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Trileptal Oxcarbazepine 150, 300, 600 mg
Most popular brand: Trileptal
Active ingredient: Oxcarbazepine
Available dosage forms: 150, 300, 600 mg
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OXCARBAZEPINE (oxcarbazepine)

The initial dose – 8 – 10 mg / kg body weight / day. Further, the dose is adjusted depending on the treatment regimen, patient’s age, treatment efficacy, renal function.

For patients with impaired renal function (creatinine clearance less than 30 ml / min) required correction initial dose and dosing regimen.

The most frequently (& ge; 10%) . drowsiness, headache, dizziness, diplopia, nausea, vomiting, fatigue.

From the hematopoietic system: sometimes – leukopenia; very rarely – the suppression of bone marrow hematopoiesis, agranulocytosis, aplastic anemia, neutropenia, pancytopenia, thrombocytopenia.

Immune system: very rarely – hypersensitivity reactions accompanied by fever and rash (including multiple organ disorders). With the development of hypersensitivity reactions may result in circulatory and lymphatic systems (eosinophilia, thrombocytopenia, lymphadenopathy, splenomegaly), muscles and joints (myalgia, swelling in the joints, arthralgia), nervous system (encephalopathy), kidney (proteinuria, interstitial nephritis, renal failure ), pulmonary (dyspnea, pulmonary edema, bronchospasm, interstitial inflammation), abnormal liver function, angioedema, anaphylactic reactions.

From a metabolism: often – hyponatremia; very rarely – clinically significant hyponatremia (sodium concentration of < 125 mg / dL ; usually within the first 3 months of drug therapy, some patients ; more than 1 g after the start of treatment), leading to the development of such symptoms and symptoms such as seizures, confusion, decreased level of consciousness, encephalopathy, visual disturbances (including blurred vision), nausea, vomiting, folic acid deficiency; very rarely – hypothyroidism.

CNS: very often – drowsiness, headache, dizziness; often – ataxia, tremor, nystagmus, disturbance of attention, amnesia; confusion, depression, apathy, agitation, emotional lability.

From the senses: very often – diplopia; often – blurred vision, blurred vision, vertigo.

Cardio – vascular system: very rarely – arrhythmias, the AV – blockade hypertension.

From the digestive system: very often – nausea, vomiting; often – diarrhea, constipation, stomach pain; sometimes – increased activity of the liver enzymes, increased blood levels of alkaline phosphatase; very rarely – pancreatitis and / or an increase in lipase and / or amylase, hepatitis.

Dermatological reactions: often – rash, alopecia, acne.

Allergic reactions: sometimes – urticaria; very rarely – angioedema, Stevens – Johnson syndrome, toxic epidermal necrolysis (Lyell’s syndrome), erythema multiforme.

Other: very often – feeling tired; often – asthenia; very rare – systemic lupus erythematosus.

For children aged up to 4 years old: very often (11%) – drowsiness; often (& ge; 1% – < 10%) – ataxia, irritability, vomiting, lethargy, fatigue, nystagmus, tremor, decreased appetite, increase in the concentration of uric acid in the blood.

Contraindications

Children under 3 years of age; hypersensitivity to oxcarbazepine.

Pregnancy and breastfeeding

Experience in the use during pregnancy is limited. Available reports indicate a possible connection receiving oxcarbazepine during pregnancy with the development of birth defects (such as cleft palate).

The experimental research in the application of oxcarbazepine in toxic doses showed an increase in fetal mortality, retardation and impaired development and fetal growth. If a patient plans to become pregnant or becomes pregnant during use of oxcarbazepine, as well as in the event of the application of oxcarbazepine during pregnancy should be carefully compare the expected benefits of therapy and the possible risks to the fetus, especially in the I trimester of pregnancy.

If pregnancy should use oxcarbazepine in the lowest effective dose.

When sufficient clinical efficacy in women of childbearing age, oxcarbazepine should be used as a single agent.

If pregnancy should not interrupt an effective antiepileptic treatment, because the progression of the disease can have a negative impact on the mother and the fetus.

It is known that during pregnancy develop folic acid deficiency. Antiepileptic drugs can enhance the deficit, which is one of the possible causes of violations of fetal development, so it is recommended supplementation with folic acid.

In the application during pregnancy is necessary to consider that the physiological changes that occur in the body of the pregnant woman, can lead to a gradual reduction of the concentration of the active metabolite in the blood plasma. For maximum control of symptoms must regularly evaluate the clinical effect of oxcarbazepine and determine the concentration of the metabolite in the blood plasma. Determination of IHP recommended concentration in blood plasma and in the postpartum period, especially in the case of pregnancy oxcarbazepine dose increased.

There are reports that the use of antiepileptic drugs during pregnancy can lead to increased bleeding in newborns. As a precaution, it is recommended the appointment of vitamin K 1 in the last few weeks of pregnancy, and newborns who receive oxcarbazepine mother.

oxcarbazepine and IHL cross the placental barrier and is excreted in breast milk. The ratio of the concentration in milk and plasma was 0.5 for both substances. Since the impact on newborns oxcarbazepine and IHL, received a mother’s milk is not known, should not be used oxcarbazepine during the breastfeeding period.

To apply caution in patients with known hypersensitivity to carbamazepine, because Patients in this group of about 25 – 30% may develop hypersensitivity reactions to oxcarbazepine. In patients without a history of hypersensitivity to the instructions on carbamazepine, also may develop hypersensitivity reactions to oxcarbazepine, including multiple organ disorders. In the case of immediate hypersensitivity reactions such as oxcarbazepine should be lifted immediately appoint an alternative therapy.

