GABAPENTIN tablet

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Akron Pharma Inc

INN (Nama Internasional):

GABAPENTIN

Komposisi:

GABAPENTIN 600 mg

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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

Ringkasan produk:

Gabapentin tablets, USP are supplied as follows: 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 500: 71399-0556-5 800 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 500: NDC 71399-0558-5 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].

Status otorisasi:

Abbreviated New Drug Application

Selebaran informasi

GABAPENTIN - GABAPENTIN TABLET
Akron Pharma Inc
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MEDICATION GUIDE
Gabapentin Tablets, 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
tablets?
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
healthca

Karakteristik produk

GABAPENTIN - GABAPENTIN TABLET
AKRON PHARMA INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GABAPENTIN TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR GABAPENTIN TABLETS .
GABAPENTIN TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1993
RECENT MAJOR CHANGES
•
INDICATIONS AND USAGE
Gabapentin is indicated for:
•
DOSAGE AND ADMINISTRATION
•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
•
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
•
USE IN SPECIFIC POPULATIONS
Warnings and Precautions: Anaphylaxis and Angioedema: discontinue
gabapentin and evaluate patient immediately
(5.2) 09/2015
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)
Tablets (functional scored): 600 mg, and 8