|
|
|
DPN Pain (2.2) | 3 divided doses per day | 300 mg/day within 1 week |
PHN (2.3) | 2 or 3 divided doses per day | 300 mg/day within 1 week. Maximum dose of 600 mg/day. |
Adjunctive Therapy for Partial-Onset Seizures in Patients 17 Years of Age and Older (2.4) | 2 or 3 divided doses per day | Maximum dose of 600 mg/day. |
Fibromyalgia (2.5) | 2 divided doses per day | 300 mg/day within 1 week. Maximum dose of 450 mg/day. |
Neuropathic Pain Associated with Spinal Cord Injury (2.6) | 2 divided doses per day | 300 mg/day within 1 week. Maximum dose of 600 mg/day. |
|
|
|
|
Adults (17 years and older) |
150 mg/day |
600 mg/day |
2 or 3 divided doses |
|
|
|
|||
Greater than or equal to 60 |
150 |
300 |
450 |
600 |
BID or TID |
30 to 60 |
75 |
150 |
225 |
300 |
BID or TID |
15 to 30 |
25 to 50 |
75 |
100 to 150 |
150 |
QD or BID |
Less than 15 |
25 |
25 to 50 |
50 to 75 |
75 |
QD |
Supplementary dosage following hemodialysis (mg)†
|
|||||
Patients on the 25 mg QD regimen: take one supplemental dose of 25 mg or 50 mg Patients on the 25 to 50 mg QD regimen: take one supplemental dose of 50 mg or 75 mg Patients on the 50 to 75 mg QD regimen: take one supplemental dose of 75 mg or 100 mg Patients on the 75 mg QD regimen: take one supplemental dose of 100 mg or 150 mg |
|
|
|
|
|
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 |
|
|
|
|
|
|
|
---|---|---|---|---|---|---|
|
|
|
|
|
|
|
Asthenia |
4 |
2 |
4 |
7 |
5 |
2 |
Accidental injury |
5 |
2 |
2 |
6 |
4 |
3 |
Back pain |
0 |
2 |
1 |
2 |
2 |
0 |
Chest pain |
4 |
1 |
1 |
2 |
2 |
1 |
Face edema |
0 |
1 |
1 |
2 |
1 |
0 |
|
|
|
|
|
|
|
Dry mouth |
3 |
2 |
5 |
7 |
5 |
1 |
Constipation |
0 |
2 |
4 |
6 |
4 |
2 |
Flatulence |
3 |
0 |
2 |
3 |
2 |
1 |
|
|
|
|
|
|
|
Peripheral edema |
4 |
6 |
9 |
12 |
9 |
2 |
Weight gain |
0 |
4 |
4 |
6 |
4 |
0 |
Edema |
0 |
2 |
4 |
2 |
2 |
0 |
Hypoglycemia |
1 |
3 |
2 |
1 |
2 |
1 |
|
|
|
|
|
|
|
Dizziness |
8 |
9 |
23 |
29 |
21 |
5 |
Somnolence |
4 |
6 |
13 |
16 |
12 |
3 |
Neuropathy |
9 |
2 |
2 |
5 |
4 |
3 |
Ataxia |
6 |
1 |
2 |
4 |
3 |
1 |
Vertigo |
1 |
2 |
2 |
4 |
3 |
1 |
Confusion |
0 |
1 |
2 |
3 |
2 |
1 |
Euphoria |
0 |
0 |
3 |
2 |
2 |
0 |
Incoordination |
1 |
0 |
2 |
2 |
2 |
0 |
Thinking abnormal†
|
1 |
0 |
1 |
3 |
2 |
0 |
Tremor |
1 |
1 |
1 |
2 |
1 |
0 |
Abnormal gait |
1 |
0 |
1 |
3 |
1 |
0 |
Amnesia |
3 |
1 |
0 |
2 |
1 |
0 |
Nervousness |
0 |
1 |
1 |
1 |
1 |
0 |
|
|
|
|
|
|
|
Dyspnea |
3 |
0 |
2 |
2 |
2 |
1 |
|
|
|
|
|
|
|
Blurry vision‡
|
3 |
1 |
3 |
6 |
4 |
2 |
Abnormal vision |
1 |
0 |
1 |
1 |
1 |
0 |
|
|
|
|
|
|
|
---|---|---|---|---|---|---|
|
|
|
|
|
|
|
Infection |
14 |
8 |
6 |
3 |
7 |
4 |
Headache |
5 |
9 |
5 |
8 |
7 |
5 |
Pain |
5 |
4 |
5 |
5 |
5 |
4 |
Accidental injury |
4 |
3 |
3 |
5 |
3 |
2 |
Flu syndrome |
1 |
2 |
2 |
1 |
2 |
1 |
Face edema |
0 |
2 |
1 |
3 |
2 |
1 |
|
||||||
Dry mouth |
7 |
7 |
6 |
15 |
8 |
3 |
