GABAPENTIN tablet

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

Direct_Rx

administration_route:

ORAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

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. 8.1 Pregnancy 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 developmenta

leaflet_short:

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 Bottles of 500 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 Bottles of 500 Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

authorization_status:

Abbreviated New Drug Application

PIL

GABAPENTIN- GABAPENTIN TABLET
Direct_Rx
----------
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 emotional
changes, aggressive behavior, problems with c

SPC

GABAPENTIN- GABAPENTIN TABLET
DIRECT_RX
----------
GABAPENTIN
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
2.1 Dosage for Postherpetic Neuralgia
In adults with postherpetic neuralgia, gabapentin tablets may be
initiated on Day 1 as a
single 300 mg dose, on Day 2 as 600 mg/day (300 mg two times a day),
and on Day 3
as 900 mg/day (300 mg three times a day). The dose can subsequently be
titrated up as
needed for pain relief to a dose of 1800 mg/day (600 mg three times a
day). In clinical
studies, efficacy was demonstrated over a range of doses from 1800
mg/day to 3600
mg/day with comparable effects across the dose range; however, in
these clinical
studies, the additional benefit of using doses greater than 1800
mg/day was not
demonstrated.
2.2 Dosage for Epilepsy with Partial Onset Seizures
Patients 12 years of age and above
The starting dose is 300 mg three times a day. The recommended
maintenance dose of
gabapentin tablets is 300 mg to 600 mg three times a day. Dosages up
to 2400 mg/day
have been well tolerated in long-term clinical studies. Doses of 3600
mg/day have also
been administered to a small number of patients for a relatively short
duration, and have
been well tolerated. Administer gabapentin three times a day using 600
mg or 800 mg
tablets. The maximum time between doses should not exceed 12 hours.
Pediatric Patients Age 3 to 11 years
The starting dose range is 10 mg/kg/day to 15 mg/kg/day, given in
three divided doses,
and the recommended maintenance dose reached by upward titration over
a period of
approximately 3 days. The recommended maintenance dose of gabapentin
tablets in
patients 3 to 4 years of age is 40 mg/kg/day, given in three divided
doses. The
recommended maintenance dose of gabapentin tablets in patients 5 to 11
years of age
is 25 mg/kg/day to 35 mg/kg/day, given in three d