Gabapentin Tablets, USP | Gabapentin
| 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 tablets are contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients.
| 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 |
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.
| 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 |
| 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 |
| 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 |
| 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
|
|
Manufacturer
Aurobindo Pharma Limited
Active Ingredients
Source
- U.S. National Library of Medicine
- DailyMed
- Last Updated: 4 May 2013
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