GABAPENTIN capsule

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Direct_Rx

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

Gabapentin is 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 developmentally toxic (in

Ürün özeti:

Gabapentin capsules and tablets, USP are supplied as follows: 100 mg capsules: White to off-white powder filled in size “3” hard gelatin capsules with opaque white colored cap and opaque white colored body imprinted SG on cap and 179 on body with black ink, available in: Bottles of 60: NDC 72189-460-60 Bottles of 90: NDC 72189-460-90 Bottles of 120: NDC 72189-460-72 Bottles of 1000: NDC 50228-179-10 300 mg capsules: White to off-white powder filled in size “1” hard gelatin capsules with opaque yellow colored cap and opaque yellow colored body imprinted SG on cap and 180 on body with black ink, available in: Bottles of 30: NDC 50228-180-30 Bottles of 100: NDC 50228-180-01 Bottles of 500: NDC 50228-180-05 Bottles of 1000: NDC 50228-180-10 400 mg capsules: White to off-white powder filled in size “0” hard gelatin capsules with opaque orange colored cap and opaque orange colored body imprinted SG on cap and 181 on body with black ink, available in: Bottles of 30: NDC 50228-181-30 Bottles of 100: NDC 50228-181-01 Bottles of 500: NDC 50228-181-05 600 mg tablets: White to off white, modified capsule shape, biconvex, film-coated functional scored tablets debossed with “SG” on one side and “177” on other side with bisect line on both sides, available in: Bottles of 30: NDC 50228-177-30 Bottles of 100: NDC 50228-177-01 Bottles of 500: NDC 50228-177-05 800 mg tablets: White to off white, modified capsule shape, biconvex, film-coated functional scored tablets debossed with “SG” on one side and “178” on other side with bisect line on both sides, available in: Bottles of 30: NDC 50228-178-30 Bottles of 100: NDC 50228-178-01 Bottles of 500: NDC 50228-178-05

Yetkilendirme durumu:

Abbreviated New Drug Application

Bilgilendirme broşürü

GABAPENTIN- GABAPENTIN CAPSULE
Direct_Rx
----------
Gabapentin Capsules, USP
Gabapentin Tablets, USP
(gab'' a pen' tin)
What is the most important information I should know about gabapentin?
Do not stop taking gabapentin without first talking to your healthcare
provider.
Stopping gabapentin 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 without first talking to a healthcare
provider.
Stopping gabapentin 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 concentration,
restlessness, changes in school
performance, and hyperactivity.
3. Gabapentin may c

Ürün özellikleri

GABAPENTIN- GABAPENTIN CAPSULE
DIRECT_RX
----------
GABAPENTIN
Gabapentin is 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 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, 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 divided doses. Ga