GABAPENTIN- gabapentin tablet, film coated

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

NuCare Pharmaceuticals, Inc.

ІПН (Міжнародна Ім'я):

GABAPENTIN

Склад:

GABAPENTIN 600 mg

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

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. 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, 1000, or 3000 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 developm

Огляд продуктів:

Capsules Gabapentin Tablets, USP 600 mg are available for oral administration as white, oval biconvex, film-coated scored tablets, and engraved “GAB” over “600” on one side and “APO” on the other side; supplied in bottles of 7 NDC 68071-3244-7 bottles of 14 NDC 68071-3244-4 bottles of 30 NDC 68071-3244-3 bottles of 60 NDC 68071-3244-6 bottles of 84 NDC 68071-3244-8 bottles of 90 NDC 68071-3244-9 bottles of 120 NDC 68071-3244-2 Storage Store gabapentin at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light resistant container [see USP]. * Maalox ® is a registered trademark of Novartis Consumer Health Inc.

Статус Авторизація:

Abbreviated New Drug Application

інформаційний буклет

NuCare Pharmaceuticals, Inc.
Reference Label Set Id: f6eb01ad-ab26-7c2d-83c6-2c02771a8ba9
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MEDICATION GUIDE
GABAPENTIN CAPSULE, USP
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?
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 th

Характеристики продукта

GABAPENTIN- GABAPENTIN TABLET, FILM COATED
NUCARE PHARMACEUTICALS, INC.
REFERENCE LABEL SET ID: F6EB01AD-AB26-7C2D-83C6-2C02771A8BA9
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GABAPENTIN SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR GABAPENTIN.
GABAPENTIN CAPSULES, USP FOR ORAL USE
GABAPENTIN TABLETS, USP FOR ORAL USE
INITIAL U.S. APPROVAL: 1993
INDICATIONS AND USAGE
Gabapentin is 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 ( 2.2)
Dose can be titrated up as needed to a dose of 1800 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 ( 2.3)
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 (
2.4, 2.5)
DOSAGE FORMS AND STRENGTHS
Capsules: 100 mg, 300 mg, and 400 mg ( 3)
Tablets: 100 mg, 300 mg, 400 mg, 600 mg and 800 mg ( 3)
CONTRAINDICATIONS
Known hypersensitivity to gabapentin or its ingredients ( 4)
WARNINGS AND PRECAUTIONS
Drug Reaction with Eosinophilia and Systemic Symptoms (Multiorgan
hypersensitivity): discontinue gabapentin if an
alternative etiology cannot be established ( 5.1)
Driving impairment: warn patients not to drive until they h