GABAPENTIN capsule

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

Akron Pharma Inc

INN (Միջազգային անվանումը):

GABAPENTIN

Կազմը:

GABAPENTIN 100 mg

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

Gabapentin is indicated for: Gabapentin is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. In nonclinical studies in mice, rats, and rabbits, gabapentin was developmentally toxic when administered to pregnant animals at doses similar to or lower than those used clinically. Gabapentin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. When pregnant mice received oral doses of gabapentin (500 mg/kg/day, 1,000 mg/kg/day, or 3,000 mg/kg/day) during the period of organogenesis, embryo-fetal toxicity (increased incidences of skeletal variations) was observed at the two highest doses. The no-effect dose for embryo-fetal developmental toxicity in mice was 500 mg/kg/day or approximately ½ of the maximum recommended human dose (MRHD) of 3,600 mg/kg on a body surface area (mg/m2 ) basis. In studies in which rats received oral

Ապրանքի ամփոփագիր:

Gabapentin capsules, 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 500: NDC 71399-0551-5 300 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 500: NDC 71399-0553-5 400 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 500: NDC 71399-0554-5 Store gabapentin capsules at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Տեղեկատվական թերթիկ

GABAPENTIN - GABAPENTIN CAPSULE
Akron Pharma Inc
---------- MEDICATION
GUIDE
Gabapentin Capsules, USP
(gab″ a pen′ tin)
Read the Medication Guide before you start taking gabapentin and each
time you get a refill. There may
be new information. This information does not take the place of
talking to your healthcare provider about
your medical condition or treatment.
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 provi

Ապրանքի հատկությունները

GABAPENTIN - GABAPENTIN CAPSULE
AKRON PHARMA INC
----------
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 USEINITIAL U.S. APPROVAL: 1993
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 USEINITIAL U.S. APPROVAL: 1993
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 USEINITIAL U.S. APPROVAL: 1993
INDICATIONS AND USAGE
Gabapentin is indicated for:
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
•
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
•
ADVERSE REACTIONS
Most common adverse reactions (incidence ≥8% and at least twice that
for placebo) were:
•Epilepsy in patients >12 years of age: somnolence, dizziness,
ataxia, fatigue, and nystagmus (6.1)•Epilepsy in patients 3 to
12 years of age: viral infection, fever, nausea and/or vomiting,
somnolence, and hostility (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT AKRON PHARMA, INC. AT
1-973-227-2000 OR FDA AT 1-
800-FDA-1088 OR _WWW.FDA.GOV/MEDWATCH._
DRUG INTERACTIONS
Morphine increases gabapentin concentrations; dose adjustment may be
needed (5.4, 7.2)
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 i