GABAPENTIN capsule

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Method Pharmaceuticals, LLC

INN (International Name):

GABAPENTIN

Sammensetning:

GABAPENTIN 100 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Gabapentin is indicated for: - Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy       Gabapentin is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. Pregnancy Category C :  There are no adequate and well-controlled studies in pregnant women. In nonclinical studies in mice, rats, and rabbits, gabapentin was developmentally toxic when administered to pregnant animals at doses similar to or lower than those used clinically. Gabapentin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. When pregnant mice received oral doses of gabapentin (500 mg/kg/day, 1,000 mg/kg/day, or 3,000 mg/kg/day) during the period of organogenesis, embryo-fetal toxicity (increased incidences of skeletal variations) was observed at the two highest doses. The no-effect dose for embryo-fetal developmental toxicity in

Produkt oppsummering:

Gabapentin capsules and tablets, USP are supplied as follows: 100 mg capsules: White to off-white powder filled in size “3” hard gelatin capsules with opaque white colored cap and opaque white colored body imprinted SG on cap and 179 on body with black ink, available in: Bottles of 100: NDC 58657-620-01 Bottles of 500: NDC 58657-620-50 300 mg capsules: White to off-white powder filled in size “1” hard gelatin capsules with opaque yellow colored cap and opaque yellow colored body imprinted SG on cap and 180 on body with black ink, available in: Bottles of 100: NDC 58657-621-01 Bottles of 500: NDC 58657-621-50 400 mg capsules: White to off-white powder filled in size “0” hard gelatin capsules with opaque orange colored cap and opaque orange colored body imprinted SG on cap and 181 on body with black ink, available in: Bottles of 100: NDC 58657-622-01 Bottles of 500: NDC 58657-622-50 600 mg tablets: White to off white, modified capsule shape, biconvex, film-coated functional scored tablets debossed with “SG” on one side and “177” on other side with bisect line on both sides, available in: Bottles of 100: NDC 58657-623-01 Bottles of 500: NDC 58657-623-50 800 mg tablets: White to off white, modified capsule shape, biconvex, film-coated functional scored tablets debossed with “SG” on one side and “178” on other side with bisect line on both sides, available in: Bottles of 100: NDC 58657-624-01 Bottles of 500: NDC 58657-624-50 Store gabapentin capsules and tablets at 20° to 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

Method Pharmaceuticals, LLC
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MEDICATION GUIDE
Gabapentin Capsules, USP
Gabapentin Tablets, USP
(gab'' a pen' tin)
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. Suicidal Thoughts. 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 o

Preparatomtale

GABAPENTIN- GABAPENTIN CAPSULE
METHOD PHARMACEUTICALS, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GABAPENTIN SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR GABAPENTIN.
GABAPENTIN CAPSULES, FOR ORAL USE
GABAPENTIN TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1993
INDICATIONS AND USAGE
Gabapentin is indicated for:
Adjunctive therapy in the treatment of partial onset seizures, with
and without secondary generalization, in adults and
pediatric patients 3 years and older with epilepsy (1)
DOSAGE AND ADMINISTRATION
Epilepsy with Partial Onset Seizures (2.2)
● Patients 12 years of age and older: starting dose is 300 mg three
times daily; may be titrated up to 600 mg three
times daily
● Patients 3 to 11 years of age: starting dose range is 10 to 15
mg/kg/day, given in three divided doses; recommended
dose in patients 3 to 4 years of age is 40 mg/kg/day, given in three
divided doses; the recommended dose in patients 5
to 11 years of age is 25 to 35 mg/kg/day, given in three divided
doses. The recommended dose is reached by upward
titration over a period of approximately 3 days
Dose should be adjusted in patients with reduced renal function (2.3,
2.4)
DOSAGE FORMS AND STRENGTHS
Capsules : 100 mg, 300 mg and 400 mg (3)
Tablets (functional scored): 600 mg, and 800 mg (3)
CONTRAINDICATIONS
Known hypersensitivity to gabapentin or its ingredients (4)
WARNINGS AND PRECAUTIONS
Drug Reaction with Eosinophilia and Systemic Symptoms (Multiorgan
hypersensitivity): discontinue if alternative
etiology is not established (5.1)
Anaphylaxis and Angioedema: discontinue and evaluate patient
immediately (5.2)
Driving impairment; Somnolence/Sedation and Dizziness: warn patients
not to drive until they have gained sufficient
experience to assess whether their ability to drive or operate heavy
machinery will be impaired (5.3, 5.4)
Increased seizure frequency may occur in patients with seizure
disorders if gabapentin is abruptly discontinued (5.5)
Suici