Constipation |
4 |
5 |
5 |
5 |
5 |
2 |
Flatulence |
2 |
1 |
2 |
3 |
2 |
1 |
Vomiting |
1 |
1 |
3 |
3 |
2 |
1 |
|
||||||
Peripheral edema |
0 |
8 |
16 |
16 |
12 |
4 |
Weight gain |
1 |
2 |
5 |
7 |
4 |
0 |
Edema |
0 |
1 |
2 |
6 |
2 |
1 |
|
||||||
Myasthenia |
1 |
1 |
1 |
1 |
1 |
0 |
|
|
|
|
|
|
|
Dizziness |
11 |
18 |
31 |
37 |
26 |
9 |
Somnolence |
8 |
12 |
18 |
25 |
16 |
5 |
Ataxia |
1 |
2 |
5 |
9 |
5 |
1 |
Abnormal gait |
0 |
2 |
4 |
8 |
4 |
1 |
Confusion |
1 |
2 |
3 |
7 |
3 |
0 |
Thinking abnormal†
|
0 |
2 |
1 |
6 |
2 |
2 |
Incoordination |
2 |
2 |
1 |
3 |
2 |
0 |
Amnesia |
0 |
1 |
1 |
4 |
2 |
0 |
Speech disorder |
0 |
0 |
1 |
3 |
1 |
0 |
|
||||||
Bronchitis |
0 |
1 |
1 |
3 |
1 |
1 |
|
||||||
Blurry vision‡
|
1 |
5 |
5 |
9 |
5 |
3 |
Diplopia |
0 |
2 |
2 |
4 |
2 |
0 |
Abnormal vision |
0 |
1 |
2 |
5 |
2 |
0 |
Eye Disorder |
0 |
1 |
1 |
2 |
1 |
0 |
|
||||||
Urinary Incontinence |
0 |
1 |
1 |
2 |
1 |
0 |
Preferred Term |
[N = 185] % |
[N = 90] % |
[N = 395] % |
[N = 670]† % |
[N = 294] % |
|
|||||
Accidental Injury | 7 | 11 | 10 | 9 | 5 |
Pain | 3 | 2 | 5 | 4 | 5 |
|
|||||
Increased Appetite | 2 | 3 | 6 | 5 | 1 |
Dry Mouth | 1 | 2 | 6 | 4 | 1 |
Constipation | 1 | 1 | 7 | 4 | 2 |
|
|||||
Weight Gain | 5 | 7 | 16 | 12 | 1 |
Peripheral Edema | 3 | 3 | 6 | 5 | 2 |
|
|||||
Dizziness | 18 | 31 | 38 | 32 | 11 |
Somnolence | 11 | 18 | 28 | 22 | 11 |
Ataxia | 6 | 10 | 20 | 15 | 4 |
Tremor | 3 | 7 | 11 | 8 | 4 |
Thinking Abnormal‡ | 4 | 8 | 9 | 8 | 2 |
Amnesia | 3 | 2 | 6 | 5 | 2 |
Speech Disorder | 1 | 2 | 7 | 5 | 1 |
Incoordination | 1 | 3 | 6 | 4 | 1 |
Abnormal Gait | 1 | 3 | 5 | 4 | 0 |
Twitching | 0 | 4 | 5 | 4 | 1 |
Confusion | 1 | 2 | 5 | 4 | 2 |
Myoclonus | 1 | 0 | 4 | 2 | 0 |
|
|||||
Blurred Vision§ | 5 | 8 | 12 | 10 | 4 |
Diplopia | 5 | 7 | 12 | 9 | 4 |
Abnormal Vision | 3 | 1 | 5 | 4 | 1 |
|
|
|
|
|
|
|
---|---|---|---|---|---|---|
|
||||||
Vertigo |
2 |
2 |
2 |
1 |
2 |
0 |
|
|
|
|
|
|
|
Vision blurred |
8 |
7 |
7 |
12 |
8 |
1 |
|
||||||
Dry mouth |
7 |
6 |
9 |
9 |
8 |
2 |
Constipation |
4 |
4 |
7 |
10 |
7 |
2 |
Vomiting |
2 |
3 |
3 |
2 |
3 |
2 |
Flatulence |
1 |
1 |
2 |
2 |
2 |
1 |
Abdominal distension |
2 |
2 |
2 |
2 |
2 |
1 |
|
||||||
Fatigue |
5 |
7 |
6 |
8 |
7 |
4 |
Edema peripheral |
5 |
5 |
6 |
9 |
6 |
2 |
Chest pain |
2 |
1 |
1 |
2 |
2 |
1 |
Feeling abnormal |
1 |
3 |
2 |
2 |
2 |
0 |
Edema |
1 |
2 |
1 |
2 |
2 |
1 |
Feeling drunk |
1 |
2 |
1 |
2 |
2 |
0 |
|
||||||
Sinusitis |
4 |
5 |
7 |
5 |
5 |
4 |
|
|
|
|
|
|
|
Weight increased |
8 |
10 |
10 |
14 |
11 |
2 |
|
||||||
Increased appetite |
4 |
3 |
5 |
7 |
5 |
1 |
Fluid retention |
2 |
3 |
3 |
2 |
2 |
1 |
|
||||||
Arthralgia |
4 |
3 |
3 |
6 |
4 |
2 |
Muscle spasms |
2 |
4 |
4 |
4 |
4 |
2 |
Back pain |
2 |
3 |
4 |
3 |
3 |
3 |
|
||||||
Dizziness |
23 |
31 |
43 |
45 |
38 |
9 |
Somnolence |
13 |
18 |
22 |
22 |
20 |
4 |
Headache |
11 |
12 |
14 |
10 |
12 |
12 |
