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Trileptal® [Oxcarbazepine]

Novartis
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2019-09-19
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Clinical Pharmacology

Antiepileptic drug. Pharmacological activity of the drug Trileptal® (oxcarbazepine) is caused, first of all, by the action of its metabolite, a monohydroxy derivative (IHP). The mechanism of action of oxcarbazepine and its MHD is associated mainly 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 conduction of 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 membrane potential. No significant interactions with brain neurotransmitters or receptor binding have been observed.

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.

Pharmacokinetics

Indications

  • Simple and complex partial epileptic seizures with or without secondary generalization in adults and children ages 1 month and older.
  • Generalized tonic-clonic epileptic seizures in adults and children aged 2 years and older.

Composition

Excipients: colloidal silicon dioxide, microcrystalline cellulose, hypromellose, crospovidone, magnesium stearate, macrogol 8000, talc, titanium dioxide (E171), purified water, iron oxide yellow (E172).

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Trileptal® [Oxcarbazepine]

Dosage and Administration

For oral use.

The initial dose is 8-10 mg / kg body weight / day. Next, the dose is adjusted depending on the treatment regimen, the patient's age, the effectiveness of treatment, and renal function.

For patients with impaired renal function (CC less than 30 ml / min), adjustment of the initial dose and dosing regimen is required.

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 dose rate is 2 times / day. The dose may be increased depending on the response to therapy. In case of replacing 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 antiepileptic 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 meals or in between meals).

Table conversion dose of the drug Trileptal® from mg to ml.

Dose in milligrams (mg) Dose in milliliters (ml)
10 mg 0.2 ml
20 mg 0.3 ml
30 mg 0.5 ml
40 mg 0.7 ml
50 mg 0.8 ml
60 mg 1.0 ml
70 mg 1.2 ml
80 mg 1.3 ml
90 mg 1.5 ml
100 mg 1.7 ml
200 mg 3.3 ml
300 mg 5.0 ml
400 mg 6.7 ml
500 mg 8.3 ml
600 mg 10.0 ml
700 mg 11.7 ml
800 mg 13.3 ml
900 mg 15.0 ml
1000 mg 16.7 ml

Before taking the suspension for ingestion, the vial 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 younger 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. Suspension can be taken directly from a 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.

Therapeutic effect of the drug Trileptal® (oxcarbazepine) is primarily due to the action of its metabolite, IHL.

Routine determination of oxcarbazepine or MHD 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 h after administration), which should be maintained at

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.

Use of the drug Trileptal® in the daily dose of 2400 mg in combination therapy without lowering the dose of another antiepileptic drug was accompanied by poor tolerance in most patients, mainly due to the development of adverse events from the nervous system.Use of the drug Trileptal® at a daily dose above 2400 mg has not been studied.

Children

With monotherapy with the 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®, component 30-46 mg / kg / day, should be achieved no earlier than 2 weeks after the start of therapy.

If necessary, to achieve the desired therapeutic effect, a gradual increase in 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 significantly decreases 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, liver enzyme inducers, 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 required 60% higher (when adjusted for body weight) than with trileptal monotherapy® 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 ≥65 years

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 adjustment of the dosing regimen is required in patients with mild or moderately impaired liver function. Care must be taken when applying to patients with severely impaired liver function.

Patients with 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.

Adverse reactions

The following adverse reactions were most frequently reported: drowsiness, headache, dizziness, diplopia, nausea, vomiting, fatigue (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 (≥1 / 10), often (≥1 / 100,

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, changes in liver function indicators), muscle and joint damage (myalgia, swelling in the joints, arthralgia), nervous system (hepatic encephalopathy), kidneys (renal failure, interstitial nephritis, proteinuria), lungs (pulmonary edema, bronchospasm, bronchial asthma, interstitial inflammation, shortness of breath), angioedema.

On the part of the endocrine system: very rarely - hypothyroidism.

On the part of metabolism and nutrition: often - hyponatremia (often observed in patients aged> 65 years); very rarely, clinically significant hyponatremia (sodium concentration®. This condition can 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 disturbances: often - systemic dizziness.

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 - an increase in the 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% -

Adverse reactions identified in the post-marketing period on the basis of individual reports and cases described in the literature.

Since data on adverse 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.

From the side of the rut and subcutaneous tissue

Drug rash with eosinophilia and systemic manifestations, acute generalized exantmatous pustus.

Musculoskeletal and connective tissue

There have been reports of a decrease in bone mineral density, osteopenia, osteoporosis and fracture detection in patients receiving long-term treatment with the drug Trileptal®. The mechanism of the effect of oxcarbazepine on bone metabolism has not been elucidated.

