GABAPENTIN capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

MedVantx Inc.

INN (International Name):

GABAPENTIN

Composition:

GABAPENTIN 300 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 capsules are also indicated as adjunctive therapy in the treatment of partial seizures in pediatric patients age 3 to 12 years. Gabapentin capsules are 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 available as follows: 300 mg - No. 0 hard gelatin capsules with an orange cap and body, filled with a white to off-white powder with small agglomerates, available in unit-dose boxes of 100 (10 x 10) and bottles of 1000. Both the capsule body and cap are imprinted with “93” and “39”. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA. Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 91010, Israel Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev. T 8/2011

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

MedVantx Inc.
----------
MEDICATION GUIDE
Gabapentin Capsules USP
Rx only
Read the Medication Guide before you start taking gabapentin capsules
USP 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 USP?
Do not stop taking gabapentin capsules USP without first talking to
your healthcare provider. Stopping
gabapentin capsules USP suddenly can cause serious problems.
Gabapentin capsules USP can cause serious side effects including:
1.Like other antiepileptic drugs, gabapentin capsules USP 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 USP without first talking to a
healthcare provider.
•
Stopping gabapentin capsules USP 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. I

Summary of Product characteristics

GABAPENTIN- GABAPENTIN CAPSULE
MEDVANTX INC.
----------
GABAPENTIN CAPSULES USP
1039
RX ONLY
DESCRIPTION
Gabapentin capsules USP are supplied as imprinted hard shell capsules
containing 300 mg of
gabapentin. In addition, each capsule contains the following inactive
ingredients: corn starch, FD&C
Red No. 3, FD&C Yellow No. 6, gelatin, talc, and titanium dioxide. The
imprinting ink contains black
iron oxide and shellac and may contain antifoam DC, propylene glycol,
and soya lecithin.
Gabapentin is described as 1-(aminomethyl)cyclohexaneacetic acid. The
structural formula of
gabapentin is:
C H NO M.W. 171.24
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.
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 antis