Finlepsin tablets 200mg, No. 50

• epilepsy: partial seizures with elementary symptoms (focal seizures), partial seizures with complex symptoms, psychomotor seizures, large seizures of mainly focal origin (large seizures during sleep, diffuse large seizures), mixed forms of epilepsy;

• trigeminal neuralgia;

• idiopathic glossopharyngeal neuralgia;

• pain in diabetic polyneuropathy;

• epileptiform convulsions in multiple sclerosis, facial muscle spasms in trigeminal neuralgia, tonic convulsions, paroxysmal dysarthria and ataxia, paroxysmal paresthesias and attacks of pain;

• alcohol withdrawal syndrome (anxiety, convulsions, hyperexcitability, sleep disturbances);

• psychotic disorders (affective and schizoaffective disorders, psychosis, dysfunction of the limbic system).

The drug is administered orally, during or after meals, with a sufficient amount of liquid. The reception mode is individual.

The tablets are white, round with a chamfer, convex on one side and a notch in the form of a wedge-shaped depression on the other, with a smooth surface, intact edges and a uniform appearance.

1 tab.

carbamazepine 200 mg

Excipients: microcrystalline cellulose (type 12), gelatin, croscarmellose sodium, magnesium stearate.

• disorders of bone marrow hematopoiesis (anemia, leukopenia);

• acute intermittent porphyria (including history);

• AV block;

• simultaneous administration of lithium preparations and MAO inhibitors;

• hypersensitivity to drug components;

• hypersensitivity to tricyclic antidepressants.

The drug should be used with caution in decompensated chronic heart failure, in violation of liver and / or kidney function, in elderly patients, in patients with chronic alcoholism (increased CNS depression, increased metabolism of carbamazepine), with dilution hyponatremia (ADH hypersecretion syndrome, hypopituitarism, hypothyroidism, insufficiency of the adrenal cortex), with inhibition of bone marrow hematopoiesis against the background of taking drugs (in history), with prostatic hyperplasia, increased intraocular pressure; with simultaneous use with sedative and hypnotic drugs.

