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Levetiracetam Warnings

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Last Updated: 23 October 2020

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General | Latest Info

Extend - release Levetiracetam tablets may cause behavioral abnormalities and psychotic symptoms. Patients treated with extend - release Levetiracetam tablets should be monitored for psychiatric signs and symptoms. A total of 7% of extend - release Levetiracetam tablet - treated patients experience non - psychotic behavioral disorders compared to 0% of placebo - treated patients. Irritability was reported in 7% of extend - release Levetiracetam tablet - treated patients. Aggression was reported in 1% of extend - release Levetiracetam tablet - treated patients. No patient discontinued treatment or had dose reduction as result of these adverse reactions. The number of patients exposed to extend - release Levetiracetam tablets was considerably smaller than the number of patients exposed to immediate - release Levetiracetam tablets in controlled trials. Therefore, certain adverse reactions observed in immediate - release Levetiracetam control trials will likely occur in patients receiving extend - release Levetiracetam tablets. A total of 13% of adult patients and 38% of pediatric patients treated with immediate - release Levetiracetam tablets experience non - psychotic behavioral symptoms, compared to 6% and 19% of adult and pediatric patients on placebo. A randomize, double - blind, placebo - control study was performed to assess the neurocognitive and behavioral effects of immediate - release Levetiracetam tablets as adjunctive therapy in pediatric patients. Exploratory analysis suggests worsening of aggressive behavior in patients treated with immediate - release Levetiracetam tablets in that study. Total of 1. 7% of adult patients treated with immediate - release Levetiracetam tablets discontinue treatment due to behavioral adverse reactions, compared to 0. 2% of placebo - treated patients. Treatment dose was reduced in 0. 8% of adult patients were treated with immediate - release Levetiracetam tablets, compared to 0. 5% of placebo - treated patients. Overall, 11% of pediatric patients treated with immediate - release Levetiracetam tablets experience behavioral symptoms associated with discontinuation or dose reduction, compared to 6. 2% of placebo - treat pediatric patients. One percent of adult patients and 2% of pediatric patients treated with immediate - release Levetiracetam tablets experience psychotic symptoms, compared to 0. 2% and 2%, respectively, in adult and placebo - treat pediatric patients. In control study that assessed neurocognitive and behavioral effects of immediate - release Levetiracetam tablets in pediatric patients 4 to 16 years of age, 1. 6% of Levetiracetam tablets - treat patients experienced paranoia, compared to no placebo - treated patients. There were 3. 1% of patients treated with immediate - release Levetiracetam tablets experienced a confusional state, compared to no placebo - treated patients. One percent of Levetiracetam tablets - treat adult patients experience psychotic symptoms compared to 0. 2% of placebo - treated patients. Two Levetiracetam tablets - treat adult patients were hospitalized and their treatment was discontinued due to psychosis. Both events, reported as psychosis, develop within the first week of treatment and resolve within 1 to 2 weeks following treatment discontinuation. There was no difference between drug and placebo - treated patients in the incidence of pediatric patients who discontinued treatment due to psychotic and non - psychotic adverse reactions. Antiepileptic drugs, including extend - release Levetiracetam tablets, 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 emergence or worsening of Depression, suicidal thoughts or behavior, and / or any unusual changes in mood or behavior.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Side Effects

Drowsiness, dizziness, unusual tiredness, or weakness may occur. These side effects are more common during the first 4 weeks and usually lessen as your body adjusts to medication. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, such as: loss of coordination, mental / mood changes, signs of infection, signs of anemia, easy bruising / bleeding. A small number of people who take anticonvulsants for any condition may experience depression, suicidal thoughts / attempts, or other mental / mood problems. Tell your doctor right away if you or your family / caregiver notice any unusual / sudden changes in your mood, thoughts, or behavior, including signs of depression, suicidal thoughts / attempts, thoughts about harming yourself. Levetiracetam can commonly cause rash that is usually not serious. However, you may not be able to tell it apart from rare rash that could be a sign of severe reaction. Tell your doctor right away if you develop any rash. Very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of serious allergic reaction, such as: rash, itching / swelling, severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1 - 800 - FDA - 1088 or at www. Fda. Gov / medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1 - 866 - 234 - 2345.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Interactions

