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Gabapentin

Blenheim Pharmacal, Inc.
Blenheim Pharmacal, Inc.

Gabapentin Capsules, USP


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

GABAPENTIN DESCRIPTION




9172
Gabapentin
a1a2

CLINICAL PHARMACOLOGY

Mechanism of Action






AB

In vitro

Pharmacokinetics and Drug Metabolism


Oral Bioavailability


max

Distribution


min

Elimination




Special Populations: Patients With Renal Insufficiency ,

DOSAGE AND ADMINISTRATION, Table 6

Special Populations

Adult Patients With Renal Insufficiency




DOSAGE AND ADMINISTRATION

Hemodialysis




DOSAGE AND ADMINISTRATION

Hepatic Disease


Age


PRECAUTIONS, Geriatric Use DOSAGE AND ADMINISTRATION

Pediatric






DOSAGE AND ADMINISTRATION

Gender


Race


Clinical Studies

Postherpetic Neuralgia



TABLE 1.  Controlled PHN Studies: Duration, Dosages, and Number of Patients
  Study  Study 
     Duration     		   Gabapentin (mg/day)a 
Target Dose		   Patients Receiving  
Gabapentin		   Patients Receiving   
Placebo
 a Given in 3 divided doses (TID)
1
 8 weeks
 3600
 113
 116
2
 7 weeks
 1800, 2400
 223
 111
 
 
Total
 336
 227







Gabapentin
Figure 1. Weekly Mean Pain Scores (Observed Cases in ITT Population): Study 1


Gabapentin
Figure 2.  Weekly Mean Pain Scores (Observed Cases in ITT Population): Study 2



Gabapentin
Figure 3. Proportion of Responders (patients with ≥50% reduction in pain score) at Endpoint: Controlled PHN Studies

Epilepsy

















Gabapentin
Figure 4. Responder Rate in Patients Receiving Gabapentin Expressed as a Difference from Placebo by Dose and Study: Adjunctive Therapy Studies in Patients ≥12 Years of Age with Partial Seizures







GABAPENTIN INDICATIONS AND USAGE

Postherpetic Neuralgia


Epilepsy


GABAPENTIN CONTRAINDICATIONS


WARNINGS


Suicidal Behavior and Ideation










TABLE 2. Risk by indication for antiepileptic drugs in the pooled analysis
   Indication    Placebo
Patients with
Events Per 1000
Patients		 Drug Patients
with Events
Per 1000
Patients		 Relative Risk:
Incidence of
Events in Drug
Patients/Incidence
in Placebo
Patients		 Risk Difference:
Additional
Drug Patients
with Events
Per
1000 Patients
  Epilepsy
 1
 3.4
 3.5
 2.4
  Psychiatric   
 5.7
 8.5
 1.5
 2.9
  Other
 1
 1.8
 1.9
 0.9
  Total
 2.4
 4.3
 1.8
 1.9





Neuropsychiatric Adverse Events—Pediatric Patients 3 to 12 years of age




Withdrawal Precipitated Seizure, Status Epilepticus





Tumorigenic Potential


in vivo PRECAUTIONS: Carcinogenesis, Mutagenesis, Impairment of Fertility

in situ

Sudden and Unexplained Death in Patients With Epilepsy




PRECAUTIONS

Information for Patients








Drug Interactions

PRECAUTIONS, Pregnancy

Laboratory Tests


Drug Interactions


In vitromax



























maxmax



PRECAUTIONS







max

®





Drug/Laboratory Test Interactions


®

Carcinogenesis, Mutagenesis, Impairment of Fertility




in vitro

in vitroin vivoin vitroin vitroin vivoin vivoin vivo

2

Pregnancy

Teratogenic effects


Pregnancy Category C.

