Ivetra/Ivetra-100/Ivetra IV Side Effects

Ivetra-100: Summary of the safety profile: Pooled safety data from clinical studies conducted with Levetiracetam Oral Solution oral formulations in adult patients with partial onset seizures showed that 46.4 % of the patients in the Levetiracetam Oral Solution group and 42.2 % of the patients in the placebo group experienced adverse reactions. Serious adverse reactions were experienced in 2.4 % of the patients in the Levetiracetam Oral Solution and 2.0 % of the patients in the placebo groups.
The most commonly reported adverse reactions were somnolence, asthenia and dizziness. In the pooled safety analysis, there was no clear dose-response relationship but incidence and severity of the central nervous system related adverse reactions decreased over time.
In monotherapy 49.8 % of the subjects experienced at least one drug related adverse reaction. The most frequently reported adverse reactions were fatigue and somnolence.
A study conducted in adults and adolescents with myoclonic seizures (12 to 65 years) showed that 33.3 % of the patients in the Levetiracetam Oral Solution group and 30.0 % of the patients in the placebo group experienced adverse reactions that were judged to be related to treatment. The most commonly reported adverse reactions were headache and somnolence. The incidence of adverse reactions in patients with myoclonic seizures was lower than that in adult patients with partial onset seizures (33.3 % versus 46.4 %).
A study conducted in adults and children (4 to 65 years) with idiopathic generalised epilepsy with primary generalised tonic-clonic seizures showed that 39.2 % of the patients in the Levetiracetam Oral Solution group and 29.8 % of the patients in the placebo group experienced undesirable effects that were judged to be related to treatment. The most commonly reported adverse reaction was fatigue.
An increase in seizure frequency of more than 25 % was reported in 14 % of levetiracetam treated adult and paediatric patients (4 to 16 years of age) with partial onset seizures, whereas it was reported in 26 % and 21 % of placebo treated adult and paediatric patients, respectively.
When Levetiracetam Oral Solution was used to treat primary generalised tonic-clonic seizures in adults and adolescents with idiopathic generalised epilepsy, there was no effect on the frequency of absences.
Adverse reactions that resulted from Levetiracetam Oral Solution intravenous use are similar to those associated with Levetiracetam Oral Solution oral use. The most frequently reported adverse reactions were dizziness, somnolence, headache and postural dizziness. Since there was limited exposure for Levetiracetam Oral Solution intravenous use and since oral and intravenous formulations are bioequivalent, the safety information of Levetiracetam Oral Solution intravenous will rely on Levetiracetam Oral Solution oral use.
Description of selected adverse reactions: The risk of anorexia is higher when topiramate is coadministered with levetiracetam. In several cases of alopecia, recovery was observed when levetiracetam was discontinued.
Paediatric population: A study conducted in paediatric patients (4 to 16 years) with partial onset seizures showed that 55.4 % of the patients in the Levetiracetam Oral Solution group and 40.2 % of the patients in the placebo group experienced adverse reactions. Serious adverse reactions were experienced in none of the patients in the Levetiracetam Oral Solution group and 1.0 % of the patients in the placebo group. The most commonly reported adverse reactions were somnolence, hostility, nervousness, emotional lability, agitation, anorexia, asthenia and headache in the paediatric population. Safety results in paediatric patients were consistent with the safety profile of levetiracetam in adults except for behavioural and psychiatric adverse reactions which were more common in children than in adults (38.6 % versus 18.6 %). However, the relative risk was similar in children as compared to adults.