Trileptal suspension for vnut. 60mg ml 100ml
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Dosage of the active ingredient Composition 1 ml of oxcarbazepine 60 mg. Excipients: propyl parahydroxybenzoate - 0.3 mg, sodium saccharinate - 0.5 mg, sorbic acid - 0.5 mg, macrogol 400 stearate - 1 mg, methyl parahydroxybenzoate - 1.2 mg, ascorbic acid - 10 mg, cellulose dispersible microcrystalline cellulose and carmellose sodium) - 15 mg, yellow plum-lemon aroma 39K020 (a solution containing 36% ethanol and 16% propylene glycol) - 2.5 mg, distilled propylene glycol - 25 mg, sorbitol 70% liquid - 250 mg, purified water - 71 7 mg. Pharmacokinetics Absorption After oral administration, oxcarbazepine in tablet form is rapidly and almost completely (> 95%) absorbed in the gastrointestinal tract and is largely metabolized to form a pharmacologically active metabolite - 10-monohydroxy derivative (IHL). After a single dose of the drug Trileptal. in the form of coated pills in a dose of 600 mg by healthy volunteers on an empty stomach, the average Сmax in the blood plasma of IHL is 31.5 μmol / l, the average time to reach it (Tmax) is about 5 hours. After a single dose of the drug, Trileptal. in the form of a suspension in a dose of 600 mg by healthy volunteers on an empty stomach, the average Сmax of MGP in the blood plasma is 24.9 μmol / l, the average maximum time to reach it is about 6 hours. The film-coated pills and oral suspension are bioequivalent, since the geometric mean Cmax and AUC of IHP with a single dose of oxcabazepine in tablet and suspension form and in equilibrium was in the range of 0.85 to 1.06 (90% confidence interval). Pharmacokinetic studies have shown that 2% unchanged oxcarbazepine and 70% MHD are detected in blood plasma. the remainder is accounted for by secondary metabolites rapidly excreted from the blood plasma. Meal does not affect the rate and extent of absorption of oxcarbazepine. Binding to plasma proteins and distribution The apparent Vd of IHL is 49 l. Approximately 40% of IHD is bound to plasma proteins, mainly albumin. In the therapeutic range, the degree of binding does not depend on the concentration of the drug in the serum. Oxcarbazepine and MHP do not bind to the .1-acid glycoprotein. Metabolism Oxcarbazepine is rapidly metabolized by the cytosolic enzymes of the liver to the pharmacologically active metabolite of IHP, which determines the pharmacological effect of the drug. PGM is further conjugated with glucuronic acid.Minor amounts of IHD (about 4% of the dose) are oxidized to form an inactive metabolite (10,11-dihydroxy derivative (BPH)). Withdrawal Oxcarbazepine is eliminated from the body mainly in the form of metabolites, predominantly by the kidneys. More than 95% of the dose is excreted by the kidneys as metabolites, less than 1% in unchanged form. About 4% of the dose is excreted in the feces. Approximately 80% of the dose is excreted as IHP, both as glucuronides (49%), and as unchanged IHD (27%). inactive BPH is about 3%, oxcarbazepine conjugates - about 13% of the dose. About 4% of the dose is excreted in the feces. Oxcarbazepine is rapidly excreted from plasma, the apparent T1 / 2 is 1.3–2.3 h. Unlike oxcarbazepine, the apparent T1 / 2 MHD averages 9.3 ± 1.8 h. Css MHP in the blood plasma is reached in 2-3 days while taking the drug Trileptal . 2 times / day. In equilibrium, the pharmacokinetic parameters of IHL are linear and dose-dependent in the range of daily doses of 300 mg-2400 mg. Pharmacokinetics in special clinical situations Children Clearance of IHP, adjusted for body weight, decreases in children with increasing age and body weight, approaching the clearance of adults. Body weight adjusted clearance in children aged 1 month to 4 years is on average 93% higher than in adults. Thus, it is assumed that the AUC of IHD in children of this age group is expected to be 2 times less than that in adults with the use of the same dose (when adjusted for body weight). Body weight adjusted clearance in children aged 4 to 12 years is on average 43% higher than in adults. The estimated AUC of IHD in children of this age group is 2/3 of that in adults with the same doses (when adjusted for body weight). It is assumed that in children aged 13 years and older due to an increase in body weight, the clearance of IHL, adjusted for body weight, corresponds to the clearance of IHD in adults. Pregnant patients During pregnancy, a number of physiological changes occur in the body, which can lead to a gradual decrease in the level of MHD in the blood plasma during this period. Elderly patients After taking the drug Trileptal. once (at a dose of 300 mg) and again (at a dose of 600 mg / day) in elderly volunteers aged 60–82 years Сmax and AUC values for IHL were 30–60% higher compared with the same indicators in young volunteers ( 18-32 years), which is associated with an age-related decrease in QA. Gender There are no differences in pharmacokinetic parameters depending on gender in children, adults or old age.Patients