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Levetiracetam
Overview
What is Levetiracetam?
Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (dark pink), and 1000 mg (white) tablets for oral administration.
The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is CHNO and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula:
Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.)
Levetiracetam tablets contain the labeled amount of levetiracetam. Inactive ingredients: copovidone, croscarmellose sodium, magnesium stearate, polyethylene glycol 3350, polysorbate 80, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide, and additional agents listed below:
250 mg tablets: FD&C Blue#2/Indigo Carmine Aluminum Lake 500 mg tablets: Iron Oxide Yellow 750 mg tablets: FD&C Red#40/Allura Red A C Aluminum Lake
What does Levetiracetam look like?
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What are the available doses of Levetiracetam?
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What should I talk to my health care provider before I take Levetiracetam?
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How should I use Levetiracetam?
Levetiracetam is indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy.
Levetiracetam is indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy.
Levetiracetam is indicated as adjunctive treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy.
Levetiracetam is indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy.
What interacts with Levetiracetam?
This product should not be administered to patients who have previously exhibited hypersensitivity to levetiracetam or any of the inactive ingredients in Levetiracetam tablets or oral solution.
What are the warnings of Levetiracetam?
Suicidal Behavior and Ideation
Antiepileptic drugs (AEDs), including Levetiracetam, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.
Pooled analyses of 199 placebo-controlled clinical trials (mono- and adjunctive therapy) of 11 different AEDs showed that patients randomized to one of the AEDs had approximately twice the risk (adjusted Relative Risk 1.8, 95% CI:1.2, 2.7) of suicidal thinking or behavior compared to patients randomized to placebo. In these trials, which had a median treatment duration of 12 weeks, the estimated incidence rate of suicidal behavior or ideation among 27,863 AED-treated patients was 0.43%, compared to 0.24% among 16,029 placebo-treated patients, representing an increase of approximately one case of suicidal thinking or behavior for every 530 patients treated. There were four suicides in drug-treated patients in the trials and none in placebo-treated patients, but the number is too small to allow any conclusion about drug effect on suicide.
The increased risk of suicidal thoughts or behavior with AEDs was observed as early as one week after starting drug treatment with AEDs and persisted for the duration of treatment assessed. Because most trials included in the analysis did not extend beyond 24 weeks, the risk of suicidal thoughts or behavior beyond 24 weeks could not be assessed.
The risk of suicidal thoughts or behavior was generally consistent among drugs in the data analyzed. The finding of increased risk with AEDs of varying mechanisms of action and across a range of indications suggests that the risk applies to all AEDs used for any indication. The risk did not vary substantially by age (5 to 100 years) in the clinical trials analyzed. Table 6 shows absolute and relative risk by indication for all evaluated AEDs.
The relative risk for suicidal thoughts or behavior was higher in clinical trials for epilepsy than in clinical trials for psychiatric or other conditions, but the absolute risk differences were similar for the epilepsy and psychiatric indications.
Anyone considering prescribing Levetiracetam or any other AED must balance the risk of suicidal thoughts or behaviors with the risk of untreated illness. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior. Should suicidal thoughts and behavior emerge during treatment, the prescriber needs to consider whether the emergence of these symptoms in any given patient may be related to the illness being treated.
Patients, their caregivers, and families should be informed that AEDs increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of the signs and symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers.
| 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 |
Neuropsychiatric Adverse Events
What are the precautions of Levetiracetam?
Hematologic Abnormalities
Hepatic Abnormalities
There were no meaningful changes in mean liver function tests (LFT) in controlled trials in adult or pediatric patients; lesser LFT abnormalities were similar in drug and placebo treated patients in controlled trials (1.4%). No adult or pediatric patients were discontinued from controlled trials for LFT abnormalities except for 1 (0.07%) adult epilepsy patient receiving open treatment.
Information For Patients
Patients and caregivers should be informed of the availability of a Medication Guide, and they should be instructed to read the Medication Guide prior to taking Levetiracetam.