pharmachologic effect

An antiepileptic drug (dibenzazepine derivative), which also has antidepressant, antipsychotic and antidiuretic effects, has an analgesic effect in patients with neuralgia. The mechanism of action is associated with the blockade of voltage-dependent sodium channels, which leads to stabilization of the membrane of overexcited neurons, inhibition of the occurrence of serial neuronal discharges and a decrease in synaptic impulse conduction. Prevents the re-formation of Na + -dependent action potentials in depolarized neurons. Reduces the release of the excitatory neurotransmitter amino acid glutamate, increases the reduced seizure threshold of the central nervous system and, thus, reduces the risk of developing an epileptic seizure. Increases K + conductivity, modulates voltage-gated Ca2 + channels,which may also contribute to the anticonvulsant action of the drug. Effective for focal (partial) epileptic seizures (simple and complex), accompanied or not accompanied by secondary generalization, with generalized tonic-clonic epileptic seizures, as well as with a combination of these types of seizures (usually ineffective for small seizures - petit mal, absences and myoclonic seizures ). In patients with epilepsy (especially in children and adolescents), there was a positive effect on the symptoms of anxiety and depression, as well as a decrease in irritability and aggression. The effect on cognitive function and psychomotor performance is dose dependent. The onset of the anticonvulsant effect varies from several hours to several days (sometimes up to 1 month due to autoinduction of metabolism).Effective for focal (partial) epileptic seizures (simple and complex), accompanied or not accompanied by secondary generalization, with generalized tonic-clonic epileptic seizures, as well as with a combination of these types of seizures (usually ineffective for small seizures - petit mal, absences and myoclonic seizures ). In patients with epilepsy (especially in children and adolescents), there was a positive effect on the symptoms of anxiety and depression, as well as a decrease in irritability and aggression. The effect on cognitive function and psychomotor performance is dose dependent. The onset of the anticonvulsant effect varies from several hours to several days (sometimes up to 1 month due to autoinduction of metabolism).Effective for focal (partial) epileptic seizures (simple and complex), accompanied or not accompanied by secondary generalization, with generalized tonic-clonic epileptic seizures, as well as with a combination of these types of seizures (usually ineffective for small seizures - petit mal, absences and myoclonic seizures ). In patients with epilepsy (especially in children and adolescents), there was a positive effect on the symptoms of anxiety and depression, as well as a decrease in irritability and aggression. The effect on cognitive function and psychomotor performance is dose dependent. The onset of the anticonvulsant effect varies from several hours to several days (sometimes up to 1 month due to autoinduction of metabolism).accompanied or not accompanied by secondary generalization, with generalized tonic-clonic epileptic seizures, as well as with a combination of these types of seizures (usually ineffective for small seizures - petit mal, absences and myoclonic seizures). In patients with epilepsy (especially in children and adolescents), there was a positive effect on the symptoms of anxiety and depression, as well as a decrease in irritability and aggression. The effect on cognitive function and psychomotor performance is dose dependent. The onset of the anticonvulsant effect varies from several hours to several days (sometimes up to 1 month due to autoinduction of metabolism).accompanied or not accompanied by secondary generalization, with generalized tonic-clonic epileptic seizures, as well as with a combination of these types of seizures (usually ineffective for small seizures - petit mal, absences and myoclonic seizures). In patients with epilepsy (especially in children and adolescents), there was a positive effect on the symptoms of anxiety and depression, as well as a decrease in irritability and aggression. The effect on cognitive function and psychomotor performance is dose dependent. The onset of the anticonvulsant effect varies from several hours to several days (sometimes up to 1 month due to autoinduction of metabolism).and also with a combination of these types of seizures (usually ineffective for small seizures - petit mal, absences and myoclonic seizures). In patients with epilepsy (especially in children and adolescents), there was a positive effect on the symptoms of anxiety and depression, as well as a decrease in irritability and aggression. The effect on cognitive function and psychomotor performance is dose dependent. The onset of the anticonvulsant effect varies from several hours to several days (sometimes up to 1 month due to autoinduction of metabolism).and also with a combination of these types of seizures (usually ineffective for small seizures - petit mal, absences and myoclonic seizures). In patients with epilepsy (especially in children and adolescents), there was a positive effect on the symptoms of anxiety and depression, as well as a decrease in irritability and aggression. The effect on cognitive function and psychomotor performance is dose dependent. The onset of the anticonvulsant effect varies from several hours to several days (sometimes up to 1 month due to autoinduction of metabolism).The onset of the anticonvulsant effect varies from several hours to several days (sometimes up to 1 month due to autoinduction of metabolism).The onset of the anticonvulsant effect varies from several hours to several days (sometimes up to 1 month due to autoinduction of metabolism).

In essential and secondary trigeminal neuralgia, carbamazepine in most cases prevents pain attacks. Relief of pain in trigeminal neuralgia is noted after 8-72 hours.

With alcohol withdrawal syndrome, the threshold of convulsive readiness increases, which in this state is usually lowered and reduces the severity of the clinical manifestations of the syndrome (hyperexcitability, tremor, gait disturbances).

Antipsychotic (antimanic) action develops after 7-10 days, may be due to inhibition of the metabolism of dopamine and norepinephrine.

Pharmacokinetics

Suction

Absorption is slow but complete (food intake does not significantly affect the rate and extent of absorption). After a single dose of the tablet, Cmax is reached after 12 hours. The average Cmax of the unchanged active substance after a single dose of carbamazepine at a dose of 400 mg is about 4.5 ?g / ml. The time to reach Cmax is 4-5 hours.

Distribution

Css of the drug in plasma is achieved after 1-2 weeks (the rate of achievement depends on the individual characteristics of metabolism: autoinduction of liver enzyme systems, heteroinduction by other drugs simultaneously used), as well as on the patient's condition, dose of the drug and duration of treatment. There are significant interindividual differences in Css values ??in the therapeutic range: in most patients, these values ??range from 4 to 12 ?g / ml (17-50 ?mol / L). Concentrations of carbamazepine-10,11-epoxide (pharmacologically active metabolite) are about 30% of the concentration of carbamazepine. Plasma protein binding in children is 55-59%, in adults - 70-80%. Apparent Vd - 0.8-1.9 l / kg. In the cerebrospinal fluid and saliva, concentrations are created in proportion to the amount of active substance unbound to proteins (20-30%).Penetrates the placental barrier. Concentration in breast milk is 25-60% of that in plasma.

