Encorate chrono, 500 mg 30 pcs

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 transport of potassium ions across neuronal membranes. The result of this effect is the suppression of the emergence as well as the spread of epileptic excitation through neurons.

Valproate has anticonvulsant activity for various degrees of epilepsy in humans. In addition, the drug has no pronounced hypnotic and sedative effects and does not have a depressant effect on the respiratory center. Encorate Chrono has no negative effect on blood pressure, heart rate, renal function and body temperature.

Pharmacokinetics

Absorption of the drug is fast and complete. C_max in plasma are reached within 2-8 hours after oral administration of controlled-release tablets.

80-90% of the drug is bound by plasma proteins, T_1/2 is 8-22 hours. Therapeutic efficacy is seen at plasma concentrations of valproic acid of 40-100 mg/L. At the same time, the pharmacological and therapeutic effects of this controlled-release drug are not always dependent on its plasma concentration. V_d is 0.2 L/kg body weight.

The drug is metabolized in the liver and excreted in the urine. No presystemic metabolism has been noted for this drug.

Indications

Seizures, Epilepsy

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

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

Partial epilepsy:

• simple or combined seizures;
• secondary generalized seizures.

Specific syndromes (West, Lennox-Gastaud)

Active ingredient

Valproic acid

Composition

Associates:

Hypromellose-K100M (metocel-K100M),

Hypromellose-K15M (metocel-K15M),

starch (dried),

purified talc,

magnesium stearate,

colloidal silicon dioxide.

Composition of the shell:

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

How to take, the dosage

The dosing regimen is adjusted individually according to the patient’s age and weight.

Monitherapy:

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

The tablets should be swallowed whole with a small amount of water. It should be taken 1 to 2 times a day. The maximum recommended dose is 1 to 2 g.

In children with a body weight of more than 20 kg: The initial dose is 400 mg/day. Increase gradually until optimal dosage is reached, usually 20-30 mg/kg once daily or in two separate doses.

Children with a body weight less than 20 kg. Enkorat Chrono should not be used in children in this category.

Elderly patients: it is characteristic that the volume of distribution increases and the plasma volume decreases. However, in normal hepatic and renal function this increase in free drug volume is not clinically significant. Dosing regimen of Encorate chrono in elderly patients is similar to that in adults and is chosen individually. In patients in whom the required therapeutic effect is achieved with Enkorat tablet therapy, it is possible to use Enkorat Chrono in appropriate daily dosage regimen.

Interaction

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

In contrast to other anticonvulsants, valproate does not cause induction of hepatic enzymes, so it does not reduce the effectiveness of oral contraceptives.

When valproate and warfarin are used together 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 increases inhibition of platelet aggregation.

Special Instructions

Caution should be exercised when operating machinery, because the drug weakens attention. Transaminases, bilirubin, blood platelets, amylase levels should be monitored regularly (every 3 months).

Valproic acid inhibits platelet aggregation, which increases the risk of increased clotting time in bleeding. The possibility of bleeding-related complications in operated patients receiving valproate should be considered. In patients taking valproate for a long time, spontaneous hematomas and bleeding may develop. If this occurs, the drug should be discontinued immediately.

Valproate may cause drug-induced pancreatitis and impaired liver function (usually in the first 6 months of use). In this regard, during the first 6 months of treatment it is necessary to monitor the condition of the pancreas, conduct hepatic tests, monitor prothrombin levels. Impairment of liver function, hepatic failure during valproate therapy is sometimes observed in children with epilepsy and combined metabolic and degenerative diseases, organic pathology of brain tissue and delayed mental development. In case of symptoms such as marked weakness, lethargy, edema, vomiting and jaundice, the drug should be stopped immediately, marked weakness, lethargy, edema, vomiting and jaundice, the drug should be stopped immediately. Use during pregnancy and lactation period:

The drug may be administered to pregnant women only when the anticipated benefit to the mother exceeds the potential risk to the fetus. In case the drug is administered during pregnancy, specialized prenatal fetal monitoring is mandatory. Valproate administration during breastfeeding is not recommended.

Contraindications

• individual intolerance to the drug;
• explicit pancreatic and hepatic dysfunction;
• particular hepatitis;
• pregnancy, pregnancy, lactation;

porphyria.acute hepatitis;

• pregnancy, lactation;
• porphyria;
• thrombocytopenia;
• children under 3 years of age.

Perhaps with liver disorders

It is contraindicated in severe liver function, acute hepatitis.

Performance in elderly patients

Elderly patients: characteristically, the volume of distribution increases and the plasma volume decreases. However, with normal hepatic and renal function this increase in free drug volume is not clinically significant. Dosing regimen of Encorate chrono in elderly patients is similar to that in adults and is chosen individually. In patients in whom the required therapeutic effect is achieved with Enkorat tablet therapy, Enkorat Chrono may be used in appropriate daily dosage regimen.

Side effects

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

• nausea, vomiting, diarrhea and/or constipation
• hepatitis
• pancreatitis
• increased body weight
skin rash, itching, photosensitization, erythema multiforme, Stephen-Johnson syndrome
• hair loss (in 2-12% of patients)
• ataxia, tremor impaired consciousness, coma
• menstrual cycle disorders, secondary amenorrhea
• anemia, hyperammonemia, hypercreatinemia, thrombocytopenia, neutropenia, leukopenia, reduced fibrinogen content, inhibition of platelet aggregation.

.

Overdose

Rare cases of accidental or intentional overdose of the drug have been reported. Nausea, vomiting, dizziness, diarrhea, respiratory depression, hyporeflexia, coma have been observed.

First aid: gastric lavage, administration of activated charcoal. If necessary – inpatient treatment with symptomatic therapy, hemodialysis.

Pregnancy use

The drug may be administered to pregnant women only when the expected benefits to the mother exceed the potential risk to the fetus. In case the drug is administered during pregnancy, specialized prenatal monitoring of the fetus is obligatory.

The use of valproate during breastfeeding is not recommended.

Pediatric use

Encorate Chrono should not be used in children with a body weight less than 20 kg.

Similarities

Convulex, Depakine, Depakine 300 enteric, Valparin XP, Depakine Chronosphere