GABAPENTIN capsule

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Lake Erie Medical DBA Quality Care Products LLC

INN (nume internaţional):

GABAPENTIN

Compoziție:

GABAPENTIN 300 mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Gabapentin is indicated for: - 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 developmental toxicity in mice was 500 mg/kg/day or app

Rezumat produs:

Gabapentin capsules USP is supplied as follows: 100 mg capsules: White hard gelatin capsules imprinted “216” on body with blue ink, available in: 55700-544-30 55700-544-60 55700-544-90 55700-544-01 300 mg capsules : Yellow hard gelatin capsules imprinted “215” on body with blue ink, available in: 400 mg capsules: Orange hard gelatin capsules imprinted “214” on body with blue ink, available in: Storage Store at 20° to 25°C (68° to 77°F); [see USP Controlled Room Temperature].

Statutul autorizaţiei:

Abbreviated New Drug Application

Prospect

GABAPENTIN- GABAPENTIN CAPSULE
Lake Erie Medical DBA Quality Care Products LLC
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MEDICATION GUIDE
Gabapentin Capsules 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
tho

Caracteristicilor produsului

GABAPENTIN- GABAPENTIN CAPSULE
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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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
INDICATIONS AND USAGE
Gabapentin is indicated for:
· 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
· Epilepsy with Partial Onset Seizures (2.2)
o 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
o 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
gabapentin if an alternative etiology cannot be established (5.1)
· Anaphylaxis and Angioedema: discontinue gabapentin and evaluate
patient immediately (5.2)
· 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
(5.3)
· Somnolence/Sedation and Dizziness: gabapentin may impair the
patient’s ability to operate complex
machinery (5.4)
· Increased seizure frequency may occur in patients with se