Metabolism

It is metabolized in the liver, mainly by the epoxy pathway with the formation of the main metabolites: active - carbamazepine-10.11-epoxide and inactive conjugate with glucuronic acid. The main isoenzyme providing the biotransformation of carbamazepine to carbamazepine-10,11-epoxide is cytochrome P450 (CYP3A4). As a result of metabolic reactions, the inactive metabolite 9-hydroxy-methyl-10-carbamoylacridane is also formed. It can induce its own metabolism. The concentration of carbamazepine-10,11-epoxide is 30% of the concentration of carbamazepine.

Withdrawal

T1 / 2 after taking a single oral dose is 25-65 hours (on average about 36 hours), after repeated administration, depending on the duration of treatment - 12-24 hours (due to autoinduction of the monooxygenase system of the liver). In patients receiving additionally other anticonvulsants-inducers of the monooxygenase system (phenytoin, phenobarbital), T1 / 2 averages 9-10 hours. After a single dose of carbamazepine inside, 72% of the dose taken is excreted in the urine and 28% in the feces. About 2% of the dose is excreted in the urine in the form of unchanged carbamazepine, about 1% in the form of a 10,11-epoxy metabolite.

Pharmacokinetics in special clinical situations

In children, due to accelerated elimination, it may be necessary to use relatively higher doses of the drug per kg of body weight compared to adults.

There are no data on changes in the pharmacokinetics of carbamazepine in elderly patients.

Side effect

When assessing the incidence of various adverse reactions, the following criteria were used: very often (? 10%), often (? 1%, but <10%), sometimes (? 0.1%, but <1%), rarely (? 0.01%, but <0.1%), very rarely (<0.01%).

From the side of the central nervous system and peripheral nervous system: often - dizziness, ataxia, drowsiness, general weakness, headache, paresis of accommodation; sometimes - abnormal involuntary movements (for example, tremor, fluttering tremor - asterixis, dystonia, tics), nystagmus; rarely - hallucinations (visual or auditory), depression, decreased appetite, anxiety, aggressive behavior, psychomotor agitation, disorientation; activation of psychosis, orofacial dyskinesia, oculomotor disorders, speech disorders (eg, dysarthria or slurred speech), choreoathetoid disorders, peripheral neuritis, paresthesias, muscle weakness, and paresis symptoms. The role of the drug in the development of ZNS, especially in combination with antipsychotics, remains unclear.

The development of adverse reactions from the central nervous system may be the result of a relative overdose of the drug or significant fluctuations in the concentration of carbamazepine in the blood plasma.

Allergic reactions: often - urticaria; sometimes - erythroderma, delayed-type multiorgan hypersensitivity reactions with fever, skin rashes, vasculitis (including erythema nodosum, as a manifestation of cutaneous vasculitis), lymphadenopathy, signs resembling lymphoma, arthralgia, leukopenia, eosinophilia, hepatosplenosis (these manifestations are found in various combinations). Other organs (eg, lungs, kidneys, pancreas, myocardium, colon), aseptic meningitis with myoclonus and peripheral eosinophilia, anaphylactoid reaction, angioedema, allergic pneumonitis, or eosinophilic pneumonia may also be involved. If the above allergic reactions occur, the drug should be discontinued.Rarely - lupus-like syndrome, pruritus, exudative erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), photosensitivity.

From the side of the hematopoietic organs: often - leukopenia, thrombocytopenia, eosinophilia; rarely - leukocytosis, lymphadenopathy, folic acid deficiency, agranulocytosis, aplastic anemia, true erythrocytic aplasia, megaloblastic anemia, acute 'intermittent' porphyria, reticulocytosis, hemolytic anemia, splenomegaly.

On the part of the digestive system: often - nausea, vomiting, dry mouth, increased GGT activity (due to the induction of this enzyme in the liver), which usually has no clinical significance, increased alkaline phosphatase activity; sometimes - increased activity of hepatic transaminases, diarrhea or constipation, abdominal pain; rarely - glossitis, gingivitis, stomatitis, pancreatitis, cholestatic, parenchymal (hepatocellular) or mixed hepatitis, jaundice, granulomatous hepatitis, liver failure.

