Mirodep Long p / o prolonged-release tablets 500mg, No. 30

In adults

- For the treatment of generalized epileptic seizures: clonic, tonic, tonic-clonic, absences, myoclonic, atonic; Lennox-Gastaut syndrome (in monotherapy or in combination with other antiepileptic drugs).

- For the treatment of partial epileptic seizures: partial seizures with secondary generalization or without it (in monotherapy or in combination with other antiepileptic drugs).

- For the treatment and prevention of bipolar disorder.

In children

- For the treatment of generalized epileptic seizures: clonic, tonic, tonic-clonic, absences, myoclonic, atonic; Lennox-Gastaut syndrome (in monotherapy or in combination with other antiepileptic drugs).

- For the treatment of partial epileptic seizures: partial seizures with secondary generalization or without it (in monotherapy or in combination with other antiepileptic drugs).

This drug is intended only for adults and children over 6 years old with a body weight of over 17 kg!

This dosage form is not recommended for children under 6 years of age (risk of getting the tablet into the respiratory tract if swallowed)!

The drug is a sustained-release dosage form of the active substance. Prolonged release allows you to avoid sharp rises in the concentration of valproic acid in the blood after taking the drug and for a longer time maintains a constant concentration of valproic acid in the blood during the day.

Valproic Acid 300mg / 500mg Extended Release Tablets may be divided to facilitate individual tailored dose administration.

The tablets are taken without crushing or chewing them.

Dosage regimen for epilepsy

The daily dose is selected individually by the attending physician.

The minimum dose effective to prevent the development of epileptic seizures should be selected (especially during pregnancy). The daily dose should be adjusted according to age and body weight. A stepwise (gradual) increase in the dose is recommended until the minimum effective dose is reached.

There was no clear relationship between daily dose, plasma concentration and therapeutic effect. Therefore, the optimal dose should be determined primarily by clinical response. Determination of the concentration of valproic acid in plasma can serve as an addition to clinical observation if epilepsy is uncontrollable or there is a suspicion of the development of side effects. The range of therapeutic blood concentrations is usually 40 - 100 mg / l (300 - 700 ?mol / l).

In monotherapy, the initial daily dose is usually 5-10 mg of valproic acid per kg of body weight, which is then gradually increased every 4-7 days at the rate of 5 mg of valproic acid per kg of body weight to the dose necessary to achieve control over epileptic seizures.

Average daily doses (with long-term use):

- for children 6-14 years old (body weight 20-30 kg) - 30 mg valproic acid / kg body weight (600-1200 mg);

- for adolescents (body weight 40-60 kg) - 25 mg valproic acid / kg body weight (1000-1500 mg);

- for adults and elderly patients (body weight from 60 kg and more) - an average of 20 mg valproic acid / kg body weight (1200-2100 mg).

Although the daily dose is determined depending on the age and body weight of the patient; a wide range of individual sensitivity to valproate should be taken into account.

If epilepsy cannot be controlled at such doses, they can be increased under the control of the patient's condition and the concentration of valproic acid in the blood. In some cases, the full therapeutic effect of valproic acid does not appear immediately, but develops within 4-6 weeks. Therefore, you should not increase the daily dose above the recommended average daily dose earlier than this.

The daily dose can be divided into 1-2 doses, preferably with meals. A single dose is possible for well-controlled epilepsy.

Active ingredient: Valproic acid 500 mg

- Hypersensitivity to sodium valproate, valproic acid, seminatrium valproate, valpromide, or to any of the components of the drug;

- Acute hepatitis;

- Chronic hepatitis;

- Severe liver disease (especially drug hepatitis) in the patient's history and / or in his close blood relatives;

- Severe liver damage with a fatal outcome when using valproic acid in close blood relatives of the patient;

- Severe violations of the liver or pancreas;

- Hepatic porphyria:

- Established mitochondrial diseases caused by mutations in the nuclear gene encoding the mitochondrial enzyme ?-polymerase (POTG), for example, Alpers-Huttenlocher syndrome. and suspicion of diseases caused by defects in ?-polymerase);

- Patients with established violations of the urea cycle (urea cycle);

- Combination with mefloquine;

- Combination with St. John's wort preparations;

- Children under 6 years of age (risk of getting the tablet into the respiratory tract when swallowing).

