Sultiame 200mg tablets

Cerebral palsy (CP) is often combined with epilepsy and epileptiform activity on the electroencephalogram. Uncontrolled epileptic seizures in CP limit rehabilitation opportunities, which aggravates motor and cognitive deficits. The main epileptic syndromes in children with CP are focal epilepsy with structural changes in the brain and benign epileptiform patterns of childhood on the electroencephalogram and structural focal epilepsy; the main types of seizures are focal motor, bilateral tonic-clonic, febrile-provoked seizures may also be observed. In CP, seizures often have a status course, can last more than 30 minutes and are stopped only in the intensive care unit. One patient may have several types of seizures, including epileptic status. Even in the absence of seizures, changes in the electroencephalogram are detected both in the form of regional epileptiform activity, often in the structure of regional prolonged slowing, and in the form of benign epileptiform patterns of childhood. Valproates, topiramate, levetiracetam, zonisamide, lamotrigine, ethosuximide, perampanel, vigabatrin, sultiame, rufinamide are recommended in the treatment of epilepsy in CP. We present a literature review and analysis of our own data on the use of zonisamide in patients with epilepsy and CP aged 6 to 17 years.

Abstract licence: CC BY

The impetus for writing this article was the recent publication in The Lancet (October 2025) of the results of a multicenter, randomized, double-blind, placebo-controlled trial of sultiame, a well-known antiepileptic drug, in patients with obstructive sleep apnea without epilepsy. This article analyzes the role of apnea in epilepsy, issues of diagnostics and therapy are considered. Key findings: apnea is a common, underestimated comorbidity of epilepsy, worsening the course of the underlying disease, and is a trigger for sudden unexpected death in epilepsy. Patients with epilepsy should be assessed for the risk of developing ictal apnea and screened for obstructive sleep apnea to ensure timely detection and treatment. A number of antiepileptic drugs (benzodiazepines, valproates) can cause or exacerbate apnea. Based on the high-quality evidence obtained, sultiame should be considered as a first-line antiepileptic drug in patients with epilepsy and apnea.

Abstract licence: CC BY

A pilot study was conducted aiming at specifying sultiame's pharmacokinetic profile, completed by in vitro assays evaluating the intraerythrocytic transfer of sultiame and by a pharmacokinetic model assessing its distribution. Single oral doses of sultiame (Ospolot® 50, 100, and 200 mg) were administered in open‐label to four healthy volunteers. Serial plasma, whole blood, and urine samples were collected. A spiking experiment was also performed to characterize sultiame's exchanges between plasma and erythrocytes in vitro. Pharmacokinetic parameters were evaluated using standard noncompartmental calculations and nonlinear mixed‐effect modeling. The plasma maximal concentrations (Cmax) showed striking nonlinear disposition of sultiame, with a 10‐fold increase while doses were doubled. Conversely, whole blood Cmax increased less than dose proportionally while staying much higher than in plasma. Quick uptake of sultiame into erythrocytes observed in vivo was confirmed in vitro, with minimal efflux. A two‐compartment model with first‐order absorption, incorporating a saturable ligand to receptor binding, described the data remarkably well, indicating apparent plasma clearance of 10.0 L/h (BSV: 29%) and distribution volume of 64.8 L; saturable uptake into an intracellular compartment of 3.3 L with a maximum binding capacity of 111 mg accounted for nonlinearities observed in plasma and whole blood concentrations. Pharmacokinetic characteristics of sultiame are reported, including estimates of clearance and volume of distribution that were so far unpublished. The noticeable nonlinearity in sultiame disposition should be taken into account for the design of future studies and the interpretation of therapeutic drug monitoring results.

Abstract licence: CC BY 4.0

The purpose of this study is to develop population pharmacokinetic models for antiepileptic drugs in a pediatric population. The interest of these models is multiple: * describe the pharmacokinetics of these molecules in children and explain the inter-individual variability of concentrations through covariates such as weight, age, co-treatments, genetic polymorphisms and renal function; * estimate maximum, minimum and exposure concentrations from the individual pharmacokinetic parameters for each patient; * propose adaptations of doses for certain classes of children (according to age, weight etc.) and individualize the doses. Conditions: Epilepsy. Interventions: Valproic acid, carbamazepine, phenobarbital, phenytoin, levetiracetam, lamotrigine, topiramate, oxcarbazepine, stiripentol, clobazam, brivaracétam, felbamate, lacosamide, rufinamide, gabapentine, pregabaline, sultiame, tiagabine, vigabatrine, mesuximide, primidone, perampanel, ethosuximide, zonisamide, cannabidiol, genetic polymorphisms.

Source: ClinicalTrials.gov (public domain)