GABAPENTIN capsule

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

Preferred Pharmaceuticals, Inc.

INN (Isem Internazzjonali):

GABAPENTIN

Kompożizzjoni:

GABAPENTIN 400 mg

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

Gabapentin is 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. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), such as gabapentin, during pregnancy. Encourage women who are taking gabapentin during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling the toll free number 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/. Risk Summary There are no adequate data on the developmental risks associated with the use of gabapentin in pregnant women. In nonclinical studies in mice, rats, and rabbits, gabapentin was developmentally toxic (increased fetal skeletal

Sommarju tal-prodott:

Gabapentin Capsules USP are supplied as follows: 400 mg capsules: Orange hard gelatin capsules imprinted “214” on body with blue ink, available in: Bottles of 30 - 68788-9509-3 Bottle of 60 - 68788-9509-6 Bottle of 90 - 68788-9509-9 Bottle of 100 - 68788-9509-1 Bottle of 120 - 68788-9509-8 Storage   Store at 20° to 25°C (68° to 77°F); [see USP Controlled Room Temperature]. 

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Fuljett ta 'informazzjoni

GABAPENTIN- GABAPENTIN CAPSULE
Preferred Pharmaceuticals, Inc.
----------
MEDICATION GUIDE
Gabapentin Capsules USP
(GA ba PEN tin)
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 other
causes.
2. Changes in behavior and thinking -Using gabapentin in children 3 to
12 years of age can cause
emotional changes, aggressive behavior, problems with concentration,
restlessn

Karatteristiċi tal-prodott

GABAPENTIN- GABAPENTIN CAPSULE
PREFERRED PHARMACEUTICALS, INC.
----------
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, Respiratory Depression (5.7) 4/2020
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
•
•
•
DOSAGE FORMS AND STRENGTHS
•
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 their ability to drive
or operate heavy machinery will be
impaired (5.3, 5.4)
• Increased seizure frequency may occur in patients with seizure
disorders if gabapentin is abruptly
discontinued (5.5)
• Suicidal Behavior and Ideation: Monitor for suicidal
thoughts/behavior (5.6)
• Respiratory Depression: May occur with gabapentin when used with
concomitant central nervous system
(CNS) depressants, including opioids, or in the setting of underlying
respiratory impairment. Monitor
patients and adjust dosage as appropriate (5.7)
• Neuropsychiatric Adverse Reactions in Children 3 to 12 Years of
Age: Monitor for such events (5.8)
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 m