GABAPENTIN capsule

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Actavis Pharma, Inc.

INN (국제 이름):

GABAPENTIN

구성:

GABAPENTIN 100 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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. 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 (increa

제품 요약:

Gabapentin capsules, USP are supplied as follows: 100 mg — Each white and light brown capsule printed with  665 on both cap and body in black ink contains 100 mg of gabapentin, USP.  Capsules are supplied in bottles of 100 (NDC 45963-555-11) and bottles of 500 (NDC 45963-555-50). 300 mg — Each yellow and light brown capsule printed with  2666 on both cap and body in black ink contains 300 mg of gabapentin, USP.  Capsules are supplied in bottles of 100 (NDC 45963-556-11) and bottles of 500 (NDC 45963-556-50). 400 mg — Each orange and light brown capsule printed with  667 on both cap and body in black ink contains 400 mg of gabapentin, USP.  Capsules are supplied in bottles of 100 (NDC 45963-557-11) and bottles of 500 (NDC 45963-557-50). 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].

승인 상태:

Abbreviated New Drug Application

환자 정보 전단

Actavis Pharma, Inc.
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MEDICATION GUIDE
Dispense with Medication Guide available at: www.tevausa.com/medguides
Gabapentin (gab" a pen' tin) Capsules
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 ca

제품 특성 요약

GABAPENTIN- GABAPENTIN CAPSULE
ACTAVIS PHARMA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GABAPENTIN
CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
GABAPENTIN
CAPSULES.
GABAPENTIN CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1993
INDICATIONS AND USAGE
Gabapentin capsules 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 1,800 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
Capsules: 100 mg, 300 mg, and 400 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 driv