Renal Function Creatinine Clearance (mL/min) |
Total Daily Dose Range (mg/day) |
Dose Regimen (mg) |
≥ 60 |
900 to 3600 |
300 TID 400 TID 600 TID 800 TID 1200 TID |
> 30 to 59 |
400 to 1400 |
200 BID 300 BID 400 BID 500 BID 700 BID |
> 15 to 29 |
200 to 700 |
200 QD 300 QD 400 QD 500 QD 700 QD |
15a
|
100 to 300 |
100 QD 125 QD 150 QD 200 QD 300 QD |
|
Post-Hemodialysis Supplemental Dose (mg)b
|
|
Hemodialysis |
125b 150b 200b 250b 350b |
Indication |
Placebo Patients with Events Per 1,000 Patients |
Drug Patients with Events Per 1,000 Patients |
Relative Risk: Incidence of Events in Drug Patients/Incidence in Placebo Patients |
Risk Difference: Additional Drug Patients with Events Per 1,000 Patients |
Epilepsy |
1.0 |
3.4 |
3.5 |
2.4 |
Psychiatric |
5.7 |
8.5 |
1.5 |
2.9 |
Other |
1.0 |
1.8 |
1.9 |
0.9 |
Total |
2.4 |
4.3 |
1.8 |
1.9 |
|
|
|
|
% |
% |
Body As A Whole |
|
|
Asthenia |
6 |
5 |
Infection |
5 |
4 |
Accidental injury |
3 |
1 |
Digestive System |
|
|
Diarrhea |
6 |
3 |
Dry mouth |
5 |
1 |
Constipation |
4 |
2 |
Nausea |
4 |
3 |
Vomiting |
3 |
2 |
Metabolic and Nutritional Disorder |
|
|
Peripheral edema |
8 |
2 |
Weight gain |
2 |
0 |
Hyperglycemia |
1 |
0 |
Nervous System |
|
|
Dizziness |
28 |
8 |
Somnolence |
21 |
5 |
Ataxia |
3 |
0 |
Abnormal thinking |
3 |
0 |
Abnormal gait |
2 |
0 |
Incoordination |
2 |
0 |
Respiratory System |
|
|
Pharyngitis |
1 |
0 |
Special Senses |
|
|
Amblyopiaa
|
3 |
1 |
Conjunctivitis |
1 |
0 |
Diplopia |
1 |
0 |
Otitis media |
1 |
0 |
a Reported as blurred vision |
|
Gabapentina N=543 % |
Placeboa
N=378 % |
Body as a Whole |
||
Fatigue |
11 |
5 |
Increased Weight |
3 |
2 |
Back Pain |
2 |
1 |
Peripheral Edema |
2 |
1 |
Cardiovascular |
||
Vasodilatation |
1 |
0 |
Digestive System |
||
Dyspepsia |
2 |
1 |
Dry Mouth or Throat |
2 |
1 |
Constipation |
2 |
1 |
Dental Abnormalities |
2 |
0 |
Nervous System |
||
Somnolence |
19 |
9 |
Dizziness |
17 |
7 |
Ataxia |
13 |
6 |
Nystagmus |
8 |
4 |
Tremor |
7 |
3 |
Dysarthria |
2 |
1 |
Amnesia |
2 |
0 |
Depression |
2 |
1 |
Abnormal thinking |
2 |
1 |
Abnormal coordination |
1 |
0 |
Respiratory System |
||
Pharyngitis |
3 |
2 |
Coughing |
2 |
1 |
Skin and Appendages |
||
Abrasion |
1 |
0 |
Urogenital System |
||
Impotence |
2 |
1 |
Special Senses |
||
Diplopia |
6 |
2 |
Amblyopiab |
4 |
1 |
|
Gabapentina N=119 % |
Placeboa
N=128 % |
Body as a Whole |
||
Viral Infection |
11 |
3 |
Fever |
10 |
3 |
Increased Weight |
3 |
1 |
Fatigue |
3 |
2 |
Digestive System |
||
Nausea and/or Vomiting |
8 |
7 |
Nervous System |
|
|
Somnolence |
8 |
5 |
Hostility |
8 |
2 |
Emotional Lability |
4 |
2 |
Dizziness |
3 |
2 |
Hyperkinesia |
3 |
1 |
Respiratory System |
|
|
Bronchitis |
3 |
1 |
Respiratory Infection |
3 |
1 |
Study |
Study Duration |
Gabapentin (mg/day)a Target Dose |
Patients Receiving Gabapentin |
Patients Receiving Placebo |
1 |
8 weeks |
3600 |
113 |
116 |
2 |
7 weeks |
1800, 2400 |
223 |
111 |
Total |
336 |
227 |