Gabapentin

INDICATIONS & USAGE

GABAPENTIN CONTRAINDICATIONS

WARNINGS

PRECAUTIONS

INFORMATION FOR PATIENTS

LABORATORY TESTS

DRUG INTERACTIONS

DRUG & OR LABORATORY TEST INTERACTIONS

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY

PREGNANCY

NURSING MOTHERS

PEDIATRIC USE

GERIATRIC USE

GABAPENTIN ADVERSE REACTIONS

Incidence in Controlled Clinical Trials
Table 3


Body System/ Preferred TermGabapentin N=336 %Placebo N=227 %**

Epilepsy
WARNINGS, Neuropsychiatric Adverse Events


Incidence in Controlled Clinical Trials
Table 4



Body System/ Adverse EventGabapentin*N=543 %Placebo*N=378 %*


Table 5


Body System/ Adverse EventGabapentin*N=119 %Placebo*N=128 %*

Other Adverse Events Observed During All Clinical Trials

Clinical Trials in Adults and Adolescents [Except Clinical Trials in Neuropathic Pain]
Table 4

Body As A Whole:
Cardiovascular System:
Digestive System:
Endocrine System:
Hematologic and Lymphatic System:
Musculoskeletal System:
Nervous System:
Respiratory System:
Dermatological:
Urogenital System:
Special Senses:

Clinical trials in Pediatric Patients With Epilepsy

Body as a Whole:
Digestive System:
Hemic and Lymphatic System:
Nervous System
Psychobiologic Function:
Respiratory System:

Clinical Trials in Adults With Neuropathic Pain of Various Etiologies
Table 3

Body as a Whole:
Cardiovascular System:
Digestive System:
Endocrine System:
Hemic and Lymphatic System
Metabolic and Nutritional: Infrequent:
Musculoskeletal:
Nervous System:
Respiratory System:
Skin and Appendages:
Special Senses:
Urogenital System:

Postmarketing and Other Experience

DRUG ABUSE AND DEPENDENCE

OVERDOSAGE

DOSAGE & ADMINISTRATION

Postherpetic Neuralgia


Epilepsy


Patients >12 years of age:

Pediatric Patients Age 3 to 12 years:CLINICAL PHARMACOLOGY, Pediatrics



Dosage in Renal Impairment







Renal Function Creatinine Clearance (mL/min)Total Daily Dose Range (mg/day)Dose Regimen (mg)**

Dosage in Elderly

HOW SUPPLIED

STORAGE AND HANDLING

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

Gabapentin Gabapentin TABLET Product Information Product Type Human prescription drug label Item Code (Source) NDC:49349-533(NDC:62756-204) Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GABAPENTIN GABAPENTIN 800 mg Inactive Ingredients Ingredient Name Strength mannitol hydroxypropyl cellulose HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED STARCH, CORN GLYCERYL BEHENATE talc MAGNESIUM STEARATE titanium dioxide HYPROMELLOSES polyethylene glycol 400 polysorbate 80 Product Characteristics Color Size Imprint Code Shape white 20 mm 204 OVAL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49349-533-20 100 in 1 CANISTER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077525 2011-09-23