From the side of the cardiovascular system: rarely - disturbances in intracardiac conduction, decrease or increase in blood pressure, bradycardia, arrhythmias, AV blockade with fainting, collapse, aggravation or development of chronic heart failure, exacerbation of coronary artery disease (including the appearance or increased frequency of angina attacks) , thrombophlebitis, thromboembolic syndrome.

From the endocrine system and metabolism: often - edema, fluid retention, weight gain, hyponatremia (decrease in plasma osmolarity due to an effect similar to that of ADH, which in rare cases leads to hyponatremia of dilution, accompanied by lethargy, vomiting, headache, disorientation and neurological disorders); rarely - an increase in the level of prolactin (may be accompanied by galactorrhea and gynecomastia), a decrease in the concentration of L-thyroxine and an increase in the concentration of thyroid-stimulating hormone (usually not accompanied by clinical manifestations), a violation of calcium-phosphorus metabolism in bone tissue (a decrease in the concentration of Ca2 + and 25-OH-colecalciferol in plasma), osteomalacia, hypercholesterolemia (including HDL cholesterol), hypertriglyceridemia and swollen lymph nodes, hirsutism.

From the genitourinary system: rarely - interstitial nephritis, renal failure, impaired renal function (for example, albuminuria, hematuria, oliguria, increased urea / azotemia), frequent urination, urinary retention, decreased potency.

From the musculoskeletal system: rarely - arthralgia, myalgia or convulsions.

From the senses: rarely - disturbances in taste, lens opacity, conjunctivitis, hearing impairment, incl. tinnitus, hyperacusis, hypoacusia, changes in pitch perception.

Others: skin pigmentation disorders, purpura, acne, sweating, alopecia.

Application during pregnancy and lactation

For women of reproductive age, FinlepsinЃ is, if possible, prescribed as monotherapy, in the minimum effective dose, because the incidence of congenital anomalies in newborns from mothers taking combined antiepileptic treatment is higher than with monotherapy.

When pregnancy occurs, it is necessary to compare the expected benefits of therapy and possible complications, especially in the first trimester of pregnancy. It is known that the children of mothers with epilepsy are predisposed to intrauterine growth disorders, including malformations. FinlepsinЃ is able to increase the risk of these disorders. There are isolated reports of cases of congenital diseases and malformations, including spina bifida. Antiepileptic drugs exacerbate folate deficiency, which is often observed during pregnancy, which can contribute to an increase in the incidence of birth defects in children, therefore, folic acid intake is recommended before the onset of a planned pregnancy and during pregnancy.

In order to prevent hemorrhagic complications in newborns, women in the last weeks of pregnancy, as well as newborns, are recommended to prescribe vitamin K.

Carbamazepine passes into breast milk, therefore, the benefits and possible undesirable effects of breastfeeding in the context of ongoing therapy should be weighed. If you continue to breastfeed while taking Finlepsin, you should monitor the baby in connection with the possibility of developing adverse reactions (for example, severe drowsiness, allergic skin reactions).

Application for violations of liver function

The drug should be used with caution in case of impaired liver function.

Application for impaired renal function

The drug should be used with caution in case of impaired renal function.

Application in children

Can be used in children according to indications.

Use in elderly patients

Elderly patients FinlepsinЃ is prescribed in an initial dose of 100 mg (1/2 tab.) 2 times / day (corresponds to 200 mg / day).

special instructions

Monotherapy for epilepsy begins with a low initial dose, gradually increasing it until the desired therapeutic effect is achieved.

When selecting the optimal dose, it is advisable to determine the concentration of carbamazepine in the blood plasma, especially in combination therapy. In some cases, the optimal dose may deviate significantly from the recommended initial maintenance dose, for example, due to the induction of microsomal liver enzymes or due to interactions in combination therapy.

In some cases, treatment with antiepileptic drugs was accompanied by the occurrence of suicidal attempts / suicidal intentions. This was also confirmed by a meta-analysis of randomized clinical trials using antiepileptic drugs. Since the mechanism of the occurrence of suicidal attempts when using antiepileptic drugs is not known, their occurrence cannot be ruled out during treatment with FinlepsinЃ. Patients and caregivers should be alerted to the need to monitor for suicidal thoughts / suicidal behavior and seek immediate medical attention if symptoms occur.