Patients should be instructed to take Levetiracetam only as prescribed.
Patients, their caregivers, and families should be counseled that AEDs, including Levetiracetam, may increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers.
Patients should be advised that Levetiracetam may cause changes in behavior (e.g. aggression, agitation, anger, anxiety, apathy, depression, hostility, and irritability) and in rare cases patients may experience psychotic symptoms.
Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during therapy. Patients should be encouraged to enroll in the North American Antiepileptic Drug (NAAED) pregnancy registry if they become pregnant. This registry is collecting information about the safety of antiepileptic drugs during pregnancy. To enroll, patients can call the toll free number 1-888-233-2334. (see).
Patients should be advised that Levetiracetam may cause dizziness and somnolence. Accordingly, patients should be advised not to drive or operate machinery or engage in other hazardous activities until they have gained sufficient experience on Levetiracetam to gauge whether it adversely affects their performance of these activities.
Laboratory Tests
Although most laboratory tests are not systematically altered with Levetiracetam treatment, there have been relatively infrequent abnormalities seen in hematologic parameters and liver function tests.
Drug Interactions
In vitro
in vitro
Levetiracetam circulates largely unbound (<10% bound) to plasma proteins; clinically significant interactions with other drugs through competition for protein binding sites are therefore unlikely.
Potential pharmacokinetic interactions were assessed in clinical pharmacokinetic studies (phenytoin, valproate, oral contraceptive, digoxin, warfarin, probenecid) and through pharmacokinetic screening in the placebo-controlled clinical studies in epilepsy patients.
Carcinogenesis, Mutagenesis, Impairment Of Fertility
Rats were dosed with levetiracetam in the diet for 104 weeks at doses of 50, 300 and 1800 mg/kg/day. The highest dose corresponds to 6 times the maximum recommended daily human dose (MRHD) of 3000 mg on a mg/m basis and it also provided systemic exposure (AUC) approximately 6 times that achieved in humans receiving the MRHD. There was no evidence of carcinogenicity. A study was conducted in which mice received levetiracetam in the diet for 80 weeks at doses of 60, 240 and 960 mg/kg/day (high dose is equivalent to 2 times the MRHD on a mg/m or exposure basis). Although no evidence for carcinogenicity was seen, the potential for a carcinogenic response has not been fully evaluated in that species because adequate doses have not been studied.
Levetiracetam was not mutagenic in the Ames test or in mammalian cells in the Chinese hamster ovary/HGPRT locus assay. It was not clastogenic in an analysis of metaphase chromosomes obtained from Chinese hamster ovary cells or in an mouse micronucleus assay. The hydrolysis product and major human metabolite of levetiracetam (1-ethyl-2-oxo-pyrolidine acetic acid ) was not mutagenic in the Ames test or the mouse lymphoma assay.
No adverse effects on male or female fertility or reproductive performance were observed in rats at doses up to 1800 mg/kg/day (approximately 6 times the maximum recommended human dose on a mg/m or exposure basis).
Pregnancy
In animal studies, levetiracetam produced evidence of developmental toxicity at doses similar to or greater than human therapeutic doses.
Administration to female rats throughout pregnancy and lactation was associated with increased incidences of minor fetal skeletal abnormalities and retarded offspring growth pre- and/or postnatally at doses ≥350 mg/kg/day (approximately equivalent to the maximum recommended human dose of 3000 mg [MRHD] on a mg/m basis) and with increased pup mortality and offspring behavioral alterations at a dose of 1800 mg/kg/day (6 times the MRHD on a mg/m basis). The developmental no effect dose was 70 mg/kg/day (0.2 times the MRHD on a mg/m basis). There was no overt maternal toxicity at the doses used in this study.
Treatment of pregnant rabbits during the period of organogenesis resulted in increased embryofetal mortality and increased incidences of minor fetal skeletal abnormalities at doses ≥600 mg/kg/day (approximately 4 times MRHD on a mg/m basis) and in decreased fetal weights and increased incidences of fetal malformations at a dose of 1800 mg/kg/day (12 times the MRHD on a mg/m basis). The developmental no effect dose was 200 mg/kg/day (1.3 times the MRHD on a mg/m basis). Maternal toxicity was also observed at 1800 mg/kg/day.
