GABAPENTIN- gabapentin capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Ranbaxy Pharmaceuticals Inc.

INN (International Name):

GABAPENTIN

Composition:

GABAPENTIN 400 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Gabapentin capsules, USP are indicated for the management of postherpetic neuralgia in adults. Gabapentin capsules, 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 capsules, USP are 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. 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 gabapentin to relieve symptoms of withdrawal from other substan

Product summary:

Gabapentin capsules, USP are supplied as follows: 100 mg Capsule ; White colored opaque cap and body, size “4 ” hard gelatin capsules, imprinted with “RX 627” on cap and body in black ink, containing white to off-white crystalline powder. NDC 63304-627-30 Bottles of 30 capsules NDC 63304-627-01 Bottles of 100 capsules NDC 63304-627-05 Bottles of 500 capsules NDC 63304-627-51 Blister pack of 50 capsules 300 mg Capsule ; Ivory colored opaque cap and body, size “0 ” hard gelatin capsules, imprinted “RX 628” on cap and body in black ink, containing white to off-white crystalline powder. NDC 63304-628-30 Bottles of 30 capsules NDC 63304-628-01 Bottles of 100 capsules NDC 63304-628-05 Bottles of 500 capsules NDC 63304-628-51 Blister pack of 50 capsules 400 mg Capsule ; Orange colored opaque cap and body, size “0el ” hard gelatin capsules, imprinted with “RX 629” on cap and body in black ink, containing white to off-white crystalline powder. NDC 63304-629-30 Bottles of 30 capsules NDC 63304-629-01 Bottles of 100 capsules NDC 63304-629-05 Bottles of 500 capsules NDC 63304-629-51 Blister pack of 50 capsules Storage Store at 20° - 25° C (68° - 77° F) [See USP Controlled Room Temperature]. Manufactured for: Ranbaxy Pharmaceuticals Inc. Jacksonville, FL 32257 USA by: Ranbaxy Laboratories Limited New Delhi – 110 019, India June 2013 FDA-12 * Maalox is a registered trademark of Aventis Pharmaceuticals.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Ranbaxy Pharmaceuticals 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 thing

Summary of Product characteristics

GABAPENTIN- GABAPENTIN CAPSULE
RANBAXY PHARMACEUTICALS INC.
----------
GABAPENTIN CAPSULES, USP
RX ONLY
DESCRIPTION
Gabapentin capsules, USP are supplied as imprinted hard shell capsules
containing 100 mg, 300 mg, and
400 mg of gabapentin, USP.
The inactive ingredients for the capsules are corn starch, gelatin,
magnesium stearate, mannitol, sodium
lauryl sulphate, talc, titanium dioxide, black edible ink which
contains iron oxide black, potassium
hydroxide, propylene glycol, and shellac. The 300 mg capsule shell
contains yellow iron oxide. The
400 mg capsule shell contains red iron oxide and yellow iron oxide.
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 powder. It is
freely soluble in water and in alkaline
and acidic 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 te