Keppra Information
Keppra (Levetiracetam) Description
Keppra (Levetiracetam) is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white) tablets and as a clear, colorless, grape-flavored liquid (100 mg/mL) 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.)
Keppra (Levetiracetam) tablets contain the labeled amount of levetiracetam. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, polyethylene glycol 3350, polyethylene glycol 6000, polyvinyl alcohol, 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 yellow #6/sunset yellow FCF aluminum lake, iron oxide red
Keppra (Levetiracetam) oral solution contains 100 mg of levetiracetam per mL. Inactive ingredients: ammonium glycyrrhizinate, citric acid monohydrate, glycerin, maltitol solution, methylparaben, potassium acesulfame, propylparaben, purified water, sodium citrate dihydrate and natural and artificial flavor.
Keppra (Levetiracetam) Clinical 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.
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.
Keppra (Levetiracetam) Clinical Studies
In the following studies, statistical significance versus placebo indicates a p value Study 1 was a double-blind, placebo-controlled, parallel-group study conducted at 41 sites in the United States comparing Keppra (Levetiracetam) 1000 mg/day (N=97), Keppra (Levetiracetam) 3000 mg/day (N=101), and placebo (N=95) given in equally divided doses twice daily. After a prospective baseline period of 12 weeks, patients were randomized to one of the three treatment groups described above. The 18-week treatment period consisted of a 6-week titration period, followed by a 12-week fixed dose evaluation period, during which concomitant AED regimens were held constant. The primary measure of effectiveness was a between group comparison of the percent reduction in weekly partial seizure frequency relative to placebo over the entire randomized treatment period (titration + evaluation period). Secondary outcome variables included the responder rate (incidence of patients with ≥50% reduction from baseline in partial onset seizure frequency). The results of the analysis of Study 1 are displayed in Table 1.
The percentage of patients (y-axis) who achieved ≥50% reduction in weekly seizure rates from baseline in partial onset seizure frequency over the entire randomized treatment period (titration + evaluation period) within the three treatment groups (x-axis) is presented in Figure 1.
Figure 1: Responder Rate (≥50% Reduction From Baseline) In Study 1
Study 2 was a double-blind, placebo-controlled, crossover study conducted at 62 centers in Europe comparing Keppra (Levetiracetam) 1000 mg/day (N=106), Keppra (Levetiracetam) 2000 mg/day (N=105), and placebo (N=111) given in equally divided doses twice daily.
The first period of the study (Period A) was designed to be analyzed as a parallel-group study. After a prospective baseline period of up to 12 weeks, patients were randomized to one of the three treatment groups described above. The 16-week treatment period consisted of the 4-week titration period followed by a 12-week fixed dose evaluation period, during which concomitant AED regimens were held constant. The primary measure of effectiveness was a between group comparison of the percent reduction in weekly partial seizure frequency relative to placebo over the entire randomized treatment period (titration + evaluation period). Secondary outcome variables included the responder rate (incidence of patients with ≥50% reduction from baseline in partial onset seizure frequency). The results of the analysis of Period A are displayed in Table 2.
The percentage of patients (y-axis) who achieved ≥50% reduction in weekly seizure rates from baseline in partial onset seizure frequency over the entire randomized treatment period (titration + evaluation period) within the three treatment groups (x-axis) is presented in Figure 2.
Figure 2: Responder Rate (≥50% Reduction From Baseline) In Study 2: Period A
The comparison of Keppra (Levetiracetam) 2000 mg/day to Keppra (Levetiracetam) 1000 mg/day for responder rate was statistically significant (=0.02). Analysis of the trial as a cross-over yielded similar results.
Study 3 was a double-blind, placebo-controlled, parallel-group study conducted at 47 centers in Europe comparing Keppra (Levetiracetam) 3000 mg/day (N=180) and placebo (N=104) in patients with refractory partial onset seizures, with or without secondary generalization, receiving only one concomitant AED. Study drug was given in two divided doses. After a prospective baseline period of 12 weeks, patients were randomized to one of two treatment groups described above. The 16-week treatment period consisted of a 4-week titration period, followed by a 12-week fixed dose evaluation period, during which concomitant AED doses were held constant. The primary measure of effectiveness was a between group comparison of the percent reduction in weekly seizure frequency relative to placebo over the entire randomized treatment period (titration + evaluation period). Secondary outcome variables included the responder rate (incidence of patients with ≥50% reduction from baseline in partial onset seizure frequency). Table 3 displays the results of the analysis of Study 3.
