Topamax capsules 25mg, No. 60

Epilepsy:

• as monotherapy in adults and children over 2 years of age with epilepsy (including in patients with newly diagnosed epilepsy);

• as part of complex therapy in adults and children over 2 years of age with partial or generalized tonic-clonic seizures, as well as for the treatment of seizures against the background of Lennox-Gastaut syndrome.

Migraine:

• prevention of migraine attacks in adults (the use of TopamaxЃ for the treatment of acute migraine attacks has not been studied).

The drug is taken orally, regardless of food intake.

The capsules should be carefully opened, mixed with a small amount (about 1 teaspoon) of any soft food. This mixture should be swallowed immediately without chewing. Do not store the drug mixed with food until the next dose. TopamaxЃ capsules can be swallowed whole.

To achieve optimal control of epileptic seizures in adults and children, it is recommended to start treatment with the drug in low doses, followed by titration to the effective dose.

The capsules are intended for patients who have difficulty swallowing tablets (for example, children and elderly patients).

Partial or generalized tonic-clonic seizures, as well as seizures associated with Lennox-Gastaut syndrome

Combined anticonvulsant therapy in adults. The minimum effective dose is 200 mg / day. Usually the total daily dose ranges from 200 mg to 400 mg and is taken in 2 divided doses. Some patients may need to increase the daily dose to a maximum of 1600 mg. It is recommended to start treatment with a low dose, followed by a gradual selection of the effective dose. The selection of the dose begins with 25-50 mg, taking them at night for 1 week. In the future, at intervals of 1-2 weeks, the dose can be increased by 25-50 mg and taken in 2 divided doses. When choosing a dose, it is necessary to be guided by the clinical effect. In some patients, the effect can be achieved by taking the drug 1 time / day. To achieve the optimal effect of treatment with TopamaxЃ, it is not necessary to control its plasma concentration.

These dosage recommendations apply to all adult patients, including elderly patients, in the absence of renal disease.

Combined anticonvulsant therapy in children over 2 years of age. The recommended total daily dose of TopamaxЃ as an adjunctive therapy is from 5 to 9 mg / kg and is taken in 2 divided doses. Dose titration should be started at 25 mg (or less, based on an initial dose of 1 to 3 mg / kg per day) at night for 1 week. In the future, the dose can be increased with an interval of 1-2 weeks by 1-3 mg / kg and taken in 2 divided doses. When choosing a dose, it is necessary to be guided by the clinical effect. A daily dose of up to 30 mg / kg is usually well tolerated.

Epilepsy (including newly diagnosed epilepsy)

When discontinuing concomitant anticonvulsants for topiramate monotherapy, consideration should be given to the possible effect of this step on seizure frequency. In cases where there is no need to abruptly discontinue concomitant antiepileptic drugs for safety reasons, it is recommended to reduce their dose gradually, reducing the dose of concomitant antiepileptic drugs by 1/3 every 2 weeks.

With the abolition of drugs that are inducers of liver microsomal enzymes, the concentration of topiramate in the blood will increase. In such situations, in the presence of clinical indications, the dose of TopamaxЃ can be reduced.

When monotherapy for adults, at the beginning of treatment, TopamaxЃ is prescribed in a dose of 25 mg at bedtime for 1 week. Then the dose is increased at intervals of 1-2 weeks by 25 mg or 50 mg in 2 divided doses. If the patient does not tolerate such a dose escalation regimen, then the intervals between dose increases can be increased, or the dose can be increased more smoothly. When choosing a dose, it is necessary to be guided by the clinical effect. The initial dose for monotherapy with topiramate in adults is 100 mg / day, and the maximum daily dose should not exceed 500 mg. Some patients with refractory forms of epilepsy tolerate topiramate monotherapy at doses up to 1000 mg / day. These dosing recommendations apply to all adults, including elderly patients without kidney disease.

For monotherapy, children over the age of 2 years in the first week of treatment, TopamaxЃ is prescribed in a dose of 0.5-1 mg / kg of body weight before bedtime. Then the dose is increased at intervals of 1-2 weeks by 0.5-1 mg / kg / day in 2 divided doses. If the child does not tolerate such a dose escalation regimen, then the dose can be increased more smoothly or the intervals between dose increases can be increased. The size of the dose and the rate of its increase depend on the clinical effect. The recommended dose range for monotherapy with topiramate in children over the age of 2 years is 100-400 mg / day. Children with recently diagnosed partial seizures can be given up to 500 mg / day.

