GABAPENTIN capsule

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

RedPharm Drug, Inc.

DCI (Denominação Comum Internacional):

GABAPENTIN

Composição:

GABAPENTIN 300 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Gabapentin capsules, 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. 8.1 Pregnancy 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. T

Resumo do produto:

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; supplied in bottles of 100's count (NDC 69097-813-07) and 500's count (NDC 69097-813-12). 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; supplied in bottles of 100's count (NDC 69097-814-07) and 500's count (NDC 69097-814-12). 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; supplied in bottles of 100's count (NDC 69097-815-07) and 500's count (NDC 69097-815-12). Store at 20°C to 25°C (68° to 77°F). [see USP Controlled Room Temperature].

Status de autorização:

Abbreviated New Drug Application

Folheto informativo - Bula

GABAPENTIN- gabapentin capsule
RedPharm Drug, Inc.
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MEDICATION GUIDE
Gabapentin Capsules, USP
(gab-ah-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
medicines. If you have suicidal thoug

Características técnicas

GABAPENTIN- GABAPENTIN CAPSULE
REDPHARM DRUG, INC.
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GABAPENTIN 300MG
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 use,
Initial U.S. Approval: 1993
RECENT MAJOR CHANGES
Warnings and Precautions: Anaphylaxis and Angioedema: discontinue
gabapentin
capsules and evaluate patient immediately (5.2) 9/2015
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 (2.1)
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, 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 gabapentin if an alternative etiology
cannot be established
(5.1)
Anaphylaxis and Angioedema: discontinue gabapentin and evaluate
patient imm