Carefully:

- With a history of liver and pancreas diseases;

- During pregnancy;

- With congenital fermentopathies;

- With the suppression of bone marrow hematopoiesis (leukopenia, thrombocytopenia, anemia);

- With renal failure (dose adjustment is required);

- With hypoproteinemia;

- When taking several anticonvulsants at the same time (due to an increased risk of liver damage);

- While taking drugs that provoke seizures or lower the seizure threshold, such as tricyclic antidepressants, selective serotonin reuptake inhibitors, phenothiazine derivatives, buterophenone derivatives, chloroquine, bupropion, tramadol (risk of provoking seizures);

- While taking antipsychotics, monoamine oxidase (MAO) inhibitors, antidepressants, benzodiazepines (the possibility of potentiating their effects);

- While taking phenobarbital, primidone, phenytoin, lamotrigine, zidovudine, felbamate. acetylsalicylic acid, indirect anticoagulants, cimetidine, erythromycin, carbapenems, rifampicin, nimodipine, rufinamide (especially in children), protease inhibitors (lopinavir, ritonavir), colestyramine (due to pharmacokinetic interactions at the level of blood metabolism or plasma changes in plasma concentrations or these drugs and / or valproic acid);

- With the simultaneous use of carbamazepine (the risk of potentiation of the toxic effects of carbamazepine and a decrease in the plasma concentration of valproic acid);

- With the simultaneous use of topiramate or acetazolamide (risk of encephalopathy);

- In patients with existing type II carnitine palmitoyltransferase (CBT) deficiency (higher risk of rhabdomyolysis with valproic acid).

Active ingredient, group

Valproic acid, Antiepileptic agent

Dosage form

Sustained-release film-coated tablets

pharmachologic effect

MIRODEP long is an antiepileptic drug that has a central muscle relaxant and sedative effect.

Valproic acid and its salt, sodium valproate, are derivatives of the fatty acid group. The most likely mechanism of action is an increase in the inhibitory effect of gamma-aminobutyric acid (GABA, GABA) due to the effect on its synthesis and subsequent metabolism.

Indications for use

In adults

- For the treatment of generalized epileptic seizures: clonic, tonic, tonic-clonic, absences, myoclonic, atonic; Lennox-Gastaut syndrome (in monotherapy or in combination with other antiepileptic drugs).

- For the treatment of partial epileptic seizures: partial seizures with secondary generalization or without it (in monotherapy or in combination with other antiepileptic drugs).

- For the treatment and prevention of bipolar disorder.

In children

- For the treatment of generalized epileptic seizures: clonic, tonic, tonic-clonic, absences, myoclonic, atonic; Lennox-Gastaut syndrome (in monotherapy or in combination with other antiepileptic drugs).

- For the treatment of partial epileptic seizures: partial seizures with secondary generalization or without it (in monotherapy or in combination with other antiepileptic drugs).

Contraindications

- Hypersensitivity to sodium valproate, valproic acid, seminatrium valproate, valpromide, or to any of the components of the drug;

- Acute hepatitis;

- Chronic hepatitis;

- Severe liver disease (especially drug hepatitis) in the patient's history and / or in his close blood relatives;

- Severe liver damage with a fatal outcome when using valproic acid in close blood relatives of the patient;

- Severe violations of the liver or pancreas;

- Hepatic porphyria:

- Established mitochondrial diseases caused by mutations in the nuclear gene encoding the mitochondrial enzyme ?-polymerase (POTG), for example, Alpers-Huttenlocher syndrome. and suspicion of diseases caused by defects in ?-polymerase);

- Patients with established violations of the urea cycle (urea cycle);

- Combination with mefloquine;

- Combination with St. John's wort preparations;

- Children under 6 years of age (risk of getting the tablet into the respiratory tract when swallowing).

Carefully:

- With a history of liver and pancreas diseases;

- During pregnancy;

- With congenital fermentopathies;

- With the suppression of bone marrow hematopoiesis (leukopenia, thrombocytopenia, anemia);

- With renal failure (dose adjustment is required);

- With hypoproteinemia;

- When taking several anticonvulsants at the same time (due to an increased risk of liver damage);

- While taking drugs that provoke seizures or lower the seizure threshold, such as tricyclic antidepressants, selective serotonin reuptake inhibitors, phenothiazine derivatives, buterophenone derivatives, chloroquine, bupropion, tramadol (risk of provoking seizures);

- While taking antipsychotics, monoamine oxidase (MAO) inhibitors, antidepressants, benzodiazepines (the possibility of potentiating their effects);

- While taking phenobarbital, primidone, phenytoin, lamotrigine, zidovudine, felbamate. acetylsalicylic acid, indirect anticoagulants, cimetidine, erythromycin, carbapenems, rifampicin, nimodipine, rufinamide (especially in children), protease inhibitors (lopinavir, ritonavir), colestyramine (due to pharmacokinetic interactions at the level of blood metabolism or plasma changes in plasma concentrations or these drugs and / or valproic acid);

- With the simultaneous use of carbamazepine (the risk of potentiation of the toxic effects of carbamazepine and a decrease in the plasma concentration of valproic acid);

- With the simultaneous use of topiramate or acetazolamide (risk of encephalopathy);

- In patients with existing type II carnitine palmitoyltransferase (CBT) deficiency (higher risk of rhabdomyolysis with valproic acid).

