Description
Release form
Controlled-release tablets, film-coated, orange, round, biconvex.
Packing
10 pcs. – aluminum strips (3) – packs of cardboard
Pharmacological action of
Sodium valproate increases the content of GABA (gamma-aminobutyric acid) in the brain, which accordingly increases the content of GABA postsynaptic neurons. In addition, sodium valproate affects the transfer of potassium ions across 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 types of epilepsy in humans. The drug does not have pronounced hypnotic and sedative effects, and also 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. Cmax in plasma is reached within 2-8 hours after oral administration of controlled release tablets.
80-90% of the drug binds to plasma proteins, T1 / 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. Vd – 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.
Indications
Treatment of generalized or partial epilepsy, especially with the following types of seizures: abscesses
myoclonic
tonic-clonic
atonic.
Partial epilepsy: simple or combined seizures
secondary generalized seizures.
Specific Syndromes (Vesta, Lennox-Gastaut)
Contraindications
individual intolerance to the drug
severe pancreatic and liver dysfunctions
acute hepatitis
pregnancy, lactation
porphyria
thrombocytopenia
children under 3 years of age.
Use for impaired liver function
Contraindicated in severe hepatic impairment, acute hepatitis.
Use in children
Do not use Encorat Chrono for 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 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.
Use during pregnancy and lactation
Prescribing to pregnant women is possible only when the intended benefits to the mother outweigh 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.
Special instructions
Caution should be exercised when working with mechanisms, since the drug weakens attention. Regular monitoring of the level 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. Consideration should be given to the possibility of bleeding complications in operated patients receiving valproate. 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, discontinue use of the drug, severe weakness, lethargy, swelling, vomiting, and jaundice should stop using the drug immediately. Use during pregnancy and lactation:
Prescribing to a pregnant woman is only possible if 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 necessary to conduct specialized prenatal monitoring of the fetus. The use of valproate during breastfeeding is not recommended.
Composition
1 tab.
sodium valproate 200 mg
valproic acid87 mg,
? which corresponds to the sodium content of valproate 100 mg
Excipients: hypromellose-K100M (metocel-K100M), hypromellose-K15M (metocel-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, yellow sunset dye.
Dosing and Administration
Dosage regimen is selected individually depending on the age and weight of the patient.
Monotherapy:
Adults: starting dose is 600 mg / day. Increase dosage by 200 mg every three days until optimal effect is achieved.
Tablets should be swallowed whole with a little water. Take 1-2 times a day. The maximum recommended dose is 1-2 g.
Children with body weight over 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 with body weight 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.
Side effects of
In rare cases, the following side effects have been reported: nausea, vomiting, diarrhea and / or constipation
hepatitis
pancreatitis
weight gain
skin rash, itching, photosensitivity, erythema multiforme, Steven-Johnson syndrome
hair loss (in 2-12% of patients)
ataxia, tremor dysmusia cycle, secondary amenorrhea
anemia, hyperammonemia, hypercreatinemia, thrombocytopenia, neutropenia, leukopenia, decreased fibrinogen, inhibition of platelet aggregation.
Drug Interactions
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.
overdose
Rare cases of accidental or deliberate overdose have been reported. In this case, nausea, vomiting, dizziness, diarrhea, respiratory depression, hyporeflexia, coma were observed.
First aid: gastric lavage, activated charcoal intake. If necessary – inpatient treatment using symptomatic therapy, hemodialysis.
Storage conditions
Store in a dry, dark place at a temperature not exceeding + 25 ° C. Keep out of reach of children
Shelf life
3 years.
Deystvuyushtee substance
Valyproevaya Chisloth
Pharmacy conditions
prescription
dosage form
tablets
Possible product names
ENKORAT HRONO 0.3 N30 TABLE P / O
ENKORAT CHRONO 0.3 N30 TABLE PROLONG P / O
Encorat Chrono 300mg Tab. counter. exp. n / a captive. X30 (R)
Encorat Chrono 300mg Tab. counter. exp. n / a captive. X30 (R) /! Until 04.11g /
Encorat Chrono 300mg Tab. counter. exp. n / a captive. X30 (R) /! Before 12.10g /
San Pharmaceutical Industries Ltd, India