22

2222

2

in utero

Nursing Mothers


Pediatric Use




CLINICAL PHARMACOLOGY, Clinical Studies

Geriatric Use






CLINICAL PHARMACOLOGY, ADVERSE REACTIONS, DOSAGE AND ADMINISTRATION

GABAPENTIN ADVERSE REACTIONS

Postherpetic Neuralgia




Incidence in Controlled Clinical Trials



TABLE 3. Treatment-Emergent Adverse Event Incidence in Controlled Trials in Postherpetic Neuralgia (Events in at least 1% of Gabapentin-Treated Patients and Numerically More Frequent Than in the Placebo Group)
a Reported as blurred vision
Body System/Preferred Term
      Gabapentin      
      N=336      
      %      
      Placebo      
      N=227      
      %      
 Body as a Whole
   Asthenia
5.7
 4.8
   Infection
5.1
 3.5
   Headache
3.3
 3.1
   Accidental injury
3.3
 1.3
   Abdominal pain
2.7
 2.6
 Digestive System
   Diarrhea
5.7
 3.1
   Dry mouth
4.8
 1.3
   Constipation
3.9
 1.8
   Nausea
3.9
 3.1
   Vomiting
3.3
 1.8
   Flatulence
2.1
 1.8
 Metabolic and
 Nutritional Disorders
   Peripheral edema
8.3
 2.2
   Weight gain
1.8
 0
   Hyperglycemia
1.2
 0.4
 Nervous System
   Dizziness
28
 7.5
   Somnolence
21.4
 5.3
   Ataxia
3.3
 0
   Thinking abnormal
2.7
 0
   Abnormal gait
1.5
 0
   Incoordination
1.5
 0
   Amnesia
1.2
 0.9
   Hypesthesia
1.2
 0.9
 Respiratory System
   Pharyngitis
1.2
 0.4
 Skin and Appendages
   Rash
1.2
 0.9
 Special Senses
   Amblyopiaa
2.7
 0.9
   Conjunctivitis
1.2
 0
   Diplopia
1.2
 0
   Otitis media
1.2
 0



Epilepsy


WARNINGS, Neuropsychiatric Adverse Events

Incidence in Controlled Clinical Trials





TABLE 4.  Treatment-Emergent Adverse Event Incidence in Controlled Add-On Trials In Patients >12 years of age (Events in at least 1% of Gabapentin patients and numerically more frequent than in the placebo group)
  Body System/Adverse Event         Gabapentina      
      N=543      
      %      		       Placeboa      
      N=378      
      %   
a Plus background antiepileptic drug therapy
b Amblyopia was often described as blurred vision.
 Body As A Whole
   Fatigue
11
 5
   Weight Increase
2.9
 1.6
   Back Pain
1.8
 0.5
   Peripheral Edema
1.7
 0.5
 Cardiovascular
   Vasodilatation
1.1
 0.3
 Digestive System
   Dyspepsia
2.2
 0.5
   Mouth or Throat Dry
1.7
 0.5
   Constipation
1.5
 0.8
   Dental Abnormalities
1.5
 0.3
   Increased Appetite
1.1
 0.8
 Hematologic and Lymphatic Systems
   Leukopenia
1.1
 0.5
 Musculoskeletal System
   Myalgia
2
 1.9
   Fracture
1.1
 0.8
 Nervous System
   Somnolence
19.3
 8.7
   Dizziness
17.1
 6.9
   Ataxia
12.5
 5.6
   Nystagmus
8.3
 4
   Tremor
6.8
 3.2
   Nervousness
2.4
 1.9
   Dysarthria
2.4
 0.5
   Amnesia
2.2
 0
   Depression
1.8
 1.1
   Thinking Abnormal
1.7
 1.3
   Twitching
1.3
 0.5
   Coordination Abnormal
1.1
 0.3
Respiratory System
   Rhinitis
4.1
 3.7
   Pharyngitis
2.8
 1.6
   Coughing
1.8
 1.3
 Skin and Appendages
   Abrasion
1.3
 0
   Pruritus
1.3
 0.5
 Urogenital System
   Impotence
1.5
 1.1
 Special Senses
   Diplopia
5.9
 1.9
   Amblyopiab
4.2
 1.1
 Laboratory Deviations
   WBC Decreased
1.1
 0.5








TABLE 5. Treatment-Emergent Adverse Event Incidence in Pediatric Patients Age 3 to 12 Years in a Controlled Add-On Trial (Events in at least 2% of Gabapentin patients and numerically more frequent than in the placebo group)
  Body System/Adverse Event        Gabapentina      
      N=119      
      %      		       Placeboa      
      N=128      
      %      
a Plus background antiepileptic drug therapy
 Body As A Whole
   Viral Infection
 10.9
 3.1
   Fever
 10.1
 3.1
   Weight Increase
 3.4
 0.8
   Fatigue
3.4
 1.6
 Digestive System
   Nausea and/or Vomiting
8.4
 7
 Nervous System
   Somnolence
 8.4
 4.7
   Hostility
 7.6
 2.3
   Emotional Lability
 4.2
 1.6
   Dizziness
 2.5
 1.6
   Hyperkinesia
2.5
 0.8
 Respiratory System
   Bronchitis
 3.4
 0.8
   Respiratory Infection
2.5
 0.8

Other events in more than 2% of pediatric patients 3 to 12 years of age but equally or more frequent in the placebo group included: pharyngitis, upper respiratory infection, headache, rhinitis, convulsions, diarrhea, anorexia, coughing, and otitis media.

