GABAPENTIN capsule GABAPENTIN tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Gabapentin (UNII: 6CW7F3G59X) (Gabapentin - UNII:6CW7F3G59X)

Available from:

Apotex Corp.

INN (International Name):

GABAPENTIN

Composition:

GABAPENTIN 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 and

Product summary:

Tablets Gabapentin tablets, USP 100 mg are available for oral administration as white, oval film-coated tablets, engraved “G 100” on one side and “APO” on the other side; supplied in bottles of 30 (NDC 60505-2548-3), bottles of 100 (NDC 60505-2548-1) and bottles of 1,000 (NDC 60505-2548-8). Gabapentin tablets, USP 300 mg are available for oral administration as white, oval film-coated tablets, engraved “G 300” on one side and “APO” on the other side; supplied in bottles of 30 (NDC 60505-2549-3), bottles of 100 (NDC 60505-2549-1) and bottles of 1,000 (NDC 60505-2549-8). Gabapentin tablets, USP 400 mg are available for oral administration as white, oval film-coated tablets, engraved “G 400” on one side and “APO” on the other side; supplied in bottles of 30 (NDC 60505-2550-3), bottles of 100 (NDC 60505-2550-1) and bottles of 1,000 (NDC 60505-2550-8).  Storage Store gabapentin at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light resistant container [see USP]. * Maalox® is a registered trademark of Novartis Consumer Health Inc.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

GABAPENTIN- GABAPENTIN TABLET, FILM COATED
Apotex Corp.
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MEDICATION GUIDE
GABAPENTIN TABLETS, USP
(GAB-a-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,
restlessness, c

Summary of Product characteristics

GABAPENTIN- GABAPENTIN CAPSULE
GABAPENTIN- GABAPENTIN TABLET, FILM COATED
APOTEX CORP.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GABAPENTIN TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR GABAPENTIN TABLETS
GABAPENTIN TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1993
RECENT MAJOR CHANGES
Warnings and Precautions, Respiratory Depression (5.7) 04/2020
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
• 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
Tablets: 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 Dizzines