 capsules imprinted with "West-ward 993"; available in: Bottles of 100's, 500's and 1,000s 400 mg capsules; Orange cap/orange body size 0 capsules imprinted with "West-ward 994"; available in: Bottles of 100's  Storage Store at 20o to 25o C (68o to 77o F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.  Distributed by: West-ward Pharmaceutical Corp. Eatontown, NJ 07724 - USA Manufactured by: Hikma Pharmaceuticals P.O. Box 182400 Amman 11118 Jordan Revised: September 2011

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

GABAPENTIN- GABAPENTIN CAPSULE
West-ward Pharmaceutical Corp
----------
MEDICATION GUIDE
MEDICATION GUIDE
Gabapentin Capsules, USP
Read the Medication Guide before you start taking Gabapentin Capsules
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
Capsules?
Do not stop taking Gabapentin Capsules without first talking to your
healthcare provider.
Stopping Gabapentin Capsules suddenly can cause serious problems.
Gabapentin Capsules can cause serious side effects including:
1. Like other antiepileptic drugs, Gabapentin Capsules 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 Capsules without first talking to a
healthcare provider.
•
Stopping Gabapentin Capsules 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 thin

Summary of Product characteristics

GABAPENTIN- GABAPENTIN CAPSULE
WEST-WARD PHARMACEUTICAL CORP
----------
GABAPENTIN CAPSULES, USP
RX ONLY
REV. 09/2011
DESCRIPTION
Gabapentin Capsules, USP are supplied as imprinted hard shell capsules
containing 100 mg, 300 mg,
and 400 mg of gabapentin.
The inactive ingredients for the capsules are corn starch and talc.
The 100 mg capsule shell contains
black iron oxide, gelatin, and titanium dioxide. The 300 mg capsule
shell contains FD&C Red No.
3, gelatin, titanium dioxide and yellow iron oxide. The 400 mg capsule
shell contains FD&C Blue No.
2, FD&C Red No. 3, gelatin, red iron oxide, titanium dioxide, and
yellow iron oxide.
Gabapentin is described as 1-(aminomethyl)cyclohexaneacetic acid with
a molecular formula of
C H NO M.W. 171.24.
The structural formula of gabapentin is:
STRUCTURAL FORMULA
Gabapentin is a white to off-white crystalline solid with a pKa
of 3.7 and a pKa
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 it