with impaired liver function The pharmacokinetic parameters and metabolism of oxcarbazepine and MHD after a single dose of the drug at a dose of 900 mg were evaluated in healthy volunteers and in patients with impaired liver function. Mild liver function impairment does not affect the pharmacokinetic parameters of oxcarbazepine and IHP. Pharmacokinetics for abnormal liver function has not been studied. Patients with impaired renal function There is a linear relationship between renal clearance of IHL and CK. In patients with impaired renal function (CC less than 30 ml / min), after a single dose of 300 mg of oxcarbazepine T1 / 2, MGP increases by 60-90% (up to 16-19 h), and AUC increases 2-fold. Pharmacological action Antiepileptic drug. Pharmacological activity of the drug Trileptal. (oxcarbazepine) is caused, first of all, by the action of its metabolite, the monohydroxy derivative (IHP). The mechanism of action of oxcarbazepine and its MHD is mainly associated with the blockade of potential-dependent sodium channels, which leads to stabilization of the overexcited neuronal membranes, inhibiting the occurrence of serial neuronal discharges and reducing synaptic impulses. The implementation of the anticonvulsant action of the drug contributes to an increase in the conductivity of potassium ions and modulation of calcium channels activated by a high potential of the membrane. No significant interactions with brain neurotransmitters or receptor binding were noted. Experimental studies have shown that oxcarbazepine and IHD have a pronounced anticonvulsant effect. Clinical efficacy The effectiveness of the drug Trileptal. in epileptic seizures, it was demonstrated both in monotherapy and in the use of Trileptal as part of combination therapy in children and adults. The drug Trileptal can be used to replace other antiepileptic drugs in cases where the use of the latter does not achieve a satisfactory therapeutic response to treatment. Indications for use - simple and complex partial epileptic seizures with secondary generalization or without it in adults and children aged 1 month and older. - generalized tonic-clonic epileptic seizures in adults and children aged 2 years and older.
Dosage and administration
: drug Trileptal. It can be used both as monotherapy and in combination with other antiepileptic drugs. In both cases, the course of treatment begins with a clinically effective dose, the reception frequency is 2 times / day. The dose may be increased depending on the response to therapy. In case of replacement of another antiepileptic drug with the drug Trileptal. at the beginning of taking the drug Trileptal. should gradually reduce the dose of the drug being replaced. When using the drug Trileptal. As part of combination therapy, a reduction in the dose of concomitant anti-epileptic drugs and / or a slower increase in the dose of the drug Trileptal may be required. due to an increase in the total dose of antiepileptic drugs. Drug trileptal. can be taken regardless of the meal (during, after a meal or in between meals). Before taking the suspension for ingestion, the bottle should be shaken thoroughly and immediately measure the required amount of suspension. The required dose (ml) is collected from the vial using the supplied syringe. When using a 10 ml syringe (supplied with a 250 ml bottle - for adults and older children), the amount of suspension should be rounded to 0.5 ml. When using a 1 ml syringe (supplied with a 100 ml bottle - for young children), the amount of suspension should be rounded to 0.1 ml. After each use, close the vial tightly and wipe the syringe with a clean, dry cloth. The suspension can be taken directly from the syringe or diluted with a small amount of water before taking. An open bottle to store no more than 7 weeks. Suspension for oral administration and pills are bioequivalent and interchangeable in equivalent doses. The therapeutic effect of the drug Trileptal. (oxcarbazepine) is due, primarily, to the action of its metabolite, IHP. Routine determination of oxcarbazepine or MHP in plasma is not warranted. However, the control of plasma IHP concentration can be used to clarify compliance with the patient's drug intake mode (compliance) or in situations where it is possible to change the clearance of IHL, for example, a change in renal function, pregnancy, simultaneous use with drugs that increase the activity of “liver” enzymes.In the above situations, the dose of the drug Trileptal should be adjusted. taking into account the concentration of MHD in the blood plasma (measured 2-4 hours after administration), which should be maintained at a level of <35 mg / L. Adult patients Monotherapy: and combination therapy. The initial dose is 600 mg / day (8-10 mg / kg body weight / day), divided into 2 doses. If necessary, a gradual increase in dose. The dose is increased by no more than 600 mg / day with an interval of about 1 week, until a desired therapeutic response is achieved. A good therapeutic response is observed in the dose