Method of administration and dosage:

This drug is intended only for adults and children over 6 years old with a body weight of over 17 kg!

This dosage form is not recommended for children under 6 years of age (risk of getting the tablet into the respiratory tract if swallowed)!

The drug is a sustained-release dosage form of the active substance. Prolonged release allows you to avoid sharp rises in the concentration of valproic acid in the blood after taking the drug and for a longer time maintains a constant concentration of valproic acid in the blood during the day.

Valproic Acid 300mg / 500mg Extended Release Tablets may be divided to facilitate individual tailored dose administration.

The tablets are taken without crushing or chewing them.

Dosage regimen for epilepsy

The daily dose is selected individually by the attending physician.

The minimum dose effective to prevent the development of epileptic seizures should be selected (especially during pregnancy). The daily dose should be adjusted according to age and body weight. A stepwise (gradual) increase in the dose is recommended until the minimum effective dose is reached.

There was no clear relationship between daily dose, plasma concentration and therapeutic effect. Therefore, the optimal dose should be determined primarily by clinical response. Determination of the concentration of valproic acid in plasma can serve as an addition to clinical observation if epilepsy is uncontrollable or there is a suspicion of the development of side effects. The range of therapeutic blood concentrations is usually 40 - 100 mg / l (300 - 700 ?mol / l).

In monotherapy, the initial daily dose is usually 5-10 mg of valproic acid per kg of body weight, which is then gradually increased every 4-7 days at the rate of 5 mg of valproic acid per kg of body weight to the dose necessary to achieve control over epileptic seizures.

Average daily doses (with long-term use):

- for children 6-14 years old (body weight 20-30 kg) - 30 mg valproic acid / kg body weight (600-1200 mg);

- for adolescents (body weight 40-60 kg) - 25 mg valproic acid / kg body weight (1000-1500 mg);

- for adults and elderly patients (body weight from 60 kg and more) - an average of 20 mg valproic acid / kg body weight (1200-2100 mg).

Although the daily dose is determined depending on the age and body weight of the patient; a wide range of individual sensitivity to valproate should be taken into account.

If epilepsy cannot be controlled at such doses, they can be increased under the control of the patient's condition and the concentration of valproic acid in the blood. In some cases, the full therapeutic effect of valproic acid does not appear immediately, but develops within 4-6 weeks. Therefore, you should not increase the daily dose above the recommended average daily dose earlier than this.

The daily dose can be divided into 1-2 doses, preferably with meals. A single dose is possible for well-controlled epilepsy.

Side effects

Congenital, hereditary and genetic disorders:

teratogenic risk.

From the side of the central nervous system: trembling of the hands or arms is possible; rarely - changes in behavior, mood or mental state, diplopia, nystagmus, spots before the eyes, impaired coordination of movements, dizziness, drowsiness, headache, unusual agitation, restlessness or irritability.

On the part of the digestive system: mild cramps in the abdomen or in the stomach, loss of appetite, diarrhea, indigestion, nausea, vomiting are possible; rarely - constipation, pancreatitis.

From the side of the blood coagulation system: thrombocytopenia, prolonged bleeding time.

From the side of metabolism: an unusual decrease or increase in body weight.

On the part of the gynecological status: menstrual irregularities.

Dermatological reactions: alopecia.

Allergic reactions: skin rash.

special instructions

¬ период лечени¤ следует соблюдать осторожность при вождении транспортных средств и других видах де¤тельности, требующих высокой концентрации внимани¤ и быстрых психомоторных реакций.

— осторожностью примен¤ют у пациентов с патологическими изменени¤ми крови, при органических заболевани¤х мозга, заболевани¤х печени в анамнезе, гипопротеинемии, нарушени¤х функции почек.

ѕациентам, которые получают другие противосудорожные средства, лечение вальпроевой кислотой следует начинать постепенно, достига¤ клинически эффективной дозы через 2 недели. «атем провод¤т постепенную отмену других противосудорожных средств. ” пациентов, не получавших лечени¤ другими противосудорожными средствами, клинически эффективна¤ доза должна быть достигнута через 1 неделю.