Migraine

For the prevention of migraine attacks, the recommended daily dose of topiramate is 100 mg in 2 divided doses. At the beginning of treatment, 25 mg is prescribed at bedtime for 1 week. Then the dose is increased by 25 mg / day with an interval of 1 week. In case of intolerance to such a therapy regimen, the dose is increased by a smaller amount or at longer intervals. The dose is selected depending on the clinical effect. In some cases, a positive result is achieved with a daily dose of 50 mg topiramate. In clinical studies, patients received various doses of topiramate, but not more than 200 mg / day.

Special patient groups

In patients with moderate to severe renal impairment, dose reduction may be necessary. It is recommended to use half of the recommended starting and maintenance dose.

Hemodialysis: since topiramate is removed from the plasma during hemodialysis, an additional dose of TopamaxЃ should be administered on the days of hemodialysis, equal to approximately half the daily dose. The additional dose should be divided into two doses taken at the beginning and after the end of the hemodialysis procedure. The additional dose may vary depending on the characteristics of the equipment used in the hemodialysis.

In patients with hepatic impairment, topiramate should be used with caution.

Hard gelatin capsules

1 caps.

topiramate

Excipients: sugar crumbs (sucrose, starch syrup) - 45 mg, povidone - 10.4199 mg, cellulose acetate - 5.423 mg.

• children under 2 years of age;

• hypersensitivity to the components of the drug.

It should be used with caution in renal or hepatic failure, nephrourolithiasis (including in the past or in a family history), with hypercalciuria.

Antiepileptic drug, belongs to the class of sulfamate-substituted monosaccharides.

Topiramate blocks sodium channels and suppresses the emergence of repeated action potentials against the background of prolonged depolarization of the neuron membrane. Topiramate increases the activity of GABA (GABA) in relation to some subtypes of GABA receptors (including GABAA receptors), and also modulates the activity of GABAA receptors themselves, prevents kainate from activating the sensitivity of the kainate / AMPK subtype (alpha-amino-3-hydroxy -5-methylisoxazole-4-propionic acid) glutamate receptors, does not affect NMDA activity against the NMDA receptor subtype. These effects of the drug are dose-dependent at a plasma concentration of topiramate from 1 ?mol to 200 ?mol, with a minimum activity ranging from 1 ?mol to 10 ?mol.

In addition, topiramate inhibits the activity of some isoenzymes of carbonic anhydrase. In terms of the severity of this pharmacological effect, topiramate is significantly inferior to acetazolamide, a well-known inhibitor of carbonic anhydrase, therefore, this activity of topiramate is not the main component of its antiepileptic activity.

Pharmacokinetics

Suction

After taking the drug inside, topiramate is quickly and effectively absorbed from the gastrointestinal tract. Bioavailability is 81%. Food intake does not have a clinically significant effect on the bioavailability of the drug.

Pharmacokinetics of topiramate is linear, plasma clearance remains constant, and AUC in the dose range from 100 mg to 400 mg increases in proportion to the dose.

After repeated oral administration at a dose of 100 mg 2 times / day, Cmax averages 6.76 ?g / ml.

Distribution

Plasma protein binding is 13-17%.

After a single oral administration in a dose of up to 1200 mg, the average Vd is 0.55-0.8 l / kg. The Vd value is gender dependent. In women, the values ??are approximately 50% of the values ??observed in men, which is associated with a higher content of adipose tissue in the body of women.

In patients with normal renal function, it may take 4 to 8 days to reach equilibrium.

Metabolism

After oral administration, about 20% of the dose is metabolized.

Six practically inactive metabolites were isolated and identified from human plasma, urine and feces.

Withdrawal

Topiramate (70%) and its metabolites are excreted mainly by the kidneys.

After oral administration, the plasma clearance of the drug is 20-30 ml / min.

After repeated administration of the drug 50 mg and 100 mg 2 times / day, the average T1 / 2 averaged 21 hours.

Pharmacokinetics in special clinical situations

The rate of excretion of topiramate by the kidneys depends on renal function and does not depend on age.

In patients with moderate and severe renal impairment (CC ? 70 ml / min), the renal and plasma clearance of topiramate decreases, as a consequence, an increase in the Css of topiramate in the blood plasma is possible compared with patients with normal renal function. The time to reach Css of topiramate in blood plasma in patients with moderate or severe renal impairment is 10 to 15 days. Patients with moderate to severe renal impairment are advised to use half the recommended starting and maintenance dose.

