Epitech Special Precautions

Behavioral Abnormalities and Psychotic Symptoms: Levetiracetam may cause behavioural abnormalities and psychotic symptoms and should be monitored for psychiatric signs and symptoms.
Behavioral abnormalities: Studies showed that levetiracetam-treated patients experienced non-psychotic behavioral symptoms like aggression, agitation, anger, anxiety, apathy, depersonalization, depression, emotional lability, hostility, hyperkinesia, irritability, nervousness, neurosis, and personality disorder. The result of a randomized, double-blind, placebo-controlled study using Levetiracetam in paediatric patients of 4 to 16 years of age indicated a worsening of the aggressive behaviour. In clinical studies in paediatric patients 1 month to < 4 years of age, irritability was reported.
Psychotic Symptoms: Studies indicate 1% of levetiracetam-treated adult patients, 2% of levetiracetam-treated paediatric patients 4 to 16 years of age, and 17% of levetiracetam-treated pediatric patients 1 month to <4 years of age experienced psychotic symptoms. Patients also experienced paranoia and confusional state. Adult patients were hospitalized, and their treatment was discontinued due to psychosis.
Acute Kidney Injury: The use of Levetiracetam has been rarely associated with acute kidney injury, with a time to onset ranging from a few days to several months.
Somnolence and Fatigue and Coordination Difficulties: Levetiracetam may cause somnolence and fatigue most frequently within the first 4 weeks of treatment. Patients should be monitored for signs and symptoms of coordination difficulties. In such cases, the patient should be advised not to drive or operate machinery when under treatment.
Serious Dermatological Reactions: Serious dermatological reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported in both pediatric and adult patients treated with levetiracetam. The median time of onset is reported to be 14 to 17 days, but cases have been reported at least four months after initiation of treatment. If signs or symptoms suggest SJS/TEN, use of this drug should not be resumed and alternative therapy should be considered.
Withdrawal Seizures: Antiepileptic drugs, including levetiracetam, should be withdrawn gradually to minimize the potential of increased seizure frequency.
Hematologic Abnormalities: Levetiracetam can cause hematologic abnormalities which includes decreases in red blood cells count (RBC), haemoglobin, and haematocrit, and increases in eosinophil counts. Decreased white blood cells count (WBC) and neutrophil counts also occurred and cases of agranulocytosis have been reported.
Increase in Blood Pressure: Studies in levetiracetam treated patients 1 month to <4 years of age a significantly higher risk of increased diastolic blood pressure was observed (17%), compared to placebo-treated patients (2%). This disparity between the levetiracetam and placebo treatment groups was not observed in the studies of older children or in adults. Hence it is necessary to monitor patients 1 month to <4 years of age for increases in diastolic blood pressure.
Seizure Control During Pregnancy: Physiological changes may gradually decrease plasma levels of levetiracetam throughout pregnancy. This decrease is more pronounced during the third trimester. It is recommended that patients be monitored carefully during pregnancy and continue through the postpartum period especially if the dose was changed during pregnancy.
Effects on Ability to Drive and Use Machine: No studies on the effects on the ability to drive and use machines have been performed. Due to possible different individual sensitivity, some patients might experience somnolence or other central nervous system related symptoms, especially at the beginning of treatment or following a dose increase. Therefore, caution is recommended in those patients when performing skilled tasks, e.g. driving vehicles or operating machinery. Patients are advised not to drive or use machines until it is established that their ability to perform such activities is not affected.