Depakene chronosphere granules of prolonged action 500mg pack №30

Dosage form

Granules of prolonged action

Composition

1 sachet contains 333.3 mg of sodium valproate, 145.14 mg of valproic acid (500 mg in total, in sodium valproate)

Packing

30 pieces

Mechanism of action

Depakene Chronosphere has anti-epileptic effect.

Indications and usage

In adults: as monotherapy or in combination with other antiepileptic drugs in the following conditions:
treatment of generalized epileptic seizures (clonic, tonic, tonic-clonic, absences, myoconic, atonic, Lennox-Gastaut syndrome);
treatment of partial epileptic seizures (partial seizures with or without secondary generalization);
treatment and prevention of bipolar affective disorders.

Contraindications

hypersensitivity to valproate or to any of the components of Depakene Chronosphere;
acute hepatitis;
chronic hepatitis;
cases of severe hepatitis in a patient or in his family history, especially caused by drugs, as well as severe dysfunction of the liver or pancreas;
porphyria;
hemorrhagic diathesis, thrombocytopenia;
combination with mefloquine;
combination with hunter;
this drug is not recommended for use in combination with lamotrigine;
children up to 6 months.
Carefully:
a history of liver and pancreas diseases;
pregnancy;
congenital fermentopathies;
oppression of bone marrow hematopoiesis (leukopenia, thrombocytopenia, anemia);
renal failure;
hypoproteinemia.

Pregnancy and Breastfeeding

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

The risk associated with valproate

According to the available data, valproate mainly causes impaired development of the neural tube: myelomeningocele, spina bifida (1-2%). Several cases of facial dysmorphia and malformations of the extremities (especially shortening of the extremities), as well as malformations of the cardiovascular system, have been described.

The risk of malformations is higher with combination antiepileptic therapy than with monotherapy with sodium valproate. However, it is rather difficult to establish a causal relationship between fetal malformations and other factors (genetic, social, environmental factors, etc.).

In connection with the above:

The use of the drug during pregnancy can be prescribed by a doctor only when the expected benefit for a pregnant woman outweighs the possible risk to the fetus.

When pregnancy should not be interrupted by antiepileptic treatment with valproate, if it is effective. In such cases, monotherapy is recommended; the minimum effective daily dose of which should be divided into several doses per day.

In addition to antiepileptic therapy, folic acid preparations can be added (at a dose of 5 mg /), since they minimize the risk of neural tube defects. However, regardless of whether the patient receives folates or not, in any case, a special antenatal monitoring of the neural tube or other malformations should be carried out.

Newborn Risk

Valproate can cause hemorrhagic syndrome in newborns. In the case of valproate, this syndrome appears to be associated with hypofibrinogenemia. Cases of the development of afibrinogenemia with fatal outcome were noted. Perhaps this is due to a decrease in a number of coagulation factors.

In a newborn, it is imperative to determine the number of platelets, plasma fibrinogen levels and blood coagulation factors.

Lactation

Excretion of valproate in milk is low, with a concentration between 1% and 10% of the serum level of the drug.

According to the literature and a small clinical experience, mothers can plan breastfeeding in the course of treatment with this drug in the form of monotherapy, taking into account its safety profile (especially hematological disorders).

Dosage and administration

The initial daily dose is usually 10-15 mg / kg, then it is increased by 5-10 mg / kg per week, until the optimum dose is reached. The average daily dose is 20-30 mg / kg. It is possible to increase the dose of the drug with careful monitoring of the patient's condition, if epilepsy is uncontrollable with the use of average daily doses. The average daily dose for infants (from the 6th month of life) and children is 30 mg / kg / day; for adolescents, 25 mg / kg; for adults, 20 mg / kg.

Adverse reactions

From the side of the central nervous system: ataxia (from ≥0.1 to <1%); cases of cognitive impairment with a progressive onset (giving a complete picture of dementia syndrome), reversible within a few weeks or months after discontinuation of the drug (≤0.01%); states of confusion or convulsions: in several cases of treatment with valproatom, stupor or lethargy is described, sometimes leading to transient coma (encephalopathy); these cases were isolated or associated with a paradoxical increase in the frequency of convulsions during therapy, their frequency decreased when the treatment process was suspended or the dose was reduced. Most often, such cases are described with complex treatment (especially with phenobarbital) or after a sharp increase in the dose of valproate; isolated cases of reversible parkinsonism; headache, mild postural tremor and drowsiness.
From the digestive system: some patients at the beginning of treatment often develop gastrointestinal disorders (nausea, vomiting, gastralgia, diarrhea), but they usually disappear without discontinuation of drug therapy within a few days; cases of pancreatitis, sometimes fatal (<0.01%), requiring early discontinuation of treatment; abnormal liver function (from ≥0.01 to <0.1%).
From the side of blood formation organs: frequent dose-dependent thrombocytopenia; inhibition of bone marrow hematopoiesis (from ≥0.01 to <0.1%), including anemia, leukopenia or pancytopenia.
From the urinary system: enuresis (<0.01%), isolated cases of reversible Fanconi syndrome (genesis is not clear).
Allergic reactions: skin rash, urticaria, vasculitis. In some cases (<0.01%), toxic epidermal necrolysis, Stevens-Johnson syndrome, and erythema multiforme were described.
Laboratory values: It is often found isolated and moderate hyperammonemia without changes in the analysis of the functions of the liver, especially during polytherapy. Cancellation of the drug in this case is not required. However, hyperammonemia associated with neurological symptoms is also described. This condition requires further examination. Perhaps an increase in liver transaminases. Individual cases of a decrease in fibrinogen level or an increase in bleeding time are described, usually without associated clinical manifestations and especially at high doses (sodium valproate has an inhibitory effect on the second stage of platelet aggregation). Hyponatremia (<0.01%)
Other: teratogenic risk; hair loss, rare reports of hearing loss (from ≥0.01 to <0.1%) both reversible and irreversible, very rare cases of mild peripheral edema (<0.01%), weight gain (because weight gain is a risk factor for polycystic ovarian syndrome, careful monitoring of such patients is recommended); there are also reports of gynecomastia, amenorrhea, and irregular menstruation.

Overdosage

Symptoms: in acute massive overdose, a coma with muscular hypotonia, hyporeflexia, miosis, respiratory depression, and metabolic acidosis is usually observed. Cases of intracranial hypertension associated with cerebral edema are described.

Treatment: emergency care in the hospital - gastric lavage, which is effective for 10-12 hours after taking the drug, monitoring the state of the cardiovascular and respiratory systems and maintaining effective diuresis. In very severe cases, dialysis is performed. Usually, the prognosis for overdose is favorable, but several deaths have been described.

In the dark place at a temperature of no higher than 25 ° C.