Encorate сhrono 500 mg, 30 pcs.

Excipients :

hypromellose -K100M (metocel-K100M),

hypromellose-K15M (metocel-K15M),

starch (dried),

peeled talc

magnesium stearate,

silicon dioxide colloidal.

Shell composition:

copolymer of methacrylate, dimethylaminoethyl methacrylate and butyl methacrylate (Eudragit E100), titanium dioxide, polyethylene glycol 6000, sodium lauryl sulfate, sunset sunset yellow.

Sodium valproate increases the content of GABA (gamma-aminobutyric acid) in the brain, which in turn increases the content of GABA in postsynaptic neurons. In addition, sodium valproate affects the transfer of potassium ions through the membranes of neurons. The result of this effect is the suppression of the occurrence, as well as the spread of epileptic excitation along neurons.

Valproate has anticonvulsant activity in various degrees of epilepsy in humans. In addition, the drug does not have pronounced hypnotic and sedative effects and does not inhibit the respiratory center. Encorat Chrono does not have a negative effect on blood pressure, heart rate, kidney function and body temperature.

Pharmacokinetics

Absorption of the drug is fast and complete. C _max  in plasma is achieved within 2-8 hours after oral administration of controlled-release tablets.

80-90% of the drug binds to plasma proteins, T _1/2  is 8-22 hours. Therapeutic efficacy is manifested when the concentration of valproic acid in blood plasma is 40-100 mg / l. At the same time, the pharmacological and therapeutic effects of this drug with controlled release do not always depend on its plasma concentration. V _d  - 0.2 l / kg body weight.

The drug is metabolized in the liver and excreted in the urine. For this drug, no presystemic metabolism was noted.

Treatment of generalized or partial epilepsy, especially with the following types of seizures:

• absences;
• myoclonic;
• tonic-clonic;
• atonic.

Partial Epilepsy:

• simple or combined seizures;
• secondary generalized seizures.

Specific Syndromes (Vesta, Lennox-Gastaut)

Prescribing the drug to pregnant women is only possible if the intended benefit to the mother outweighs the potential risk to the fetus. In the case of taking the drug during pregnancy, it is necessary to conduct specialized prenatal monitoring of the fetus.

The use of valproate during breastfeeding is not recommended.

Use in children

Do not use Encorat Chrono for children weighing up to 20 kg.

• individual intolerance to the drug;
• severe dysfunction of the pancreas and liver;
• acute hepatitis;
• pregnancy, lactation;
• porphyria;
• thrombocytopenia;
• children's age up to 3 years.

Use for impaired liver function

Contraindicated in severe hepatic impairment, acute hepatitis.

Use in elderly patients

Elderly patients: it is characteristic that the volume of distribution increases and the volume of plasma decreases. However, with normal liver and kidney function, this increase in the amount of free drug is not clinically significant. The dosage regimen of Encorat Chrono in elderly patients is similar to the dosage regimen in adults and is selected individually. In patients for whom the necessary therapeutic effect is achieved during therapy with Encorat tablets, Encorat Chrono may be used in the appropriate daily dosage.

In rare cases, the following side effects have been reported:

• nausea, vomiting, diarrhea and / or constipation
• hepatitis
• pancreatitis
• weight gain
• skin rash, pruritus, photosensitization, erythema multiforme, Steven-Johnson syndrome
• hair loss (2-12% of patients)
• ataxia, tremor impaired consciousness, coma
• menstrual irregularities, secondary amenorrhea
• anemia, hyperammonemia, hypercreatinemia, thrombocytopenia, neutropenia, leukopenia, decreased fibrinogen content, inhibition of platelet aggregation.

Valproate enhances the effects of antipsychotic drugs, anticonvulsants, and antidepressants.

Unlike other anticonvulsants, valproate does not induce liver enzymes, therefore, does not reduce the effectiveness of oral contraceptives.

With the combined use of valproate and warfarin, the percentage of plasma protein binding of the latter decreases.

Valproate alters plasma concentrations of phenytoin and lamotrigine.

In combination with anticoagulants and acetylsalicylic acid derivatives, inhibition of platelet aggregation increases.

The dosage regimen is selected individually depending on the age and weight of the patient.

Monotherapy

Adults: the initial dose is 600 mg / day. Increase dosage by 200 mg every three days until optimal effect is achieved.

The tablets should be swallowed whole with a little water. Take 1-2 times a day. The maximum recommended dose is 1-2 g.

Children weighing more than 20 kg: initial dose - 400 mg / day. Increase the dosage gradually until the optimum is achieved, usually 20-30 mg / kg once a day or in two separate doses.

Children weighing up to 20 kg. Do not use Encorat Chrono for children in this category.

Elderly patients: it is characteristic that the volume of distribution increases and the volume of plasma decreases. However, with normal liver and kidney function, this increase in the amount of free drug is not clinically significant. The dosage regimen of Encorat Chrono in elderly patients is similar to the dosage regimen in adults and is selected individually. In patients for whom the necessary therapeutic effect is achieved during therapy with Encorat tablets, Encorat Chrono may be used in the appropriate daily dosage.

Rare cases of accidental or deliberate overdose of the drug have been reported. In this case, nausea, vomiting, dizziness, diarrhea, respiratory depression, hyporeflexia, coma were observed.

First aid: gastric lavage, intake of activated carbon. If necessary, inpatient treatment using symptomatic therapy, hemodialysis.

Caution should be exercised when working with mechanisms, since the drug weakens attention. Regular monitoring of the levels of transaminases, bilirubin, blood platelets, amylase (every 3 months) is necessary.

Valproic acid inhibits platelet aggregation, which increases the risk of increased blood clotting time during bleeding. The possibility of the development of complications associated with bleeding in operated patients receiving valproate should be considered. Patients who take valproate for a long time may develop spontaneous hematomas and bleeding. In this case, you should immediately stop taking the drug.

Valproate can cause drug pancreatitis and impaired liver function (usually in the first 6 months of use). In this regard, it is necessary during the first 6 months of treatment to monitor the state of the pancreas, conduct liver tests, monitor the level of prothrombin. Impaired liver function, liver failure during valproate therapy is sometimes observed in children with epilepsy and combined metabolic and degenerative diseases, organic pathology of the brain tissue and slow mental development. If symptoms such as severe weakness, lethargy, swelling, vomiting, and jaundice occur, you should immediately stop using the drug, severe weakness, lethargy, swelling, vomiting, and jaundice should stop using the drug immediately.

Prescribing the drug to pregnant women is only possible if the intended benefit to the mother outweighs the potential risk to the fetus. In the case of taking the drug during pregnancy, it is necessary to conduct specialized prenatal monitoring of the fetus. The use of valproate during breastfeeding is not recommended.

Pills