Safety Information

Special instructions:

• Do not use Keppra during pregnancy without extreme necessity (given that gaps in anticonvulsant therapy can lead to an exacerbation of the disease, which is harmful to the mother and fetus).
• Keppra, like other antiepileptic drugs, should be canceled gradually (for example, a reduction in the dose by 500 mg when taken 2 times a day every 2-4 weeks). In children, the dose reduction should not exceed 10 mg/kg of body weight 2 times/day every 2 weeks.
• The drug does not affect the activity of liver enzymes, and therefore its interaction with other drugs, that are subjected to microsomal oxidation or affecting it, is unlikely.
• Concomitant antiepileptic drugs (during the transfer of patients to receive Levetiracetam) should be gradually canceled.
• It is recommended to observe the function of the kidneys before treatment for patients with kidney disease and decompensated liver disease. If the kidney function is impaired, a dose adjustment may be required.
• Due to reports of cases of suicide, suicidal intentions and suicide attempts during the treatment with Keppra, patients should be warned to immediately notify the attending physician of any symptoms of depression or suicidal intentions.
• The solution for oral ingestion contains maltitol, therefore, taking Keppra in the appropriate dosage form is contraindicated for patients with impaired tolerance to fructose.
• The available information on the use of Keppra in children does not indicate any of its negative effects on development and puberty. However, the long-term consequences of treatment concerning the ability of children to learn, their intellectual development, growth, endocrine gland functions, sexual development, and fertility remain unknown.
• When taking Keppra, one should take care when driving vehicles and performing other potentially dangerous activities. The effect of Keppra on the ability to drive vehicles and control mechanisms has not been specifically studied. Nevertheless, due to the different individual sensitivity to the drug from the CNS during the treatment period (some patients may experience drowsiness), it is necessary to refrain from driving motor vehicles and practicing potentially dangerous activities that require a high concentration of attention and speed of psychomotor reactions.

Interaction with other drugs

• Levetiracetam does not interact with anticonvulsant drugs (phenytoin, carbamazepine, valproic acid, phenobarbital, lamotrigine, gabapentin, and primidone).
• Levetiracetam in a daily dose of 1 g does not change the pharmacokinetics of oral contraceptives (ethinyl estradiol and levonorgestrel).
• Levetiracetam in a daily dose of 2 g does not change the pharmacokinetics of warfarin and digoxin.
• Digoxin, oral contraceptives, and warfarin do not affect the pharmacokinetics of levetiracetam.
• When taking Keppra with topiramate, the probability of anorexia is higher.
• Completeness of absorption of levetiracetam does not change under the influence of food, while the rate of absorption is somewhat reduced.
• Data on the interaction of levetiracetam with alcohol are absent.

Taking Keppra during pregnancy and lactation

Treatment of pregnant women with Keppra should be carried out under special supervision. Physiological changes in the body of a woman during pregnancy can affect the plasma concentration of levetiracetam, as well as other antiepileptic drugs. A decrease in the concentration of levetiracetam in plasma was observed. This decrease is more pronounced in the first trimester (up to 60% of the baseline concentration in the period preceding the pregnancy).

Levetiracetam is excreted in breast milk, so breastfeeding during treatment with the drug is not recommended. However, if treatment with levetiracetam is necessary during lactation, the risk/benefit ratio of treatment should be carefully weighed against the importance of breastfeeding.