GABAPENTIN solution

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Kiel Laboratories, Inc.

INN (Internationale Bezeichnung):

GABAPENTIN

Zusammensetzung:

GABAPENTIN 250 mg in 5 mL

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Gabapentin oral solution is indicated for the management of postherpetic neuralgia in adults. Gabapentin oral solution 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 oral solution is also indicated as adjunctive therapy in the treatment of partial seizures in pediatric patients age 3 - 12 years. Gabapentin oral solution is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. The abuse and dependence potential of gabapentin oral solution has not been evaluated in human studies.

Produktbesonderheiten:

Gabapentin Oral Solution is supplied as follows: 250 mg/5 mL oral solution; clear colorless to slightly yellow solution; each 5 mL of oral solution contains 250 mg of gabapentin; available in: Bottles containing 470 mL (NDC 59063-127-47). Store refrigerated, 2°-8°C (36°-46°F) Rx only PHARMACIST: Dispense in tight, light-resistant containers as defined in the USP/NF, with a child-resistant closure. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Made in Germany Manufactured For: KIEL LABORATORIES® 2225 Centennial Dr. Gainesville, GA 30504 Trademarks are the property of their respective owners. Rev:04/2012

Berechtigungsstatus:

Abbreviated New Drug Application

Gebrauchsinformation

Kiel Laboratories, Inc.
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MEDICATION GUIDE
Gabapentin Oral Solution 250 mg / 5 mL
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).
Suicidal thoughts or actions can be caused by thin

Fachinformation

GABAPENTIN- GABAPENTIN SOLUTION
KIEL LABORATORIES, INC.
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GABAPENTIN ORAL SOLUTION
250 MG / 5 ML
R ONLY
DESCRIPTION
Gabapentin oral solution is supplied as an oral solution containing
250 mg/5 mL of gabapentin. The
inactive ingredients for the oral solution are anise flavor,
artificial strawberry flavor, glycerin,
hydrochloric acid, purified water, sodium hydroxide 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 the max