FinlepsinЃ should not be combined with sedative-hypnotics. If necessary, it can be combined with other substances used to treat alcohol withdrawal symptoms. During treatment, it is necessary to regularly monitor the content of carbamazepine in the blood plasma. In connection with the development of side effects from the central nervous system and the autonomic nervous system, patients are carefully monitored in a hospital setting.

When transferring a patient to carbamazepine, the dose of the previously prescribed antiepileptic drug should be gradually reduced until it is completely canceled. Sudden discontinuation of carbamazepine can trigger epileptic seizures. If it is necessary to abruptly interrupt treatment, the patient should be transferred to another antiepileptic drug under the cover of the drug shown in such cases (for example, diazepam administered intravenously or rectally, or phenytoin administered intravenously).

Several cases of vomiting, diarrhea and / or low nutrition, seizures and / or respiratory depression have been reported in newborns whose mothers took carbamazepine concurrently with other anticonvulsants (these reactions may be manifestations of withdrawal symptoms in newborns).

Before prescribing carbamazepine and during treatment, it is necessary to study liver function, especially in patients with a history of liver disease, as well as in elderly patients. In the event of an increase in already existing liver dysfunctions or when an active liver disease appears, the drug should be discontinued immediately.

Before starting treatment, it is necessary to conduct a study of the blood picture (including counting platelets, reticulocytes), the level of iron in the blood serum, a general urine test, the level of urea in the blood, an electroencephalogram, the determination of the concentration of electrolytes in the blood serum (and periodically during treatment, because development of hyponatremia is possible). Subsequently, these indicators should be monitored weekly during the first month of treatment, and then monthly.

In most cases, a transient or persistent decrease in the number of platelets and / or leukocytes is not a precursor to the onset of aplastic anemia or agranulocytosis. However, before starting treatment, as well as periodically during treatment, clinical blood tests should be performed, including counting the number of platelets and, possibly, reticulocytes, as well as determining the level of iron in the blood serum. Non-progressive asymptomatic leukopenia does not require withdrawal, but treatment should be discontinued if hypersensitivity reactions or symptoms appear, presumably indicating the development of Stevens-Johnson syndrome or Lyell's syndrome.Mild skin reactions (isolated macular or maculopapular exanthema) usually disappear within a few days or weeks, even with continued treatment or after reducing the dose of the drug (the patient should be under close medical supervision at this time).

The possibility of activation of latent psychoses should be taken into account, and in elderly patients - the possibility of the development of disorientation or psychomotor agitation.

Violations of male fertility and / or disorders of spermatogenesis are possible, however, the relationship of these disorders with taking carbamazepine has not yet been established.

The appearance of intermenstrual bleeding is possible with the simultaneous use of oral contraceptives. Carbamazepine can adversely affect the reliability of oral contraceptive drugs, so women of reproductive age should use alternative methods of preventing pregnancy during treatment. Carbamazepine should only be used under medical supervision.

Patients should be advised of early signs of toxicity, as well as skin and liver symptoms. The patient is informed of the need to immediately consult a doctor in case of such adverse reactions as fever, sore throat, rash, ulceration of the oral mucosa, unreasonable bruising, hemorrhages in the form of petechiae or purpura.

Before starting treatment, it is recommended to conduct an ophthalmologic examination, including examination of the fundus with a slit lamp and measurement of intraocular pressure. In the case of prescribing the drug to patients with increased intraocular pressure, constant monitoring of this indicator is required.

Patients with severe cardiovascular diseases, liver and kidney damage, as well as elderly people are prescribed lower doses of the drug.

’от¤ взаимосв¤зь между дозой карбамазепина, его концентрацией и клинической эффективностью или переносимостью весьма незначительна, тем не менее, регул¤рное определение уровн¤ карбамазепина может оказатьс¤ полезным в следующих ситуаци¤х: при резком повышении частоты приступов; дл¤ того, чтобы проверить, принимает ли пациент препарат должным образом; во врем¤ беременности; при лечении детей или подростков; при подозрении на нарушени¤ всасывани¤ препарата; при подозрении на развитие токсических реакций в случае, если пациент принимает несколько лекарственных средств.

