GABAPENTIN capsule

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

ACETRIS HEALTH, LLC

ИНН (Международная Имя):

GABAPENTIN

состав:

GABAPENTIN 100 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 are contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. Teratogenic Effects 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 dose

Обзор продуктов:

Gabapentin Capsules USP, 100 mg are white/white size '3' hard gelatin capsules imprinted with 'D' on white cap and '02' on white body with black edible ink filled with white to off-white crystalline powder.                                             Bottles of 90       NDC 52343-030-90                                             Bottles of 100     NDC 52343-030-01                                             Bottles of 180     NDC 52343-030-18                                             Bottles of 270     NDC 52343-030-27                                                                                 Bottles of 1000   NDC 52343-030-99 Gabapentin Capsules USP, 300 mg are yellow/yellow size '1' hard gelatin capsules imprinted with 'D' on yellow cap and '03' on yellow body with black edible ink filled with white to off-white crystalline powder.                                            Bottles of 30         NDC 52343-031-30                                            Bottles of 60         NDC 52343-031-60                                            Bottles of 90         NDC 52343-031-90                                            Bottles of 100       NDC 52343-031-01                                            Bottles of 180       NDC 52343-031-18                                            Bottles of 270       NDC 52343-031-27                                                                              Bottles of 1000     NDC 52343-031-99 Gabapentin Capsules USP, 400 mg are orange/orange size '0' hard gelatin capsules imprinted with 'D' on orange cap and '04' on orange body with black edible ink filled with white to off-white crystalline powder.                                            Bottles of 90           NDC 52343-032-90                                            Bottles of 100         NDC 52343-032-01                                            Bottles of 270         NDC 52343-032-27                                            Bottles of 500         NDC 52343-032-05 Store gabapentin capsules 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].

Статус Авторизация:

Abbreviated New Drug Application

тонкая брошюра

ACETRIS HEALTH, LLC
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MEDICATION GUIDE
Gabapentin Capsules, USP
(gab'' a pen' tin)
Read the Medication Guide before you start taking gabapentin capsules
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
capsules?
Do not stop taking gabapentin capsules without first talking to your
healthcare provider.
Stopping gabapentin capsules suddenly can cause serious problems.
Gabapentin capsules can cause serious side effects including:
1. Suicidal Thoughts. Like other antiepileptic drugs, gabapentin
capsules 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
me

Характеристики продукта

GABAPENTIN - GABAPENTIN CAPSULE
ACETRIS HEALTH, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GABAPENTIN CAPSULES, USP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR GABAPENTIN CAPSULES,
USP. GABAPENTIN CAPSULES, USP FOR
ORAL USE INITIAL U.S. APPROVAL: 1993
INDICATIONS AND USAGE
Gabapentin capsules, USP 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 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 (2.2)
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 the