Sulthiame: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: February 20, 2026🚩 Report this page

Sulthiame

Other Antiepileptics

GB MHRA

Drug class: Other Antiepileptics
Availability: See label
Markets covered: 1
Products on record: 1

Overview

Sulthiame is an active pharmaceutical ingredient in the Other Antiepileptics group (N03AX). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
GB United Kingdom	MHRA	1	February 20, 2026

GBUnited Kingdom· MHRA

1 product

Uses

GBOfficial regulatory label· revised February 20, 2026[1]

For treatment of Rolandic epilepsy (benign childhood epilepsy with centrotemporal spikes).
Note:
Treatment with Ospolot should only be conducted by a paediatric neurologist with sufficient experience in treating epilepsy. There is limited evidence from controlled clinical trials on the efficacy and safety of Ospolot. Prior to starting treatment with sulthiame, a thorough differential diagnostic procedure regarding other types of childhood epilepsies is indicated.
Rolandic epilepsies demonstrate a high percentage of spontaneous remissions – even without drug treatment – and usually show a favourable course of disease and a good prognosis.

How to take

Sources & citations

[1]MHRA (UK) · PL140400041 · revised February 20, 2026

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

GBOfficial regulatory label· revised February 20, 2026[1]

Posology The dose must be established and monitored by the doctor on an individual basis. The maintenance dose is about 5 to 10 mg per kg body weight per day. It should be built up step-wise (tapered in) over a one-week period. Due to the short half-life of sulthiame, the daily dose should as far as possible be spread over three single doses (see tables 1 and 2 with dosing examples).
If the daily dose is spread over the day in this way, constant plasma levels are to be expected after five to six days. Therapeutic plasma concentrations of sulthiame have not yet been determined. A switch from another medicinal product or from combination treatment should be done gradually.
Paediatric population Ospolot is suitable for use in children and adolescents weighing 12 kg or more. For dosing examples, refer to tables 1 and 2. However, dose titration must be carried out on an individual basis. 25 ml = 5 mg sulthiame Duration of treatment Ospolot should not be discontinued abruptly.
A paediatric neurologist experienced in treating epilepsy should decide on the duration of treatment and discontinuation on an individual basis. If therapy is not successful, treatment with sulthiame should be discontinued after about one to two months.
Method of administration Ospolot is for oral use. A graduated 10 ml oral syringe with a corresponding adapter, and instructions for use within the package leaflet, are provided. Before taking Ospolot, the bottle should be shaken very well (at least once for 30 seconds) and the dose drawn-up immediately afterwards (to avoid sedimentation).
The oral suspension may be swallowed directly from the oral syringe, or taken straight after mixing it, preferably with a small volume of water or alternatively with orange juice, milk, yoghurt or wheat porridge. When taking the oral suspension directly from the oral syringe, the patient should drink some water, juice or milk immediately afterwards due to the bitter taste of sulthiame.
Ospolot may be taken with or without food but carbonated beverages or hot food should be avoided as these can cause eructation or slowed swallowing. It is preferable that the way Ospolot is taken remains constant during therapy. The oral suspension may also be administered via a feeding tube that should be flushed with a minimum of 15 ml of water immediately after administration.
If this method of administration is used, the dose should be prepared as above immediately before administration.

This is not medical advice. Consult a qualified healthcare professional.

Side effects & warnings

GBOfficial regulatory label· Adverse reactions· revised February 20, 2026[1]

g. g. nausea, vomiting (in about 10% of patients) Not known: diarrhoea Hepatobiliary disorders Not known: hepatotoxic reactions, increase in liver enzymes Skin and subcutaneous disorders Not known: Stevens-Johnson syndrome, TEN (toxic epidermal necrolysis) Musculoskeletal and connective tissue disorders Uncommon: joint pain Renal and urinary disorders Not known: acute renal failure *Dose-dependent, if necessary the dose should be adjusted.
One patient with long-standing refractory epilepsy experienced progressive weakness of the limbs, hypersalivation, slurred speech, increasing drowsiness up to coma. The symptoms abated within hours of sulthiame being discontinued. Sulthiame is a carbonic anhydrase inhibitor.
g. 5). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

GBOfficial regulatory label· Warnings and precautions· revised February 20, 2026[1]

Sulthiame should not be administered, or only administered with special caution - in patients with impaired renal function - in patients with a history of psychiatric disorders. Laboratory monitoring It is recommended that blood count, liver enzymes and renal function are measured before starting treatment with Ospolot.
They should then be monitored weekly for the first month then at monthly intervals during the first six months. After six months of treatment, two to four checks per year are sufficient.
Note:
Treatment should be discontinued if a persistent increase in creatinine occurs.
Hypersensitivity reactions:
Instructions should be given to seek urgent medical advice if fever, sore throat, allergic skin reactions with lymph node swelling and/or flu-like symptoms occur during treatment with Ospolot. In cases of severe allergic reactions Ospolot must be discontinued immediately.
Progressive thrombocytopenia or leukopenia accompanied by clinical symptoms require discontinuation of Ospolot.
LHON:
In two patients with the inherited Leber hereditary optic neuropathy (LHON), sulthiame was considered a trigger for visual loss. Suicidal ideation and suicidal behaviour Suicidal ideation and behaviour have been reported in patients treated with antiepileptic medicinal products in several indications.
A meta-analysis of randomised placebo controlled trials of anti-epileptic medicinal products has also shown a small increased risk of suicidal ideation and behaviour. The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for sulthiame.
Therefore patients should be monitored for signs of 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 suicidal ideation or behaviour emerge.
Excipients Sodium methyl parahydroxybenzoate (E219) and sodium propyl parahydroxybenzoate (E217) may cause allergic reactions (possibly delayed). Sulphur dioxide (E 220) may rarely cause severe hypersensitivity reactions and bronchospasm.
0026 mg fructose in each ml. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose- isomaltase insufficiency should not take this medicine. Glucose, fructose and sucrose may be harmful to the teeth.
This medicinal product contains less than 1 mmol sodium (23 mg) per ml, that is to say it is essentially “sodium-free”.

This is not medical advice. Consult a qualified healthcare professional.

Overview

Regulatory status by market

GBUnited Kingdom· MHRA

Drugs in the same class

Sources & citations