Levetiracetam Tablets | Levetiracetam
Absorption of levetiracetam is rapid, with peak plasma concentrations occurring in about an hour following oral administration in fasted subjects. The oral bioavailability of levetiracetam tablets is 100% and the tablets and oral solution are bioequivalent in rate and extent of absorption. Food does not affect the extent of absorption of levetiracetam but it decreases C by 20% and delays T by 1.5 hours. The pharmacokinetics of levetiracetam are linear over the dose range of 500 to 5000 mg. Steady state is achieved after 2 days of multiple twice-daily dosing. Levetiracetam and its major metabolite are less than 10% bound to plasma proteins; clinically significant interactions with other drugs through competition for protein binding sites are therefore unlikely.
| * statistically significant versus placebo |
|||
| Placebo (N=95) |
Levetiracetam 1000 mg/day (N=97) |
Levetiracetam 3000 mg/day (N=101) |
|
| Percent reduction in partial seizure frequency over placebo |
– |
26.1%* |
30.1%* |
The comparison of levetiracetam 2000 mg/day to levetiracetam 1000 mg/day for responder rate was statistically significant (P=0.02). Analysis of the trial as a cross-over yielded similar results.
| * statistically significant versus placebo |
|||
| Placebo (N=111) |
Levetiracetam 1000 mg/day (N=106) |
Levetiracetam 2000 mg/day (N=105) |
|
| Percent reduction in partial seizure frequency over placebo |
– |
17.1%* |
21.4%* |
| * statistically significant versus placebo |
||
| |
Placebo (N=104) |
Levetiracetam 3000 mg/day (N=180) |
| Percent reduction in partial seizure frequency over placebo |
– |
23%* |
| * statistically significant versus placebo |
||
| |
Placebo (N=97) |
Levetiracetam (N=101) |
| Percent reduction in partial seizure frequency over placebo |
- |
26.8%* |
| 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 |
| Body System/ Adverse Event |
Levetiracetam (N=769) % |
Placebo (N=439) % |
|---|---|---|
|
Body as a Whole
|
|
|
| Asthenia |
15 |
9 |
| Headache |
14 |
13 |
| Infection |
13 |
8 |
| Pain |
7 |
6 |
|
Digestive System
|
||
| Anorexia |
3 |
2 |
|
Nervous System
|
||
| Somnolence |
15 |
8 |
| Dizziness |
9 |
4 |
| Depression |
4 |
2 |
| Nervousness |
4 |
2 |
| Ataxia |
3 |
1 |
| Vertigo |
3 |
1 |
| Amnesia |
2 |
1 |
| Anxiety |
2 |
1 |
| Hostility |
2 |
1 |
| Paresthesia |
2 |
1 |
| Emotional Lability |
2 |
0 |
|
Respiratory System
|
||
| Pharyngitis |
6 |
4 |
| Rhinitis |
4 |
3 |
| Cough Increased |
2 |
1 |
| Sinusitis |
2 |
1 |
|
Special Senses
|
|
|
| Diplopia |
2 |
1 |
| Body System/ Adverse Event |
Levetiracetam (N=101) % |
Placebo (N=97) % |
|---|---|---|
|
Body as a Whole
|
|
|
| Accidental Injury |
17 |
10 |
| Asthenia |
9 |
3 |
| Pain |
6 |
3 |
| Flu Syndrome |
3 |
2 |
| Face Edema |
2 |
1 |
| Neck Pain |
2 |
1 |
| Viral Infection |
2 |
1 |
|
Digestive System
|
||
| Vomiting |
15 |
13 |
| Anorexia |
13 |
8 |
| Diarrhea |
8 |
7 |
| Gastroenteritis |
4 |
2 |
| Constipation |
3 |
1 |
|
Hemic and Lymphatic System
|
||
| Ecchymosis |
4 |
1 |
|
Metabolic and Nutritional
|
||
| Dehydration |
2 |
1 |
|
Nervous System
|
||
| Somnolence |
23 |
11 |
| Hostility |
12 |
6 |
| Nervousness |
10 |
2 |
| Personality Disorder |
8 |
7 |
| Dizziness |
7 |
2 |
| Emotional Lability |
6 |
4 |
| Agitation |
6 |
1 |
| Depression |
3 |
1 |
| Vertigo |
3 |
1 |
| Reflexes Increased |
2 |
1 |
| Confusion |
2 |
0 |
|
Respiratory System
|
||
| Rhinitis |
13 |
8 |
| Cough Increased |
11 |
7 |
| Pharyngitis |
10 |
8 |
| Asthma |
2 |
1 |
|
Skin and Appendages
|
||
| Pruritus |
2 |
0 |
| Skin Discoloration |
2 |
0 |
| Vesiculobullous Rash |
2 |
0 |
|
Special Senses
|
||
| Conjunctivitis |
3 |
2 |
| Amblyopia |
2 |
0 |
| Ear Pain |
2 |
0 |
|
Urogenital System
|
||
| Albuminuria |
4 |
0 |
| Urine Abnormality |
2 |
1 |
| |
Number (%) |
|
| Levetiracetam (N=769) |
Placebo (N=439) |
|
| Asthenia |
10 (1.3%) |
3 (0.7%) |
| Convulsion |
23 (3%) |
15 (3.4%) |
| Dizziness |
11 (1.4%) |
0 |
| Rash |
0 |
5 (1.1%) |
| Somnolence |
34 (4.4%) |
7 (1.6%) |
| |
Number (%) |
|
| Levetiracetam (N=101) |