Medicines that interact with levetiracetam may either decrease its effect, affect how long it works for, increase side effects, or have less of an effect when taken with levetiracetam. Interaction between two medications does not always mean that you must stop taking one of the medications; however, sometimes it does Speak to your doctor about how drug interactions should be manage. Antidepressants, such as SSRIs and monoamine oxidase inhibitors, such as isocarboxazid, selegiline, or tranylcypromine antiepileptics, such as carbamazepine and phenytoin benzodiazepines, such as diazepam, oxazepam, and temazepam brivaracetam buprenorphine clozapine mefloquine Methotrexate methotrimeprazine minocycline metoclopramide opioids, such as methadone, oxycodone, morphine, or codeine sedatives, or any medication that causes sedation, such as sedating antihistamines, sleeping pills or muscle relaxants tramadol. Note that this list is not all - inclusive and includes only common medications that may interact with levetiracetam. You should refer to prescribing information for levetiracetam for a complete list of interactions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

3. Downsides

If you are between the ages of 18 and 60, taking no other medication or have no other medical conditions, side effects you are more likely to experience include: drowsiness which may affect your ability to drive or operate machinery. Avoid alcohol. Aggression, nasal congestion, headache, decreased appetite, infection, dizziness, pain, sore throat, depression, nervousness, and fatigue are reasonably common side effects. Hematologic abnormalities, co - ordination difficulties and serious dermatological reactions have also been report. Young children are more likely than adults to experience behavioral abnormalities or psychotic symptoms as well as other side effects such as decreased appetite, increased blood pressure, or nasal congestion while taking levetiracetam. As with other antiepileptics, levetiracetam may increase the risk of suicidal thoughts or behavior; monitor for worsening depression or mood changes. Levetiracetam may also cause behavioral problems such as aggression, anxiety, irritability, and nervousness; talk to your doctor if you experience any changes in your mood. Dosage may be reduced in people with kidney disease. It may not be suitable for everybody, including those with kidney disease, with history of mental health problems, and taking certain medications. Generally, less likely than some other anticonvulsants to interact with other medications. In children aged 1 month to 4 years, levetiracetam has been associated with an increase in blood pressure. Alcohol may worsen side effects of levetiracetam such as drowsiness and dizziness.


5. Side effects

Tell doctor straight away if you have serious side effect, including: flu - like symptoms and rash on your face, or rash that spread or forms blisters - These can be signs of a rare serious skin condition called Stevens - Johnson syndrome seizures getting worse passing very little pee, feeling tired or confuse, or having swell legs, ankles or feet - these could be signs of kidney problems signs of serious mental changes, or someone around you notices signs of confusion, sleepiness, loss of memory, forgetfulness, abnormal behaviour or uncontrolled movements thoughts of harming or killing yourself - small number of people taking levetiracetam have had suicidal thoughts in rare cases, it's possible to have serious allergic reaction to levetiracetam.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Precautions

The highest known dose of KEPPRA received in the clinical development program was 6000 mg / day. Other than drowsiness, there were no adverse reactions in few known cases of overdose in clinical trials. Cases of somnolence, agitation, aggression, depressed level of consciousness, respiratory depression and coma were observed with KEPPRA overdoses in postmarketing use. There is no specific antidote for overdose with KEPPRA. If indicate, elimination of unabsorbed Drug should be attempted by emesis or gastric lavage; usual precautions should be observed to maintain airway. General supportive care of patient is indicated, including monitoring of vital signs and observation of the patient's clinical status. Certify Poison Control Center should be contacted for up - to - date information on management of overdose with KEPPRA. Standard hemodialysis procedures result in significant clearance of levetiracetam and should be considered in cases of overdose. Although hemodialysis has not been performed in few known cases of overdose, it may be indicated by patient's clinical state or in patients with significant renal impairment.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Overview

It has a quick onset or effect on older adults with dementia. It has no particularly worrisome side effects. Keppra has demonstrated that older age groups tolerate it well. It does not have significant interactions with other drugs. It is thought that KEPPRA does not add to deficits in cognition in individuals with dementia. Keppra is an antiepileptic drug available as blue tablet of 250 mg, yellow tablet of 500 mg, orange tablet of 750 mg, and white tablet of 1 000. It also comes as a colorless, clear, grape - flavored liquid of 100 mg / mL for oral administration.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