range of 600-2400 mg / day, while most patients have a good clinical effect at a dose of 900 mg / day. In patients who have not previously received anti-epileptic therapy, the effective dose is 1200 mg / day, in patients who have previously received, but responded poorly to therapy with other anti-epileptic drugs - 2400 mg / day. The use of the drug Trileptal. in the daily dose of 2400 mg in combination therapy without lowering the dose of another antiepileptic agent was accompanied by poor tolerance in most patients, mainly due to the development of adverse events in the nervous system. The use of the drug Trileptal. at a daily dose above 2400 mg has not been studied. Children With monotherapy drug Trileptal. and when using the drug in combination therapy, the recommended initial dose of 8–10 mg / kg body weight per day is divided into 2 doses. In combination therapy, the target dose of the drug Trileptal, which is 30-46 mg / kg / day, should be reached no earlier than 2 weeks after the start of therapy. If necessary, to achieve the desired therapeutic effect, a gradual increase in the dose is possible - with an interval of about 1 week, the dose is increased - up to a maximum of 10 mg / kg / day, up to a maximum daily dose of 60 mg / kg body weight. When using the drug Trileptal. in monotherapy and in combination therapy, when adjusting for body weight, the apparent clearance of IHD in children decreases significantly with increasing age. Children aged 1 month to 4 years may require a dose of the drug, 2 times the dose for adults, when adjusting for body weight. Children aged 4 to 12 years may require a dose that is 50% higher than the dose for adults when adjusting for body weight.In children aged 1 month to 4 years, the effect of antiepileptic drugs - inducers of liver enzymes on their apparent clearance is more pronounced than in children of older age groups (when adjusted for body weight). When using the drug Trileptal. in children aged 1 month to 4 years in combination with antiepileptic drugs - liver enzyme inducers, a dose of oxcarbazepine may be 60% higher (when adjusted for body weight) than with monotherapy with Trileptal. or when used in combination with antiepileptic drugs that do not induce enzymes. For children of older age groups during the combination therapy with the drug Trileptal. with liver enzyme inducers, it may be necessary to slightly increase the dose of the drug compared to monotherapy. In children younger than 3 years old, the drug should be used in the form of a syrup due to the difficulty of applying solid dosage forms in this age group. Patients aged & # 8805 .65 years old Special correction of the dosing regimen in this category of patients is necessary in case of impaired renal function (CC less than 30 ml / min). If there is a risk of hyponaemia, it is necessary to carefully monitor the sodium content of blood plasma. Patients with impaired liver function. No need to adjust the dosage regimen in patients with mild or moderately impaired liver function. Care must be taken when applying to patients with severe hepatic impairment. Patients with impaired renal function For patients with impaired renal function (CC less than 30 ml / min), the recommended starting dose is 300 mg / day. The dose should be increased slowly, at intervals of at least 1 week, until the desired therapeutic response is achieved. Careful monitoring of patients during dose selection is necessary. Contraindications - children up to 1 month. - hypersensitivity to oxcarbazepine or any other components of the drug. It should be used with caution in patients with known hypersensitivity to carbamazepine, because in this group of patients, hypersensitivity reactions to oxcarbazepine may develop in approximately 25–30% of cases.In patients with no history of indications of hypersensitivity to carbamazepine, it is also possible to develop hypersensitivity reactions to the drug, including multiorgan disorders. The use of the drug Trileptal. in patients with impaired liver function has not been studied, so it is necessary to use the drug with caution in this category of patients. Precautions for use in impaired liver function It is not necessary to adjust the dosing regimen in patients with mild or moderately impaired liver function. Care must be taken when applying to patients with severe hepatic impairment. Application for impaired renal function For patients with impaired renal function (CC less than 30 ml / min), the recommended initial dose is 300 mg / day. The dose should be increased slowly, at intervals of at least 1 week, until the desired therapeutic response is achieved. Careful monitoring of patients during dose selection is necessary. Use in children Application is possible according to the dosing regimen. Contraindicated in children under 1 month. Use in elderly patients Special correction of the dosing regimen in this category of patients is necessary in case of impaired renal function (QC less than 30 ml / min). If there is a risk of hyponaemia, it