GABAPENTIN- gabapentin tablet, film coated

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Preferred Pharmaceuticals, Inc.

DCI (Denominação Comum Internacional):

GABAPENTIN

Composição:

GABAPENTIN 600 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Gabapentin tablets are indicated for: Gabapentin tablets are contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), such as gabapentin, during pregnancy. Encourage women who are taking gabapentin during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling the toll free number 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/ . Risk Summary There are no adequate data on the developmental risks associated with the use of gabapentin in pregnant women. In nonclinical studies in mice, rats, and rabbits, gabapentin was developmentally toxic (increased fetal skeletal and visceral abnormalities, and increased embryofetal mortality) when administered to pregnant animals at doses similar to or lower than those used clinically [see Data]. In the U.S. general populat

Resumo do produto:

Gabapentin Tablets, USP are supplied as follows: Gabapentin Tablets USP, 600 mg are white, biconvex, elliptical, film-coated tablets, with deep break line on both sides and debossed with ‘D’ and ‘24’ on either side of the break line on one side and plain on other side. Bottle of 30 - 68788-9923-3 Bottle of 60 - 68788-9923-6 Bottle of 90 - 68788-9923-9 Bottle of 100 - 68788-9923-1 Bottle of 120 - 68788-9923-8 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Status de autorização:

Abbreviated New Drug Application

Folheto informativo - Bula

GABAPENTIN- GABAPENTIN TABLET, FILM COATED
Preferred Pharmaceuticals, Inc.
----------
MEDICATION GUIDE
Gabapentin Tablets, USP
(gab'' a pen' tin)
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
medicines. If you have suicidal
thoughts or actions, your healthcare provider may check for other
causes.
2. Changes in behavior and thinking - Using gabapentin tablets in
children 3 to 12 years of age can caus

Características técnicas

GABAPENTIN- GABAPENTIN TABLET, FILM COATED
PREFERRED PHARMACEUTICALS, INC.
----------
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:
•
•
DOSAGE AND ADMINISTRATION
•
•
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
Known hypersensitivity to gabapentin or its ingredients (4)
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
ADVERSE REACTIONS
Most common adverse reactions (incidence ≥8% and at least twice that
for placebo) were:
•
•
•
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)
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)
Tablets: 600 mg, and 800 mg (3)
Drug Reaction with Eosinophilia and Systemic Symptoms (Multiorgan
hypersensitivity): Discontinue if alternative
etiology is not established (5.1)
Anaphylaxis and Angioedema: Discontinue and