In elderly people who do not suffer from kidney disease, the plasma clearance of topiramate does not change.

In patients receiving concomitant therapy with antiepileptic drugs that induce enzymes involved in drug metabolism, the metabolism of topiramate increased by 50%.

Topiramate is effectively eliminated by hemodialysis. Prolonged hemodialysis can lead to a decrease in the concentration of topiramate in the blood below the amount required to maintain anticonvulsant activity. To avoid a rapid drop in plasma topiramate concentration during hemodialysis, an additional dose of TopamaxЃ may be required. When adjusting the dose, you should take into account:

1) the duration of hemodialysis;

2) the amount of clearance of the used hemodialysis system;

3) effective renal clearance of topiramate in a patient on dialysis.

Plasma clearance of topiramate is reduced by an average of 26% in patients with moderate to severe hepatic impairment. Therefore, patients with hepatic impairment should use topiramate with caution.

In children under 12 years of age, the pharmacokinetic parameters of topiramate, as in adults receiving the drug as an adjuvant therapy, are linear, while its clearance does not depend on the dose, and Css in plasma increases in proportion to the dose increase. It should be borne in mind that in children, the clearance of topiramate is increased, and its T1 / 2 is shorter. Therefore, at the same dose per 1 kg of body weight, plasma concentrations of topiramate in children may be lower than in adults. In children, as in adults, antiepileptic drugs that induce liver enzymes cause a decrease in the concentration of topiramate in the blood plasma.

Side effect

Determination of the frequency of side effects: very often (? 1/10), often (? 1/100, <1/10), infrequently (? 1/1000 and <1/100), rarely (? 1/10 000 and <1 / 1000) and very rarely (<1/10 000).

From the nervous system: very often - drowsiness, dizziness, paresthesia, in children - apathy, impaired attention; often - nystagmus, lethargy, memory impairment, impaired concentration, tremor, amnesia, hypesthesia, perversion of taste, impaired thinking, speech impairment, cognitive impairment, apathy, mental impairment, psychomotor impairment, sedative effect; infrequently - loss of gustatory sensitivity, akinesia, loss of smell, aphasia, apraxia, aura, burning sensation (mainly on the face and limbs), cerebellar syndrome, disturbance of the circadian rhythm of sleep, impaired coordination of movements, complex partial seizures, convulsions, postural dizziness, increased salivation , dysesthesia, dysgraphia, dyskinesia, dysphasia, dystonia, feeling of 'goose bumps' on the body,tonic-clonic seizures of the grand mal type, hyperesthesia, hypogeusia, hypokinesia, hyposmia, peripheral neuropathy, parosmia, pre-syncope, repetitive speech, impaired touch, stupor, fainting, lack of response to stimuli, in children - psychomotor hyperactivity.

Mental disorders: often - slow thinking, confusion, depression, insomnia, aggressive reactions, agitation, disorientation, emotional lability, erectile dysfunction, in children - behavior change; infrequently - anorgasmia, sexual dysfunction, crying, sexual arousal disorder, dysfemia, early awakening in the morning, euphoric mood, auditory and visual hallucinations, hypomanic states, decreased libido, mania, panic, paranoid states, perseveration of thinking, impaired reading skills, anxiety , sleep disturbances, suicidal ideation or attempts, tearfulness; very rarely - a feeling of hopelessness.

From the digestive system: very often - decreased appetite, anorexia; often - nausea, diarrhea; infrequently - abdominal pain, constipation, dry mouth, impaired sensitivity in the oral cavity, pancreatitis, increased appetite, gastritis, gastroesophageal reflux, bleeding gums, bad breath, flatulence, glossodynia, pain in the oral cavity, thirst, dyspeptic symptoms ( discomfort in the stomach, discomfort in the epigastric region, heaviness in the stomach), in children - vomiting.

From the musculoskeletal system: often - myalgia, muscle spasms, muscle cramps, muscle pain in the chest area, arthralgia; infrequently - pain in the side, muscle stiffness; very rarely - joint swelling, discomfort in the limbs.

From the side of the cardiovascular system: infrequently - bradycardia, palpitations, hot flushes, orthostatic hypotension, Raynaud's phenomenon.