When pregnant rats were treated during the period of organogenesis, fetal weights were decreased and the incidence of fetal skeletal variations was increased at a dose of 3600 mg/kg/day (12 times the MRHD). 1200 mg/kg/day (4 times the MRHD) was a developmental no effect dose. There was no evidence of maternal toxicity in this study.
Treatment of rats during the last third of gestation and throughout lactation produced no adverse developmental or maternal effects at doses of up to 1800 mg/kg/day (6 times the MRHD on a mg/m basis).
There are no adequate and well-controlled studies in pregnant women. Levetiracetam should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Pregnancy Registries
To provide information regarding the effects of in utero exposure to Levetiracetam, physicians are advised to recommend that pregnant patients taking Levetiracetam enroll in the North American Antiepileptic Drug (NAAED) pregnancy registry. This can be done by calling the toll free number 1-888-233-2334, and must be done by the patients themselves. Information on the registry can also be found at the website http://www.aedpregnancyregistry.org/.
To ensure broad program access and reach, either a healthcare provider or the patient can initiate enrolment in the North American Antiepileptic Drug Pregnancy Registry by calling (888) 233-2334 (toll free).
Labor And Delivery
The effect of Levetiracetam on labor and delivery in humans is unknown.
Nursing Mothers
Levetiracetam is excreted in breast milk. Because of the potential for serious adverse reactions in nursing infants from Levetiracetam, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric Use
Safety and effectiveness in patients below 4 years of age have not been established.
Studies of levetiracetam in juvenile rats (dosing from day 4 through day 52 of age) and dogs (dosing from week 3 through week 7 of age) at doses of up to 1800 mg/kg/day (approximately 7 and 24 times, respectively, the maximum recommended pediatric dose of 60 mg/kg/day on a mg/m basis) did not indicate a potential for age-specific toxicity.
Geriatric Use
Of the total number of subjects in clinical studies of levetiracetam, 347 were 65 and over. No overall differences in safety were observed between these subjects and younger subjects. There were insufficient numbers of elderly subjects in controlled trials of epilepsy to adequately assess the effectiveness of Levetiracetam in these patients.
A study in 16 elderly subjects (age 61 to 88 years) with oral administration of single dose and multiple twice-daily doses for 10 days showed no pharmacokinetic differences related to age alone.
Levetiracetam is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
Use In Patients With Impaired Renal Function
Clearance of levetiracetam is decreased in patients with renal impairment and is correlated with creatinine clearance. Caution should be taken in dosing patients with moderate and severe renal impairment and in patients undergoing hemodialysis. The dosage should be reduced in patients with impaired renal function receiving Levetiracetam and supplemental doses should be given to patients after dialysis (see and ).
What are the side effects of Levetiracetam?
The prescriber should be aware that the adverse event incidence figures in the following tables, obtained when Levetiracetam was added to concurrent AED therapy, cannot be used to predict the frequency of adverse experiences in the course of usual medical practice where patient characteristics and other factors may differ from those prevailing during clinical studies. Similarly, the cited frequencies cannot be directly compared with figures obtained from other clinical investigations involving different treatments, uses, or investigators. An inspection of these frequencies, however, does provide the prescriber with one basis to estimate the relative contribution of drug and non-drug factors to the adverse event incidences in the population studied.
Partial Onset Seizures
In well-controlled clinical studies in adults with partial onset seizures, the most frequently reported adverse events associated with the use of Levetiracetam in combination with other AEDs, not seen at an equivalent frequency among placebo-treated patients, were somnolence, asthenia, infection and dizziness. In the well-controlled pediatric clinical study in children 4 to 16 years of age with partial onset seizures, the adverse events most frequently reported with the use of Levetiracetam in combination with other AEDs, not seen at an equivalent frequency among placebo-treated patients, were somnolence, accidental injury, hostility, nervousness, and asthenia.
