Keppra Special Precautions

Renal impairment: The administration of KEPPRA 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).
Suicide: Suicide, suicide attempt, suicidal ideation and behavior have been reported in patients treated with anti-epileptic agents (including levetiracetam). A meta-analysis of randomized placebo-controlled trials of anti-epileptic medicinal products has shown a small increased risk of suicidal thoughts and behavior. The mechanism of this risk is not known.
Therefore patients should be monitored for signs of depression and/or suicidal ideation and behaviours and appropriate treatment should be considered. Patients (and caregivers of patients) should be advised to seek medical advice should signs of depression and/or suicidal ideation or behavior emerge.
Excipients - oral solution: Keppra 100 mg/ml oral solution contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possible delayed).
It also contains maltitol liquid; patients with rare hereditary problems of fructose intolerance should not take this medicinal product.
Excipients - concentrate for solution for infusion: This medicinal product contains 2.5 mmol (or 57 mg) sodium per maximum single dose (0.8 mmol [or 19 mg] per vial). To be taken into consideration by patients on a controlled sodium diet.
Ability to perform tasks that require judgement, motor or cognitive skills: Levetiracetam has minor or moderate influence on the ability to drive and use machines.
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.
Use in Children: The tablet formulation is not adapted for use in infants and children under the age of 6 years.
Available data in children did not suggest impact on growth and puberty. However, long term effects on learning, intelligence, growth, endocrine function, puberty and childbearing potential in children remain unknown.