Metabolism and nutrition

Syndrome of inadequate secretion of antidiuretic hormone, manifested lethargy, nausea, dizziness, decreased plasma osmolality, vomiting, headache, confusion and other symptoms of the nervous system.

Injuries, intoxication and complications of manipulations

The fall.

The nervous system

Speech disorders (including dysarthria), especially during the dose selection period.

It should be carefully prescribed the drug to 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.

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.

Application for violations of the liver

No adjustment of the dosing regimen is required in patients with mild or moderately impaired liver function. Care must be taken when applying to patients with severely impaired liver function.

Application for violations of renal function

Drug interactions

Enzyme inhibition

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

Being 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 MHD, it may be necessary to increase the doses of concurrently used drugs that are metabolized with the participation of CYP3A4 isoenzyme or uridine diphosphate glucouronyl transferase. In case of cancellation of the drug Trileptal® may require a decrease in 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 effect of oxcarbazepine and IHP on other CYP isoenzymes is unknown.

Antiepileptic drugs (PEP)

Possible drug interactions Trileptal® and other antiepileptic drugs have been evaluated during clinical trials. Data on the effect of these interactions on the AUC and the minimum concentration Cminsummarized in the table:

PEP The effect of the drug Trileptal® on probe
Cmin
Effect of PEP on PGM
AUC
Carbamazepine 0-22% reduction (30% increase in carbamazepine-10,11-epoxide) 40% reduction
Clobazam Not studied Does not affect
Felbamate Not studied Does not affect
Phenobarbital 14-15% increase 30-31% reduction
Phenytoin 0-40% increase 29-35% decrease
Valproic acid Does not affect 0-18% decrease

The concentration of phenytoin in the blood plasma is increased to 40% with the simultaneous appointment 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 blood plasma decreases (by 29-40%). Thus, it is necessary to control the concentration of MHP in the blood plasma and, if necessary, adjust the dose of the drug while using oxcarbazepine with one or more of the above drugs.

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 patients receiving treatment with Trileptal®It is recommended the additional use of reliable non-hormonal methods of contraception.

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

Cimetidine, erythromycin, dextropropoxyphene do not affect the pharmacokinetic parameters of IHL; 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 have been noted, either with a single simultaneous dose, or with repeated doses of the drug Trileptal.®.

Drug trileptal® may enhance the sedative effect of ethanol.

Pregnancy and Lactation

Children of patients with epilepsy are more likely to develop developmental disorders, including congenital malformations.

Experience of using the drug Trileptal® during pregnancy is limited. Available reports suggest a possible connection with the use of the drug during pregnancy with the development of congenital malformations (CDF). The most frequent malformations in children whose mothers received therapy with the drug Trileptal® during pregnancy, there were: atrial septal defect, atrioventricular septal defect, cleft hard palate and upper lip, Down syndrome, hip joint dysplasia (both single and bilateral), tuberous sclerosis and ear defects.

According to the North American Pregnant Women Register, the incidence of gross malformations related to structural abnormalities requiring surgical, medical or cosmetic correction, diagnosed within 12 weeks after birth, was 2.0% (95% confidence interval from 0.6 to 5.1%) among pregnant women who took in the first trimester, oxcarbazepine in monotherapy. Compared to pregnant women who did not receive therapy with any antiepileptic drugs during pregnancy, the relative risk of developing developmental malformations in children is 1.6 with a confidence interval of 95% from 0.46 to 5.7.

Patients of childbearing age should use reliable methods of contraception during treatment with the drug Trileptal® (Optimally, intrauterine contraceptives), because when used concomitantly with oral contraceptives containing ethinyl estradiol or levonorgestrel, the effectiveness of these drugs may decrease.

If the patient is planning a pregnancy or pregnancy is diagnosed during the use of the drug, as well as when there is a question about the use of the drug Trileptal® during pregnancy, it is necessary to carefully compare the expected benefits of therapy and the possible risk to the fetus, especially in the first trimester of pregnancy.

When pregnancy should use the minimum effective dose of the drug. With sufficient clinical efficacy in women of childbearing age, the drug Trileptal® should be used in monotherapy.

The patient should be warned about possible violations of the development of the fetus and the need for antenatal diagnosis.

During pregnancy, effective antiepileptic treatment should not be interrupted, as the progression of the disease can have a negative effect on the mother and fetus. It is known that during pregnancy, folic acid deficiency develops. Antiepileptic drugs can exacerbate this deficiency, which is one of the possible causes of impaired fetal development, so additional folic acid supplementation is recommended.

When using the drug during pregnancy, it is necessary to take into account that the physiological changes that occur in the body during pregnancy can lead to a gradual decrease in plasma levels of 10-monohydroxy derivative (MHD). To achieve maximum control over the symptoms of the disease in pregnant patients, it is necessary to regularly evaluate the clinical effect of the drug and determine the concentration of MHD in the blood plasma.

