Encorate, 300 mg 100 pcs

The active substance Enkorat is able to have a central myorelaxant and sedative effect.

This is associated with reduction of seizure readiness and excitability of motor zones located in the brain.

In addition, regular intake of Encorate helps to improve the mood and mental state of patients.

Indications

– epilepsy – small seizures (absences, complex absences);

– large seizures;

– focal seizures.

Active ingredient

Composition

1 tablet sodium valproate 300 mg

Supplementary substances:

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,

painting crimson 4R lacquer,

dye Sunset Yellow (Sunset Yellow) FCF lacquer.

How to take, the dosage

Overly with meals, the dosage is set individually. The tablet should be swallowed whole, without breaking and chewing. The dose and the scheme of treatment should not be changed without consulting a doctor.

Adults: the drug is prescribed in an initial daily dose of 0.3-0.6 g in 2 doses. The dose is gradually increased by 0.1-1.15 g/day every 3-4 days until the desired effect is achieved. Maximum daily dose is 2.4 g.

In children with body weight less than 40 kg: the drug is prescribed in a daily dose of 20 mg/kg.

In children with a body weight of 40 kg or more: the maximum daily dose is 40 mg/kg of body weight. The frequency of administration is 2 times a day.

The treatment is withdrawn with gradual reduction of the dose, over a period of 1-2 years. If therapy is effective, recalculation of the dose in relation to the child’s body weight may not be performed if no worsening of the ECG is noted.

Interaction

Valproic acid increases the effects, including side effects, of other antiepileptic drugs (phenytoin, lamotrigine), anxiolytics (tranquilizers), MAO inhibitors, thymoleptics, ethanol.

The addition of valproate to clonazepam in single cases may increase the severity of absences.

When valproic acid is used concomitantly with barbiturates or irimidone an increase in their plasma concentrations has been noted.

Lengthen the T1/2 of lamotrigine (it inhibits liver enzymes, causes slowing of lamotrigine metabolism, so that its T1/2 lengthens to 70 hours in adults and to 45-55 hours in children).

Limits the clearance of zidovudine by 38%, while its T1/2 does not change.

Tricyclic antidepressants, MAO inhibitors, antipsychotics (neuroleptics), drugs that reduce the threshold of seizure activity, reduce the effectiveness of valproic acid.

When combined with salicylates, an increase in the effects of valproic acid is observed (displacement from binding to plasma proteins).

It enhances the effect of antiaggregants (acetylsalicylic acid) and indirect anticoagulants.

When combined with phenytoin, mefloquine decreases the serum valproic acid (metabolism acceleration).

Felbamate increases the plasma concentration of valproic acid by 35-50% (dose adjustment is necessary).

When valproic acid is used concomitantly with ethanol and other CNS-depressant drugs (tricyclic antidepressants, MAO inhibitors and antipsychotics), CNS depression may be increased.

Ethanol and other hepatotoxic agents increase the likelihood of liver damage.

Valproic acid does not cause induction of hepatic enzymes and does not decrease the effectiveness of oral contraceptives.

When combined with phenobarbitate, phenytoin, carbamazepine, mefloquine, the serum content of valproic acid decreases.

In combination with myelotoxic agents the risk of suppression of medullary hematopoiesis increases.

Special Instructions

Before and during treatment it is recommended to monitor the functional state of the liver and pancreas, peripheral blood count, blood clotting parameters. In case of occurrence or suspicion of liver and pancreatic function disorders, as well as blood clotting disorders the drug should be discontinued.

When combined therapy with other anticonvulsants and drugs, it is advisable to monitor, especially at the beginning of treatment, the plasma concentration of the other drug, since it may be altered by Encorat.

Patients who are receiving other antiepileptic agents should be switched to valproic acid administration gradually, reaching clinically effective dose in 2 weeks after which gradual withdrawal of other antiepileptic agents is possible. In patients who have not been treated with other antiepileptic agents, the clinically effective dose should be reached after 1 week.

The risk of liver side effects is increased with combined anticonvulsant therapy and in children.

The increased risk of bleeding in patients receiving anticoagulant or thrombolytic therapy should be considered.

A false positive urine reaction for ketone bodies is possible during treatment with Encorate.

There have been reports of changes in the functional state of the thyroid gland during treatment with Encorate.

Before surgical intervention, a general blood count (including platelet count), determination of bleeding time, coagulogram values are necessary.

If symptoms of acute abdomen occur against the background of treatment, blood amylase levels should be determined prior to surgical intervention to rule out acute pancreatitis.

At the time of treatment, the possible distortion of urine test results in diabetes mellitus (due to increased ketoic acid content), thyroid function parameters should be taken into account.

If any acute serious side effects develop, the appropriateness of continuing or discontinuing treatment should be discussed with the physician immediately.

In order to reduce the risk of dyspeptic disorders, antispasmodics and sedatives may be taken.

Impact on driving and operating machinery

When using the drug, one should refrain from potentially hazardous activities requiring increased attention, quick mental and motor reactions.

Contraindications

– expressed liver and/or pancreatic function disorders;

– porphyria;

– hemorrhagic diathesis;

– expressed thrombocytopenia;

– leukopenia;

– children under 3 years of age;

– pregnancy;

– lactation period;

– hypersensitivity to the drug.

With caution in patients with history of liver and pancreatic diseases and bone marrow lesions; renal dysfunction; congenital enzymopathies; mentally retarded children; organic brain lesions, hyoprotenemia.

Side effects

Digestive system disorders: at the beginning of treatment transient disorders are possible: anorexia, stomach pain, nausea, vomiting, diarrhea, increased appetite; rarely – constipation, pancreatitis up to severe lesions with lethal outcome.

CNS disorders: lethargy, ataxia, tremor, changes in behavior, mood or mental state (depression, fatigue, hallucinations, aggressiveness, hyperactive state, psychosis, unusual agitation, motor anxiety or irritability), dizziness, somnolence, headache, dysarthria, enuresis, stupor, impaired consciousness, coma.

Sensory organs: diplopia, nystagmus, flickering of flickers before the eyes.

Hepatic disorders: transient increase of liver enzymes activity is possible, observed during the first few months of treatment and often not manifested by any clinical symptoms (incidence about 40%). The risk of these side effects depends on the drug dose; when the dose is reduced, these effects decrease or disappear. Very rarely, there is development of fulminant hepatitis with fatal outcome, and it is far from always possible to detect previous changes in liver function parameters.

Allergic reactions: skin rash, alopecia, urticaria, angioedema, photosensitization, erythema malignant exudative (Stevens-Johnson syndrome) are possible.

Endocrine system disorders: dysmenorrhea, secondary amenorrhea, breast enlargement, galactorrhea.

Hematopoietic disorders: anemia, thrombocytopenia, leukopenia, decreased fibrinogen, platelet aggregation and blood clotting, accompanied by prolongation of bleeding time, petechial hemorrhages, bruises, hematomas, bleeding.

Metabolic disorders: decrease or increase in body weight.

Laboratory findings: hypercreatininemia, hyperbilirubinemia, hyperammonemia.

Others: peripheral edema.

Overdose

Symptoms: increased severity of side effects – nausea, vomiting, dizziness, diarrhea, respiratory dysfunction, muscle hypotonia, hyporeflexia, miosis, coma.

Treatment: gastric lavage, maintenance of adequate diuresis, hemodialysis and hemoperfusion, symptomatic therapy.

Pregnancy use

It is contraindicated during pregnancy and lactation.

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