GABAPENTIN- gabapentin solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Gabapentin (UNII: 6CW7F3G59X) (Gabapentin - UNII:6CW7F3G59X)

Available from:

Taro Pharmaceuticals U.S.A., Inc.

INN (International Name):

Gabapentin

Composition:

Gabapentin 250 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Gabapentin is indicated for the management of postherpetic neuralgia in adults. 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. 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 substances. When prescribing gabapentin carefully ev

Product summary:

Gabapentin Oral Solution, 250 mg/5 mL is a clear colorless to slightly yellow solution; each 5 mL of oral solution contains 250 mg of gabapentin and is available as follows: Bottles containing 470 mL    NDC 51672-4075-9 Store refrigerated, 2° - 8°C (36° - 46°F)

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

GABAPENTIN- GABAPENTIN SOLUTION
Taro Pharmaceuticals U.S.A., Inc.
----------
MEDICATION GUIDE
GABAPENTIN (gab" a pen' tin)
Oral Solution
Read the Medication Guide before you start taking gabapentin oral
solution 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
oral solution?
Do not stop taking gabapentin oral solution without first talking to
your healthcare provider.
Stopping gabapentin oral solution suddenly can cause serious problems.
Gabapentin oral solution can cause serious side effects including:
1. Like other antiepileptic drugs, gabapentin oral solution 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 oral solution without first talking to a
healthcare provider.
•
Stopping gabapentin oral solution 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).
Suic

Summary of Product characteristics

GABAPENTIN- GABAPENTIN SOLUTION
TARO PHARMACEUTICALS U.S.A., INC.
----------
GABAPENTIN
ORAL SOLUTION
250 MG/ 5 ML
RX ONLY
DESCRIPTION
Gabapentin Oral Solution is supplied as oral solution containing 250
mg/5 mL of gabapentin.
The inactive ingredients are anise flavor natural and artificial,
cooling agent flavor artificial, glycerin,
purified water, strawberry flavor artificial and xylitol.
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.
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 antiseizure activity in mice and
rats in both th