GABAPENTIN  - gabapentin capsule 
NorthStar Rx LLC

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Gabapentin Capsules, USP

DESCRIPTION




9 17 2
Chemical Structure

a1 a2

CLINICAL PHARMACOLOGY

Mechanism of Action






A B

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)
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







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

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


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

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



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

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

Epilepsy

















Figure 4. Responder Rate in Patients Receiving Gabapentin Expressed as a Difference from Placebo by Dose and Study

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







INDICATIONS AND USAGE

Postherpetic Neuralgia


Epilepsy


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 vitro max



























max max



PRECAUTIONS







max

®





Drug/Laboratory Test Interactions


®

Carcinogenesis, Mutagenesis, Impairment of Fertility




in vitro

in vitro in vivo in vitro in vitro in vivo in vivo in vivo

2

Pregnancy

Teratogenic effects


Pregnancy Category C.

2 2

2 2 2 2

2

in utero

Nursing Mothers


Pediatric Use




CLINICAL PHARMACOLOGY, Clinical Studies

Geriatric Use






CLINICAL PHARMACOLOGY, ADVERSE REACTIONS, DOSAGE AND ADMINISTRATION

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






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

Cr Cr
Cr Cr

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

Dosage in Elderly


HOW SUPPLIED


Gabapentin Capsules USP, 100 mg





Gabapentin Capsules USP, 300 mg






Gabapentin Capsules USP, 400 mg





Store at


®









PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 400 mg (100 Capsule Bottle)


Rx only
NDC 16714-663-01
Gabapentin Capsules, USP
400 mg
100 Capsules
Northstar Rx LLC
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 400 mg (100 Capsule Bottle)

GABAPENTIN 
gabapentin   capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 16714-661
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GABAPENTIN (GABAPENTIN) GABAPENTIN 100 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN  
TALC  
GELATIN  
TITANIUM DIOXIDE  
SODIUM LAURYL SULFATE  
FERROSOFERRIC OXIDE  
SHELLAC  
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code D;02
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 16714-661-01 100 CAPSULE In 1 BOTTLE None
2 16714-661-02 500 CAPSULE In 1 BOTTLE None
3 16714-661-03 1000 CAPSULE In 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078787 01/31/2008

GABAPENTIN 
gabapentin   capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 16714-662
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GABAPENTIN (GABAPENTIN) GABAPENTIN 300 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN  
TALC  
GELATIN  
TITANIUM DIOXIDE  
SODIUM LAURYL SULFATE  
FERRIC OXIDE YELLOW  
FERROSOFERRIC OXIDE  
SHELLAC  
Product Characteristics
Color YELLOW Score no score
Shape CAPSULE Size 20mm
Flavor Imprint Code D;03
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 16714-662-01 100 CAPSULE In 1 BOTTLE None
2 16714-662-02 500 CAPSULE In 1 BOTTLE None
3 16714-662-03 1000 CAPSULE In 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078787 01/31/2008

GABAPENTIN 
gabapentin   capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 16714-663
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GABAPENTIN (GABAPENTIN) GABAPENTIN 400 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN  
TALC  
GELATIN  
TITANIUM DIOXIDE  
SODIUM LAURYL SULFATE  
FERRIC OXIDE YELLOW  
FERRIC OXIDE RED  
FERROSOFERRIC OXIDE  
SHELLAC  
Product Characteristics
Color ORANGE Score no score
Shape CAPSULE Size 22mm
Flavor Imprint Code D;04
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 16714-663-01 100 CAPSULE In 1 BOTTLE None
2 16714-663-02 500 CAPSULE In 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078787 01/31/2008

Labeler - NorthStar Rx LLC (830546433)
Registrant - Aurobindo Pharma Limited (650082092)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 918917642 MANUFACTURE
Revised: 12/2009 NorthStar Rx LLC