GABAPENTIN- gabapentin tablet

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

NuCare Pharmaceuticals,Inc.

INN (Algemene Internationale Benaming):

GABAPENTIN

Samenstelling:

GABAPENTIN 800 mg

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Gabapentin tablets USP are indicated for: - Management of postherpetic neuralgia in adults - 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, 1000, or 3000 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

Product samenvatting:

Gabapentin Tablets USP, 800 mg are white to off white film-coated, oval shaped, biconvex scored tablets debossed with G and 13 on one side. They are available as: NDC 68071-4087-3 Bottles of 30 NDC 68071-4087-6 Bottles of 60 NDC 68071-4087-8 Bottles of 84 NDC 68071-4087-9 Bottles of 90 NDC 68071-4087-1 Bottles of 120 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Autorisatie-status:

Abbreviated New Drug Application

Bijsluiter

NuCare Pharmaceuticals,Inc.
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MEDICATION GUIDE
Gabapentin Tablets USP
(gab´´ a pen´ tin)
Read the Medication Guide before you start taking gabapentin tablets
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
tablets?
Do not stop taking gabapentin tablets without first talking to your
healthcare provider.
Stopping gabapentin tablets suddenly can cause serious problems.
Gabapentin tablets can cause serious side effects including:
1. Suicidal Thoughts. Like other antiepileptic drugs,gabapentin
tablets 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 tablets without first talking to a
healthcare provider.
•
Stopping gabapentin tablets 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
me

Productkenmerken

GABAPENTIN- GABAPENTIN TABLET
NUCARE PHARMACEUTICALS,INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GABAPENTIN TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR GABAPENTIN TABLETS.
GABAPENTIN TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1993
INDICATIONS AND USAGE
Gabapentin tablets are indicated for:
Postherpetic neuralgia in adults ( 1)
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
Postherpetic Neuralgia (2 .1)
Dose can be titrated up as needed to a dose of 1800 mg/day
Day 1: Single 300 mg dose
Day 2: 600 mg/day (i.e., 300 mg two times a day)
Day 3: 900 mg/day (i.e., 300 mg three times a day)
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
Tablets: 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 gabapentin if an
alternative etiology cannot be established ( 5.1)
Anaphylaxis and Angioedema: discontinue gabapentin 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