GABAPENTIN capsule

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

Direct_Rx

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

Gabapentin capsules 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 capsules 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

Produktu pārskats:

Gabapentin capsules, USP are supplied as follows: 100 mg — Each white and light brown capsule printed with [1] 665 on both cap and body in black ink contains 100 mg of gabapentin, USP. Capsules are supplied in bottles of 100 and bottles of 500 300 mg — Each yellow and light brown capsule printed with [1] 2666 on both cap and body in black ink contains 300 mg of gabapentin, USP. Capsules are supplied in bottles of 100 and bottles of 500 400 mg — Each orange and light brown capsule printed with [1] 667 on both cap and body in black ink contains 400 mg of gabapentin, USP. Capsules are supplied in bottles of 100 and bottles of 500 Dispense in a tight, light-resistant container as defined in the USP. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Autorizācija statuss:

Abbreviated New Drug Application

Lietošanas instrukcija

GABAPENTIN- GABAPENTIN CAPSULE
Direct_Rx
----------
Gabapentin (gab" a pen' tin) Capsules, USP
What is the most important information I should know about gabapentin
capsules?
Do not stop taking gabapentin capsules without first talking to your
healthcare provider.
Stopping gabapentin capsules suddenly can cause serious problems.
Gabapentin can cause serious side effects including:
1. Suicidal Thoughts. Like other antiepileptic drugs, gabapentin 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 capsules without first talking to a
healthcare provider.
Stopping gabapentin capsules 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 capsules in
children 3 to 12 years of age can
cause emotional changes, aggressive behavior, problems with
concentration, restlessness, changes in
school performance, and hyper

Produkta apraksts

GABAPENTIN- GABAPENTIN CAPSULE
DIRECT_RX
----------
GABAPENTIN
Gabapentin capsules 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 1,800 mg/day (600 mg
three times a day). In clinical studies, efficacy was demonstrated
over a range of doses from 1,800
mg/day to 3,600 mg/day with comparable effects across the dose range;
however, in these clinical
studies, the additional benefit of using doses greater than 1,800
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 is 300
mg to 600 mg three times a day. Dosages up to 2,400 mg/day have been
well tolerated in long-term
clinical studies. Doses of 3,600 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. 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 divided doses. Dosages
up to 50