¬о врем¤ лечени¤ ‘инлепсином рекомендуетс¤ воздержатьс¤ от употреблени¤ алкогол¤.

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

¬ период лечени¤ необходимо воздерживатьс¤ от зан¤тий потенциально опасными видами де¤тельности, требующих повышенной концентрации внимани¤ и быстроты психомоторных реакций.

ѕередозировка

—имптомы: обычно отражают нарушени¤ со стороны ?Ќ—, сердечно-сосудистой и дыхательной системы.

—о стороны ?Ќ— и органов чувств: угнетение функций ?Ќ—, дезориентаци¤, сонливость, возбуждение, галлюцинации, кома, затуманенность зрени¤, невн¤тна¤ речь, дизартри¤, нистагм, атакси¤, дискинези¤, гиперрефлекси¤ (в начале), гипорефлекси¤ (позже), судороги, психомоторные расстройства, миоклонус, гипотерми¤, мидриаз.

—о стороны сердечно-сосудистой системы: тахикарди¤, снижение ј?, иногда - повышение ј?, нарушени¤ внутрижелудочковой проводимости с расширением комплекса QRS, обмороки, остановка сердца.

—о стороны дыхательной системы: угнетение дыхани¤, отек легких.

—о стороны пищеварительной системы: тошнота и рвота, задержка эвакуации пищи из желудка, снижение моторики толстой кишки.

—о стороны мочевыделительной системы: задержка мочи, олигури¤ или анури¤, задержка жидкости, гипонатриеми¤.

Ћабораторные показатели: лейкоцитоз или лейкопени¤, гипонатриеми¤, возможен метаболический ацидоз, возможна гипергликеми¤ и глюкозури¤, повышение мышечной фракции  ‘ .

Ћечение: специфический антидот отсутствует. Ќеобходимо симптоматическое поддерживающее лечение в ќ»“, мониторирование функций сердца, температуры тела, корнеальных рефлексов, функций почек и мочевого пузыр¤, коррекци¤ электролитных расстройств. Ќеобходимо определение концентрации карбамазепина в плазме дл¤ подтверждени¤ отравлени¤ этим средством и оценки степени передозировки, промывание желудка, назначение активированного угл¤. ѕоздн¤¤ эвакуаци¤ желудочного содержимого может привести к отсроченному всасыванию на 2 и 3 сутки и повторному по¤влению симптомов интоксикации в период выздоровлени¤. ‘орсированный диурез, гемодиализ и перитонеальный диализ неэффективны, однако диализ показан при сочетании т¤желого отравлени¤ и почечной недостаточности. ” маленьких детей может возникнуть потребность в гемотрансфузии.

Ћекарственное взаимодействие

ќдновременное назначение карбамазепина с ингибиторами CYP3A4 может привести к повышению его концентрации в плазме крови и развитию побочных реакций.

—овместное применение индукторов CYP3A4 может привести к ускорению метаболизма карбамазепина, снижению его концентрации в плазме крови и уменьшению терапевтического эффекта; напротив, их отмена может снижать скорость биотрансформации карбамазепина и приводить к повышению его концентрации.

ѕовышают концентрацию карбамазепина в плазме: верапамил, дилтиазем, фелодипин, декстропропоксифен, вилоксазин, флуоксетин, флувоксамин, циметидин, ацетазоламид, даназол, дезипрамин, никотинамид (у взрослых, только в высоких дозах), макролиды (эритромицин, джозамицин, кларитромицин, тролеандомицин), азолы (итраконазол, кетоконазол, флуконазол), терфенадин, лоратадин, изониазид, пропоксифен, грейпфрутовый сок, ингибиторы вирусной протеазы, используемые при терапии ¬»„-инфекции (например, ритонавир) - требуетс¤ коррекци¤ режима дозировани¤ или мониторирование концентрации карбамазепина в плазме.

‘елбамат снижает концентрацию карбамазепина в плазме и повышает концентрацию карбамазепин-10,11-эпоксида, при этом возможно одновременное снижение концентрации в сыворотке фелбамата.

