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Gabapentin

Aidarex Pharmaceuticals LLC

Gabapentin Tablets, 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





max



min

Elimination



Special Populations: Patients With Renal Insufficiency ,

DOSAGE AND ADMINISTRATION

Special Populations

Adult Patients With Renal Insufficiency




DOSAGE AND ADMINISTRATION





DOSAGE AND ADMINISTRATION







PRECAUTIONS, Geriatric Use DOSAGE AND ADMINISTRATION

Pediatric






DOSAGE AND ADMINISTRATION







Clinical Studies





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






GabapentinFigure 1. Weekly Mean Pain Scores (Observed Cases in ITT Population): Study 1
GabapentinFigure 2. Weekly Mean Pain Scores (Observed Cases in ITT Population): Study 2


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


















GabapentinFigure 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


Gabapentin tablets are contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients.

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





Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity
 


PRECAUTIONS

Information for Patients








Drug Interactions

PRECAUTIONS, Pregnancy

p

Laboratory Tests


Drug Interactions


In vitromax



























maxmax



PRECAUTIONS







max

®





Drug/Laboratory Tests 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


Gabapentin is secreted into human milk following oral administration. A nursed infant could be exposed to a maximum dose of approximately 1 mg/kg/day of gabapentin. Because the effect on the nursing infant is unknown, gabapentin should be used in women who are nursing only if the benefits clearly outweigh the risks.

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)
Body System/Preferred Term Gabapentin
N=336
%		 Placebo
N=227
%
 a Reported as blurred vision
  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 Adverse Events Observed During All Clinical Trials







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:





Body as a Whole:

Digestive System:

Hemic and Lymphatic System:

Nervous System:

Psychobiologic Function:

Respiratory System:







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









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


Dosage in Elderly
 

HOW SUPPLIED

Gabapentin Tablets USP, 600 mg are white, biconvex, elliptical, film-coated tablets, with deep break line on both sides and debossed with ‘D’ and ‘24’ on either side of the break line on one side and plain on other side.
 
Bottles of 10     NDC 33261-051-10
Bottles of 20     NDC 33261-051-20
Bottles of 21     NDC 33261-051-21
Bottles of 30     NDC 33261-051-30
Bottles of 42     NDC 33261-051-42
Bottles of 45     NDC 33261-051-45
Bottles of 60     NDC 33261-051-60
Bottles of 81     NDC 33261-051-81
Bottles of 90     NDC 33261-051-90
Bottles of 100   NDC 33261-051-00
Bottles of 120   NDC 33261-051-02
Bottles of 126   NDC 33261-051-97
Bottles of 180   NDC 33261-051-99


 
Gabapentin Tablets USP, 800 mg are white, biconvex, elliptical, film-coated tablets, with deep break line on both sides and debossed with ‘D’ and ‘25’ on either side of the break line on one side and plain on other side.
 
Bottles of 10 NDC 33261-116-10
Bottles of 20 NDC 33261-116-20
Bottles of 21 NDC 33261-116-21
Bottles of 30 NDC 33261-116-30
Bottles of 42 NDC 33261-116-42
Bottles of 45 NDC 33261-116-45
Bottles of 60 NDC 33261-116-60
Bottles of 81 NDC 33261-116-81
Bottles of 90 NDC 33261-116-90
Bottles of 100 NDC 33261-116-00
Bottles of 120 NDC 33261-116-02
Bottles of 126 NDC 33261-116-97
Bottles of 180 NDC 33261-116-99
 
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
 
Maalox® is a registered trademark of Novartis Consumer Health, Inc. 
 
Manufactured for:
Aurobindo Pharma USA, Inc.
2400 Route 130 North
Dayton, NJ 08810
 
Manufactured by:
Aurobindo Pharma Limited
Unit-VII (SEZ)
Mahaboob Nagar (Dt)
AP-509302, INDIA

Repackaged By:
Aidarex Pharmaceuticals, LLC.
Corona, CA 92880
 
Issued: August 2011

MEDICATION GUIDE


Gabapentin Tablets, USP
Rx only



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.

Gabapentin tablets can cause serious side effects including:
 
1. Like other antiepileptic drugs, gabapentin tablets may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.

Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:
   
  • thoughts about suicide or dying
  • attempts to commit suicide
  • new or worse depression
  • new or worse anxiety
  • feeling agitated or restless
  • panic attacks
  • trouble sleeping (insomnia)
  • new or worse irritability
  • acting aggressive, being angry, or violent
  • acting on dangerous impulses
  • an extreme increase in activity and talking (mania)
  • other unusual changes in behavior or mood

How can I watch for early symptoms of suicidal thoughts and actions?
 
  • Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
  • Keep all follow-up visits with your healthcare provider as scheduled.



Do not stop taking gabapentin tablets without first talking to a healthcare provider.
  • Stopping gabapentin tablets suddenly can cause serious problems. Stopping a seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus).



2.  Changes in behavior and thinking

3.  Gabapentin tablets may cause a serious or life-threatening allergic reaction
  • skin rash
  • hives
  • fever
  • swollen glands that do not go away
  • swelling of your lip and tongue
  • yellowing of your skin or of the whites of the eyes
  • unusual bruising or bleeding
  • severe fatigue or weakness
  • unexpected muscle pain
  • frequent infections



What are gabapentin tablets?


  • Pain from damaged nerves (postherpetic pain) that follows healing of shingles (a painful rash that comes after a herpes zoster infection) in adults.
  • Partial seizures when taken together with other medicines in adults and children 3 years of age and older.

Who should not take gabapentin tablets?



