GABAPENTIN tablet, film coated

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Aphena Pharma Solutions - Tennessee, LLC

INN (Algemene Internationale Benaming):

Gabapentin

Samenstelling:

Gabapentin 800 mg

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Postherpetic Neuralgia Gabapentin tablets USP are indicated for the management of postherpetic neuralgia in adults. Epilepsy Gabapentin tablets 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 tablets USP are also indicated as adjunctive therapy in the treatment of partial seizures in pediatric patients age 3 to 12 years. Gabapentin tablets USP 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 samenvatting:

Gabapentin Tablets, USP 600 mg: White colored film coated, Modified Capsule shaped, biconvex tablets de-bossed with '1' on the left side of the bisect and '2' on the right side of the bisect on one side and bisect on other; supplied in bottles of 90's count (NDC 76282-405-90), 100's count (NDC 76282-405-01) and 500’s count (NDC 76282-405-05). Gabapentin Tablets, USP 800 mg: White colored film coated, Modified Capsule shaped, biconvex tablets de-bossed with '1' on the left side of the bisect and '3' on the right side of the bisect on one side and bisect on other; supplied in bottles of 90's count (NDC 76282-406-90), 100's count (NDC 76282-406-01) and 500’s count (NDC 76282-406-05). Store at 20° to 25°C (68° to 77°F). [See USP controlled room temperature]. Rev: 10/12.

Autorisatie-status:

Abbreviated New Drug Application

Bijsluiter

Aphena Pharma Solutions - Tennessee, LLC
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SPL MEDGUIDE
Gabapentin Tablets, USP
Read the Medication Guide before you start taking gabapentin 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?
Do not stop taking gabapentin without first talking to your healthcare
provider.
Stopping gabapentin suddenly can cause serious problems.
Gabapentin can cause serious side effects including:
1. Like other antiepileptic drugs, gabapentin 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 without first talking to a healthcare
provider.
•
Stopping gabapentin 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. If you have suicidal thoughts
or actions, your healthcare provider may check for other ca

Productkenmerken

GABAPENTIN - GABAPENTIN TABLET, FILM COATED
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
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GABAPENTIN TABLETS, USP
RX ONLY
DESCRIPTION
Gabapentin tablets, USP are white colored film coated, modified
capsule shaped biconvex tablets
containing 600 mg and 800 mg of gabapentin, USP.
Each tablet for oral administration contains the following inactive
ingredients: Mannitol, Hydroxypropyl
Cellulose, Crospovidone, Talc, Magnesium Stearate and Aquarius
BP18114 Cool Vanilla.
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.
This product(Gabapentin Tablets, USP 600 mg and 800 mg) meets the USP
Dissolution Test 1.
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