GABAPENTIN capsule

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

Medsource Pharmaceuticals

ИНН (Международная Имя):

GABAPENTIN

состав:

GABAPENTIN 400 mg

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

Gabapentin capsules, USP 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, USP are 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, 1000 mg, 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

Обзор продуктов:

Gabapentin Capsules, USP are supplied as follows: 100 mg capsules: Hard Gelatin Capsules size "3" with White Opaque Cap and White Opaque Body imprinted with 100 mg and IG321, filled with White to Off-white powder; 300 mg capsules: Hard Gelatin Capsules size "1" with Yellow Opaque Cap and Yellow Opaque Body imprinted with 300 mg and IG322, filled with White to Off-white powder; 400 mg capsules: Hard Gelatin Capsules size "0" with Orange Opaque Cap and Orange Opaque Body imprinted with 400 mg and IG323, filled with White to Off-white powder; Store at 20°C to 25°C (68° to 77°F). [see USP Controlled Room Temperature].

Статус Авторизация:

Abbreviated New Drug Application

тонкая брошюра

Medsource Pharmaceuticals
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MEDICATION GUIDE
Gabapentin Capsules, USP
(gab-ah-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 p

Характеристики продукта

GABAPENTIN- GABAPENTIN CAPSULE
MEDSOURCE PHARMACEUTICALS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
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, USP FOR ORAL USE,
INITIAL U.S. APPROVAL: 1993
INDICATIONS AND USAGE
Gabapentin is indicated for: (1)
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
DOSAGE AND ADMINISTRATION
Postherpetic Neuralgia ( 2.1)
Epilepsy with partial Onset Seizures ( 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)
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; the effective dose
in patients 3 to 4 years of age is 40 mg/kg/day, given in three
divided doses; the effective dose in patients 5 to 11 years
of age is 25 to 35 mg/kg/day, given in three divided doses. The
effective 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)
DOSAGE FORMS AND STRENGTHS
• Capsules: 100 mg, 300 mg, 400 mg (3)
CONTRAINDICATIONS
Known hypersensitivity to gabapentin or its ingredients (4)
WARNINGS AND PRECAUTIONS
_Drug Reaction with Eosinophilla and Systemic Symptoms (Mutiorgan
hypersensitivity):_discontinue gabapentin if an
alternative etiology cannot be established ( 5.1)
_Driving impairment:_warn patients not to drive until they have gained
sufficient experience withgabapentinto assess
whether it will impair their ability to drive ( 5.2)
_Somnolence/Sedation and Dizz