Enkorat Chrono tablets of prolonged action, p / o 500mg, No. 30

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

• absences;

• myoclonic;

• tonic-clonic;

• atonic.

Partial epilepsy:

• simple or combined seizures;

• secondary generalized seizures.

Specific syndromes (Vesta, Lennox-Gastaut)

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

Monitherapy:

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 over 20 kg: Initial dose 400 mg / day. Increase the dosage gradually until the optimal dosage is reached, usually 20-30 mg / kg once a day or in two divided doses.

Children weighing up to 20 kg . Enkorat Chrono should not be used in children of 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 clinically insignificant. The dosage regimen of Enkorat Chrono in elderly patients is similar to the dosage regimen in adults and is selected individually. In patients who have achieved the desired therapeutic effect with Encorat tablets therapy, it is possible to use Encorat Chrono in an appropriate daily dosage.

sodium valproate - 333 mg

valproic acid - 145 mg, which corresponds to the sodium content of valproate - 167 mg

Excipients: hypromellose -K100M (methocel-K100M), hypromellose-K15M (methocel-K15M), starch (dried), purified talc, magnesium stearate, colloidal silicon dioxide.

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

• individual intolerance to the drug;

• severe dysfunctions of the pancreas and liver;

• acute hepatitis;

• pregnancy, lactation;

• porphyria;

• thrombocytopenia;

• children's age up to 3 years.

Clinical and pharmacological group: Anticonvulsant drug

Pharmaco-therapeutic group: Anticonvulsant

pharmachologic effect

Sodium valproate increases the content of GABA (gamma-aminobutyric acid) in the brain, which accordingly increases the content of GABA in postsynaptic neurons. In addition, sodium valproate affects the transport of potassium ions across neuronal membranes. The result of such an effect is the suppression of the occurrence, as well as the spread of epileptic excitation through neurons.

Valproate has anticonvulsant activity in various types of epilepsy in humans. The drug does not have pronounced hypnotic and sedative effects, and also does not depress the respiratory center. Enkorat Chrono does not have a negative effect on blood pressure, heart rate, renal function and body temperature.

Pharmacokinetics

The absorption of the drug is fast and complete. Cmax in plasma is achieved within 2-8 hours after oral administration of controlled-release tablets.

80-90% of the drug binds to blood plasma proteins, T1 / 2 is 8-22 hours. Therapeutic efficacy is manifested at a concentration of valproic acid in blood plasma of 40-100 mg / l. At the same time, the pharmacological and therapeutic effects of this controlled release drug do not always depend on its plasma concentration. Vd - 0.2 l / kg body weight.

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

Indications for Encorat Chrono

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

• absences;

• myoclonic;

• tonic-clonic;

• atonic.

Partial epilepsy:

• simple or combined seizures;

• secondary generalized seizures.

Specific syndromes (Vesta, Lennox-Gastaut)

Dosage regimen

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

Monitherapy:

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 over 20 kg: Initial dose 400 mg / day. Increase the dosage gradually until the optimal dosage is reached, usually 20-30 mg / kg once a day or in two divided doses.

Children weighing up to 20 kg . Enkorat Chrono should not be used in children of 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 clinically insignificant. The dosage regimen of Enkorat Chrono in elderly patients is similar to the dosage regimen in adults and is selected individually. In patients who have achieved the desired therapeutic effect with Encorat tablets therapy, it is possible to use Encorat Chrono in an appropriate daily dosage.

Side effect

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

• nausea, vomiting, diarrhea and / or constipation

• hepatitis

• pancreatitis

• weight gain

• skin rash, pruritus, photosensitivity, erythema multiforme, Steven-Johnson syndrome

• hair loss (in 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.

Contraindications for use

• individual intolerance to the drug;

• severe dysfunctions of the pancreas and liver;

• acute hepatitis;

• pregnancy, lactation;

• porphyria;

• thrombocytopenia;

• children's age up to 3 years.

Application during pregnancy and lactation

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

The use of valproate during breastfeeding is not recommended.

Application for violations of liver function

Contraindicated in severe liver dysfunction, acute hepatitis.

Application in children

Do not use Enkorat Chrono in children weighing up to 20 kg.

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 clinically insignificant. The dosage regimen of Enkorat Chrono in elderly patients is similar to the dosage regimen in adults and is selected individually. In patients who have achieved the desired therapeutic effect during therapy with Encorat tablets, it is possible to use Encorat Chrono in an appropriate daily dosage.

special instructions

Care should be taken when working with mechanisms, as the drug weakens attention. It is necessary to regularly monitor the level of transaminases, bilirubin, blood platelets, amylase (every 3 months).

Valproic acid inhibits platelet aggregation, which increases the risk of increased blood clotting time during bleeding. Consideration should be given to the possibility of bleeding complications in operated patients receiving valproate. Patients taking 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-induced pancreatitis and liver dysfunction (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, and monitor the level of prothrombin. Liver dysfunction, liver failure during valproate therapy is sometimes observed in children with epilepsy and combined metabolic and degenerative diseases, organic pathology of brain tissue and retarded mental development. If symptoms such as severe weakness, lethargy, edema, vomiting and jaundice occur, the drug should be discontinued immediately, severe weakness, lethargy, edema, vomiting and jaundice should be discontinued immediately.Application during pregnancy and lactation:

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

Overdose

Rare cases of accidental or intentional drug overdose have been reported. At the same time, nausea, vomiting, dizziness, diarrhea, respiratory depression, hyporeflexia, and coma were observed.

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

Drug interactions

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

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

With the combined use of valproate and warfarin, the percentage of binding by blood plasma proteins of the latter decreases.

Valproate alters the plasma concentrations of phenytoin and lamotrigine.

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

Storage conditions

Store in a dry, dark place at a temperature not exceeding + 25 ? C. Keep out of the reach of children.

Shelf life

Shelf life is 3 years.

Terms of sale

On prescription.

Contacts for inquiries

SAN PHARMACYTICAL INDUSTRIES LTD. (India)