Disturbance in attention |
4 |
4 |
6 |
6 |
5 |
1 |
Balance disorder |
2 |
3 |
6 |
9 |
5 |
0 |
Memory impairment |
1 |
3 |
4 |
4 |
3 |
0 |
Coordination abnormal |
2 |
1 |
2 |
2 |
2 |
1 |
Hypoesthesia |
2 |
2 |
3 |
2 |
2 |
1 |
Lethargy |
2 |
2 |
1 |
2 |
2 |
0 |
Tremor |
0 |
1 |
3 |
2 |
2 |
0 |
|
||||||
Euphoric Mood |
2 |
5 |
6 |
7 |
6 |
1 |
Confusional state |
0 |
2 |
3 |
4 |
3 |
0 |
Anxiety |
2 |
2 |
2 |
2 |
2 |
1 |
Disorientation |
1 |
0 |
2 |
1 |
2 |
0 |
Depression |
2 |
2 |
2 |
2 |
2 |
2 |
|
||||||
Pharyngolaryngeal pain |
2 |
1 |
3 |
3 |
2 |
2 |
Preferred term |
|
|
|
||
Vertigo | 2.7 | 1.1 |
|
||
Vision blurred | 6.6 | 1.1 |
|
||
Dry mouth | 11 | 2.9 |
Constipation | 8.2 | 5.7 |
Nausea | 4.9 | 4 |
Vomiting | 2.7 | 1.1 |
|
||
Fatigue | 11 | 4 |
Edema peripheral | 10.4 | 5.2 |
Edema | 8.2 | 1.1 |
Pain | 3.3 | 1.1 |
|
||
Nasopharyngitis | 8.2 | 4.6 |
|
||
Weight increased | 3.3 | 1.1 |
Blood creatine phosphokinase increased | 2.7 | 0 |
|
||
Muscular weakness | 4.9 | 1.7 |
Pain in extremity | 3.3 | 2.3 |
Neck pain | 2.7 | 1.1 |
Back pain | 2.2 | 1.7 |
Joint swelling | 2.2 | 0 |
|
||
Somnolence | 35.7 | 11.5 |
Dizziness | 20.9 | 6.9 |
Disturbance in attention | 3.8 | 0 |
Memory impairment | 3.3 | 1.1 |
Paresthesia | 2.2 | 0.6 |
|
||
Insomnia | 3.8 | 2.9 |
Euphoric mood | 2.2 | 0.6 |
|
||
Urinary incontinence | 2.7 | 1.1 |
|
||
Decubitus ulcer | 2.7 | 1.1 |
|
||
Hypertension | 2.2 | 1.1 |
Hypotension | 2.2 | 0 |
|
|
Hypoglycemics Glyburide, insulin, metformin |
Diuretics Furosemide |
Antiepileptic Drugs Tiagabine |
|
Antiepileptic Drugs Carbamazepine, lamotrigine, phenobarbital, phenytoin, topiramate, valproic acid |
|
|
|
|
|
|
|
|||||
Placebo |
BID |
100 |
9.5 |
0 |
|
50 mg/day |
BID |
88 |
10.3 |
-9 |
0.4230 |
150 mg/day |
BID |
86 |
8.8 |
-35 |
0.0001 |
300 mg/day |
BID |
90 |
9.8 |
-37 |
0.0001 |
600 mg/day |
BID |
89 |
9 |
-51 |
0.0001 |
|
|||||
Placebo |
TID |
96 |
9.3 |
1 |
|
150 mg/day |
TID |
99 |
11.5 |
-17 |
0.0007 |
600 mg/day |
TID |
92 |
12.3 |
-43 |
0.0001 |
|
|||||
Placebo |
BID/TID |
98 |
11 |
-1 |
|
600 mg/day |
BID |
103 |
9.5 |
-36 |
0.0001 |
600 mg/day |
TID |
111 |
10 |
-48 |
0.0001 |
|
|||
|
|
|
|
Placebo | 47.6 | (40,55.2) | |
PGB 300 | 68.1 | (60.9, 75.3) | |
PGB 450 | 77.8 | (71.5, 84) | |
PGB 600 | 66.1 | (59.1, 73.1) | |
PGB = Pregabalin |
|
|
|
|
o thoughts about suicide or dying | o trouble sleeping (insomnia) |
o attempts to commit suicide | o new or worse irritability |
o new or worse depression | o acting aggressive, being angry, or violent |
o new or worse anxiety | o acting on dangerous impulses |
o feeling agitated or restless | o an extreme increase in activity and talking (mania) |
o panic attacks | o other unusual changes in behavior or mood |
• dizziness | • weight gain | • trouble concentrating |
• blurry vision | • sleepiness | • swelling of hands and feet |
• dry mouth |