Enkorat Chrono - Instructions For Use, Price, Tablets 500 Mg, 300 Mg, 200 Mg

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Encorat Chrono

Encorat chrono: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Instructions for use: method and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. For violations of liver function
13. 13. Drug interactions
14. 14. Analogs
15. 15. Terms and conditions of storage
16. 16. Terms of dispensing from pharmacies
17. 17. Reviews
18. 18. Price in pharmacies

Latin name: Encorate chrono

ATX code: N03AG01

Active ingredient: valproic acid (valproic acid)

Manufacturer: Sun Pharmaceutical Industries Ltd. (India)

Description and photo update: 2018-21-11

Prices in pharmacies: from 166 rubles.

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Encorat Chrono is a drug with antiepileptic action.

Release form and composition

Dosage form of Encorata chrono - tablets of prolonged action (with controlled release), film-coated: orange, biconvex; 200 and 300 mg - round, 500 mg - capsule-shaped (in a carton box 3 or 5 strips of 10 tablets).

Active ingredients in 1 tablet:

• sodium valproate - 133.5 mg, 200 mg or 333 mg;
• valproic acid - 58 mg, 87 mg or 145 mg (equivalent to sodium valproate - 66.5 mg, 100 mg or 167 mg).

Auxiliary components (200/300/500 mg):

• core: dried starch - 13 / 21.25 / 45.25 mg; purified talc - 21.875 / 32.4 / 43.753 mg; colloidal silicon dioxide - 20/30/45 mg; hypromellose-K100M (Metocel-K100M) - 50/72/75 mg; hypromellose-K15M (Metocel-K15M) - 20/27/45 mg; magnesium stearate - 5.438 / 7.95 / 13.13 mg;
• shell: macrogol-6000 - 0.47 / 0.6 / 0.94 mg; titanium dioxide - 1.875 / 2.4 / 3.753 mg; copolymer of methyl methacrylate, butyl methacrylate and dimethylaminoethyl methacrylate (Eudragit E-100) - 2.35 / 3 / 4.7 mg; dye sunset sunset yellow - 0.45 / 0.57 / 0.9 mg.

Pharmacological properties

Pharmacodynamics

Encorate Chrono is an antiepileptic agent with a sedative and central muscle relaxant effect. It has antiarrhythmic activity.

Sodium valproate increases the content of GABA (gamma-aminobutyric acid) in the central nervous system. Due to this, the content of GABA in postsynaptic neurons increases. In addition, sodium valproate influences the transport of potassium ions across neuronal membranes. This leads to a decrease in the excitability and convulsive readiness of the areas of the brain.

As a result of the use of Enkorat Chrono, the mood and mental state of patients are improved.

Pharmacokinetics

Valproic acid in the form of prolonged-release tablets is characterized by the absence of absorption latency, slow absorption, identical bioavailability, lower (by 25%), but relatively more stable plasma concentration.

Food absorption rate decreases slightly; bioavailability - approximately 100%. After oral administration of Encorat chrono, the maximum plasma concentrations are reached within 2-8 hours, the equilibrium plasma concentration - after 2-4 days of therapy (depending on the intervals between single doses).

The relationship of valproic acid with blood plasma proteins at a plasma concentration of up to 50 mg / l is in the range from 90 to 95%, at a concentration of 50-100 mg / l, this indicator decreases to 80-85%. With uremia, liver cirrhosis and hypoproteinemia, binding to plasma proteins is also reduced. The therapeutic efficacy of Encorat Chrono is manifested when the concentration of valproic acid in blood plasma is in the range of 40–100 mg / l. At the same time, the therapeutic and pharmacological effects do not always depend on the plasma concentration of the substance. The volume of distribution is 0.2 l / kg.

Excretion of valproic acid (1–3%) and its metabolites (in the form of oxidation products, conjugates, including ketometabolites) occurs by the kidneys; a small amount is excreted in feces and exhaled air. No pre-systemic metabolism was noted. Penetrates the placental and blood-brain barriers. It is excreted in breast milk (in breast milk, the concentration ranges from 1 to 10% of the plasma concentration of the mother).

The half-life is 8–22 hours. When combined with other drugs, this figure can be 6–8 hours, which is associated with the induction of metabolic enzymes (with impaired liver function, in elderly patients and children under 18 months of age, it can increase significantly).

Indications for use

According to the instructions, Enkorat Chrono is prescribed as monotherapy or in combination with other AEDs (antiepileptic drugs) in the following cases:

• partial epilepsy (partial seizures with / without secondary generalization);
• generalized epilepsy, especially with the following types of seizures - tonic-clonic, clonic, myoclonic, tonic, atonic, absences;
• specific syndromes (Vesta, Lennox - Gastaut);
• children's tics, febrile convulsions (children);
• manic-depressive psychosis with bipolar course, which does not respond to treatment with Li ⁺ or other drugs (adults);
• behavioral and character changes associated with epilepsy (adults).

