Convulsophin-retarded pills prolonged 300mg, 100pcs

Composition

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of 1 tab. contains:

Active ingredients:

sodium valproate – 199.8 mg,

valproic acid-87 mg, which corresponds to sodium valproate 100.2 mg.

Auxiliary substances:

hypromellose 2910-57 mg,

hypromellose 2208-57

mg, colloidal water silicon dioxide = 27 mg,

acesulfame potassium-3.6 mg.

Composition of the film shell:

copolymer of butyl methacrylate – 11.5 mg, magnesium stearate-2.89 mg, titanium dioxide-1.97 mg, dibutyl sebacate-1.75 mg, sodium lauryl sulfate-0.84 mg

Pharmacological action

An antiepileptic drug.

The mechanism of action is associated with an increase in the content of the inhibitory neurotransmitter gamma-aminobutyric acid (GABA) in the central nervous system due to inhibition of the enzyme GABA-transferase.

This reduces the excitability and convulsive readiness of the motor areas of the brain.

Convulsofin inhibits the spread of epileptic arousal in the area of cortical epileptogenic foci and increases the cortical convulsive threshold to electrical stimuli.

Indications

Generalized epileptic seizures in the form of absences, myoclonic seizures, tonic-clonic seizures;

partial seizures;

secondary generalized seizures.

Contraindications

 Severe liver function disorders; severe pancreatic function disorders; drug-induced liver damage in the anamnesis (including family);

hypersensitivity to valproic acid.

Side effects

From the digestive system: nausea, vomiting, stomach pain, diarrhea are possible (these phenomena can be eliminated by taking the drug after meals and preventing its appointment in gradually increasing doses), a transient increase in the activity of hepatic transaminases, increased salivation; rarely – severe liver and pancreatic dysfunction (occurring in the first 6 months of treatment, most often at 2-12 weeks and during combined antiepileptic therapy); in isolated cases-stomatitis.

From the central nervous system: fatigue, tremor, paresthesia, ataxia, dizziness, headache; in some cases – drowsiness and impaired consciousness up to a comatose state.

From the side of the blood coagulation system: thrombocytopenia, prolongation of bleeding time.

Other: increased or decreased body weight, increased appetite, alopecia, leukopenia, peripheral edema.

Interaction

Concomitant use of Convulsofin and sleeping pills, sedatives, antipsychotics, antidepressants and MAO inhibitors may increase their effect.

Concomitant use of Convulsofin with other anticonvulsants (phenobarbital, phenytoin, carbamazepine) may increase the elimination of valproic acid from the body and decrease the activity of Convulsofin.

Concomitant use of Convulsofin with hepatotoxic drugs and ethanol may increase the toxic effect of Convulsofin on the liver.

With the simultaneous use of Convulsofin and anticoagulants, including acetylsalicylic acid, there is a mutual potentiation of the effect on the blood coagulation system.

With the simultaneous use of phenobarbital and primidone with Convulsofin, the concentration of barbiturates in blood plasma increases.

With the simultaneous use of Convulsofin and phenytoin, it is possible to reduce the concentration of the latter in blood plasma.

How to take, course of use and dosage

The initial dose of Convulsofin is 5-10 mg / kg of body weight.

Every 4-7 days, this dose is increased by 5 mg.

The average daily dose for adults is 20 mg / kg of body weight, for children over 14 years of age-25 mg/kg of body weight, for children under 14 years of age – 30 mg/kg of body weight.

The daily dose is divided into 2-4 doses.

If renal function is impaired, the daily dose of Convulsofin should be reduced.

The drug should be taken during or after a meal, without chewing and with a small amount of liquid.

Overdose

Symptoms: it is possible to increase the manifestations of the described side effects.

Special instructions

Convulsofin should be prescribed with extreme caution and under close medical supervision to patients with congenital enzymatic insufficiency, with a history of bone marrow diseases, with blood clotting disorders, especially during combined antiepileptic therapy.

The transition from treatment with another anticonvulsant drug to Convulsofin therapy is made slowly, gradually lowering the dose of the previous drug. When prescribing Convulsofin simultaneously with other antiepileptic drugs, the dose of the latter, especially phenobarbital, should be reduced. Side effects are more likely to occur with combination therapy than with monotherapy with Convulsofin.

If, against the background of the use of Convulsofin, there is an increase in epileptic seizures, indicating a decrease in the effectiveness of the drug, as well as an increase in the severity of side effects, it is necessary to conduct a thorough examination of the patient with the determination of laboratory parameters of liver function, pancreas, blood coagulation system. If significant violations are detected, Convulsofin should be discontinued.

Before surgical and dental manipulations, patients taking Convulsofin should determine the time of bleeding. It should be borne in mind that against the background of taking Convulsofin, false positive reactions to the presence of ketone bodies in the urine are possible.

Monitoring of laboratory parameters. During Convulsofin therapy, it is necessary to periodically monitor the activity of hepatic transaminases, the level of bilirubin, total protein, fibrinogen in blood plasma, alpha-amylase in urine, and thromboplastin time. In children, these indicators should be determined before the start of treatment, then at short intervals (after 1,3,5,7,9 weeks) and then once every 4 weeks until the end of the first 6 months of treatment; in adults and adolescents – before the start of treatment and every month during the first half of treatment.

Use in pediatrics. Convulsofin should be prescribed with extreme caution and under close medical supervision to young children, especially when conducting combined antiepileptic therapy.

The risk of developing severe hepatic impairment while taking Convulsofin is increased in children and children under 1.5 years of age with severe epileptic seizures, especially if along with this there are brain injuries, mental retardation and / or congenital metabolic disease. In this case, Convulsofin can only be used for monotherapy. In children older than 10 years, the incidence of hepatotoxic effect decreases significantly.

Influence on the ability to drive motor vehicles and manage mechanisms.

The drug may weaken the speed of psychomotor reactions and the ability to concentrate, so patients taking Convulsofin should refrain from potentially dangerous activities.

Active ingredient

Valproic Acid

Conditions of release from pharmacies

By prescription

Dosage form

long-acting tablets