TID = Three times a day; BID = Two times a day; QD = Single daily dose | ||||||
Renal Function Creatinine Clearance (mL/min) |
Total Daily Dose Range (mg/day) |
Dose Regimen (mg) |
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≥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 |
15 |
100 to 300 | 100 QD | 125 QD | 150 QD | 200 QD | 300 QD |
Post-Hemodialysis Supplemental Dose (mg) |
||||||
Hemodialysis | 125 |
150 |
200 |
250 |
350 |
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 | 1.0 | 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 |
Gabapentin N=336 % |
Placebo N=227 % |
|
|
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Asthenia | 6 | 5 |
Infection | 5 | 4 |
Accidental injury | 3 | 1 |
|
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Diarrhea | 6 | 3 |
Dry mouth | 5 | 1 |
Constipation | 4 | 2 |
Nausea | 4 | 3 |
Vomiting | 3 | 2 |
|
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Peripheral edema | 8 | 2 |
Weight gain | 2 | 0 |
Hyperglycemia | 1 | 0 |
|
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Dizziness | 28 | 8 |
Somnolence | 21 | 5 |
Ataxia | 3 | 0 |
Abnormal thinking | 3 | 0 |
Abnormal gait | 2 | 0 |
Incoordination | 2 | 0 |
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Pharyngitis | 1 | 0 |
|
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Amblyopia |
3 | 1 |
Conjunctivitis | 1 | 0 |
Diplopia | 1 | 0 |
Otitis media | 1 | 0 |
Gabapentin N=543 % |
Placebo N=378 % |
|
|
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Fatigue | 11 | 5 |
Increased Weight | 3 | 2 |
Back Pain | 2 | 1 |
Peripheral Edema | 2 | 1 |
|
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Vasodilatation | 1 | 0 |
|
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Dyspepsia | 2 | 1 |
Dry Mouth or Throat | 2 | 1 |
Constipation | 2 | 1 |
Dental Abnormalities | 2 | 0 |
|
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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 |
|
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Pharyngitis | 3 | 2 |
Coughing | 2 | 1 |
|
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Abrasion | 1 | 0 |
|
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Impotence | 2 | 1 |
|
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Diplopia | 6 | 2 |
Amblyopia |
4 | 1 |
Gabapentin N=119 % |
Placebo N=128 % |
|
---|---|---|
|
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Viral Infection | 11 | 3 |
Fever | 10 | 3 |
Increased Weight | 3 | 1 |
Fatigue | 3 | 2 |
|
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Nausea and/or Vomiting | 8 | 7 |
|
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Somnolence | 8 | 5 |
Hostility | 8 | 2 |
Emotional Lability | 4 | 2 |
Dizziness | 3 | 2 |
Hyperkinesia | 3 | 1 |
|
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Bronchitis | 3 | 1 |
Respiratory Infection | 3 | 1 |
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Study | Study Duration | Gabapentin (mg/day) Target Dose |
Patients Receiving Gabapentin |
Patients Receiving Placebo |
1 | 8 weeks | 3600 | 113 | 116 |
2 | 7 weeks | 1800, 2400 | 223 | 111 |
Total | 336 | 227 |