Table 7 lists treatment-emergent adverse events that occurred in at least 1% of adult epilepsy patients treated with Levetiracetam participating in placebo-controlled studies and were numerically more common than in patients treated with placebo. Table 8 lists treatment-emergent adverse events that occurred in at least 2% of pediatric epilepsy patients (ages 4 to 16 years) treated with Levetiracetam participating in the placebo-controlled study and were numerically more common than in pediatric patients treated with placebo. In these studies, either Levetiracetam or placebo was added to concurrent AED therapy. Adverse events were usually mild to moderate in intensity.
Other events reported by at least 1% of adult Levetiracetam-treated patients but as or more frequent in the placebo group were the following: abdominal pain, accidental injury, amblyopia, arthralgia, back pain, bronchitis, chest pain, confusion, constipation, convulsion, diarrhea, drug level increased, dyspepsia, ecchymosis, fever, flu syndrome, fungal infection, gastroenteritis, gingivitis, grand mal convulsion, insomnia, nausea, otitis media, rash, thinking abnormal, tremor, urinary tract infection, vomiting and weight gain.
Other events occurring in at least 2% of pediatric Levetiracetam-treated patients but as or more frequent in the placebo group were the following: abdominal pain, allergic reaction, ataxia, convulsion, epistaxis, fever, headache, hyperkinesia, infection, insomnia, nausea, otitis media, rash, sinusitis, status epilepticus (not otherwise specified), thinking abnormal, tremor, and urinary incontinence.
| Body System/ Adverse Event | Levetiracetam(N=769)% | Placebo(N=439)% |
|---|---|---|
| Asthenia | 15 | 9 |
| Headache | 14 | 13 |
| Infection | 13 | 8 |
| Pain | 7 | 6 |
| Anorexia | 3 | 2 |
| 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 |
| Pharyngitis | 6 | 4 |
| Rhinitis | 4 | 3 |
| Cough Increased | 2 | 1 |
| Sinusitis | 2 | 1 |
| Diplopia | 2 | 1 | Body System/ Adverse Event | Levetiracetam(N=101)% | Placebo(N=97)% |
| 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 |
| Vomiting | 15 | 13 |
| Anorexia | 13 | 8 |
| Diarrhea | 8 | 7 |
| Gastroenteritis | 4 | 2 |
| Constipation | 3 | 1 |
| Ecchymosis | 4 | 1 |
| Dehydration | 2 | 1 |
| 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 |
| Rhinitis | 13 | 8 |
| Cough Increased | 11 | 7 |
| Pharyngitis | 10 | 8 |
| Asthma | 2 | 1 |
| Pruritus | 2 | 0 |
| Skin Discoloration | 2 | 0 |
| Vesiculobullous Rash | 2 | 0 |
| Conjunctivitis | 3 | 2 |
| Amblyopia | 2 | 0 |
| Ear Pain | 2 | 0 |
| Albuminuria | 4 | 0 |
| Urine Abnormality | 2 | 1 |
Myoclonic Seizures
Although the pattern of adverse events in this study seems somewhat different from that seen in patients with partial seizures, this is likely due to the much smaller number of patients in this study compared to partial seizure studies. The adverse event pattern for patients with JME is expected to be essentially the same as for patients with partial seizures.
In the well-controlled clinical study that included both adolescent (12 to 16 years of age) and adult patients with myoclonic seizures, the most frequently reported adverse events associated with the use of Levetiracetam in combination with other AEDs, not seen at an equivalent frequency among placebo-treated patients, were somnolence, neck pain, and pharyngitis.
Table 9 lists treatment-emergent adverse events that occurred in at least 5% of juvenile myoclonic epilepsy patients experiencing myoclonic seizures treated with Levetiracetam and were numerically more common than in patients treated with placebo. In this study, either Levetiracetam or placebo was added to concurrent AED therapy. Adverse events were usually mild to moderate in intensity.
