As monotherapy for the treatment of adults and children from the age of 6 with partial onset seizures with or without secondary generalized seizures and initially generalized tonic-clonic seizures. As adjunctive therapy for the treatment of adults and children from 2 years of age with partial onset seizures with or without secondary generalized seizures or initially generalized tonic-clonic seizures associated with Lennox-Gasto syndrome. For the prevention of migraine attacks in adults, after careful evaluation of alternative treatment options. Topiramate is not recommended for the treatment of acute conditions.
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Composition and form of release
Main active ingredient: topiramate.
Auxiliary components are: cellulose, celactose, sodium croscarmellose, stearic acid, titanium dioxide, talc, etc.
It is produced in the form of tablets, in a dosage of 50 mg.
This pharmaceutical agent is included in the group of antiepileptic drugs.
Its main component, topiramate, belongs to sulfamate-substituted monosaccharides.
Electrophysiological and biochemical studies were carried out, which established that topiramate has three mechanisms of drug action, which make it possible to realize its antiepileptic effects.
This substance is primarily capable of blocking sodium channels and suppressing the appearance of repetitive exposure potentials.
Also, thanks to topiramate, certain receptors are activated with the help of g-aminobutyrate, due to which these receptors are stimulated to produce a stream of chloride ions up to neurons. As a consequence, inhibitory neurotransmitters activate their effects.
Finally, topiramate is able to inhibit the activation of certain receptors for glutamate amino acids.
The indicated properties of topiramate are dose-dependent.
In addition to the listed effects, topiramate helps to inhibit the activity of certain isoenzymes of the enzyme carbonic anhydrase, which is encoded in humans using the CA4 gene.
It should be noted that topiramate is less effective than acetazolamide (a carbonic anhydrase inhibitor).
Used for the treatment of epilepsy, both in monotherapy and in combination (with partial, generalized tonic-clonic seizures, as well as seizures associated with Lennox-Gastaut syndrome).
Also used to prevent the development of migraine attacks (in adults).
The drug in question is contraindicated for use in cases where the patient has severe hypersensitivity (allergy) to the main or to one of the auxiliary components.
It is contraindicated to use in pediatrics until the age of 6 years. From 2 years old it can be used as part of combination therapy.
Application during pregnancy and lactation
This drug is contraindicated in the treatment of pregnant women.
If it is necessary to administer the drug during breastfeeding, then lactation should be suspended for the duration of treatment.
Method of administration and dosage
This drug is used in the minimum effective dosage, it is taken once a day, before going to bed, or 2 times a day (at doses over 25 mg per day).
In monotherapy, treatment begins with minimal dosages (25 mg per day in children, 100 mg in adults), with a gradual increase in dosage (if necessary) by 25-50 mg per week.
If necessary, end treatment – interruption of admission is also made by gradually reducing the dosage (by 100 mg per week).
It is taken orally, the effect does not depend on food intake. The maximum recommended dose per day is 500 mg, with a refractory form – up to 1 thousand mg. The maximum allowable daily dose is 1600 mg.
The maximum daily dose for children is calculated at the rate of 5 to 9 mg per 1 kg of patient weight, per day. The initial dose is 0.5-1 mg per 1 kg, increases by the same amount per week and is brought to 3-6 mg per 1 kg of body weight. As with adults, it can be taken once a day.
In renal diseases, the dose is reduced by 50%.
When used in combination therapy, the initial dosage is the same as that used in monotherapy. The usual recommended dose per day is 200 mg, on average, 200-400 mg per day is taken (no more than 1,000 mg).
Migraines are treated with an average dosage of 100 mg per day, with an initial dose of 25 mg per day.
Overdose can cause:
- convulsions, drowsiness, dizziness, agitation / depression;
- disorders of speech, vision, thinking, coordination of movements;
- diplopia, lethargy, stupor;
- arterial hypotension, metabolic acidosis.
Urgent gastric lavage, symptomatic therapy, hemodialysis, and increased fluid intake are recommended.
In some cases, there may be some side effects in the form of:
- nervousness, dizziness, headache, speech disorders, vision, thinking, coordination of movements, as well as ataxia, fatigue;
- anorexia, nystagmus, paresthesia, depression;
- in children – personality disorders, salivation, hyperkinesia, disturbances in taste, emotional lability, apathy, psychosis, aggression, in rare cases – suicidal thoughts, hallucinations;
- decrease in the depth of the anterior chamber of the eye, eye hyperemia, increased intraocular pressure, diplopia, mydriasis;
- dyspepsia, nausea, diarrhea, abdominal pain, dry lips, hepatitis, liver failure;
- weight loss, asthenia, nephrolithiasis, oligohydrosis (in children), metabolic acidosis, fever;
- erythema multiforme, pemphigus, Stevens-Johnson syndrome, toxic epidermal necrolysis;
- leukopenia, neutropenia;
- thromboembolism (isolated cases).
Storage conditions and periods
The shelf life is up to 2 years.
Storage temperature – no higher than 25 ° С.