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:

Sun Pharmaceutical Industries, Inc.

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

Product summary:

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 (“2” on one side of score line and “02” on other side of score line), available in: Bottles of 100:    Child Resistant Cap ------------------------------------------ NDC 62756-202-01 Bottles of 500:    Non Child Resistant Cap------------------------------------ NDC 62756-202-03 800 mg tablets; White to off white, biconvex, oval shaped, film-coated tablet scored on both sides and debossed with “204” on one side (“2” on one side of score line and “04” on other side of score line), available in: Bottles of 100:    Child Resistant Cap ------------------------------------------ NDC 62756-204-01 Bottles of 500:    Non Child Resistant Cap ------------------------------------ NDC 62756-204-03 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].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

GABAPENTIN - GABAPENTIN CAPSULE
GABAPENTIN - GABAPENTIN TABLET, FILM COATED
Sun Pharmaceutical Industries, Inc.
----------
MEDICATION GUIDE
Dispense with Medication Guide available at:
https://www.sunpharma.com/usa/products
Gabapentin Capsules, USP
Gabapentin Tablets, 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 beh

Summary of Product characteristics

GABAPENTIN - GABAPENTIN CAPSULE
GABAPENTIN - GABAPENTIN TABLET, FILM COATED
SUN PHARMACEUTICAL INDUSTRIES, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GABAPENTIN CAPSULES
AND GABAPENTIN TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
GABAPENTIN CAPSULES AND GABAPENTIN TABLETS.
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 (2.1)
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 (2.2)
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 mg/kg/day 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 mg/kg/day 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)
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 if alternative etiology is not established (5.1)
Anaphylaxis and Angioedema: Discontinue and evaluate patient
imm