Other events occurring in at least 5% of Levetiracetam-treated patients with myoclonic seizures but as or more frequent in the placebo group were the following: fatigue and headache.
| Vertigo | 5 | 3 |
| Pharyngitis | 7 | 0 |
| Influenza | 5 | 2 |
| Neck pain | 8 | 2 |
| Somnolence | 12 | 2 |
| Depression | 5 | 2 |
Time Course Of Onset Of Adverse Events For Partial Onset Seizures
Of the most frequently reported adverse events in adults experiencing partial onset seizures, asthenia, somnolence and dizziness appeared to occur predominantly during the first 4 weeks of treatment with Levetiracetam.
Discontinuation Or Dose Reduction In Well-Controlled Clinical Studies
In well-controlled adult clinical studies, 15.0% of patients receiving Levetiracetam and 11.6% receiving placebo either discontinued or had a dose reduction as a result of an adverse event. Table 10 lists the most common (>1%) adverse events that resulted in discontinuation or dose reduction.
In the well-controlled pediatric clinical study, 16.8% of patients receiving Levetiracetam and 20.6% receiving placebo either discontinued or had a dose reduction as a result of an adverse event. The adverse events most commonly associated (≥3% in patients receiving Levetiracetam) with discontinuation or dose reduction in the well-controlled study are presented in Table 11.
| Number (%) | ||
| Levetiracetam(N=769) | Placebo(N=439) | |
| Asthenia | 10 (1.3%) | 3 (0.7%) |
| Convulsion | 23 (3.0%) | 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%) | 0 |
| Hostility | 7 (6.9%) | 2 (2.1%) |
| Somnolence | 3 (3.0%) | 3 (3.1%) |
Myoclonic Seizures
In the placebo-controlled study, 8.3% of patients receiving Levetiracetam and 1.7% receiving placebo either discontinued or had a dose reduction as a result of an adverse event. The adverse events that led to discontinuation or dose reduction in the well-controlled study are presented in Table 12.
| Anxiety | 2 (3.3%) | 1 (1.7%) |
| Depressed mood | 1 (1.7%) | 0 |
| Depression | 1 (1.7%) | 0 |
| Diplopia | 1 (1.7%) | 0 |
| Hypersomnia | 1 (1.7%) | 0 |
| Insomnia | 1 (1.7%) | 0 |
| Irritability | 1 (1.7%) | 0 |
| Nervousness | 1 (1.7%) | 0 |
| Somnolence | 1 (1.7%) | 0 |
Comparison Of Gender, Age And Race
The overall adverse experience profile of Levetiracetam was similar between females and males. There are insufficient data to support a statement regarding the distribution of adverse experience reports by age and race.
Postmarketing Experience
In addition to the adverse experiences listed above, the following have been reported in patients receiving marketed Levetiracetam worldwide. The listing is alphabetized: abnormal liver function test, hepatic failure, hepatitis, leukopenia, neutropenia, pancreatitis, pancytopenia (with bone marrow suppression identified in some of these cases), thrombocytopenia, and weight loss. Alopecia has been reported with Levetiracetam use; recovery was observed in majority of cases where Levetiracetam was discontinued.
These adverse experiences have not been listed above, and data are insufficient to support an estimate of their incidence or to establish causation.
What should I look out for while using Levetiracetam?
This product should not be administered to patients who have previously exhibited hypersensitivity to levetiracetam or any of the inactive ingredients in Levetiracetam tablets or oral solution.
What might happen if I take too much Levetiracetam?
How should I store and handle Levetiracetam?
Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].Levetiracetam tablets are supplied as follows:Levetiracetam 250 mg tablets are blue, oblong-shaped, scored, film-coated tablets debossed with "OL" and "250" on one side. They are supplied in white HDPE BOTTLE, PLASTICs containing 120 tablets (NDC 67850-011-01).Levetiracetam 500 mg tablets are yellow, oblong-shaped, scored, film-coated tablets debossed with "OL" and "500" on one side. They are supplied in white HDPE BOTTLE, PLASTICs containing 120 tablets (NDC 67850-012-01).Levetiracetam 750 mg tablets are dark pink, oblong-shaped, scored, film-coated tablets debossed with "OL" and "750" on one side. They are supplied in white HDPE BOTTLE, PLASTICs containing 120 tablets (NDC 67850-013-01).Levetiracetam 1000 mg tablets are white, oblong-shaped, scored, film-coated tablets debossed with "OL" and "1000" on one side. They are supplied in white HDPE BOTTLE, PLASTICs containing 60 tablets (NDC 67850-014-02).Levetiracetam tablets are supplied as follows:Levetiracetam 250 mg tablets are blue, oblong-shaped, scored, film-coated tablets debossed with "OL" and "250" on one side. They are supplied in white HDPE BOTTLE, PLASTICs containing 120 tablets (NDC 67850-011-01).Levetiracetam 500 mg tablets are yellow, oblong-shaped, scored, film-coated tablets debossed with "OL" and "500" on one side. They are supplied in white HDPE BOTTLE, PLASTICs containing 120 tablets (NDC 67850-012-01).Levetiracetam 750 mg tablets are dark pink, oblong-shaped, scored, film-coated tablets debossed with "OL" and "750" on one side. They are supplied in white HDPE BOTTLE, PLASTICs containing 120 tablets (NDC 67850-013-01).Levetiracetam 1000 mg tablets are white, oblong-shaped, scored, film-coated tablets debossed with "OL" and "1000" on one side. They are supplied in white HDPE BOTTLE, PLASTICs containing 60 tablets (NDC 67850-014-02).Levetiracetam tablets are supplied as follows:Levetiracetam 250 mg tablets are blue, oblong-shaped, scored, film-coated tablets debossed with "OL" and "250" on one side. They are supplied in white HDPE BOTTLE, PLASTICs containing 120 tablets (NDC 67850-011-01).Levetiracetam 500 mg tablets are yellow, oblong-shaped, scored, film-coated tablets debossed with "OL" and "500" on one side. They are supplied in white HDPE BOTTLE, PLASTICs containing 120 tablets (NDC 67850-012-01).Levetiracetam 750 mg tablets are dark pink, oblong-shaped, scored, film-coated tablets debossed with "OL" and "750" on one side. They are supplied in white HDPE BOTTLE, PLASTICs containing 120 tablets (NDC 67850-013-01).Levetiracetam 1000 mg tablets are white, oblong-shaped, scored, film-coated tablets debossed with "OL" and "1000" on one side. They are supplied in white HDPE BOTTLE, PLASTICs containing 60 tablets (NDC 67850-014-02).Levetiracetam tablets are supplied as follows:Levetiracetam 250 mg tablets are blue, oblong-shaped, scored, film-coated tablets debossed with "OL" and "250" on one side. They are supplied in white HDPE BOTTLE, PLASTICs containing 120 tablets (NDC 67850-011-01).Levetiracetam 500 mg tablets are yellow, oblong-shaped, scored, film-coated tablets debossed with "OL" and "500" on one side. They are supplied in white HDPE BOTTLE, PLASTICs containing 120 tablets (NDC 67850-012-01).Levetiracetam 750 mg tablets are dark pink, oblong-shaped, scored, film-coated tablets debossed with "OL" and "750" on one side. They are supplied in white HDPE BOTTLE, PLASTICs containing 120 tablets (NDC 67850-013-01).Levetiracetam 1000 mg tablets are white, oblong-shaped, scored, film-coated tablets debossed with "OL" and "1000" on one side. They are supplied in white HDPE BOTTLE, PLASTICs containing 60 tablets (NDC 67850-014-02).Levetiracetam tablets are supplied as follows:Levetiracetam 250 mg tablets are blue, oblong-shaped, scored, film-coated tablets debossed with "OL" and "250" on one side. They are supplied in white HDPE BOTTLE, PLASTICs containing 120 tablets (NDC 67850-011-01).Levetiracetam 500 mg tablets are yellow, oblong-shaped, scored, film-coated tablets debossed with "OL" and "500" on one side. They are supplied in white HDPE BOTTLE, PLASTICs containing 120 tablets (NDC 67850-012-01).Levetiracetam 750 mg tablets are dark pink, oblong-shaped, scored, film-coated tablets debossed with "OL" and "750" on one side. They are supplied in white HDPE BOTTLE, PLASTICs containing 120 tablets (NDC 67850-013-01).Levetiracetam 1000 mg tablets are white, oblong-shaped, scored, film-coated tablets debossed with "OL" and "1000" on one side. They are supplied in white HDPE BOTTLE, PLASTICs containing 60 tablets (NDC 67850-014-02).