The percentage of patients (y-axis) who achieved ≥50% reduction in weekly seizure rates from baseline in partial onset seizure frequency over the entire randomized treatment period (titration + evaluation period) within the two treatment groups (x-axis) is presented in Figure 3.
Figure 3: Responder Rate (≥50% Reduction From Baseline) In Study 3
The effectiveness of Keppra (Levetiracetam) as adjunctive therapy (added to other antiepileptic drugs) in pediatric patients was established in one multicenter, randomized double-blind, placebo-controlled study, conducted at 60 sites in North America, in children 4 to 16 years of age with partial seizures uncontrolled by standard antiepileptic drugs (AEDs). Eligible patients on a stable dose of 1-2 AEDs, who still experienced at least 4 partial onset seizures during the 4 weeks prior to screening, as well as at least 4 partial onset seizures in each of the two 4-week baseline periods, were randomized to receive either Keppra (Levetiracetam) or placebo. The enrolled population included 198 patients (Keppra (Levetiracetam) N=101, placebo N=97) with refractory partial onset seizures, whether or not secondarily generalized. The study consisted of an 8-week baseline period and 4-week titration period followed by a 10-week evaluation period. Dosing was initiated at a dose of 20 mg/kg/day in two divided doses. During the treatment period, Keppra (Levetiracetam) doses were adjusted in 20 mg/kg/day increments, at 2-week intervals to the target dose of 60 mg/kg/day. The primary measure of effectiveness was a between group comparison of the percent reduction in weekly partial seizure frequency relative to placebo over the entire 14-week randomized treatment period (titration + evaluation period). Secondary outcome variables included the responder rate (incidence of patients with ≥ 50% reduction from baseline in partial onset seizure frequency per week). Table 4 displays the results of this study.
The percentage of patients (y-axis) who achieved ≥ 50% reduction in weekly seizure rates from baseline in partial onset seizure frequency over the entire randomized treatment period (titration + evaluation period) within the two treatment groups (x-axis) is presented in Figure 4.
Figure 4: Responder Rate (≥ 50% Reduction From Baseline)
The effectiveness of Keppra (Levetiracetam) as adjunctive therapy (added to other antiepileptic drugs) in patients 12 years of age and older with juvenile myoclonic epilepsy (JME) experiencing myoclonic seizures was established in one multicenter, randomized, double-blind, placebo-controlled study, conducted at 37 sites in 14 countries. Of the 120 patients enrolled, 113 had a diagnosis of confirmed or suspected JME. Eligible patients on a stable dose of 1 antiepileptic drug (AED) experiencing one or more myoclonic seizures per day for at least 8 days during the prospective 8-week baseline period were randomized to either Keppra (Levetiracetam) or placebo (Keppra (Levetiracetam) N=60, placebo N=60). Patients were titrated over 4 weeks to a target dose of 3000 mg/day and treated at a stable dose of 3000 mg/day over 12 weeks (evaluation period). Study drug was given in 2 divided doses.
The primary measure of effectiveness was the proportion of patients with at least 50% reduction in the number of days per week with one or more myoclonic seizures during the treatment period (titration + evaluation periods) as compared to baseline. Table 5 displays the results for the 113 patients with JME in this study.
The effectiveness of Keppra (Levetiracetam) as adjunctive therapy (added to other antiepileptic drugs) in patients 6 years of age and older with idiopathic generalized epilepsy experiencing primary generalized tonic-clonic (PGTC) seizures was established in one multicenter, randomized, double-blind, placebo-controlled study, conducted at 50 sites in 8 countries. Eligible patients on a stable dose of 1 or 2 antiepileptic drugs (AEDs) experiencing at least 3 PGTC seizures during the 8-week combined baseline period (at least one PGTC seizure during the 4 weeks prior to the prospective baseline period and at least one PGTC seizure during the 4-week prospective baseline period) were randomized to either Keppra (Levetiracetam) or placebo. The 8-week combined baseline period is referred to as "baseline" in the remainder of this section. The population included 164 patients (Keppra (Levetiracetam) N=80, placebo N=84) with idiopathic generalized epilepsy (predominately juvenile myoclonic epilepsy, juvenile absence epilepsy, childhood absence epilepsy, or epilepsy with Grand Mal seizures on awakening) experiencing primary generalized tonic-clonic seizures. Each of these syndromes of idiopathic generalized epilepsy was well represented in this patient population. Patients were titrated over 4 weeks to a target dose of 3000 mg/day for adults or a pediatric target dose of 60 mg/kg/day and treated at a stable dose of 3000 mg/day (or 60 mg/kg/day for children) over 20 weeks (evaluation period). Study drug was given in 2 equally divided doses per day.