—ледует иметь в виду, что риск развити¤ побочных эффектов со стороны печени повышен при проведении комбинированной противосудорожной терапии.

¬ период лечени¤ необходимо регул¤рно контролировать функцию печени, картину периферической крови, состо¤ние свертывающей системы крови (особенно в течение первых 6 мес¤цев лечени¤).

” детей повышен риск развити¤ т¤желого или угрожающего жизни гепатотоксического действи¤. ” пациентов в возрасте до 2 лет и у детей, получающих комбинированную терапию, риск еще более высок, но с увеличением возраста он снижаетс¤.

ѕрименение при беременности и лактации

ѕротивопоказано.

¬заимодействие

ѕри одновременном применении нейролептиков, антидепрессантов, ингибиторов ћјќ, производных бензодиазепина, этанола усиливаетс¤ угнетающее вли¤ние на ?Ќ—.

ѕри одновременном применении средств, обладающих гепатотоксическим действием, возможно усиление гепатотоксического действи¤.

ѕри одновременном применении усиливаютс¤ эффекты антиагрегантов (в т.ч. ацетилсалициловой кислоты) и антикоагул¤нтов.

ѕри одновременном применении повышаетс¤ концентраци¤ зидовудина в плазме крови, что приводит к усилению его токсичности.

ѕри одновременном применении с карбамазепином уменьшаетс¤ концентраци¤ вальпроевой кислоты в плазме крови вследствие повышени¤ скорости ее метаболизма, обусловленного индукцией микросомальных ферментов печени под вли¤нием карбамазепина. ¬альпроева¤ кислота потенцирует токсическое действие карбамазепина.

ѕри одновременном применении замедл¤етс¤ метаболизм ламотриджина и увеличиваетс¤ его T1/2.

ѕри одновременном применении с мефлохином повышаетс¤ метаболизм вальпроевой кислоты в плазме крови и повышаетс¤ риск развити¤ судорог.

ѕри одновременном применении с меропенемом возможно снижение концентрации вальпроевой кислоты в плазме крови; с примидоном - повышение концентрации примидона в плазме крови; с салицилатами - возможно усиление эффектов вальпроевой кислоты вследствие ее вытеснени¤ салицилатами из св¤зи с белками плазмы крови.

ѕри одновременном применении с фелбаматом повышаетс¤ концентраци¤ вальпроевой кислоты в плазме крови, что сопровождаетс¤ про¤влени¤ми токсического действи¤ (тошнота, сонливость, головна¤ боль, уменьшение количества тромбоцитов, когнитивные нарушени¤).

ѕри одновременном применении с фенитоином в течение нескольких первых недель обща¤ концентраци¤ фенитоина в плазме крови может уменьшатьс¤ за счет его вытеснени¤ из мест св¤зывани¤ с белками плазмы вальпроатом натри¤, индукции микросомальных ферментов печени и ускорени¤ метаболизма фенитоина. ?алее происходит ингибирование метаболизма фенитоина вальпроатом и, вследствие этого, повышение концентрации фенитоина в плазме крови. ‘енитоин уменьшает концентрацию вальпроата в плазме крови, веро¤тно, за счет повышени¤ его метаболизма в печени. ѕолагают, что фенитоин как индуктор печеночных ферментов, возможно, также повышает образование второстепенного, но обладающего гепатотоксичностью, метаболита вальпроевой кислоты.

ѕри одновременном применении вальпроева¤ кислота вытесн¤ет фенобарбитал из св¤зи с белками плазмы, в результате увеличиваетс¤ его концентраци¤ в плазме крови. ‘енобарбитал повышает скорость метаболизма вальпроевой кислоты, что приводит к уменьшению ее концентрации в плазме крови.

»меютс¤ сообщени¤ об усилении эффектов флувоксамина и флуоксетина при их одновременном применении с вальпроевой кислотой. ѕри одновременном применении с флуоксетином у некоторых пациентов наблюдалось увеличение или уменьшение концентрации вальпроевой кислоты в плазме крови.

ѕри одновременном применении циметидина, эритромицина возможно повышение концентрации вальпроевой кислоты в плазме за счет снижени¤ ее метаболизма в печени.

”слови¤ хранени¤

¬ защищенном от света месте при температуре не выше 25?—.

’ранить в недоступном дл¤ детей месте.

—рок годности

2 года.

Do not use after the expiration date.

Conditions of dispensing from pharmacies

On prescription.