Gabapentin description, usages, side effects, indications, overdosage, supplying and lots more!

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Gabapentin

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

GABAPENTIN DESCRIPTION




Gabapentin



CLINICAL PHARMACOLOGY







PHARMACOKINETICS






Special Populations:Patients With Renal Insufficiency
DOSAGE AND ADMINISTRATION, Table 6

DOSAGE AND ADMINISTRATION

DOSAGE AND ADMINISTRATION

PRECAUTIONS, Geriatric UseDOSAGE AND ADMINISTRATION


DOSAGE AND ADMINISTRATION






StudyStudyGabapentinPatients ReceivingPatients ReceivingDuration(mg/day)a TargetGabapentinPlaceboDoseTotal




Gabapentin


Gabapentin



Gabapentin











Gabapentin







INDICATIONS & USAGE

INDICATIONS & USAGE





GABAPENTIN CONTRAINDICATIONS

CONTRAINDICATIONS


WARNINGS


















PRECAUTIONS: Carcinogenesis, Mutagenesis, Impairment of Fertility





PRECAUTIONS





Drug Interactions
PRECAUTIONS, Pregnancy

LABORATORY TESTS




DRUG INTERACTIONS










PRECAUTIONS





DRUG & OR LABORATORY TEST INTERACTIONS




CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY







PREGNANCY






NURSING MOTHERS




PEDIATRIC USE



CLINICAL PHARMACOLOGY, Clinical Studies

GERIATRIC USE




CLINICAL PHARMACOLOGYADVERSE REACTIONSDOSAGE AND ADMINISTRATION

GABAPENTIN ADVERSE REACTIONS







Body System Preferred TermGabapentin CapsulesPlaceboPreferred TermN = 336N = 227%%Body as a WholeDigestive SystemMetabolic and Nutritional DisordersNervous SystemRespiratory SystemSkin and AppendagesSpecial Senses




WARNINGS, Neuropsychiatric Adverse Events





Body System /Gabapentin CapsulesaPlaceboaAdverse EventN = 543N = 378%%Body as a WholeCardiovascularDigestive SystemHematologic and Lymphatic SystemsMusculoskeletal SystemNervous SystemRespiratory SystemSkin and AppendagesUrogenital SystemSpecial SensesLaboratory Deviations







Body System/Gabapentin CapsulesaPlaceboaAdverse EventN = 119N = 128%%Body as a WholeDigestive SystemNervous SystemRespiratory System












































DRUG ABUSE AND DEPENDENCE

DRUG ABUSE AND DEPENDENCE


OVERDOSAGE

OVERDOSAGE




DOSAGE & ADMINISTRATION

DOSAGE & ADMINISTRATION







CLINICAL PHARMACOLOGY, Pediatrics
















HOW SUPPLIED

















STORAGE AND HANDLING











PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Gabapentin

Gabapentin

Gabapentin

Gabapentin CAPSULE

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-265(NDC:53746-103)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
GABAPENTIN GABAPENTIN 400 mg

Inactive Ingredients

Ingredient Name Strength
FERROSOFERRIC OXIDE
STARCH, CORN
D&C YELLOW NO. 10
FD&C BLUE NO. 2
FD&C RED NO. 40
GELATIN
mannitol
SHELLAC
propylene glycol
ferric oxide red
SILICON DIOXIDE
SODIUM LAURYL SULFATE
talc
titanium dioxide
FERRIC OXIDE YELLOW

Product Characteristics

Color Size Imprint Code Shape
brown 21 mm IP103 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-265-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078428 2011-03-31


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