Kepreptol Special Precautions

Caution is exercised in the following patients: Suicide, suicide attempt and suicidal ideation have been reported in patients treated with levetiracetam. Patients should be advised to immediately report any symptoms of depression and/or suicidal ideation to their prescribing physician.
The administration of Levetiracetam to patients with renal impairment may require dose adjustment. In patients with severely impaired hepatic function, assessment of renal function is recommended before dose selection (see Dosage & Administration).
This drug contains Yellow No.5 (Sunset yellow FCF). This drug should be carefully used to patients who have a hypersensitivity to the component or history of allergy.
General Caution: 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.
Effects on the Ability to Drive or Operate Machinery: 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 at the beginning of treatment or following a dose increase. Therefore, caution is recommended in those patients when performing skilled tasks, eg. Driving vehicles or operating machinery.
Use in Children: Safety and effectiveness of oral preparation in patients below 1 month of age have not been established. The tablet formulation is not adapted for use in infants and children under the age of 4 years and the liquid formulation should be used in children older than 1 month of age. Safety and effectiveness of injection in patients below 16 years of age have not been established.
Use in the Elderly: 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 61-88 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.