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Gabapentin Capsules, USP | Gabapentin

05:46 EDT 27th August 2014 | BioPortfolio

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IMAGE gabapentin-str.jpgIMAGE gabapentin-fig1.jpgIMAGE gabapentin-fig2.jpgIMAGE gabapentin-fig3.jpg
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
IMAGE gabapentin-fig4.jpg
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
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

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.

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
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

Manufacturer

Blenheim Pharmacal, Inc.

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