What should I tell my healthcare provider before taking gabapentin tablets?
 
Before taking gabapentin tablets, tell your healthcare provider if you:
  • have or have had kidney problems or are on hemodialysis 
  • have or have had depression, mood problems, or suicidal thoughts or behavior
  • are pregnant or plan to become pregnant. It is not known if gabapentin tablets can harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking gabapentin tablets. You and your healthcare provider will decide if you should take gabapentin tablets while you are pregnant.
    • If you become pregnant while taking gabapentin tablets, talk to your healthcare provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of this registry is to collect information about the safety of antiepileptic drugs during pregnancy. You can enroll in this registry by calling 1-888-233-2334.  
  • are breastfeeding or plan to breastfeed. Gabapentin can pass into breast milk. You and your healthcare provider should decide how you will feed your baby while you take gabapentin tablets.

Tell your healthcare provider about all the medicines you take,





How should I take gabapentin tablets?
 
  • Take gabapentin tablets exactly as prescribed. Your healthcare provider will tell you how much gabapentin tablets to take.
    • Do not change your dose of gabapentin tablets without talking to your healthcare provider. If you break a tablet in half the unused half of the tablet should be taken at your next scheduled dose. Half tablets not used within several days of breaking should be thrown away.
  • Gabapentin tablets can be taken with or without food. If you take an antacid containing aluminum and magnesium, such as Maalox®, Mylanta®, Gelusil®, Gaviscon®, or Di-Gel®, you should wait at least 2 hours before taking your next dose of gabapentin tablets.
  • If you take too much gabapentin tablets, call your healthcare provider or your local Poison Control Center right away.

What should I avoid while taking gabapentin tablets?
  • Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking gabapentin tablets without first talking with your healthcare provider. Taking gabapentin tablets with alcohol or drugs that cause sleepiness or dizziness may make your sleepiness or dizziness worse.
  • Do not drive, operate heavy machinery, or do other dangerous activities until you know how gabapentin tablets affect you. Gabapentin tablets can slow your thinking and motor skills.

What are the possible side effects of gabapentin tablets?
 
  • See “What is the most important information I should know about gabapentin tablets?”
  • The most common side effects of gabapentin tablets include:
    • dizziness
    • difficulty with speaking
    • lack of coordination
    • temporary loss of memory (amnesia)
    • viral infection
    • tremor
    • feeling drowsy
    • difficulty with coordination
    • feeling tired
    • double vision
    • fever
    • unusual eye movement
    • jerky movements





Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store gabapentin tablets?
 
  • Store gabapentin tablets between 20° to 25°C (68° to 77°F).  

Keep gabapentin tablets and all medicines out of the reach of children.

General information about the safe and effective use of gabapentin tablets







What are the ingredients in gabapentin tablets?

Active ingredient:

Inactive ingredients:






Aurobindo Pharma USA, Inc.




Aurobindo Pharma Limited




PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 600 mg (100 Tablet Bottle)


Gabapentin

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 800 mg (100 Tablet Bottle)


Gabapentin

Gabapentin

Gabapentin TABLET, FILM COATED

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:33261-051(NDC:65862-523)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
GABAPENTIN GABAPENTIN 600 mg

Inactive Ingredients

Ingredient Name Strength
COPOVIDONE K25-31
STARCH, CORN
CROSPOVIDONE
HYDROXYPROPYL CELLULOSE (TYPE H)
MAGNESIUM STEARATE
cellulose, microcrystalline
talc

Product Characteristics

Color Size Imprint Code Shape
WHITE 17 mm D;24 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:33261-051-00 100 in 1 BOTTLE
2 NDC:33261-051-02 120 in 1 BOTTLE
3 NDC:33261-051-10 10 in 1 BOTTLE
4 NDC:33261-051-20 20 in 1 BOTTLE
5 NDC:33261-051-21 21 in 1 BOTTLE
6 NDC:33261-051-30 30 in 1 BOTTLE
7 NDC:33261-051-42 42 in 1 BOTTLE
8 NDC:33261-051-45 45 in 1 BOTTLE
9 NDC:33261-051-60 60 in 1 BOTTLE
10 NDC:33261-051-81 81 in 1 BOTTLE
11 NDC:33261-051-90 90 in 1 BOTTLE
12 NDC:33261-051-97 126 in 1 BOTTLE
13 NDC:33261-051-99 180 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200651 2011-10-06


Gabapentin

Gabapentin TABLET, FILM COATED

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:33261-116(NDC:65862-524)
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
COPOVIDONE K25-31
STARCH, CORN
CROSPOVIDONE
HYDROXYPROPYL CELLULOSE (TYPE H)
MAGNESIUM STEARATE
cellulose, microcrystalline
talc

Product Characteristics

Color Size Imprint Code Shape
WHITE 19 mm D;25 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:33261-116-00 100 in 1 BOTTLE
2 NDC:33261-116-02 120 in 1 BOTTLE
3 NDC:33261-116-10 10 in 1 BOTTLE
4 NDC:33261-116-20 20 in 1 BOTTLE
5 NDC:33261-116-21 21 in 1 BOTTLE
6 NDC:33261-116-30 30 in 1 BOTTLE
7 NDC:33261-116-42 42 in 1 BOTTLE
8 NDC:33261-116-45 45 in 1 BOTTLE
9 NDC:33261-116-60 60 in 1 BOTTLE
10 NDC:33261-116-81 81 in 1 BOTTLE
11 NDC:33261-116-90 90 in 1 BOTTLE
12 NDC:33261-116-97 126 in 1 BOTTLE
13 NDC:33261-116-99 180 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200651 2011-10-06


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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