Gabapentin by is a Prescription medication manufactured, distributed, or labeled by Blenheim Pharmacal, Inc.. Drug facts, warnings, and ingredients follow.
Study | Study Duration | Gabapentin (mg/day)a
Target Dose | Patients Receiving Gabapentin | Patients Receiving Placebo |
---|---|---|---|---|
a Given in 3 divided doses (TID) |
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1 | 8 weeks | 3600 | 113 | 116 |
2 | 7 weeks | 1800, 2400 | 223 | 111 |
| | Total | 336 | 227 |
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 |
a Reported as blurred vision |
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Body System/Preferred Term
| Gabapentin
N=336 % | Placebo
N=227 % |
Body as a Whole
|
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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
|
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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 |
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Peripheral edema | 8.3 | 2.2 |
Weight gain | 1.8 | 0 |
Hyperglycemia | 1.2 | 0.4 |
Nervous System
|
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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
|
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Pharyngitis | 1.2 | 0.4 |
Skin and Appendages
|
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Rash | 1.2 | 0.9 |
Special Senses
|
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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. |
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Body As A Whole
|
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Fatigue | 11 | 5 |
Weight Increase | 2.9 | 1.6 |
Back Pain | 1.8 | 0.5 |
Peripheral Edema | 1.7 | 0.5 |
Cardiovascular
|
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Vasodilatation | 1.1 | 0.3 |
Digestive System
|
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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
|
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Leukopenia | 1.1 | 0.5 |
Musculoskeletal System
|
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Myalgia | 2 | 1.9 |
Fracture | 1.1 | 0.8 |
Nervous System
|
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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
|
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Rhinitis | 4.1 | 3.7 |
Pharyngitis | 2.8 | 1.6 |
Coughing | 1.8 | 1.3 |
Skin and Appendages
|
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Abrasion | 1.3 | 0 |
Pruritus | 1.3 | 0.5 |
Urogenital System
|
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Impotence | 1.5 | 1.1 |
Special Senses
|
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Diplopia
| 5.9 | 1.9 |
Amblyopiab
| 4.2 | 1.1 |
Laboratory Deviations
|
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WBC Decreased
| 1.1 | 0.5 |
Body System/Adverse Event | Gabapentina
N=119 % | Placeboa
N=128 % |
---|---|---|
a Plus background antiepileptic drug therapy |
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Body As A Whole
|
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Viral Infection | 10.9 | 3.1 |
Fever | 10.1 | 3.1 |
Weight Increase | 3.4 | 0.8 |
Fatigue | 3.4 | 1.6 |
Digestive System
|
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Nausea and/or Vomiting | 8.4 | 7 |
Nervous System
|
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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
|
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Bronchitis | 3.4 | 0.8 |
Respiratory Infection | 2.5 | 0.8 |
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.
Renal Function Creatinine Clearance (mL/min) | Total Daily Dose Range (mg/day) | Dose Regimen (mg) | ||||
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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. |
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≥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
|
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Hemodialysis | 125b
| 150b
| 200b
| 250b
| 350b
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GABAPENTIN
gabapentin capsule |
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Labeler - Blenheim Pharmacal, Inc. (171434587) |
Registrant - Blenheim Pharmacal, Inc. (171434587) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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Blenheim Pharmacal, Inc. | 171434587 | repack |