OSPOLOT

What it is

Ospolot is a film-coated tablet containing 50 mg or 200 mg of sulthiame. The structure of sulthiame is distinct from that of other anticonvulsants and is a cyclic sulfonamide derivative without antimicrobial activity. Sulthiame is a carbonic anhydrase inhibitor.

Approved indications

Ospolot is indicated as an anticonvulsant for the following: — Behavioural disorders associated with epilepsy — Hyperkinetic behaviour — Temporal lobe epilepsy — Myoclonic seizures — Grand mal attacks — Jacksonian seizures

Dosing overview

Treatment should start with a low dosage which is gradually increased until clinical response is satisfactory, which may require four weeks. Ospolot tablets should preferably be swallowed whole with a little fluid after meals. For adults, the initial dose is 100 mg twice daily or 50 mg three times daily, with an optimum dose of 200 mg three times daily. For children, the initial dose is 3–5 mg/kg daily in equal divided doses, with an optimum dose of 10–15 mg/kg daily in equal divided doses.

Key safety warnings

Antiepileptic drugs, including sulthiame, increase the risk of suicidal thoughts or behaviour in patients taking these drugs for any indication. Patients treated with any antiepileptic drug should be monitored for the emergence or worsening of depression, suicidal thoughts or behaviour, and any unusual changes in mood or behaviour. The increased risk of suicidal thoughts or behaviour with antiepileptic drugs was observed as early as one week after starting drug treatment and persisted for the duration of treatment assessed. Patients, their caregivers, and families should be instructed to consult the attending doctor immediately if fever, sore throat, allergic skin reactions with lymph node swelling and/or flu-like symptoms occur during treatment. Progressive thrombocytopenias or leukopenias that are accompanied by clinical symptoms, such as fever or sore throat, require interruption of treatment. Alcohol must not be consumed during treatment, as sulthiame is a sulfonamide derivative and can theoretically have a similar effect to Disulfiram, causing a very unpleasant, although generally self-limiting systemic reaction with symptoms including pulsating headache, respiratory depression, nausea, vomiting, tachycardia, hypotension, confusion, shock reactions, arrhythmias, loss of consciousness and seizures.

Contraindications

Ospolot may not be used in cases of known hypersensitivity to sulthiame, other sulfonamides or to any of the excipients. Sulthiame should not be used in patients with known acute porphyria, hyperthyroidism or arterial hypertension. Patients with rare hereditary problems of galactose intolerance, lactase deficiency or glucose-galactose malabsorption should not take Ospolot.

PBS listing

Ospolot 50 mg tablets are listed on the PBS with a restricted listing, at an ex-manufacturer price of A$52.23, with 2 PBS items. Ospolot 200 mg tablets are listed on the PBS with a restricted listing, at an ex-manufacturer price of A$137.17, with 2 PBS items.

Regulatory history

Ospolot was first approved on 8 October 1991. The 50 mg tablets (ARTG 18847) and 200 mg tablets (ARTG 18848) were both first listed on the Australian Register of Therapeutic Goods on 1991-10-08.