 онцентрацию карбамазепина снижают фенобарбитал, фенитоин, примидон, метсуксимид, фенсуксимид, теофиллин, рифампицин, цисплатин, доксорубицин, возможно, клоназепам, вальпромид, вальпроева¤ кислота, окскарбазепин и растительные лекарственные средства, содержащие зверобой продыр¤вленный (Hypericum perforatum).

—уществует возможность вытеснени¤ вальпроевой кислотой и примидоном карбамазепина из св¤зи с белками плазмы и повышение концентрации фармакологически активного метаболита (карбамазепина-10,11-эпоксида). ѕри сочетанном применении ‘инлепсина с вальпроевой кислотой в исключительных случа¤х может наступить кома или спутанность сознани¤.

»зотретиноин измен¤ет биодоступность и/или клиренс карбамазепина и карбамазепина-10,11-эпоксида (необходим мониторинг концентрации карбамазепина в плазме).

 арбамазепин может снизить концентрацию в плазме (уменьшить или даже полностью нивелировать эффекты), что может потребовать коррекцию доз следующих препаратов: клобазама, клоназепама, дигоксина этосуксимида, примидона, вальпроевой кислоты, алпразолама, v — (преднизолона, дексаметазона), циклоспорина, тетерациклинов (доксициклин), галоперидола, метадона, пероральных препаратов, содержащих эстрогены и/или прогестерон (необходим подбор альтернативных методов контрацепции), теофиллина, пероральных антикоагул¤нтов (варфарина, фенпрокумона, дикумарола), ламотриджина, топирамата, трициклических антидепрессантов (имипрамина, амитриптилина, нортриптилина, кломипрамина), клозапина, фелбамата, тиагабина, окскарбазепина, ингибиторов протеаз, примен¤емых при терапии ¬»„-инфекции (индинавира, ритонавира, саквинавира), блокаторов кальциевых каналов (группа дигидропиридина, например фелодипин), итраконазола, левотироксина, мидазолама, оланзапина, празиквантела, рисперидона, трамадола, зипрасидона.

—уществует возможность повышени¤ или снижени¤ уровн¤ фенитоина в плазме крови на фоне карбамазепина и повышени¤ уровн¤ мефенитоина.

ѕри одновременном применении карбамазепина и препаратов лити¤ могут усиливатьс¤ нейротоксические вли¤ни¤ обоих активных веществ.

“етрациклины могут ослабл¤ть терапевтический эффект карбамазепина.

ѕри совместном применении с парацетамолом повышаетс¤ риск его токсического вли¤ни¤ на печень и снижаетс¤ терапевтическа¤ эффективность (ускорение метаболизма парацетамола).

ќдновременное назначение карбамазепина с фенотиазином, пимозидом, тиоксантенами, молиндоном, галоперидолом, мапротилином, клозапином и трициклическими антидепрессантами приводит к усилению угнетающего действи¤ на центральную нервную систему и ослаблению противосудорожного эффекта карбамазепина.

»нгибиторы ћјќ увеличивают риск развити¤ гиперпиретических кризов, гипертонических кризов, судорог, смертельного исхода (перед назначением карбамазепина ингибиторы ћјќ должны быть отменены, как минимум, за 2 недели или, если позвол¤ет клиническа¤ ситуаци¤, даже за больший срок).

ќдновременное назначение с диуретиками (гидрохлоротиазид, фуросемид) может приводить к гипонатриемии, сопровождающейс¤ клиническими про¤влени¤ми.

ќслабл¤ет эффекты недепол¤ризующих миорелаксантов (панкурони¤). ¬ случае применени¤ такой комбинации может возникнуть необходимость повышени¤ дозы миорелаксантов, при этом необходим тщательный мониторинг состо¤ни¤ пациента в св¤зи с возможностью более быстрого прекращени¤ действи¤ миорелаксантов.

 арбамазепин снижает переносимость этанола.

ћиелотоксические лекарственные препараты усиливают про¤вление гематотоксичности препарата.

It accelerates the metabolism of indirect anticoagulants, hormonal contraceptives, folic acid, praziquantel, and can enhance the elimination of thyroid hormones.

It accelerates the metaboli