Encorate chrono, pills 300mg, 30pcs

Composition

Auxiliary substances:

hypromellose-To 100 M (metocel – To 100 M),

hypromellose – To 15 M (metocel – To 15 M),

starch (dried),

purified talc,

magnesium stearate,

colloidal silicon dioxide.

Shell composition:  

copolymer of methacrylate, dimethylaminoethylmethacrylate and butylmethacrylate (eudragit E 100), titanium dioxide, polyethylene glycol 6000, sodium lauryl sulfate, dye sunset yellow.

Pharmacological action

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 act depressingly on the respiratory center.

Encorat Chrono has no negative effect on blood pressure, heart rate, kidney function and body temperature.

Indications

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

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

Partial epilepsy:

• simple or combined seizures;
• secondary generalized seizures.

Specific syndromes (West, Lennox-Gastaut)

Use during pregnancy and lactation

Prescribing the drug to pregnant women is possible only if the intended benefit to the mother exceeds the potential risk to the fetus. In the case of taking the drug during pregnancy, it is mandatory 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 in children with a body weight of up to 20 kg.

Contraindications

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

Use in patients with liver function disorders

Contraindicated in severe liver dysfunction, acute hepatitis.

Use in elderly patients

Elderly patients: it is characteristic that the volume of distribution increases and the plasma volume 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 who have achieved the necessary therapeutic effect with Encorat tablets, it is possible to use Encorat Chrono in the appropriate daily dosage.

Side effects

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, Stephen-Johnson
• syndrome menstrual disorders, secondary amenorrhea
• anemia, hyperammonemia, hypercreatinemia, thrombocytopenia, neutropenia, leukopenia, decreased fibrinogen content, inhibition of platelet aggregation.
• hair loss (in 2-12% of patients)
• ataxia, tremor impaired consciousness, coma

Interaction

Valproate changes the plasma concentrations of phenytoin and lamotrigine.

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

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

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

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

How to take, course of use and dosage

The dosage regimen is selected individually depending on 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 the optimal effect is achieved.

Tablets should be swallowed whole, washed down with a small amount of water. Take 1-2 times a day. The maximum recommended dose is 1-2 g.

Children weighing more than 20 kg:  the initial dose is 400 mg / day. Gradually increase the dosage until the optimal dose is reached, 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 of this category.

Elderly patients:  characteristically, the volume of distribution increases and the plasma volume 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 who have achieved the necessary therapeutic effect with Encorat tablets, it is possible to use Encorat Chrono in the appropriate daily dosage.

Overdose

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

First aid: gastric lavage, taking activated charcoal. If necessary, inpatient treatment with the use of symptomatic therapy, hemodialysis.

Special instructions

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

Valproic acid inhibits platelet aggregation, which increases the risk of increased blood clotting time during bleeding. The possibility of bleeding-related complications in operated patients receiving valproate should be considered. 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 impaired liver function (usually in the first 6 months of use). In this regard, it is necessary to monitor the condition of the pancreas, conduct liver tests, and monitor the level of prothrombin during the first 6 months of treatment. Impaired liver function, liver 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. If symptoms such as severe weakness, lethargy, swelling, vomiting and jaundice occur, the use of the drug should be stopped immediately, severe weakness, lethargy, swelling, vomiting and jaundice, the use of the drug should be stopped immediately. Use during pregnancy and lactation:

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

Form of production

Tablets

Storage conditions

Store in a dry place, protected from light, at a temperature not exceeding 25 °C

Shelf life

3 years

Active ingredient

Valproic Acid

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Description

Children as prescribed by a doctor, Adults as prescribed by a doctor

Indications

Epilepsy