Pfizer Levetiracetam Special Precautions

Acute kidney injury: The use of Levetiracetam has been very rarely associated with acute kidney injury with a time to onset ranging from a few days to several months.
Blood cell counts: Rare cases of decreased blood cell counts (neutropenia, agranulocytosis, leukopenia, thrombocytopenia and pancytopenia) have been described in association with Levetiracetam administration, generally at the beginning of the treatment. Complete blood cell counts are advised in patients experiencing important weakness, pyrexia, recurrent infections or coagulation disorders (see Adverse Reactions).
Suicide: Suicide, suicide attempt, suicidal ideation and behavior have been reported in patients treated with antiepileptic agents (including Levetiracetam). A meta-analysis of randomized placebo-controlled trials of antiepileptic 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 behaviors 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.
Abnormal and aggressive behaviors: Levetiracetam may cause psychotic symptoms and behavioral abnormalities including irritability and aggressiveness. Patients treated with levetiracetam should be monitored for developing psychiatric signs suggesting important mood and/or personality changes. If such behaviors are noticed, treatment adaptation or gradual discontinuation should be considered. If discontinuation is considered, refer to Dosage & Administration.
Worsening of seizures: As with other types of antiepileptic drugs, levetiracetam may rarely exacerbate seizure frequency or severity. This paradoxical effect was mostly reported within the first month after levetiracetam initiation or increase of the dose, and was reversible upon drug discontinuation or dose decrease. Patients should be advised to consult their physician immediately in case of aggravation of epilepsy.
Electrocardiogram QT interval prolongation: Rare cases of ECG QT interval prolongation have been observed during the post-marketing surveillance. Levetiracetam should be used with caution in patients with QTc-interval prolongation, in patients concomitantly treated with drugs affecting the QTc-interval, or in patients with relevant pre-existing cardiac disease or electrolyte disturbances.
Excipients: This medicinal product contains 19 mg of sodium per vial. The maximum single dose (corresponding to 1,500 mg levetiracetam) contains 57 mg of sodium, equivalent to 2.85% of the WHO maximum recommended daily intake (RDI) of 2 g sodium for an adult. To be taken into consideration by patients on a controlled sodium diet.
This medicinal product may be diluted with sodium-containing solutions (see Dosage & Administration) and this should be considered in relation to the total sodium from all sources that will be administered to the patient.
Effects on Ability to Drive and Use Machines: 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.
Renal impairment: 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).
Use in Children: 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.