GABAPENTIN- gabapentin capsule

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC

INN (International ime):

GABAPENTIN

Sastav:

GABAPENTIN 400 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Postherpetic Neuralgia Gabapentin is indicated for the management of postherpetic neuralgia in adults. Epilepsy 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 – 12 years. Gabapentin is 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.

Proizvod sažetak:

Gabapentin Capsules, USP are supplied as follows: 100 mg : Hard Gelatin Capsules size "3" with White Opaque Cap and White Opaque Body imprinted with 100 mg and IG321, filled with White to Off-white powder; supplied in bottles of 100's count (NDC 31722-221-01) and 500's count (NDC 31722-221-05). 300 mg : Hard Gelatin Capsules size "1" with Yellow Opaque Cap and Yellow Opaque Body imprinted with 300 mg and IG322, filled with White to Off-white powder; supplied in bottles of 100's count (NDC 31722-222-01) and 500's count (NDC 31722-222-05). 400 mg : Hard Gelatin Capsules size "0" with Orange Opaque Cap and Orange Opaque Body imprinted with 400 mg and IG323, filled with White to Off-white powder; supplied in bottles of 100's count (NDC 31722-223-01) and 500's count (NDC 31722-223-05). Store at 20°-25°C (68°-7JOF). [See USP controlled room temperature.] Rx only Manufactured by: InvaGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 Rev: 01/10 Barcode 323-01-2010

Status autorizacije:

Abbreviated New Drug Application

Uputa o lijeku

GABAPENTIN- GABAPENTIN CAPSULE
Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC
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Gabapentin Capsules, USP
(gab-ah-PEN-tin)
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. Suicidal Thoughts. 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
medicine

Svojstava lijeka

GABAPENTIN- GABAPENTIN CAPSULE
LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC
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GABAPENTIN CAPSULES, USP
DESCRIPTION
Gabapentin Capsules, USP are supplied as imprinted hard gelatin
capsules containing 100 mg, 300 mg
and 400 mg of gabapentin, USP.
The inactive ingredients are mannitol, pre-gelatinized starch and
talc. The 100 mg capsule shell contains
titanium dioxide. The 300 mg capsule contains FD&C Red 40, D&C Yellow
10 and titanium dioxide.
The 400 mg capsule shell contains FD&C Red 40, D&C Yellow 10 and
titanium dioxide.
Gabapentin, USP 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:
C H NO M.W. 171.24
C H NO M.W. 171.24
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
u