Pharmacological group: Antiepileptic drugs. ATX code N03A X11.
Active ingredient: Topiramate
1 tablet contains 100 mg Topiramate; excipients: microcrystalline cellulose lactose monohydrate, corn starch; sodium starch (type A); copolyvidone; talc silicon dioxide colloidal magnesium stearate; coating for coating Opadry II Yellow (Topiromax 100): polyvinyl alcohol, polyethylene glycol, quinoline yellow (E 104), talc, titanium dioxide (E 171), iron oxide yellow (E172), iron oxide red (E 172).
- Monotherapy for the treatment of adults and children over 6 years of age with partial epileptic seizures with or without secondary generalized seizures and with primary generalized tonic-clonic seizures;
- adjunctive therapy for the treatment of adults and children over 2 years of age with partial epileptic seizures with or without secondary generalized seizures, or primary generalized tonic-clonic seizures and treatment for seizures associated with Lennox-Gastaut syndrome;
- prevention of migraine attacks in adults after careful assessment of alternative treatment options;
- Topiramate is not recommended for the treatment of acute conditions.
Hypersensitivity to the components of the drug. Prevention of migraine in pregnant women and women of reproductive age, unless they use highly effective methods of contraception.
Method of administration and dosage:
In both adults and children, treatment should be started with the lowest dose of Topiramate, and then the effective dose should be gradually selected. The dose of the drug and the level of its increase should be selected in accordance with the effect of the treatment. The drug can be taken with or without food.
Monitoring plasma concentrations of topiramate is not necessary to optimize treatment. In rare cases, concomitant phenytoin therapy with Topiramate may require a dose adjustment of phenytoin to achieve optimal clinical response. The addition or withdrawal of phenytoin or carbamazepine during concomitant therapy with topiramate may require dose adjustment.
Antiepileptic drugs, including Topiramate, should be withdrawn gradually to minimize the possibility of seizures and an increase in seizure frequency, regardless of a history of attacks or epilepsy. Reduce daily doses by 50-100 mg at weekly intervals in adult patients with epilepsy and by 25-50 mg in adults who received topiramate at a dose of up to 100 mg per day for the prevention of migraine. For children, the difference between topiramate should be carried out gradually over 2-8 weeks.
The use of monotherapy with Topamax should be based on observations of the manifestations of seizures when concomitant therapy with antiepileptic drugs is canceled. If, for safety reasons, it is not necessary to urgently discontinue concomitant antiepileptic drugs, it is recommended to consistently reduce their dose by about one third of the previous dose within 2 weeks.
After stopping the intake of drugs with the properties of enzyme inducers responsible for the metabolism of drugs, the levels of topiramate increase. The patient’s health condition may require a reduction in doses of topiramate.
Dose selection should begin with 25 mg of topiramate taken at night for a week. In the future, the dose can be increased by 25-50 mg at weekly or two-week intervals and taken in two doses. If the patient does not have time to adapt to the dose increase, smaller dose increases or larger intervals between increases can be used.
When choosing a dose, you should be guided by therapeutic efficacy. The recommended level of the initial target dose of Topamax for monotherapy in adults is from 100 mg to 200 mg per day, divided into 2 doses, and the maximum recommended dose is 500 mg per day. Some patients with refractory forms of epilepsy tolerate Topamax monotherapy at a dose of 1000 mg per day well. These dosage recommendations may be appropriate for all adult patients, including elderly patients, in the absence of renal disease.
Children from the age of 6.
Treatment of children over 6 years old should be started with 0.5-1 mg / kg body weight of Topamax at night during the first week. In the future, the dose can be increased by 0.5-1 mg / kg of body weight per day with a weekly or two-week interval; the daily dose can be divided into 2 doses. If the child is unable to adjust to the dose adjustment regimen, smaller dose increases or longer intervals between increases may be used.
When choosing a dose, you should be guided by therapeutic efficacy. The recommended level of the initial target dose of Topamax for monotherapy in children aged 6 years and older is 100 mg per day, depending on the clinical response (about 2 mg / kg of body weight per day for children 6-16 years old). If it is necessary to use smaller doses, other Topiramate preparations should be taken with the possibility of such dosage.
Store in its original packaging at a temperature not exceeding 25 °C.
Produced in Ukraine