Contraindications

Absolute:

• liver failure;
• porphyria;
• hemorrhagic diathesis;
• severe dysfunction of the pancreas;
• hepatitis in acute and chronic course;
• metabolic disorders of the urea cycle, including a burdened family history;
• severe thrombocytopenia;
• combination therapy with St. John's wort, mefloquine, lamotrigine;
• period of breastfeeding;
• body weight less than 20 kg;
• individual intolerance to the components of the drug.

Relative (Enkorat Chrono is prescribed under medical supervision):

• burdened history of diseases of the pancreas and liver;
• hypoproteinemia;
• oppression of bone marrow hematopoiesis, including leukopenia, thrombocytopenia, anemia;
• renal failure;
• organic diseases of the brain;
• congenital fermentopathies;
• mental retardation in children;
• age up to 3 years;
• pregnancy.

Instructions for the use of Enkorat Chrono: method and dosage

Encorat Chrono is intended for oral administration. The tablets should be swallowed whole with a little water.

The daily dose can be taken in 1 or 2 doses, preferably with meals.

The scheme of application is determined individually, it depends on the age and weight of the patient, as well as individual sensitivity to the action of the drug.

Recommended dosage regimen for Enkorata chrono during monotherapy:

• adults: initial daily dose - 600 mg. Then every three days the dose is increased by 200 mg until the optimal effect is achieved. The maximum recommended dose is 1000–2000 mg;
• children weighing more than 20 kg: initial dose - 400 mg. Then the dose is gradually increased until the optimal effect is achieved, usually 20–30 mg / kg.

If the desired therapeutic effect has been achieved during therapy with Encorat, it is possible to switch to Encorat chrono in the appropriate daily dose.

Side effects

• digestive system: diarrhea, constipation, hepatitis, nausea, gastralgia, vomiting, increased / decreased appetite, pancreatitis, up to severe lesions with a fatal outcome (occurs in the first 6 months of therapy, more often at 2-12 weeks);
• nervous system: headache, enuresis, dysarthria, ataxia, drowsiness, dizziness, encephalopathy, stupor, tremors, changes in behavior, mental state or mood (in the form of feelings of fatigue, depression, hallucinations, hyperactivity, aggressiveness, psychosis, unusual excitement, irritability or motor restlessness), coma, impaired consciousness;
• endocrine system: galactorrhea, secondary amenorrhea, dysmenorrhea, breast enlargement;
• hematopoietic organs and the hemostasis system: inhibition of bone marrow hematopoiesis (leukopenia, anemia), thrombocytopenia, a decrease in the content of fibrinogen and platelet aggregation (leads to the appearance of hypocoagulation, accompanied by petechial hemorrhages, lengthening of bleeding time, hematomas, bruising and.)
• metabolism: increase / decrease in body weight;
• sense organs: nystagmus, diplopia, flashing before the eyes of flies;
• laboratory parameters: hyperbilirubinemia, hyperammonemia, hypercreatininemia, hyperglycemia, a slight dose-dependent increase in the activity of hepatic transaminases, lactate dehydrogenase;
• allergic reactions: photosensitivity, angioedema, urticaria, skin rash, malignant exudative erythema;
• others: alopecia, peripheral edema.

Overdose

An overdose of Enkorata Chrono has been rarely reported.

The main symptoms are: coma, vomiting, nausea, dizziness, respiratory depression, diarrhea, miosis, hyporeflexia.

Therapy: gastric lavage (no later than 10-12 hours), forced diuresis, intake of activated charcoal. In cases of need, inpatient treatment using hemodialysis, symptomatic treatment is indicated.

special instructions

During the period of therapy, it is advisable to control the activity of hepatic transaminases, the concentration of bilirubin, the picture of peripheral blood, blood platelets, the state of the blood coagulation system, the activity of amylase (every 3 months, especially when combined with other AEDs).

For patients receiving other AEDs, transfer to Encorat chrono should be carried out gradually, reaching a clinically effective dose in 2 weeks. At the end of this period, a gradual cancellation of other AEDs is possible. In patients who have not received treatment with other AEDs, a clinically effective dose should be achieved after 7 days.

When carrying out combined anticonvulsant therapy, as well as in children, there is an increased risk of side effects from the liver.

You cannot take alcohol during the period of therapy.

Before surgery, a general blood test (including platelet count), determination of coagulogram parameters, bleeding time is required.

