GABAPENTIN tablet

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

REMEDYREPACK INC.

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Gabapentin tablets 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 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 (inc

Produkt oversigt:

Gabapentin Tablets, USP are supplied as follows: Gabapentin Tablets, USP, 600 mg are white to off-white film-coated, oval shaped, biconvex scored tablets debossed with “G” and “31” on one side. They are available as: Bottles of 100 NDC 68462-126-01 Bottles of 500 NDC 68462-126-05 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: Bottles of 100 NDC 68462-127-01 Bottles of 500 NDC 68462-127-05 Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Autorisation status:

Abbreviated New Drug Application

Indlægsseddel

GABAPENTIN- GABAPENTIN TABLET
REMEDYREPACK INC.
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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 in children 3
to 12 years of age can cause
emotio

Produktets egenskaber

GABAPENTIN- GABAPENTIN TABLET
REMEDYREPACK 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 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 ope