The use of Epitomax for the treatment of acute migraine attacks has not been studied. Caution should be exercised in patients with renal and hepatic impairment, nephrourolithiasis (including personal and family history), hypercalciuria. Patients with impaired renal function and patients on hemodialysis require correction of epitomax dosing regimen.
Epitomax should be discontinued gradually to minimize the possibility of increased seizure frequency. In clinical trials in adults treated for epilepsy, doses were reduced by 50-100 mg at 1 week intervals and by 25-50 mg in adults receiving Epitomax at a dose of 100 mg/day to prevent migraine. In children in clinical trials, Epitomax was gradually withdrawn over 2-8 weeks. If a rapid withdrawal of Epitomax is medically necessary, it is recommended to monitor the patient’s condition.
Fluid intake should be increased during treatment to reduce the risk of nephrolithiasis. Against the background of Epitomax use there may be decreased sweating and hyperthermia, especially in young children, in conditions of high ambient temperature. Sufficient fluid replacement before and during activities such as exercise or exposure to high temperatures may reduce the risk of overheating-related complications.
Patients should be monitored during the treatment period for signs of suicidal ideation and appropriate treatment should be prescribed. Patients (and their caregivers, if necessary) should be advised to seek immediate medical attention if signs of suicidal ideation or suicidal behavior appear.
If visual disturbances occur, including syndrome involving myopia associated with closed-angle glaucoma, Epitomax should be discontinued as soon as the treating physician considers it possible. If necessary, measures should be taken to lower intraocular pressure.
To avoid the occurrence of metabolic acidosis, necessary tests, including determination of serum bicarbonate concentrations, are recommended during treatment with Epitomax. If metabolic acidosis occurs and persists, it is recommended to reduce the dose or discontinue Epitomax. In children, chronic metabolic acidosis may lead to growth retardation. The effect of Epitomax on growth and possible complications related to the bone system have not been systematically studied in children and adults.
If body weight decreases during treatment, dietary adjustments should be made. Simultaneous use of other drugs that have a depressing effect on the central nervous system is not recommended. During the treatment the patient should avoid drinking alcohol.
Caution should be used in patients engaged in potentially hazardous activities that require increased attention and rapid psychomotor reactions, because epitomax may cause drowsiness, dizziness, visual disturbances.