GABAPENTIN- gabapentin tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Teva Pharmaceuticals USA, Inc.

INN (International Name):

GABAPENTIN

Composition:

GABAPENTIN 600 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Gabapentin tablets are 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 s

Product summary:

Gabapentin Tablets USP, 600 mg are available as white, oval shaped tablets, debossed “Ivax hourglass logo” “4443”, with a partial score on one side and “600” on the other side containing 600 mg gabapentin, USP. NDC 0093-4443 -01 600 mg packaged in bottles of 100 tablets NDC 0093-4443 -05 600 mg packaged in bottles of 500 tablets NDC 0093-4443 -10 600 mg packaged in bottles of 1000 tablets Gabapentin Tablets USP, 800 mg are available as white, oval shaped tablets, debossed “Ivax hourglass logo” “4444”, with a partial score on one side and “800” on the other side containing 800 mg gabapentin, USP. NDC 0093-4444 -01 800 mg packaged in bottles of 100 tablets NDC 0093-4444 -05 800 mg packaged in bottles of 500 tablets Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

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 useInitial U.S. Approval: 1993

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GABAPENTIN-
gabapentin tablet  Teva Pharmaceuticals
USA, Inc.
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MEDICATION GUIDE
Gabapentin (GA-ba-PEN'-
tin) Tablets
What is the most important information
I should know about gabapentin tablets?
Do not stop taking gabapentin tablets
without first talking to your healthcare provider.
Stopping gabapentin tablets suddenly can cause serious
problems.
Gabapentin tablets can cause serious
side effects including:

Suicidal Thoughts. Like other
antiepileptic drugs, gabapentin tablets may cause suicidal
thoughts or actions in a very small number of people, about 1 in
500.

Read the complete document

Summary of Product characteristics

GABAPENTIN- GABAPENTIN TABLET
TEVA PHARMACEUTICALS USA, INC.
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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
INDICATIONS AND USAGE
Gabapentin tablets are indicated for:
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DOSAGE AND ADMINISTRATION
•
•
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DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Most common adverse reactions (incidence ≥8% and at least twice that
for placebo) were:
•
•
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)
Postherpetic Neuralgia (2.1)
o
o
o
o
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)
o
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
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)
Tablets: 600 mg, and 800 mg (3)
Known hypersensitivity to gabapentin or its ingredients (4)
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
immediate