2 DOSAGE AND ADMINISTRATION

Keppra injection is an Antiepileptic drug available as a clear, colorless, sterile solution for intravenous administration. The chemical name of levetiracetam, single enantiomer, is - ethyl - 2oxo - 1pyrrolidine acetamide, Its molecular formula is C 8 H 14 N 2 O 2 and its molecular weight is 170. 21. Levetiracetam is chemically unrelated to existing Antiepileptic drugs. It has the following structural formula: levetiracetam is white to off - white crystalline powder with a faint odor and bitter taste. It is very soluble in water. It is freely soluble in chloroform and in methanol, soluble in ethanol, sparingly soluble in acetonitrile and practically insoluble in N - hexane. The Keppra injection contains 100 mg of levetiracetam per mL. It is supplied in single - use 5 mL vials containing 500 mg of levetiracetam, water for injection, 45 mg of sodium chloride, and buffer at approximately pH 5. 5 with glacial acetic acid and 8. 2 mg sodium acetate trihydrate. Keppra injection must be diluted prior to intravenous infusion.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

6 ADVERSE REACTIONS

Levetiracetam may cause behavioral abnormalities and psychotic symptoms. Patients treated with levetiracetam should be monitored for psychiatric signs and symptoms. In clinical studies, 13% of adult levetiracetam - treated patients and 38% of pediatric levetiracetam - treated patients, compared to 6% and 19% of adult and pediatric placebo - treated patients, experience non - psychotic behavioral symptoms. A randomized double - blind, placebo - control study was performed to assess the neurocognitive and behavioral effects of levetiracetam as adjunctive therapy in pediatric patients. Results from exploratory analysis indicate worsening in levetiracetam - treated patients on aggressive behavior as measured in a standardized and systematic way using a validated instrument, Achenbach Child Behavior Checklist. In clinical studies in pediatric patients 1 month to less than 4 years of age, irritability was reported in 12% of levetiracetam - treated patients compared to 0% of placebo - treated patients. In clinical studies, 1. 7% of adult levetiracetam - treated patients discontinue treatment due to behavioral adverse reactions, compared to 0. 2% of placebo - treated patients. Treatment dose was reduced to 0. 8% of adult levetiracetam - treated patients and in 0. 5% of placebo - treated patients. Overall, 11% of levetiracetam - treated pediatric patients experience behavioral symptoms associated with discontinuation or dose reduction, compared to 6% of placebo - treated patients. In clinical studies, 1% of levetiracetam - treat adult patients, 2% of levetiracetam - treat pediatric patients 4 to 16 years of age, and 17% of levetiracetam - treat pediatric patients 1 month to less than 4 years of age experience psychotic symptoms, compared to 0. 2%, 2%, and 5% in corresponding age groups were treated with placebo. In a controlled study that assessed neurocognitive and behavioral effects of levetiracetam in pediatric patients 4 to 16 years of age, 1. 6% of levetiracetam - treated patients experience paranoia, compared to 0% of placebo - treated patients. In the same study, 3. 1% of levetiracetam - treated patients experienced a confusional state, compared to 0% of placebo - treated patients. In clinical studies, two levetiracetam - treat adult patients were hospitalized and their treatment was discontinued due to psychosis. Both events, reported as psychosis, develop within the first week of treatment and resolve within 1 to 2 weeks following treatment discontinuation. There was no difference between drug and placebo - treated patients in the incidence of pediatric patients who discontinued treatment due to psychotic and non - psychotic adverse reactions.


Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of drug cannot be directly compared to rates in clinical trials of another drug and may not reflect rates observed in practice. In Controlled clinical Studies in Adults with Partial Onset Seizures, most common Adverse Reactions in patients receiving Levetiracetam in combination with other AEDs, for events with rates greater than Placebo, were somnolence, asthenia, infection, and dizziness. Of the most common Adverse Reactions in Adults Experiencing Partial Onset Seizures, asthenia, somnolence, and dizziness occur predominantly during the first 4 weeks of treatment with Levetiracetam. Table 3 lists Adverse Reactions that occur in at least 1% of Adult Epilepsy Patients receiving Levetiracetam in Placebo - control Studies and were numerically more common than in patients treated with Placebo. In these studies, either Levetiracetam or Placebo was added to concurrent AED therapy. Table 3: Adverse Reactions in Pooled Placebo - control, Add - on Studies in Adults Experiencing Partial Onset Seizures in Controlled Adult clinical Studies, 15% of Patients receiving Levetiracetam and 12% receiving Placebo either discontinued or had Dose Reduction as result of Adverse reaction. Table 4 lists the most common Adverse Reactions that result in Discontinuation or Dose Reduction and that occur more frequently in Levetiracetam - treated patients than in Placebo - treated patients. Table 4: Adverse Reactions that result in Discontinuation or Dose Reduction in Placebo - control Studies in Adult Patients Experiencing Partial Onset Seizures Adverse reaction data presented below was obtained from Pooled analysis of two control Pediatric clinical Studies in Pediatric Patients 4 to 16 Years of Age with Partial Onset Seizures. The Most common Adverse Reactions in Pediatric Patients receiving Levetiracetam in combination with other AEDs, for events with rates greater than Placebo, were fatigue, aggression, nasal congestion, decreased appetite, and irritability. Table 5 lists Adverse Reactions from pool Pediatric control Studies that occur in at least 2% of Pediatric Levetiracetam - treated Patients 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. T able 5: Adverse Reactions in Pooled Placebo - control, Add - on Studies in Pediatric Patients Age 4 to 16 Years Experiencing Partial Onset Seizures in control Pooled Pediatric clinical Studies in Patients 4 to 16 Years of Age, 7% of patients receiving Levetiracetam and 9% receiving Placebo discontinue as result of Adverse reaction. In a 7 - day, control Pediatric clinical Study in children 1 Month to less than 4 Years of Age with Partial Onset Seizures, most common Adverse Reactions in patients receiving Levetiracetam in combination with other AEDs, for events with rates greater than Placebo, were somnolence and irritability. Because of the shorter exposure period, incidences of Adverse Reactions are expected to be lower than in other Pediatric Studies in Older Patients. Therefore, other control Pediatric data, presented above, should also be considered to apply to this age group.


adults

In controlled clinical studies in adults with partial - onset seizures, most common adverse reactions in patients receiving levetiracetam tablets in combination with other AEDs, for events with rates greater than placebo, were somnolence, asthenia, infection, and dizziness. Of the most common adverse reactions in adults experiencing partial - onset seizures, asthenia, somnolence, and dizziness occur predominantly during the first 4 weeks of treatment with levetiracetam tablets. Table 3 lists adverse reactions that occurred in at least 1% of adult epilepsy patients receiving levetiracetam tablets in placebo - control studies and were numerically more common than in patients treated with placebo. In these studies, either levetiracetam tablets or placebo were added to concurrent AED therapy. In controlled adult clinical studies, 15% of patients receiving levetiracetam tablets and 12% receiving placebo either discontinued or had dose reduction as result of adverse reaction. Table 4 lists the most common adverse reactions that result in discontinuation or dose reduction and that occur more frequently in levetiracetam tablets - treat patients than in placebo - treated patients.


myoclonic seizures

Effectiveness of Myoclonic Seizures in Patients Greater than or Equal to 12 Years of Age with Juvenile Myoclonic Epilepsy effectiveness of levetiracetam as adjunctive therapy in Patients 12 Years of Age and older with Juvenile Myoclonic Epilepsy experiencing Myoclonic Seizures was established in one multicenter, randomize, double - blind, placebo - control Study, conducted at 37 sites in 14 countries. Of 120 patients enrol, 113 had a diagnosis of confirmed or suspected JME. Eligible Patients on stable dose of 1 antiepileptic drug experiencing one or more Myoclonic Seizures Per day for at least 8 Days during the prospective 8 - Week Baseline period were randomized to either levetiracetam or placebo. Patients were titrated over 4 weeks to a target dose of 3 000 mg / day and treated at a stable dose of 3 000 mg / day over 12 weeks. Study drug was given in 2 divided doses. The primary measure of effectiveness was the proportion of patients with at least 50% Reduction in number of Days Per Week with one or more Myoclonic Seizures during treatment period as compared to baseline. Table 14 displays results for 113 patients with JME in this study. Table 14: Responder Rate in Myoclonic Seizure Days Per Week for Patients with JME in Study 6