From the side of the organ of vision: often - diplopia, blurred vision, dry eyes; infrequently - violation of accommodation, amblyopia, blepharospasm, transient blindness, one-sided blindness, increased lacrimation, mydriasis, night blindness, photopsia, presbyopia, scotoma (including atrial fibrillation), decreased visual acuity; very rarely - angle-closure glaucoma, involuntary movements of the eyeballs, eyelid edema, myopia, conjunctival edema, maculopathy.

From the side of the organ of hearing: often - ear pain, ringing in the ears, in children - vertigo; infrequently - deafness (including neurosensory and unilateral), discomfort in the ears, hearing impairment.

From the respiratory system: often - shortness of breath, nosebleeds; infrequently - hoarseness, shortness of breath on exertion, nasal congestion, hypersecretion in the paranasal sinuses, in children - rhinorrhea; very rarely - nasopharyngitis.

On the part of the skin and subcutaneous tissues: often - rash, alopecia, itching, decreased sensitivity of the face; infrequently - lack of sweating, allergic dermatitis, skin redness, impaired skin pigmentation, unpleasant skin odor, urticaria; very rarely - erythema multiforme, paraorbital edema, Stevens-Johnson syndrome, toxic epidermal necrolysis.

From the urinary system: often - nephrolithiasis, dysuria, pollakiuria; infrequently - exacerbation of urolithiasis, hematuria, urinary incontinence, frequent urge to urinate, renal colic, pain in the kidney; very rarely - renal tubular acidosis.

From the hematopoietic system: often - anemia; infrequently - leukopenia, lymphadenopathy, thrombocytopenia, in children - eosinophilia; very rarely - neutropenia.

On the part of laboratory parameters: infrequently - a decrease in the content of bicarbonates in the blood (by an average of 4 mmol / l), crystalluria, leukopenia, hypokalemia (a decrease in the level of potassium in the blood serum below 3.5 mmol / l).

General disorders: very often - fatigue, irritability, weight loss; often - asthenia, anxiety, in children - fever; infrequently - facial edema, allergic reactions, hyperchloremic acidosis, increased appetite, metabolic acidosis, polydipsia, cold extremities, fatigue, weakness, calcification; very rarely - generalized edema, flu-like diseases, allergic edema, weight gain.

Application during pregnancy and lactation

There have been no specific controlled studies in which TopamaxЃ was used to treat pregnant women. Topiramate can be damaging to the fetus when used in pregnant women.

Pregnancy records indicate that infants exposed to topiramate in utero are at increased risk of congenital malformations (eg, craniofacial defects such as cleft lip or palate, hypospadias, and malformations of various body systems). These malformations were recorded both with topiramate monotherapy and with its use within the framework of polytherapy.

Compared with the group of patients not taking antiepileptic drugs, the data on the registration of pregnancies with monotherapy with TopamaxЃ indicate an increase in the likelihood of having children with low body weight (less than 2500 g). The relationship of the observed phenomena with the intake of the drug has not been established. In addition, pregnancy records and the results of other studies indicate that the risk of teratogenic effects with combined treatment with antiepileptic drugs is higher than with monotherapy.

The use of TopamaxЃ during pregnancy is justified only if the potential benefit of therapy to the mother outweighs the possible risk to the fetus.

When treating and counseling women of childbearing age, the attending physician should weigh the benefits / risks of treatment and consider alternative treatment options.

If TopamaxЃ is used during pregnancy, or if the patient becomes pregnant while taking the drug, she should be warned of the potential risk to the fetus.

The limited number of observations suggests that topiramate is excreted in breast milk in women. If it is necessary to use TopamaxЃ during lactation, it is necessary to decide whether to stop breastfeeding or to stop taking the drug.

Application for violations of liver function

It should be used with caution in liver failure. In patients with moderate to severe hepatic dysfunction, plasma clearance decreases.

Application for impaired renal function

When prescribing the drug to patients with moderately or severely impaired renal function, it should be borne in mind that it may take 10-15 days to achieve an equilibrium state in this category of patients, as opposed to 4-8 days in patients with normal renal function. Since topiramate is removed from the plasma during hemodialysis, an additional dose of the drug equal to half the daily dose should be prescribed on the days of it, in 2 divided doses (before and after the procedure).

It should be used with caution in renal failure, nephrourolithiasis (including in the past or in a family history), with hypercalciuria.

