Ospolot

/ Megapharm

The dosage must be established and monitored by the doctor on an individual basis. The maintenance dose is about 5 to 10 mg/kg body weight per day. It should be build up step-wise (tapered in) over a one-week period. This drug have a dose notch. Due to the short half-life of sulthiame, the daily dose should as far as possible be spread over three single doses. 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.
Administration: The film-coated tablets are to be taken unchewed with plenty of liquid (roughly one glass of water), as far as possible spread over 3 single doses.
A change from another medication or to combination treatment must be done gradually.  This drug should not be discontinued abruptly. A neuropaediatrician experienced in treating epilepsy should decide on dose adjustment, 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.
It is recommendable to monitor the blood count and renal function parameters before treatment, then at weekly intervals in the first month of treatment, and
thereafter at monthly intervals. After six months’ treatment, checks every three to six months are sufficient.

Epilepsy.

Ospolot may not be administered in the case of known hypersensitivity to sulthiame, other sulphonamides or other constituents of the drug. Sulthiame should not be administered in patients with a history of acute porphyria in patients with hyperthyroidism or arterial hypertension.

Sulthiame should not be administered, or only administered with special caution in in patients with impaired renal function in patients with a history of psychiatric diseases.
Note: The patient and his or her parents should be told 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 with Ospolot. Due to the potential side effects and allergic reactions mentioned, the blood count and renal function must be regularly monitored. Progressive thrombopenias or leucopenias that are accompanied by clinical symptoms, such as fever or sore throat, necessitate that treatment be interrupted. In the event of severe allergic
reactions, Ospolot must be discontinued immediately. Treatment should also be interrupted if a lasting increase in creatinine occurs.
Use in pregnancy and lactation:  Ospolot may not be used during pregnancy and lactation, as no investigations are available on safety for this period.
May impair alertness. Wine or alcohol should not be consumed. Perform blood, urine and renal function tests.

Gastric complaints can occur in about 10% of patients. The following side effects occasionally occur dose-dependent: paraesthesias in the extremities and in the face, tachypnoea, hyperpnoea, dyspnoea, dizziness, headache, stenocardia, tachycardia, double vision, singultus, weight loss or lack of appetite. In rare cases, hallucinations, anxiety, myasthenic phenomena, lack of drive, joint pain, a grand mal state or increased seizure activity can be triggered. In individual cases, it has been suspected that sulthiame may be associated with the induction of acute renal failure, Stevens-Johnson syndrome, Lyell’s syndrome, or polyneuritis.
In one case, the administration of Ospolot led to progressive weakness of the limbs, hypersalivation, slurred speech, increasing drowsiness up to coma. The symptoms abated within hours of Ospolot being discontinued. See prescribing information for full details.

If sulthiame is combined with phenytoin, the plasma levels of phenytoin can be markedly elevated. This combination requires especially strict monitoring and frequent controls of the phenytoin plasma levels, particularly in the case of impaired renal function. In combination with lamotrigine, an elevation of lamotrigine levels in the blood has also been observed in individual cases. Therefore, lamotrigine levels should be checked more frequently at the beginning of such a treatment. If sulthiame is combined with primidone, the intensity of the side effects of sulthiame may increase; especially in children, dizziness, uncertain gait and drowsiness can occur. During treatment with sulthiame, the patient should abstain from alcohol, since sulphonamides have
an effect similar to that of disulfiram, and sulthiame, as a sulphonamide derivative, can theoretically have a similar effect. These symptoms include a very unpleasant, although generally self-limiting systemic reaction caused by vasodilatation, with pulsating headache, respiratory depression, nausea, vomiting, tachycardia, hypotension, amblyopia, confusion, shock reactions, arrhythmias, loss of consciousness and seizures. The degree and duration of these symptoms can vary to a great extent.

May not be used during pregnancy and lactation, as no investigations are available on safety for this period.

Symptoms of intoxication: Headache, dizziness, ataxia, impaired consciousness, metabolic acidosis, crystals in the urine. Sulthiame has a low toxicity, overdoses of 4 to 5 g sulthiame have been survived. The intake of around 20 g sulthiame by adults with the intention of committing suicide was fatal in one case. In another case, the patient made a full recovery.
Therapy of intoxications: A specific antidote is not known. The standard measures (gastric lavage and active charcoal) for minimising absorption and for maintaining vital functions should be taken. Sodium
bicarbonate can be infused to treat acidosis. Alkalising diuretic therapy is recommended for preventing renal damage and crystalluria.