The primary measure of effectiveness was the percent reduction from baseline in weekly PGTC seizure frequency for Keppra (Levetiracetam) and placebo treatment groups over the treatment period (titration + evaluation periods). There was a statistically significant decrease from baseline in PGTC frequency in the Keppra (Levetiracetam) -treated patients compared to the placebo-treated patients.
The percentage of patients (y-axis) who achieved ≥50% reduction in weekly seizure rates from baseline in PGTC seizure frequency over the entire randomized treatment period (titration + evaluation period) within the two treatment groups (x-axis) is presented in Figure 5.
Figure 5: Responder Rate (≥50% Reduction From Baseline) In PGTC Seizure Frequency Per Week
Keppra (Levetiracetam) Indications And Usage
Keppra (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.
Keppra (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.
Keppra (Levetiracetam) is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy.
Keppra (Levetiracetam) Contraindications
This product should not be administered to patients who have previously exhibited hypersensitivity to levetiracetam or any of the inactive ingredients in Keppra (Levetiracetam) tablets or oral solution.
Keppra (Levetiracetam) Warnings
Antiepileptic drugs (AEDs), including Keppra (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 (5-100 years) in the clinical trials analyzed. Table 7 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 Keppra (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.
Keppra (Levetiracetam) Precautions
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 Keppra (Levetiracetam) . The Medication Guide may also be found in the full prescribing information for Keppra (Levetiracetam) posted on http://www.ucb-usa.com or by calling 1-866-822-0068. Patients should be instructed to take Keppra (Levetiracetam) only as prescribed.
Patients, their caregivers, and families should be counseled that AEDs, including Keppra (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 Keppra (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. UCB, Inc. has established the UCB AED Pregnancy Registry to advance scientific knowledge about safety and outcomes associated with pregnant women being treated with all UCB antiepileptic drugs, including Keppra (Levetiracetam) . To ensure broad program access and reach, either a healthcare provider or the patient can initiate enrollment in the UCB AED Pregnancy Registry by calling (888) 537-7734 (toll free) (See Section).
Patients should be advised that Keppra (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 Keppra (Levetiracetam) to gauge whether it adversely affects their performance of these activities.
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Levetiracetam circulates largely unbound (
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.
Keppra (Levetiracetam) Labor And Delivery
The effect of Keppra (Levetiracetam) on labor and delivery in humans is unknown.
Keppra (Levetiracetam) Nursing Mothers
Levetiracetam is excreted in breast milk. Because of the potential for serious adverse reactions in nursing infants from Keppra (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.
Keppra (Levetiracetam) 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.
Keppra (Levetiracetam) 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 Keppra (Levetiracetam) in these patients.
A study in 16 elderly subjects (age 61-88 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.
Keppra (Levetiracetam) Adverse Reactions
The prescriber should be aware that the adverse event incidence figures in the following tables, obtained when Keppra (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.
In well-controlled clinical studies in adults with partial onset seizures, the most frequently reported adverse events associated with the use of Keppra (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 Keppra (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 8 lists treatment-emergent adverse events that occurred in at least 1% of adult epilepsy patients treated with Keppra (Levetiracetam) participating in placebo-controlled studies and were numerically more common than in patients treated with placebo. Table 9 lists treatment-emergent adverse events that occurred in at least 2% of pediatric epilepsy patients (ages 4-16 years) treated with Keppra (Levetiracetam) participating in the placebo-controlled study and were numerically more common than in pediatric patients treated with placebo. In these studies, either Keppra (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 Keppra (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 Keppra (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.
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 Keppra (Levetiracetam) in combination with other AEDs, not seen at an equivalent frequency among placebo-treated patients, were somnolence, neck pain, and pharyngitis.
Table 10 lists treatment-emergent adverse events that occurred in at least 5% of juvenile myoclonic epilepsy patients experiencing myoclonic seizures treated with Keppra (Levetiracetam) and were numerically more common than in patients treated with placebo. In this study, either Keppra (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 Keppra (Levetiracetam) -treated patients with myoclonic seizures but as or more frequent in the placebo group were the following: fatigue and headache.
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 PGTC seizures is expected to be essentially the same as for patients with partial seizures.
In the well-controlled clinical study that included patients 4 years of age and older with primary generalized tonic-clonic (PGTC) seizures, the most frequently reported adverse event associated with the use of Keppra (Levetiracetam) in combination with other AEDs, not seen at an equivalent frequency among placebo-treated patients, was nasopharyngitis.