It is also recommended to determine the level of IHD in the blood plasma in the postpartum period, especially if the dose of the drug was increased during pregnancy.

There are reports that the use of antiepileptic drugs during pregnancy can lead to increased bleeding in the newborn. Vitamin K is recommended as a precautionary measure.1 in the last few weeks of pregnancy, as well as newborns whose mothers received the drug Trileptal®.

Oxcarbazepine and MHP penetrate the placental barrier. Oxcarbazepine and IHD are excreted in breast milk. The ratio of concentrations in milk and plasma was 0.5 for both substances. Since the effect on oxcarbazepine and IHD on newborns that are received through breast milk is unknown, do not use Trileptal® during breastfeeding.

Use in children under 1 month

No data on the safety and efficacy of the use of the drug Trileptal® in children under the age of 1 month.

Impact on fertility

No data on the effect of the drug on fertility in humans. In animal studies, no effects of oxcarbazepine and MHP on fertility were found in individuals of both sexes at daily doses of 150 and 450 mg / kg, respectively.When using maximum doses of IHD in females, however, there was a violation of the astral cycle, a decrease in the number of luteal bodies, a decrease in the number of implantations and the number of live embryos.

Special instructions

There are reports of a risk of worsening the course of epileptic seizures when using the drug Trileptal.®. An increased risk of worsening seizures 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 stopped.

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 (region of the glottis), tongue, lips, eyelids developed both at the first and at the repeated use of the drug Trileptal®. In the case of the development of immediate type hypersensitivity, the drug Trileptal should be immediately discontinued.® 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, you should immediately discontinue the drug Trileptal®.

Hyponatremia

In 2.7% of patients receiving the drug Trileptal®, hyponatremia was observed (serum sodium content less than 125 mmol / l), which was usually not accompanied by clinical manifestations and did not require correction of 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, 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), prior to the start of therapy 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 paid to these risk factors in elderly patients. If necessary, the use of diuretics and other drugs that reduce the content of sodium in the blood serum, in patients receiving therapy with 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 serum sodium 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 the serum. In the event of hyponatremia, limit the amount of fluid consumed. Since with the use of oxcarbazepine in very rare cases, a violation of cardiac conduction is possible, careful monitoring of patients with previous conduction disorders (atrioventricular block, arrhythmia) receiving the drug Trileptal is necessary®.

Hematologic changes

According to post-marketing messages during treatment with the drug Trileptal® in patients in very rare cases, the development of agranulocytosis, aplastic anemia and pancytopenia was noted. Given the low frequency of occurrence of agranulocytosis, aplastic anemia and pancytopenia, as well as associated factors (for example, simultaneous use of other drugs, the presence of associated diseases), a causal relationship between the development of these adverse events and the use of the drug cannot be established. With the development of symptoms of pronounced oppression of bone marrow hematopoiesis, it is necessary to consider the issue of drug withdrawal.

Suicidal thoughts and behavior

Patients who received anticonvulsants had episodes of suicidal behavior and suicidal thoughts. The results of methanalysis of randomized, placebo-controlled studies showed a slight increase in the risk of suicidal behavior in patients who received anticonvulsants. The mechanism of increasing the risk of suicide in this category of patients has not been established. Therefore, at all stages of treatment, careful monitoring of patients receiving drug treatment is necessary. Patients and medical personnel should be warned about the risk of suicidal thoughts and episodes in patients receiving treatment with Triepleptal®.

Dermatological reactions

When using the drug Trileptal® very rarely reported on the development of serious dermatological reactions, such as: Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), exudative erythema multiforme. Patients with the above dermatological reactions may require hospitalization due to the development of life-threatening conditions; fatal outcomes are very rare. When using the drug Trileptal® Dermatological reactions were observed in both children and adults, and developed on average 19 days after the start of the drug. There are separate reports of cases of recurrence of serious skin reactions with the resumption of taking the drug Trileptal®. With the development of skin reactions on the background of the use of the drug Trileptal® Consideration should be given to discontinuing the drug and using another antiepileptic drug.

Correlation with HLA-B * 1502

There is a significant amount of data confirming the role of human leukocyte antigen (HLA) alleles in the development of serious skin reactions in patients with a predisposition to such conditions. Due to the similarity

  • Brand name: Trileptal
  • Active ingredient: Oxcarbazepine
  • Dosage form: Yellow-coated pills, oval, slightly biconvex, risky on both sides, TF / TF marking on one side and CG / CG on the other.
  • Manufacturer: Novartis
  • Country of Origin: Switzerland

Studies and clinical trials of Oxcarbazepine (Click to expand)

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