Placebo (N=97) |
|
| Asthenia |
3 (3%) |
0 |
| Hostility |
7 (6.9%) |
2 (2.1%) |
| Somnolence |
3 (3%) |
3 (3.1%) |
| Patient Weight |
Daily Dose |
||
| 20 mg/kg/day (BID dosing) |
40 mg/kg/day (BID dosing) |
60 mg/kg/day (BID dosing) |
|
| 20.1-40 kg |
500 mg/day (1 x 250 mg tablet BID) |
1000 mg/day (1 x 500 mg tablet BID) |
1500 mg/day (1 x 750 mg tablet BID) |
| >40 kg |
1000 mg/day (1 x 500 mg tablet BID) |
2000 mg/day (2 x 500 mg tablets BID) |
3000 mg/day (2 x 750 mg tablets BID) |
|
1 Following dialysis, a 250 to 500 mg supplemental dose is recommended. |
|||
| Group |
Creatinine Clearance (mL/min) |
Dosage (mg) |
Frequency |
| Normal |
> 80 |
500 to 1,500 |
Every 12 h |
| Mild |
50 – 80 |
500 to 1,000 |
Every 12 h |
| Moderate |
30 – 50 |
250 to 750 |
Every 12 h |
| Severe |
< 30 |
250 to 500 |
Every 12 h |
| ESRD patients using dialysis |
---- |
500 to 1,000 |
1Every 24 h |
Manufacturer
Greenstone LLC
Active Ingredients
Source
- U.S. National Library of Medicine
- DailyMed
- Last Updated: 4 May 2013
Drugs and Medications
Levetiracetam [Mutual Pharmaceutical Company, Inc.]
These highlights do not include all the information needed to use extended-release levetiracetam tablets safely and effectively. See full prescribing information for extended-release levetiracetam tab...
Levetiracetam [Lupin Pharmaceuticals, Inc]
Levetiracetam Tablets 1000 mg
Levetiracetam [Actavis Mid Atlantic LLC]
Levetiracetam Oral Solution 100 mg/mL
Levetiracetam [American Health Packaging]
Levetiracetam Tablets 1000 mg
Levetiracetam [VistaPharm, Inc]
LEVETIRACETAM ORAL SOLUTION 100 mg/mL
Clinical Trials
Levetiracetam for Treatment of Pain Associated With Fibromyalgia
The purpose of this study is to assess the safety and effectiveness of levetiracetam in reducing the pain of fibromyalgia when compared to placebo. Levetiracetam, an anti-seizure drug, is...
Safety Study Of Intravenous Levetiracetam
The test article for this study is levetiracetam (Keppra, which is commercially available. Keppra is indicated for use as adjunctive therapy in the treatment of partial onset seizure disor...
For ethical reasons to give opportunity for adult subjects (≥16 or 18 years) suffering from newly diagnosed epilepsy who completed the therapeutic confirmatory, open-label trial N01175 (...
Safety and Tolerability Study of Levetiracetam to Treat Patients With Status Epilepticus
The purpose of this study is to determine whether levetiracetam is safe and well tolerated by patients while suffering a status epilepticus. Levetiracetam is added to the standard treatmen...
A Bioequivalence Study of Levetiracetam Versus Keppra
The purpose of this study is to assess the bioequivalence of Levetiracetam versus Keppra administered under fasting conditions to healthy adult subjects.
PubMed Articles
A case of levetiracetam-induced thrombocytopenia.
Rare cases of levetiracetam-induced thrombocytopenia have been reported in the literature. We report a case of glioblastoma multiforme and partial epilepsy treated with levetiracetam with subsequent d...
Levetiracetam-induced acute generalized exanthematous pustulosis.
Abstract Antiepileptic drugs have been associated with many adverse effects, including different types of rashes; however, the frequency of rash varies among the drugs. The most common adverse effects...
Several new antiepileptic drugs (AEDs) have been introduced for clinical use recently. These new AEDs, like the classic AEDs, target multiple cellular sites both pre- and postsynaptically. The use of...
The effectiveness of levetiracetam in the treatment of neuropathic pain.
INTRODUCTION. Pharmacological treatment is the first that should be taken into account in dealing with neuropathic pain, antiepileptic drugs being one of the leading options. Levetiracetam is a state...
Intramuscular and intravenous levetiracetam in humans: Safety and pharmacokinetics.
A study in dogs demonstrated that the commercially available formulation of IV levetiracetam (LEV) could be given safely IM and was quickly and completely absorbed. In this crossover study, 5 women an...