is necessary to carefully monitor the sodium content of blood plasma. Interaction with other drugs. Inhibition of enzymes Oxcarbazepine and its pharmacologically active metabolite MHP are inhibitors of cytochrome CYP2C19. Thus, the simultaneous use of the drug Trileptal. in high doses and prepartures that are metabolized with the participation of the CYP2C19 isoenzyme (for example, phenobarbital, phenytoin), can lead to their interaction. For some patients, it may be necessary to reduce the dose of drugs - substrates of CYP2C19. Oxcarbazepine and MHP have been shown to interact poorly or not at all with the following microsomal isoenzymes: CYP1A2, CYP2A6, CYP2C9, CYP2D9, CYP2E1, CYP4A4 and CYP4C11. Enzyme induction As weak inducers of CYP3A4 and CYP3A5 cytochromes, they reduce plasma concentrations of drugs metabolized by these enzymes: dihydropyridine calcium antagonists, oral contraceptives and antiepileptic drugs (for example, carbamazepine).With the simultaneous use of the drug Trileptal. It is also possible to reduce the concentration in plasma and other drugs that are substrates of CYP3A4 and CYP3A5 isoenzymes (for example, drugs from the group of immunosuppressants - cyclosporine). Since in vitro oxcarbazepine and MHP are weak inducers of uridine diphosphate glucuronyl transferase, it is unlikely that in vivo they can have a clinically significant effect on the metabolism of drugs excreted as conjugates with glucuronic acid (for example, valproic acid and lamotrigine). But, taking into account even the weak inducing ability of oxcarbazepine and MHP, it may be necessary to increase the doses of concurrently used drugs that are metabolized with the participation of a CYP3A4 isoenzyme or uridine diphosphate glucouronyl transferase. In case of cancellation of the drug Trileptal. It may be necessary to reduce the dose of these drugs on the basis of clinical and laboratory monitoring. In vitro studies have confirmed the weak inducing ability of oxcarbazepine and IHP in relation to isoenzymes of the subsystems of the enzymes CYP2B and CYP3A4. The inductive effects of oxcarbazepine and IHP on other CYP isoenzymes are unknown. Antiepileptic drugs (PEP) Possible drug interactions Trileptal. and other antiepileptic drugs have been evaluated during clinical trials. The concentration of phenytoin in the blood plasma is increased to 40% with simultaneous administration of the drug Trileptal. at a dose of 1200 mg / day and above. Therefore, when using the drug Trileptal. in the above doses, a dose reduction of phenytoin may be required. Increase in plasma concentration of phenobarbital with simultaneous use with the drug Trileptal. slightly (15%). With the simultaneous use of strong inducers of cytochrome P450 (i.e., carbamazepine, phenytoin and phenobarbital), the concentration of MHD in the blood plasma decreases (by 29-40%). Thus, the concentration of MHP in the blood plasma should be monitored and, if necessary, the dose of the drug should be adjusted with simultaneous use of oxcarbazepine with one or more of the above drugs. At drug Trileptal. no autoinduction phenomena were detected. Hormonal contraceptives. Proven drug interaction Trileptal. with components of oral contraceptives: ethinyl estradiol and levonorgestrel. The average AUC values decreased by 48–52% and 32–52%, respectively. Trileptal drug interaction research. with other oral or implantable contraceptives not conducted.Thus, the simultaneous use of the drug Trileptal. and hormonal contraceptives can lead to a decrease in the effectiveness of the latter, and therefore, additional treatment with reliable non-hormonal methods of contraception is recommended for patients receiving treatment with Trileptal. Calcium channel blockers Simultaneous use of the drug Trileptal. and felodipine can lead to a 28% decrease in the AUC value of felodipine, although plasma concentrations remain within the therapeutic range. On the other hand, with simultaneous use with verapamil, it is possible to reduce the concentration of MHD in the blood plasma by 20%. Such a decrease in the concentration of PGM has no clinical significance. Interaction with other drugs Zimetidin, erythromycin, dextropropoxyphene do not affect the pharmacokinetic parameters of IHP. Viloxazin has little effect on plasma IHP concentration (IHP concentration increases by 10% after repeated co-administration). No interaction with warfarin was noted when taking both single and multiple doses of the drug Trileptal. No interactions with warfarin were noted, either as a single simultaneous dose, or when taking repeated doses of the drug Trileptal. Trileptal. may enhance the sedative effect of ethanol. Side Effects The most frequently reported adverse reactions include drowsiness, headache, dizziness, diplopia, nausea, vomiting, feeling tired (more than 10% of patients). In clinical studies, it was shown that undesirable effects are usually mild or moderately pronounced, are transient in nature and are observed mainly at the beginning of