Description
Release form
Tablets.
Packing
Per pack 100 pcs.
Pharmacological action
The active substance of Encorat is able to have a central muscle relaxant and sedative effect. This is due to a decrease in convulsive readiness and excitability of motor zones located in the brain. Moreover, Regular intake of Encorat helps to improve the mood and mental state of patients.
Indications
– epilepsy – minor seizures (absences, complex absences)
– large convulsive seizures
– focal seizures.
Contraindications
– severe dysfunctions of the liver and / or pancreas
– porphyria
– hemorrhagic diathesis
– severe thrombocytopenia
– leukopenia
– child age up to 3 years srll period srdl – srdl period
Caution in patients with anamnestic data on diseases of the liver and pancreas, as well as damage to the bone marrow by impaired renal function by congenital enzymopathies for mentally retarded children with organic brain lesions, gioprotennemia.
Use during pregnancy and lactation
Contraindicated in pregnancy and lactation.
Special instructions
Before starting treatment and during treatment it is recommended to monitor the functional state of the liver and pancreas, the picture of peripheral blood, and blood coagulation. If there is or suspicion of impaired liver and pancreas function, as well as blood clotting disorders, the drug should be discontinued.
In combination therapy with other anticonvulsants and drugs, it is advisable to control especially at the beginning of treatment, the concentration in the blood plasma of another drug, since it can change under the influence of Encorat.
Patients who receive other antiepileptic drugs should be gradually transferred to valproic acid, reaching a clinically effective dose after 2 weeks, after which other antiepileptic drugs may be phased out. In patients not treated with other antiepileptic drugs, a clinically effective dose should be reached after 1 week.
The risk of developing side effects from the liver is increased during combination anticonvulsant therapy, as well as in children.
An increased risk of bleeding should be considered in patients receiving anticoagulant or thrombolytic therapy.
Against the background of treatment with Encorat, a false-positive urine reaction to ketone bodies is possible.
There are reports of changes in the functional state of the thyroid gland during the treatment with Encorat.
Before surgery, a complete blood count (including platelet count), determination of bleeding time, and coagulation parameters are necessary.
If symptoms of acute abdomen occur during treatment, prior to surgery, it is recommended to determine the level of amylase in the blood to exclude acute pancreatitis.
During treatment, one should take into account the possible distortion of the results of urine tests for diabetes mellitus (due to an increase in the content of keto products), indicators of thyroid function.
If any acute serious side effects develop, you should immediately discuss with your doctor the advisability of continuing or stopping treatment.
To reduce the risk of dyspeptic disorders, it is possible to take antispasmodics and enveloping agents.
Influence on the ability to drive vehicles and control mechanisms
When using the drug, one should refrain from potentially hazardous activities that require increased attention, quick mental and motor reactions.
Composition
1 tablet contains sodium valproate – 300 mg.
Excipients: colloidal silicon dioxide, microcrystalline cellulose, corn starch, polyvinylpyrrolidone K30, calcium silicate, magnesium stearate, purified talc, sodium starch glycolate (type A), hypromellose 2910, dibutyl phthalate, methacrylic acid copolymer (type C), titanium dioxide, crimson dye 4R lacquer, sunset dye yellow Yellow) FCF lacquered.
Dosage and administration
Inside with meals, the doses are set individually. The tablet should be swallowed whole without breaking without chewing. You can not change the dose and treatment regimen without consulting a doctor.
Adults: the drug is prescribed in an initial daily dose of 0.3-0.6 g in 2 divided doses. The dose is gradually increased by 0.1-1.15 g / day every 3-4 days until the desired effect is achieved. The maximum daily dose is 2.4 g.
Children with a body weight of less than 40 kg: the drug is prescribed in a daily dose of 20 mg / kg.
Children weighing 40 kg or more: the maximum daily dose is 40 mg / kg body weight. Multiplicity of appointment – 2 times / day.
Withdrawal of treatment is carried out with a gradual reduction in dose, within 1-2 years. In the case of the effectiveness of therapy, dose recalculation depending on the child s body weight may not be carried out if ECG deterioration is not observed.
Drug interactions
Valproic acid enhances effects, including side, other antiepileptic drugs (phenytoin, lamotrigine), anxiolytic drugs (tranquilizers), MAO inhibitors, timoleptics, ethanol.
Adding valproate to clonazepam in isolated cases can lead to increased severity of the abscess status.
With the simultaneous use of valproic acid with barbiturates or irimidone, an increase in their concentration in blood plasma is noted.
Increases lamotrigine T1 / 2 (inhibits liver enzymes, slows down lamotrigine metabolism, as a result of which its T1 / 2 lengthens up to 70 hours in adults and up to 45-55 hours in children).
Reduces zidovudine clearance by 38%, while its T1 / 2 does not change.
Tricyclic antidepressants, MAO inhibitors, antipsychotics (antipsychotics), drugs that lower the threshold of convulsive activity, reduce the effectiveness of valproic acid.
When combined with salicylates, an increase in the effects of valproic acid is observed (displacement from the association with plasma proteins).
Enhances the effect of antiplatelet agents (acetylsalicylic acid) and indirect anticoagulants.
When combined with phenytoin, mefloquine, the content of valproic acid in the blood decreases (accelerates metabolism).
Felbamate increases the concentration of valproic acid in plasma by 35-50% (dose adjustment is necessary).
With the simultaneous use of valproic acid with ethanol and other drugs that depress the central nervous system (tricyclic antidepressants, MAO inhibitors, and antipsychotics), an increase in central nervous system depression is possible.
Ethanol and other hepatotoxic drugs increase the likelihood of liver damage.
Valproic acid does not induce hepatic enzymes and does not reduce the effectiveness of oral contraceptives.
When combined with phenobarbitate, phenytoin, carbamazepine, mefloquine, the content of valproic acid in the blood decreases.
When combined with myelotoxic drugs, the risk of suppression of bone marrow hematopoiesis is increased.
Overdose
Symptoms: increased severity of side effects – nausea, vomiting, dizziness, diarrhea, impaired respiratory function, muscle hypotension, hyporeflexia, miosis, coma.
Treatment: gastric lavage, maintenance of adequate diuresis, hemodialysis and hemoperfusion, symptomatic therapy.
Storage Conditions
Keep out of reach of children, in a dry, dark place at a temperature not exceeding 25 ° C.
Shelf life
3 years.
Active ingredient
Valproic acid
Pharmacy conditions
recipe
tablet dosage form of tablets
Possible product names
ENCORAT 0.3 N100 TABLE S / L
ENCORAT TAB. P / O KSH / SOLV. 300MG No. 100
Encorat tablet p / o enteric. 300mg N100 India
Encorat tablets 300 mg, 100 pcs.
San Pharmaceutical Industries Ltd, India
