GABAPENTIN- gabapentin capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Safecor Health, LLC

INN (International Name):

GABAPENTIN

Composition:

GABAPENTIN 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Postherpetic Neuralgia Gabapentin capsules, USP are indicated for the management of postherpetic neuralgia in adults. Epilepsy 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 capsules are contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. Controlled Substance Gabapentin is not a scheduled drug. Abuse 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

Product summary:

Gabapentin capsules are supplied as follows: Gabapentin Capsules USP, 100 mg are white/white size ‘3’ hard gelatin capsules imprinted with ‘D’ on white cap and ‘02’ on white body with black edible ink filled with white to off-white crystalline powder.         Boxes of 100 Unit Dose Robot-Rx®1 Pouches NDC 48433-307-10 (Unit-Dose NDC 48433-307-01) Storage Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Maalox® is a registered trademark of Novartis Consumer Health, Inc. Robot-Rx® is a registered trademark of Aesynt, Inc. Rev: 306-00 08/2014

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

GABAPENTIN- GABAPENTIN CAPSULE
Safecor Health, LLC
----------
MEDICATION GUIDE
Gabapentin Capsules, USP
Rx only
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 things other than
medic

Summary of Product characteristics

GABAPENTIN- GABAPENTIN CAPSULE
SAFECOR HEALTH, LLC
----------
GABAPENTIN CAPSULES, USP
DESCRIPTION
Gabapentin capsules, USP are supplied as imprinted hard shell capsules
containing 100 mg, 300 mg, and
400 mg of gabapentin USP. Each capsule contains the following inactive
ingredients: corn starch and
talc. The empty hard gelatin capsule shell consists of gelatin,
titanium dioxide, and sodium lauryl
sulfate. In addition 300 mg also contains yellow iron oxide and 400 mg
also contains yellow iron oxide
and red iron oxide. The capsules are printed with edible ink
containing black iron oxide and shellac.
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