therapy. The data below summarizes information on adverse reactions (HP) registered during clinical trials, as well as data on the safety profile of the drug, obtained during its use in clinical practice. HPs are grouped according to the classification of organs and systems of MedDRA organs, and are listed in order of decreasing importance. Criteria for assessing the frequency of occurrence of adverse events: very often (& # 8805 .1 / 10), often (& # 8805 .1 / 100, <1/10), infrequently (& # 8805 .1 / 1000, <1/100) , rarely (& # 8805 .1 / 10 000, <1/1000), very rarely (<1/10 000, including individual messages).From the side of blood and lymphatic system: infrequently - leukopenia. very rarely - suppression of bone marrow hematopoiesis, agranulocytosis, aplastic anemia, neutropenia, pancytopenia, thrombocytopenia. On the part of the immune system: very rarely - anaphylactic reactions, hypersensitivity reactions (including multiple organ dysfunctions), which are characterized by such phenomena as rash and an increase in body temperature. Damage to the circulatory and lymphatic systems (eosinophilia, thrombocytopenia, leukopenia, lymphadenopathy, splenomegaly), liver (hepatitis, altered liver function), muscle and joint damage (myalgia, swelling in the joints, arthralgia), nervous system (hepatic encephalopathy), kidney (renal failure, interstitial nephritis, proteinuria), lungs (pulmonary edema, bronchospasm, asthma, interstitial inflammation, shortness of breath), angioedema. On the part of the endocrine system: very rarely - hypothyroidism. Metabolism and nutrition: often - hyponatremia (often observed in patients aged> 65 years). very rarely - clinically significant hyponatremia (sodium concentration <125 mmol / l) - as a rule, during the first 3 months of drug therapy. in some patients more than 1 year after starting treatment with Trileptal .. This condition may lead to the development of such manifestations and symptoms as convulsive seizures, encephalopathy, decreased consciousness, confusion, visual disturbances (including blurred vision), hypothyroidism , vomiting, nausea, folic acid deficiency. On the part of the psyche: often - agitation (including nervousness), emotional lability, confusion, depression, apathy. On the part of the nervous system: very often - drowsiness (22.5%), headache (14.6%), dizziness (22.6%). often - ataxia, tremor, nystagmus, impaired attention, amnesia. From the organ of vision: very often - diplopia (13.9%). often - blurred vision, visual disturbances. On the part of the organ of hearing and labyrinth disorders: often - systemic vertigo. From the side of the heart: very rarely - AV-blockade, arrhythmias. On the part of the vessels: very rarely - arterial hypertension. On the part of the digestive system: very often - vomiting (11.1%), nausea (14.1%). often - diarrhea, abdominal pain, constipation. very rarely - pancreatitis. On the part of the liver and biliary tract: very rarely - hepatitis.From the skin and subcutaneous tissues: often - rash, alopecia, acne. infrequently - urticaria. very rarely, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome caused by medication), angioedema, erythema multiforme, systemic lupus erythematosus. General disorders and disorders at the injection site: very often - feeling tired (12%). often - asthenia. Laboratory and instrumental data: infrequently - increased activity of liver enzymes, alkaline phosphatase. very rarely - increased activity of amylase, lipase. In clinical studies conducted in children aged 1 month to 4 years, drowsiness was most often observed (in 11% of patients). With a frequency of> 1% - <10% (often) there was ataxia, irritability, vomiting, lethargy, fatigue, nystagmus, tremor, loss of appetite, and an increase in the concentration of uric acid in the blood. Adverse reactions identified in the post-marketing period on the basis of individual reports and cases described in the literature. Since data on undesirable reactions in the post-marketing period were obtained on the basis of voluntary reports from a population of unknown size, it is impossible to estimate the frequency of their occurrence (frequency is unknown). Undesirable reactions are classified by organ systems, within each organ system adverse reactions are arranged in order of decreasing severity. On the part of the ruts and subcutaneous tissues Drug eruption with eosinophilia and systemic manifestations, acute generalized exanthematic pustules. On the part of the musculoskeletal and connective tissues There have been reports of a decrease in bone mineral density, osteopenia, osteoporosis and fractures in patients receiving long-term treatment with Trileptal. The mechanism of the effect of oxcarbazepine on bone metabolism has not been clarified. Metabolism and nutrition Syndrome of inadequate secretion of antidiuretic hormone, manifested by lethargy, nausea, dizziness, decreased plasma osmolality, vomiting, headache, confusion and other symptoms of the nervous system. Injuries, intoxication and