To apply caution in patients with severely impaired hepatic function.

In patients with impaired renal function, and having a low sodium concentration in the blood serum, or in patients receiving concomitant treatment with drugs that promote sodium excretion from the body (diuretics, drugs that affect the secretion of ADH), prior to initiating therapy with oxcarbazepine should be determined serum sodium concentration. Further should be controlled in the serum sodium concentration of 2 weeks after initiation of therapy and then monthly for 3 months or as needed. With special attention to these risk factors should be treated in older patients. The appointment of diuretics and other drugs that reduce the concentration of sodium in the blood serum of patients receiving oxcarbazepine, should follow the same recommendations. When clinical symptoms suggestive of hyponatraemia should measure the sodium concentration in the blood serum. For the remaining patients in the serum sodium concentration measurement can be performed during routine blood tests.

With the development of symptom suppression of bone marrow hematopoiesis is necessary to consider the abolition of oxcarbazepine.

Patients treated with anticonvulsants, rarely observed episodes of suicidal behavior and thinking. The mechanism of increase suicide risk in these patients is not established. Therefore, at all stages of the treatment should be carefully monitored for patients receiving oxcarbazepine.

It is necessary to control body weight for all patients with heart failure to timely identification of fluid retention. When liquid or delay in the progression of heart failure symptoms sodium concentration should be determined in the blood serum. In case of hyponatremia should limit the amount of fluid consumed. In the application of oxcarbazepine in very rare cases may impair cardiac conduction, so the period of treatment should be carefully monitored for patients with prior conduction disturbances (AV – block, arrhythmia).

When using oxcarbazepine dermatologic reactions have been observed in both children and adults, and developed an average of 19 days after the start of treatment. There are some reports of recurrence of skin reactions at the resumption of receiving oxcarbazepine. With the development of skin reactions during treatment with oxcarbazepine should consider its abolition and appointment of other antiepileptic drugs.

If you suspect that hepatitis is necessary to consider the abolition of oxcarbazepine.

As with any other antiepileptic drugs, oxcarbazepine should be withdrawn gradually from the – to the risk of increased frequency of seizures.

Effects on ability to drive vehicles and management mechanisms

Patients who during treatment with oxcarbazepine appears dizziness, drowsiness or other disorders of the central nervous system, do not drive vehicles or operate machinery during treatment.

oxcarbazepine and its pharmacologically active metabolite of IHL are inhibitors of cytochrome CYP2C19. Therefore, the application of high doses of oxcarbazepine possible drug interactions with drugs metabolized by CYP2C19 (phenobarbital, phenytoin). Some patients may require a dose reduction of drugs – CYP2C19 substrates. It has been demonstrated that oxcarbazepine and IHL is weak or does not interact with the following microsomal isoenzymes: CYP1A2, CYP2A6, CYP2C9, CYP2D9, CYP2E1, CYP4A4 and CYP4C11.

As inducers of CYP3A4 and CYP3A5, oxcarbazepine and IHL reduce plasma concentrations of drugs metabolized by these isoenzymes: dihydropyridine calcium antagonists, oral contraceptives, and antiepileptic drugs (eg, carbamazepine). In an application with oxcarbazepine is also possible to decrease the plasma concentrations of other drugs that are substrates of CYP3A4 and CYP3A5 enzyme (eg, drugs of immunosuppressants ; tacrolimus).

As in vitro IHP is a weak inducer of UDP – glucuronyl transferase and, therefore, it is unlikely that in vivo it is able to affect the metabolism of drugs that are excreted as conjugates of glucuronic acid c (eg, valproic acid and lamotrigine). However, even taking into account the weak inducing ability of oxcarbazepine and IHL, may require increased doses of both the drugs metabolized by CYP3A4 or UDP – glucuronyl. In case of cancellation of oxcarbazepine may require dose reduction of these drugs.

In vitro studies have confirmed the ability of inducing a weak oxcarbazepine and IHL with regard to isozymes of subsystems CYP2V and CYP3A4 enzymes. Inducing influence of oxcarbazepine and IHL to other CYP enzymes is unknown.

The concentration of phenytoin in blood plasma increases to 40% while the use of oxcarbazepine in a dose of 1200 mg / day or higher. Therefore, when used in doses of oxcarbazepine may require dose reduction of phenytoin.

Increased serum concentration of phenobarbital while the use of oxcarbazepine slightly (15%).

Co-administration of strong inducers of cytochrome P450 isoenzymes (ie carbamazepine, phenytoin and phenobarbital) decreases the IHL plasma concentrations (29 – 40%).

It is proved oxcarbazepine interaction with ethinylestradiol and levonorgestrel. The mean values ​​for AUC are decreased by 48 – 52% and 35 – 52%, respectively. Studies of interaction of oxcarbazepine with other oral or implanted contraceptives have been conducted. Thus, the simultaneous use of hormonal contraceptives and oxcarbazepine may reduce the effectiveness of the latter.

The simultaneous use of oxcarbazepine felodipine and may reduce the value of felodipine AUC by 28%, although the plasma concentration remains within the therapeutic range.

On the other hand, while the application with verapamil may reduce IHL serum concentration by 20%. This reduction has no clinical significance.

cimetidine, erythromycin, dextropropoxyphene do not affect the pharmacokinetic parameters of IHL; viloksazin little effect on the plasma concentration of IHP (IHP concentration increased by 10% after the second joint application). There was no any – any interaction with warfarin when receiving both single and multiple doses of oxcarbazepine.

oxcarbazepine may enhance the sedative effect of ethanol.

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