primary generalized tonic-clonic seizures

Although the pattern of adverse reactions in this study seems somewhat different from that seen in patients with partial - onset Seizures, this is likely due to the much smaller number of patients in this study compared to partial Seizure studies. The adverse reaction pattern for patients with Primary generalized Tonic - Clonic Seizures is expected to be essentially the same as for patients with partial Seizures. In a controlled clinical study that included patients 4 years of age and older with PGTC Seizures, most common adverse reaction in patients receiving levetiracetam tablets in combination with other AEDs, for events with rates greater than placebo, was nasopharyngitis. Table 9 lists adverse reactions that occur in at least 5% of idiopathic generalized epilepsy patients experiencing PGTC Seizures treated with levetiracetam tablets and were numerically more common than in patients treated with placebo. In this study, either levetiracetam tablets or placebo were added to concurrent AED therapy. In the placebo - control study, 5% of patients receiving levetiracetam tablets and 8% receiving placebo either discontinued or had dose reduction during the treatment period as result of adverse reaction. This study was too small to adequately characterize adverse reactions that could be expected to result in discontinuation of treatment in this population. It is expected that adverse reactions that would lead to discontinuation in this population would be similar to those resulting in discontinuation in other epilepsy trials. In addition, following adverse reactions were seen in other control adult studies of levetiracetam tablets: balance disorder, disturbance in attention, eczema, memory impairment, myalgia, and blurred vision.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

8 USE IN SPECIFIC POPULATIONS

Extend - release levetiracetam tablets may cause behavioral abnormalities and psychotic symptoms. Patients treated with extend - release levetiracetam tablets should be monitored for psychiatric signs and symptoms. A total of 7% of extend - release levetiracetam tablet - treated patients experience non - psychotic behavioral disorders compared to 0% of placebo - treated patients. Irritability was reported in 7% of extend - release levetiracetam tablets - treat patients. Aggression was reported in 1% of extend - release levetiracetam tablet - treated patients. No patient discontinued treatment or had dose reduction as result of these adverse reactions. The number of patients exposed to extend - release levetiracetam tablets was considerably smaller than the number of patients exposed to immediate - release levetiracetam tablets in controlled trials. Therefore, certain adverse reactions observed in immediate - release levetiracetam tablets control trials will likely occur in patients receiving extend - release levetiracetam tablets. A total of 13% of adult patients and 38% of Pediatric patients treated with immediate - release levetiracetam experience non - psychotic behavioral symptoms, compared to 6% and 19% of adult and Pediatric patients on placebo. A randomize, double - blind, placebo - control study was performed to assess the neurocognitive and behavioral effects of immediate - release levetiracetam tablets as adjunctive therapy in Pediatric Patients. Exploratory analysis suggests worsening in aggressive behavior in patients treated with immediate - release levetiracetam tablets in that study. Total of 1. 7% of adult patients treated with immediate - release levetiracetam discontinued treatment due to behavioral adverse reactions, compared to 0. 2% of placebo - treated patients. Treatment dose was reduced to 0. 8% of adult patients treated with immediate - release levetiracetam compared to 0. 5% of placebo - treated patients. Overall, 11% of pediatric patients treated with immediate - release levetiracetam tablets experience behavioral symptoms associated with discontinuation or dose reduction, compared to 6. 2% of placebo - treat pediatric patients. One percent of adult patients and 2% of pediatric patients treated with immediate - release levetiracetam tablets experience psychotic symptoms, compared to 0. 2% and 2%, respectively, in adult and placebo - treat Pediatric Patients. In control study that assessed neurocognitive and behavioral effects of immediate - release levetiracetam tablets in Pediatric Patients 4 to 16 years of age, 1. 6% of immediate - release levetiracetam tablet - treated patients experienced paranoia, compared to no placebo - treated patients. There were 3. 1% of patients treated with immediate - release levetiracetam experienced a confusional state, compared to no placebo - treated patients. One percent of immediate - release levetiracetam tablet - treat adult patients experience psychotic symptoms compared to 0. 2% of placebo - treated patients. Two immediate - release levetiracetam tablet - treat adult patients were hospitalized and their treatment was discontinued due to psychosis. Both events, reported as psychosis, develop within the first week of treatment and resolve within 1 to 2 weeks following treatment discontinuation. There was no difference between drug and placebo - treated patients in the incidence of pediatric patients who discontinued treatment due to psychotic and non - psychotic adverse reactions. Antiepileptic drugs, including extend - release levetiracetam tablets, 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 emergence or worsening of depression, suicidal thoughts or behavior, and / or any unusual changes in mood or behavior.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Sources

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

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