GABAPENTIN tablet

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Direct_Rx

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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 tablets are 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 developmentally t

Rezumat produs:

Gabapentin tablets, USP are supplied as follows: 600 mg tablets: White colored film coated, Oval Shaped, biconvex tablets de-bossed with ‘T’ on the left side of the bisect and ‘1’ on the right side of the bisect on one side and bisect on other side; supplied in Bottles of 100: NDC 31722-166-01 Bottles of 500: NDC 31722-166-05 800 mg tablets: White colored film coated, Oval Shaped, biconvex tablets de-bossed with ‘T’ on the left side of the bisect and ‘3’ on the right side of the bisect on one side and bisect on other side; supplied in Bottles of 100: NDC 31722-167-01 Bottles of 500: NDC 31722-167-05 Store gabapentin tablets at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Statutul autorizaţiei:

Abbreviated New Drug Application

Prospect

GABAPENTIN- GABAPENTIN TABLET
Direct_Rx
----------
Gabapentin Tablets, USP
(gab-ah-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 cause
emotional changes, aggressive behavior, problems with concentration,
restlessness, changes in school
performance, an

Caracteristicilor produsului

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 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 300
mg or 400 mg
capsules, or 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
in patients 3
to 4 years of age is 40 mg/kg/day, given in three divided doses. The
recommended
maintenance dose of gabapentin in patients 5 to 11 years of age is 25
mg/kg/day to 35
mg/kg/day, given in three div