Application in children

The drug is contraindicated for use in children under 2 years of age.

special instructions

Cancellation of TopamaxЃ (like other antiepileptic drugs) should be gradual in order to minimize the possibility of an increase in the frequency of seizures. In clinical studies, the dose of the drug was reduced by 50-100 mg once a week - for adults in the treatment of epilepsy and by 25-50 mg - in adults receiving TopamaxЃ at a dose of 100 mg / day for the prevention of migraine. In children in clinical trials, TopamaxЃ was gradually withdrawn over 2-8 weeks. If, for medical reasons, a quick cancellation of TopamaxЃ is required, it is recommended to carry out appropriate monitoring of the patient's condition.

 ак и при любом заболевании, схему подбора дозы следует устанавливать в соответствии с клиническим эффектом (т.е. степень контролировани¤ припадков, отсутствие побочных эффектов) и учитывать то, что у больных с нарушением функции почек дл¤ установлени¤ стабильной концентрации в плазме дл¤ каждой дозы может понадобитьс¤ более продолжительное врем¤.

ѕри терапии топираматом возможно возникновение олигогидроза (уменьшенное потоотделение) и ангидроза. ”меньшение потоотделени¤ и гипертерми¤ (повышение температуры тела) могут возникнуть у детей, подверженных воздействию высокой температуры окружающей среды. ѕри терапии топираматом очень важно адекватное повышение объема потребл¤емой жидкости, что способствует снижению риска развити¤ нефролитиаза, а также побочных эффектов, которые могут возникнуть под воздействием физических нагрузок или повышенных температур.

ѕри лечении топираматом наблюдаетс¤ повышенна¤ частота возникновени¤ расстройств настроени¤ и депрессии.

ѕри применении противоэпилептических препаратов, включа¤ “опамаксЃ, увеличиваетс¤ риск по¤влени¤ суицидальных мыслей и суицидального поведени¤ у пациентов, принимающих эти препараты по любым из показаний.

¬ двойных слепых клинических исследовани¤х, частота развити¤ ¤влений, св¤занных с суицидом (суицидальные мысли, попытки суицида, суицид), составл¤ла 0.5% у пациентов, получавших топирамат (у 46 человек из 8652), что примерно в 3 раза выше по сравнению с пациентами, получавшими плацебо (0.2%; 8 человек из 4045). ќдин случай суицида был зафиксирован в двойном слепом исследовании бипол¤рного расстройства у пациента, получавшего топирамат.

“аким образом, необходимо контролировать состо¤ние пациентов с целью вы¤влени¤ признаков суицидальных мыслей и назначать соответствующее лечение. Ќеобходимо рекомендовать пациентам (и при необходимости лицам, ухаживающим за пациентами) сразу же обращатьс¤ за медицинской помощью в случае по¤влени¤ признаков суицидальных мыслей или суицидального поведени¤.

” некоторых пациентов, особенно с предрасположенностью к нефролитиазу, возможно повышение риска образовани¤ камней в почках и по¤влени¤ св¤занных с этим симптомов, таких как почечна¤ колика. „тобы уменьшить этот риск, необходимо адекватное повышение объема потребл¤емой жидкости. ‘акторами риска развити¤ нефролитиаза ¤вл¤ютс¤ нефролитиаз в анамнезе (в т.ч. в семейном), гиперкальциури¤, сопутствующа¤ терапи¤ другими препаратами, способствующими развитию нефролитиаза.

—ледует соблюдать осторожность при назначении препарата “опамаксЃ пациентам с почечной недостаточностью (   <70 мл/мин). Ёто св¤зано с тем, что у таких пациентов клиренс препарата понижен.

” пациентов с нарушени¤ми функции печени “опамаксЃ следует примен¤ть с осторожностью из-за возможного снижени¤ клиренса топирамата.

ѕри применении препарата “опамаксЃ описан синдром, включающий острую миопию с сопутствующей вторичной закрытоугольной глаукомой. —имптомы включают острое снижение остроты зрени¤ и/или боль в глазу. ѕри офтальмологическом обследовании может обнаруживатьс¤ миопи¤, уплощение передней камеры глаза, гипереми¤ (покраснение) глазного ¤блока, повышение внутриглазного давлени¤. ћожет наблюдатьс¤ мидриаз. Ётот синдром может сопровождатьс¤ секрецией жидкости, привод¤щей к смещению хрусталика и радужной оболочки вперед с развитием вторичной закрытоугольной глаукомы. —имптомы обычно по¤вл¤ютс¤ через 1 мес¤ц после начала применени¤ препарата “опамаксЃ. ¬ отличие от первичной открытоугольной глаукомы, котора¤ редко наблюдаетс¤ у больных до 40 лет, вторична¤ закрытоугольна¤ глаукома наблюдаетс¤ при применении топирамата как у взрослых, так и у детей. ѕри возникновении синдрома, включающего миопию, св¤занную с закрытоугольной глаукомой, лечение включает прекращение приема препарата “опамаксЃ, как только лечащий врач сочтет это возможным, и соответствующие меры, направленные на понижение внутриглазного давлени¤. ќбычно эти меры привод¤т к нормализации внутриглазного давлени¤.

