GABAPENTIN capsule

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Direct Rx

DCI (Denominação Comum Internacional):

GABAPENTIN

Composição:

GABAPENTIN 300 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Gabapentinis 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. 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, 1,000, 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-f

Resumo do produto:

Gabapentin capsules, USP are supplied as follows: 100 mg capsules: White hard gelatin capsules printed with “137” on cap and body; available in: Bottles of 100: Child Resistant Cap ------------------------------------------ NDC 62756-137-02 Non Child Resistant Cap ------------------------------------ NDC 62756-137-03 Bottles of 500: Non Child Resistant Cap ------------------------------------ NDC 62756-137-05 Bottles of 1000: Non Child Resistant Cap ------------------------------------ NDC 62756-137-04 Unit dose 50's: ---------------------------------------------------------------------- NDC 62756-137-01 300 mg capsules: Yellow hard gelatin capsules printed with “138” on cap and body; available in: Bottles of 100: Child Resistant Cap ------------------------------------------NDC 62756-138-02 Non Child Resistant Cap ------------------------------------ NDC 62756-138-03 Bottles of 500: Non Child Resistant Cap ------------------------------------ NDC 62756-138-05 Bottles of 1000: Non Child Resistant Cap ------------------------------------ NDC 62756-138-04 Unit dose 50's: ----------------------------------------------------------------------NDC 62756-138-01 400 mg capsules: Orange hard gelatin capsules printed with “139” on cap and body; available in: Bottles of 100: Child Resistant Cap ------------------------------------------ NDC 62756-139-02 Non Child Resistant Cap ------------------------------------ NDC 62756-139-03 Bottles of 500: Non Child Resistant Cap ------------------------------------ NDC 62756-139-05 Bottles of 1000: Non Child Resistant Cap ------------------------------------ NDC 62756-139-04 Unit dose 50's: ---------------------------------------------------------------------- NDC 62756-139-01 Gabapentin tablets, USP are supplied as follows: 600 mg tablets: White to off white, biconvex, oval shaped, film-coated tablet scored on both sides and debossed with “202” on one side, available in: Bottles of 100: Child Resistant Cap ------------------------------------------ NDC 62756-202-01 Non Child Resistant Cap ------------------------------------ NDC 62756-202-02 Bottles of 500: Non Child Resistant Cap------------------------------------ NDC 62756-202-03 Unit dose 50’s: --------------------------------------------------------------------- NDC 62756-202-04 800 mg tablets; White to off white, biconvex, oval shaped, film-coated tablet scored on both sides and debossed with “204” on one side, available in: Bottles of 100: Child Resistant Cap ------------------------------------------ NDC 62756-204-01 Non Child Resistant Cap ------------------------------------ NDC 62756-204-02 Bottles of 500: Non Child Resistant Cap ------------------------------------ NDC 62756-204-03 Unit dose 50’s: --------------------------------------------------------------------- NDC 62756-204-04 Storage Store at 20° to 25°C (68 to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [See USP Controlled Room Temperature].

Status de autorização:

Abbreviated New Drug Application

Folheto informativo - Bula

GABAPENTIN- GABAPENTIN CAPSULE
Direct Rx
----------
SPL MEDGUIDE SECTION
Gabapentin Capsules, USP
Gabapentin Tablets, USP
(GA ba 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 provider may check for

Características técnicas

GABAPENTIN- GABAPENTIN CAPSULE
DIRECT RX
----------
GABAPENTIN
INFORMATION FOR PATIENTS SECTION
These highlights do not include all the information needed to use
GABAPENTIN safely and
effectively. See full prescribing information for GABAPENTIN.
GABAPENTIN capsules, for oral use
GABAPENTIN tablets, 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 1,800 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: 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 have gained
sufficient experience with
gabapentin to assess whether it will impair their ability to drive
(5.2)
Somnolence/Sedation and Di