If symptoms of an acute abdomen occur during therapy, in order to exclude acute pancreatitis, it is recommended to determine the concentration of amylase in the blood before the start of surgery.

During the period of therapy for diabetes mellitus, possible distortion of the results of urine tests, indicators of thyroid function should be taken into account.

In cases of the development of any acute serious adverse reactions, it is necessary to assess the feasibility of further taking Encorat Chrono.

In order to reduce the likelihood of developing dyspeptic disorders, antispasmodics and enveloping drugs may additionally be prescribed.

With a sharp cessation of taking valproic acid, an increase in epileptic seizures is possible.

Influence on the ability to drive vehicles and complex mechanisms

Care should be taken while driving Encorata Chrono.

Application during pregnancy and lactation

• lactation period: therapy is contraindicated;
• pregnancy: Encorat Chrono can be prescribed under medical supervision after assessing the balance of benefits and risks.

During pregnancy, generalized tonic-clonic epileptic seizures, status epilepticus with the development of hypoxia can be a risk factor for death for the mother and the fetus.

When planning a pregnancy, it is necessary to reconsider the indications for antiepileptic treatment.

During pregnancy, antiepileptic treatment with valproate, if effective, should not be interrupted. In such cases, monotherapy is recommended; the minimum effective daily dose of Encorat Chrono should be taken in several doses.

To minimize the risk of neural tube defects, folic acid supplements may be prescribed in addition to antiepileptic therapy.

Pediatric use

• body weight less than 20 kg: therapy is contraindicated;
• age up to 3 years: Enkorat Chrono should be used under medical supervision.

With impaired renal function

With renal failure, therapy should be carried out with caution.

For violations of liver function

• liver failure: therapy is contraindicated;
• burdened history of liver disease: Encorat Chrono should be used under medical supervision.

Drug interactions

Possible interactions:

• other AEDs (lamotrigine, phenytoin), antidepressants, antipsychotic drugs (antipsychotics), anxiolytics, barbiturates, monoamine oxidase inhibitors, thymoleptics, ethanol: their effects are enhanced, including side effects;
• clonazepam: the severity of the absence status in isolated cases increases;
• barbiturates, primidone: their plasma concentration increases;
• lamotrigine: its half-life is increased;
• zidovudine: its clearance is significantly reduced, while the half-life remains unchanged;
• monoamine oxidase inhibitors, tricyclic antidepressants, antipsychotics and other drugs that lower the threshold of seizure activity: the effectiveness of Encorat Chrono decreases;
• salicylates: the effects of valproic acid are enhanced;
• antiplatelet agents (acetylsalicylic acid), indirect anticoagulants: their effects are enhanced;
• phenobarbital, phenytoin, carbamazepine, mefloquine: the serum valproic acid content in the blood decreases (associated with an acceleration of metabolism);
• felbamate: the plasma concentration of valproic acid increases (dose adjustment of Chrono Encorata is required);
• ethanol and drugs that depress the central nervous system (monoamine oxidase inhibitors, tricyclic antidepressants and antipsychotic drugs): suppression of the central nervous system increases;
• ethanol and other hepatotoxic drugs: the likelihood of liver damage increases;
• myelotoxic drugs: the risk of inhibition of bone marrow hematopoiesis increases;
• ethosuximide: its concentration may increase or decrease;
• meropenem: the plasma concentration of valproic acid decreases, which may cause a decrease in the anticonvulsant effect;
• topiramate: the likelihood of encephalopathy and hyperammonemia increases.

Analogs

Analogs of Encorat chrono are: Valproic acid, Depakine, Konvuleks, Konvulsofin, Valparin, Enkorat, Valopixim.

Terms and conditions of storage

Store in a place protected from light and moisture at temperatures up to 25 ° C. Keep out of the reach of children.

The shelf life is 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Enkorat Chrono

According to reviews, Enkorat Chrono is an effective remedy mainly used in the treatment of epileptic seizures. In some cases, it is noted that it is better tolerated than other AEDs. Other patients indicate that the side effects are pronounced, and the therapeutic effect is insufficient or absent.

Price for Enkorat Chrono in pharmacies

The approximate price for Encorat Chrono 300 mg is 171-196 rubles for 30 tablets, Encorat Chrono 500 mg - 344-421 rubles for 30 tablets.

Enkorat chrono: prices in online pharmacies

Drug name Price Pharmacy

Enkorat chrono 300 mg film-coated tablets of prolonged action 30 pcs. 166 r Buy

Enkorat chrono 500 mg film-coated tablets of prolonged action 30 pcs. 316 RUB Buy

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!