ѕовышенное внутриглазное давление любой этиологии при отсутствии адекватного лечени¤ может привести к серьезным осложнени¤м, вплоть до потери зрени¤.

ѕри применении топирамата может возникать гиперхлоремический, не св¤занный с дефицитом анионов, метаболический ацидоз (например, снижение концентрации бикарбонатов в плазме ниже нормального уровн¤ при отсутствии респираторного алкалоза). ѕодобное снижение концентрации бикарбонатов сыворотки крови ¤вл¤етс¤ следствием ингибирующего эффекта топирамата на почечную карбоангидразу. ¬ большинстве случаев, снижение концентрации бикарбонатов происходит в начале приема препарата, хот¤ данный эффект может про¤витьс¤ в любом периоде лечени¤ топираматом. ”ровень снижени¤ концентрации обычно слабый или умеренный (среднее значение составл¤ет 4 ммоль/л при применении у взрослых пациентов в дозе более 100 мг/сут и около 6 мг/кг/сут при применении в педиатрической практике). ¬ редких случа¤х у пациентов отмечалось снижение концентрации ниже 10 ммоль/л. Ќекоторые заболевани¤ или способы лечени¤, предрасполагающие к развитию ацидоза (например, заболевани¤ почек, т¤желые респираторные заболевани¤, эпилептический статус, диаре¤, хирургические вмешательства, кетогенна¤ диета, прием некоторых лекарственных препаратов) могут быть дополнительными факторами, усиливающими бикарбонат-снижающий эффект топирамата.

” детей хронический метаболический ацидоз может приводить к замедлению роста. ¬ли¤ние топирамата на рост и возможные осложнени¤, св¤занные с костной системой, не изучались систематически у детей и у взрослых.

¬ св¤зи с вышеизложенным, при лечении топираматом рекомендуетс¤ проводить необходимые исследовани¤, включа¤ определение концентрации бикарбонатов в сыворотке. ѕри возникновении метаболического ацидоза и его персистировании, рекомендуетс¤ снизить дозу или прекратить прием препарата “опамаксЃ.

?сли на фоне приема препарата “опамаксЃ у пациента уменьшаетс¤ масса тела, то следует рассмотреть вопрос о целесообразности усиленного питани¤.

¬ли¤ние на способность к вождению автотранспорта и управлению механизмами

“опамаксЃ действует на ?Ќ— и может вызывать сонливость, головокружение, нарушение зрени¤ и другие симптомы. Ёти неблагопри¤тные эффекты могут представл¤ть опасность дл¤ больных, управл¤ющих автомобилем и движущимис¤ механизмами, особенно в период, пока не будет установлена реакци¤ больного на препарат.

ѕередозировка

—имптомы: судороги, сонливость, нарушени¤ речи и зрени¤, диплопи¤, нарушени¤ мышлени¤, нарушени¤ координации, летарги¤, ступор, артериальна¤ гипотензи¤, боль в животе, головокружение, возбуждение и депресси¤. ¬ большинстве случаев клинические последстви¤ не были т¤желыми, но были отмечены смертельные случаи после передозировки с использованием смеси нескольких лекарственных средств, включа¤ топирамат. ¬озможно развитие т¤желого метаболического ацидоза.

There is a known case of overdose when the patient took a dose of topiramate from 96 to 110 g, which resulted in a coma, which lasted 20-24 hours. After 3-4 days, the symptoms of overdose resolved.

Treatment: if, shortly before taking an excessive dose of the drug, the patient has eaten, it is necessary to immediately flush the stomach or induce vomiting. In vitro studies have shown that activated carbon adsorbs topiramate. If necessary, symptomatic therapy should be carried out. An effective way to remove topiramate from the body is hemodialysis. Patients are advised to adequately increase the volume of fluid intake.