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
The precise mechanism(s) by which levetiracetam exerts its antiepileptic effect is unknown. The antiepileptic activity of levetiracetam was assessed in a number of animal models of epileptic seizures. Levetiracetam did not inhibit single seizures induced by maximal stimulation with electrical current or different chemoconvulsants and showed only minimal activity in submaximal stimulation and in threshold tests. Protection was observed, however, against secondarily generalized activity from focal seizures induced by pilocarpine and kainic acid, two chemoconvulsants that induce seizures that mimic some features of human complex partial seizures with secondary generalization. Levetiracetam also displayed inhibitory properties in the kindling model in rats, another model of human complex partial seizures, both during kindling development and in the fully kindled state. The predictive value of these animal models for specific types of human epilepsy is uncertain.
In vitro
in vivo
Levetiracetam at concentrations of up to 10 µM did not demonstrate binding affinity for a variety of known receptors, such as those associated with benzodiazepines, GABA (gamma-aminobutyric acid), glycine, NMDA (N-methyl-D-aspartate), re-uptake sites, and second messenger systems. Furthermore, studies have failed to find an effect of levetiracetam on neuronal voltage-gated sodium or T-type calcium currents and levetiracetam does not appear to directly facilitate GABAergic neurotransmission. However, studies have demonstrated that levetiracetam opposes the activity of negative modulators of GABA- and glycine-gated currents and partially inhibits N-type calcium currents in neuronal cells.
A saturable and stereoselective neuronal binding site in rat brain tissue has been described for levetiracetam. Experimental data indicate that this binding site is the synaptic vesicle protein SV2A, thought to be involved in the regulation of vesicle exocytosis. Although the molecular significance of levetiracetam binding to synaptic vesicle protein SV2A is not understood, levetiracetam and related analogs showed a rank order of affinity for SV2A which correlated with the potency of their antiseizure activity in audiogenic seizure-prone mice. These findings suggest that the interaction of levetiracetam with the SV2A protein may contribute to the antiepileptic mechanism of action of the drug.
Non-Clinical Toxicology
This product should not be administered to patients who have previously exhibited hypersensitivity to levetiracetam or any of the inactive ingredients in Levetiracetam tablets or oral solution.Levetiracetam circulates largely unbound (<10% bound) to plasma proteins; clinically significant interactions with other drugs through competition for protein binding sites are therefore unlikely.
Potential pharmacokinetic interactions were assessed in clinical pharmacokinetic studies (phenytoin, valproate, oral contraceptive, digoxin, warfarin, probenecid) and through pharmacokinetic screening in the placebo-controlled clinical studies in epilepsy patients.
The prescriber should be aware that the adverse event incidence figures in the following tables, obtained when Levetiracetam was added to concurrent AED therapy, cannot be used to predict the frequency of adverse experiences in the course of usual medical practice where patient characteristics and other factors may differ from those prevailing during clinical studies. Similarly, the cited frequencies cannot be directly compared with figures obtained from other clinical investigations involving different treatments, uses, or investigators. An inspection of these frequencies, however, does provide the prescriber with one basis to estimate the relative contribution of drug and non-drug factors to the adverse event incidences in the population studied.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).