Table 11 lists treatment-emergent adverse events that occurred in at least 5% of idiopathic generalized epilepsy patients experiencing PGTC seizures treated with Keppra (Levetiracetam) and were numerically more common than in patients treated with placebo. In this study, either Keppra (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 Keppra (Levetiracetam) -treated patients with PGTC seizures but as or more frequent in the placebo group were the following: dizziness, headache, influenza, and somnolence.
Keppra (Levetiracetam) Drug Abuse And Dependence
The abuse and dependence potential of Keppra (Levetiracetam) has not been evaluated in human studies.
Keppra (Levetiracetam) Dosage And Administration
Keppra (Levetiracetam) is indicated as adjunctive treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy.
Keppra (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.
Keppra (Levetiracetam) is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy.
Keppra (Levetiracetam) How Supplied
Keppra (Levetiracetam) 500 mg tablets are yellow, oblong-shaped, scored, film-coated tablets debossed with "ucb 500" on one side. They are supplied in white HDPE bottles containing 15 tablets (NDC 21695-070-15).
Keppra (Levetiracetam)
Keppra (Levetiracetam) Medication Guide
Read this Medication Guide before you start taking Keppra (Levetiracetam) and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.
Keppra (Levetiracetam) is a prescription medicine taken by mouth that is used with other medicines to treat:
It is not known if Keppra (Levetiracetam) is safe or effective in children under 4 years of age.
Before taking your medicine, make sure you have received the correct medicine. Compare the name above with the name on your bottle and the appearance of your medicine with the description of Keppra (Levetiracetam) provided below. Tell your pharmacist immediately if you think you have been given the wrong medicine.
250 mg Keppra (Levetiracetam) tablets are blue, oblong-shaped, scored, film-coated tablets marked with "ucb 250" on one side.
500 mg Keppra (Levetiracetam) tablets are yellow, oblong-shaped, scored, film-coated tablets marked with "ucb 500" on one side.
750 mg Keppra (Levetiracetam) tablets are orange, oblong-shaped, scored, film-coated tablets marked with "ucb 750" on one side.
1000 mg Keppra (Levetiracetam) tablets are white, oblong-shaped, scored, film-coated tablets marked with "ucb 1000" on one side.
Keppra (Levetiracetam) oral solution is a clear, colorless, grape-flavored liquid.
Before taking Keppra (Levetiracetam) , tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Do not start a new medicine without first talking with your healthcare provider.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist each time you get a new medicine.
Take Keppra (Levetiracetam) exactly as prescribed.
Do not drive, operate machinery or do other dangerous activities until you know how Keppra (Levetiracetam) affects you. Keppra (Levetiracetam) may make you dizzy or sleepy.
Keppra (Levetiracetam) can cause serious side effects.
Call your healthcare provider right away if you have any of these symptoms:
The most common side effects seen in people who take Keppra (Levetiracetam) include:
The most common side effects seen in children who take Keppra (Levetiracetam) include, in addition to those listed above:
These side effects can happen at any time but happen more often within the first 4 weeks of treatment except for infection.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of Keppra (Levetiracetam) . For more information, ask your healthcare provider or pharmacist.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Keppra (Levetiracetam) for a condition for which it was not prescribed. Do not give Keppra (Levetiracetam) to other people, even if they have the same symptoms that you have. It may harm them.
This Medication Guide summarizes the most important information about Keppra (Levetiracetam) . If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Keppra (Levetiracetam) that is written for health professionalsYou can also get information about Keppra (Levetiracetam) at www.Keppra (Levetiracetam) .com or call 1-866-822-0068.
Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, polyethylene glycol 3350, polyethylene glycol 6000, polyvinyl alcohol, 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 yellow #6/sunset yellow FCF aluminum lake, iron oxide red
Inactive ingredients: ammonium glycyrrhizinate, citric acid monohydrate, glycerin, maltitol solution, methylparaben, potassium acesulfame, propylparaben, purified water, sodium citrate dihydrate and natural and artificial flavor.
Keppra (Levetiracetam) does not contain lactose or gluten. Keppra (Levetiracetam) oral solution does contain carbohydrates. The liquid is dye-free.
This Medication Guide has been approved by the US Food and Drug Administration.
Distributed byUCB, Inc.Smyrna, GA 30080
Keppra (Levetiracetam) is a registered trademark of the UCB Group of companies©2009, UCB, Inc., Smyrna, GA 30080All rights reserved.Printed in the U.S.A.
Rev. 1E 04/2009
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