Other Adverse Events Observed During All Clinical Trials

Clinical Trials in Adults and Adolescents (Except Clinical Trials in Neuropathic Pain)






Body As A Whole: Frequent: Infrequent: Rare:

Cardiovascular System: Frequent: Infrequent: Rare:

Digestive System: Frequent:Infrequent: Rare:

Endocrine System: Rare:

Hematologic and Lymphatic System: Frequent: Infrequent: Rare:

Musculoskeletal System: Frequent: Infrequent: Rare:

Nervous System: Frequent: Infrequent: Rare:

Respiratory System: Frequent:Infrequent: Rare:

Dermatological: Infrequent: Rare:

Urogenital System: Infrequent: Rare:

Special Senses: Frequent: Infrequent: Rare:

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






Body as a Whole: Infrequent:Rare:

Cardiovascular System: Infrequent:Rare:

Digestive System: Infrequent:Rare:

Endocrine System: Infrequent:

Hemic and Lymphatic System: Infrequent:Rare:

Metabolic and Nutritional: Infrequent:Rare:

Musculoskeletal: Infrequent:Rare:

Nervous System: Frequent:Infrequent:Rare:

Respiratory System: Infrequent:Rare:

Skin and Appendages: Infrequent: Rare:

Special Senses: Infrequent:Rare:

Urogenital System: Infrequent:Rare:, ,

Postmarketing and Other Experience





DRUG ABUSE AND DEPENDENCE


OVERDOSAGE






GABAPENTIN DOSAGE AND ADMINISTRATION




Postherpetic Neuralgia


Epilepsy


Patients >12 years of age


Pediatric Patients Age 3 to 12 years


CLINICAL PHARMACOLOGY, Pediatrics



Dosage in Renal Impairment


Cr

CrCr
CrCr

Cr


TABLE 6. Gabapentin Dosage Based on Renal Function
Renal Function
Creatinine Clearance
(mL/min)		 Total Daily
Dose Range
(mg/day)		 Dose Regimen (mg)
a For patients with creatinine clearance <15 mL/min, reduce daily dose in proportion to creatinine 
   clearance (e.g., patients with a creatinine clearance of 7.5 mL/min should receive one-half the 
   daily dose that patients with a creatinine clearance of 15 mL/min receive).
b Patients on hemodialysis should receive maintenance doses based on estimates of creatinine 
   clearance as indicated in the upper portion of the table and a supplemental post-hemodialysis dose 
   administered after each 4 hours of hemodialysis as indicated in the lower portion of the table.
≥60
 900-3600
 300 TID
 400 TID
 600 TID
 800 TID
 1200 TID
>30-59
 400-1400
 200 BID
 300 BID
 400 BID
 500 BID
 700 BID
>15-29
 200-700
 200 QD
 300 QD
 400 QD
 500 QD
 700 QD
15a
100-300
 100 QD
 125 QD
 150 QD
 200 QD
 300 QD
 
 
Post-Hemodialysis Supplemental Dose (mg)b
Hemodialysis
 125b
150b
200b
250b
350b
The use of gabapentin in patients <12 years of age with compromised renal function has not been studied.

Dosage in Elderly


HOW SUPPLIED


Gabapentin Capsules USP, 100 mg





Gabapentin Capsules USP, 300 mg





Gabapentin Capsules USP, 400 mg




Store at

®









10544-185-30 Bottle LabelGabapentin

Gabapentin

Gabapentin CAPSULE

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:10544-185(NDC:16714-661)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
GABAPENTIN GABAPENTIN 100 mg

Inactive Ingredients

Ingredient Name Strength
STARCH, CORN
talc
GELATIN
titanium dioxide
SODIUM LAURYL SULFATE
FERROSOFERRIC OXIDE
SHELLAC

Product Characteristics

Color Size Imprint Code Shape
white 16 mm D;02 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:10544-185-30 30 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078787 2010-10-08


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