complications of manipulations. Fall. From the nervous system Speech disorders (includingdysarthria), especially during the dose selection period. Overdose There are isolated reports of overdose. The maximum dose described in the reports was approximately 48,000 mg. Symptoms: Disorders of water and electrolyte balance: hyponatremia. On the part of the organ of vision: diplopia, miosis, blurred vision. On the part of the digestive system: nausea, vomiting, hyperkinesia. General disorders and disorders at the injection site: fatigue. Laboratory and instrumental data: reduction in the frequency of respiratory movements, prolongation of the QTc interval. Nervous system disorders: drowsiness, dizziness, ataxia, nystagmus, tremor, incoordination, convulsions, headache, coma, loss of consciousness, dyskinesia. Mental disorders: aggression, agitation, confusion. From the side of blood vessels: decrease in blood pressure. On the part of the respiratory system, organs of the chest and mediastinum: shortness of breath. Treatment. There is no specific antidote. Conduct symptomatic and supportive treatment. It should be borne in mind that in order to reduce the absorption of oxcarbazepine, gastric lavage may be performed and activated carbon may be administered. It is necessary to monitor the vital functions of the body, paying special attention to violations of water and electrolyte balance, cardiac conduction and disorders of the respiratory system. Cautions There are reports of the risk of worsening of the course of epileptic seizures when using the drug Trileptal. An increased risk of worsening of the course of attacks has been observed, mainly in children, however, it can also occur in adults. If against the background of the use of the drug Trileptal. there is a worsening of the course of epileptic seizures, the use of the drug should be discontinued. Hypersensitivity Reactions When using the drug Trileptal. in clinical practice, in some cases (post-marketing messages), the development of immediate-type hypersensitivity reactions (type I), including rash, pruritus, urticaria, angioedema, and anaphylactic reactions was noted. Hypersensitivity reactions can cause the development of disorders of the skin, liver, blood and lymphatic system and other organs, both individually and as part of a systemic reaction.Angioedema and anaphylactic reactions with lesions of the larynx, vocal folds (glottis), tongue, lips, eyelids developed both at the first and at the repeated use of the drug Trileptal. and prescribe an alternative therapy. It should be used with caution in patients with known hypersensitivity to carbamazepine, because in this group of patients, in approximately 25–30% of cases, hypersensitivity reactions to oxcarbazepine may develop. In patients with no history of indications of hypersensitivity to carbamazepine, it is also possible to develop hypersensitivity reactions to the drug, including multiorgan disorders. If signs and symptoms of hypersensitivity reactions occur, the drug Trileptal should be immediately discontinued. Hyponatremia 2.7% of patients receiving Trileptal received hyponatremia (serum sodium content less than 125 mmol / l), which was usually not accompanied by clinical manifestations and did not require correction therapy. The sodium content is normalized with the cancellation (dose reduction) of the drug Trileptal. or conservative treatment (limiting fluid intake). In patients with impaired renal function in history and low serum sodium (for example, in patients with the syndrome of inadequate secretion of antidiuretic hormone), or in patients receiving simultaneous treatment with drugs that promote sodium excretion from the body (diuretics, drugs that affect antidiuretic hormone secretion), before starting treatment with the drug Trileptal. should determine the content of sodium in serum. In the future, the serum sodium content should be monitored 2 weeks after the start of therapy and then monthly for 3 months or as needed. Special attention should be given to these risk factors in elderly patients. If necessary, the use of diuretics and other drugs that reduce the content of sodium in the serum, in patients receiving therapy with the drug Trileptal., Should follow the same recommendations.With the appearance of clinical symptoms of hyponatremia, it is necessary to determine the content of sodium in the serum. For other patients, the determination of sodium in the serum can be carried out during routine blood tests. It is necessary to monitor body weight in all patients with heart failure for the timely diagnosis of fluid retention. When fluid retention or the progression of symptoms of heart failure should be determined by the content of sodium in serum. In the event of hyponatremia, limit the amount of fluid consumed. Since in the application of oxcarbazepine in very rare cases, there may be a violation of cardiac conduction, careful observation is necessaryActive ingredients
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Suspension