Below is a list of adverse reactions that are in controlled clinical trials were recorded in children under 2 or tamoxifen alternatives more times more frequently than in adults: loss of appetite, increased appetite, hyperchloraemic acidosis, hypokalemia, behavioral disorders, aggressive reaction, apathy, disturbance of sleep, suicidal thoughts , impaired concentration, lethargy, circadian rhythm sleep, poor quality sleep, lacrimation increased, sinus bradycardia, feeling unwell, gait disturbance.
Below is a list of adverse reactions that are in controlled clinical trials were registered only in children: eosinophilia, psychomotor hyperactivity, vertigo, vomiting, hyperthermia, pyrexia, impaired ability to learn.
Signs and symptoms of an overdose of the drug tamoxifen alternatives: convulsions, drowsiness, speech disturbances, and vision, diplopia, impaired judgment, impaired coordination, lethargy, stupor, hypotension, abdominal pain, dizziness, agitation and depression. In most cases, clinical consequences were not severe, but were observed after an overdose deaths, using a mixture of several drugs, including topiramate. Overdose topiramate can cause severe the metabolic acidosis-cue (see. “Special Instructions” section).
A case of overdose when the patient has received a dose of topiramate is from 96 to 110 g, which resulted in a coma, which lasted 20-24 hours. After 3-4 days of overdose symptoms resolved.
In acute overdose of the drug tamoxifen alternatives , if shortly before the patient took food, should immediately wash out the stomach and cause vomiting. In in vitro studies have shown that activated carbon adsorbs topiramate. If necessary spend symptomatic therapy. An effective way of removing topiramate from the body is hemodialysis. Patients are advised to increase the volume of adequate fluid intake.
Interaction with other drugs
Effect at concentrations of other antiepileptic drugs
Simultaneous treatment) has no effect on the values of their equilibrium concentrations in the plasma, except for certain patients in whom the addition to phenytoin may increase phenytoin concentrations plasma. This may be due to inhibition of a specific enzyme polymorphic isoform of cytochrome . Therefore, each patient who receives phenytoin and which develop clinical signs or symptoms of toxicity, it is necessary to monitor the concentration of phenytoin in plasma. In a study of the pharmacokinetics in patients with epilepsy the addition of topiramate to lamotrigine had no effect on the equilibrium concentration of the last at doses of 100-400 mg topiramate per day. During and after the abolition of lamotrigine (mean dose of 327 mg per day), the equilibrium concentration of topiramate did not change.
Effects of other antiepileptic drugs on the concentration of the drug
Phenytoin and carbamazepine concentrations reduce the drug lasma. The addition or withdrawal of phenytoin or carbamazepine on the background of treatment may require a change in the dose of the latter. The dose should be selected, focusing on achieving the desired clinical effect. The addition or withdrawal of valproic acid does not cause clinically significant changes in the concentration of the drug tamoxifen alternatives in plasma and, hence, enforcement does not require changes .
Digoxin: a study with a single dose of the area under the curve “concentration-time” of digoxin in plasma while taking was decreased by 12%. The clinical relevance of this observation is not clear. The appointment or termination patients receiving digoxin, special attention should be paid to monitoring of digoxin serum concentrations.
Means, depressing the central nervous system: in clinical studies the effects of co-administration with alcohol or other substances depressing the central nervous system, have not been studied. It is recommended with alcohol or other drugs that cause central nervous system depression.
St. John’s wort
a joint reception Topamax and on the basis of Hypericum perforatum preparations (Hypericum perforatum) the concentration of topiramate in plasma can be reduced and, as a consequence, the effectiveness of the drug may also decrease. Clinical studies of the interaction of the drug tamoxifen alternatives® and preparations based on St. John’s wort is not held.