Depakine Chronosphere, 100 mg, extended-release granules, 30 pcs., Sanofi-Aventis France buy in Moscow at a low price

The drug "Depakine Chronosphere" has a number of chemical properties that give it anticonvulsant activity. Neurologists actively use the medication to treat various forms of epilepsy and prevent seizures. The product summary contains several other indications for which its active substances can bring significant benefits. The medicine is intended for patients of different age groups. With a responsible approach to therapy, it rarely provokes negative consequences.

Pharmacodynamics and pharmacokinetics

Depakine Chronosphere is an antiepileptic drug that has a sedative as well as a central muscle relaxant effect . The active substance of the drug affects the GABAergic system . It increases the concentration of GABA (gamma-aminobutyric acid) in the central nervous system and activates GABAergic transmission .

The bioavailability of the drug in the blood after oral administration is approximately 100%. It enters the brain and cerebrospinal fluid . To achieve a therapeutic effect, the minimum concentration of the drug in the blood serum is 40–50 mg/l. At a concentration of 200 mg/l, the dosage should be reduced. The maximum content in blood plasma is after approximately 7 hours.

A stable concentration in plasma is formed by 3-4 days of use. High degree of binding to plasma proteins. The drug is mainly excreted in the urine. Food intake does not affect pharmacokinetics.

Registration numbers

prolonged granules actions 250 mg: sachets 30 or 50 pcs. LSR-005197/08 (2003-07-08 – 0000-00-00) prolonged granules. actions 1000 mg: sachets 30 or 50 pcs. LSR-005197/08 (2003-07-08 – 0000-00-00) prolonged granules. actions 500 mg: sachets 30 or 50 pcs. LSR-005197/08 (2003-07-08 – 0000-00-00) prolonged granules. actions 750 mg: sachets 30 or 50 pcs. LSR-005197/08 (2003-07-08 – 0000-00-00) prolonged granules. actions 100 mg: sachets 30 or 50 pcs. LSR-005197/08 (2003-07-08 – 0000-00-00)

Indications for use

Adults are recommended to take Depakine Chronosphere for treatment of:

bipolar affective disorders;
generalized epileptic seizures;
partial epileptic seizures.

For children, the drug is prescribed for the treatment of partial and generalized epileptic seizures .

In addition, it is used as a prophylactic in case of high fever to prevent seizures, if necessary.

Compound

The antiepileptic drug is based on valproic acid.

For better absorption of the substance by the body in the production of tablet form, the following are used:

sodium saccharin;
hypromellose;
talc;
macrogoal

Other chemical compounds are also used as auxiliary components, depending on the form produced:

solution for external use (drops);
granules;
lyophilisate (for intravenous administration);
syrup.

Side effects

When using Depakine Chronosphere, the following side effects may occur:

genetic disorders: teratogenic risk ;
from the central nervous system: tremor of the limbs, drowsiness , ataxia ;
from the hearing organs: reversible and irreversible deafness;
from the gastrointestinal tract: epigastric , nausea, vomiting, diarrhea ;
from the skin: transient or dose-dependent alopecia ;
from the immune system: allergic reactions , angioedema , drug rash syndrome with eosinophilia ;
from the psyche: irritability, confusion, hyperactive state, hallucinations ;
from the blood and lymphatic system: thrombocytopenia , agranulocytosis , decreased concentration of fibrinogen in the blood;
from the organs of vision: diplopia , nystagmus ;
from the genital organs: male infertility;
Metabolism: isolated and moderate hyperammonemia ;
general disorders: weight gain.

In addition, in rare cases, when taking the drug, the following are possible:

pancytopenia;
leukopenia;
anemia;
disorders of bone marrow hematopoiesis;
pancreatitis;
toxic epidermal necrolysis ;
Stevens-Johnson syndrome;
erythema multiforme;
rash;
vasculitis;
amenorrhea;
dysmenorrhea;
extrapyramidal disorders;
dementia;
enuresis;
syndrome of impaired secretion of antidiuretic hormone;
hyponatremia;
minor peripheral edema;
liver damage;
changes in behavior, mood;
feeling tired;
psychoses;
motor restlessness;
depression;
aggressiveness;
unusual agitation;
dysarthria.

special instructions

The prescription of an antiepileptic drug may occasionally be accompanied by the resumption or development of new seizures in the patient, regardless of the spontaneous changes in the course of the disease observed in some epileptic conditions.

With regard to valproate, this primarily concerns the combination regimen for the treatment of epilepsy or pharmacokinetic interactions, toxicity (hepato- or encephalopathy) and overdose.

Since sodium valproate is converted into valproic acid in the body, it should not be combined with other medicinal substances that undergo the same type of biotransformation in order to prevent an overdose of valproic acid.

Liver failure

At increased risk are infants and children under 3 years of age with severe epilepsy, especially epilepsy associated with brain damage, mental retardation, and/or congenital metabolic or degenerative diseases. Over the age of 3 years, the frequency of such complications decreases significantly and gradually decreases with age.

In most cases, liver dysfunction was observed during the first 6 months of treatment, usually between 2 and 12 weeks, and most often with combined antiepileptic treatment.

Early diagnosis is based primarily on clinical examination. In particular, two factors that may precede jaundice should be taken into account, especially in patients at risk.

On the one side,
nonspecific general symptoms,
usually appearing suddenly
such as asthenia,
anorexia,
extreme fatigue
drowsiness,
sometimes accompanied by repeated vomiting and abdominal pain;
on the other side,
recurrence of epileptic seizures during antiepileptic therapy.

It is recommended to inform the patient, and if it is a child, then his family, that if such clinical symptoms develop, you should immediately consult a doctor. In addition to clinical examination, an immediate liver function test should be performed.

Liver function should be checked periodically during the first 6 months of treatment. Among the classical tests, the most important are those reflecting liver protein synthesis, and especially the prothrombin index. If an abnormally low level of prothrombin is detected, a significant decrease in the level of fibrinogen and coagulation factors, an increase in the level of bilirubin and liver transaminases, treatment with Depakin® Chronosphere™ should be suspended. It is also necessary to interrupt treatment with salicylates if they were included in the treatment regimen, since they share metabolic pathways with valproate.

Pancreatitis

In rare cases, severe forms of pancreatitis, sometimes fatal, have been reported. These cases were observed regardless of the patient's age and duration of treatment, although the risk of developing pancreatitis decreased with increasing age of the patients.

Liver failure due to pancreatitis increases the risk of death. It is necessary to measure liver function before starting treatment and periodically during the first 6 months of treatment, especially in patients at risk.

It should be emphasized that during treatment with both Depakine® Chronosphere™ and other antiepileptic drugs, a slight, isolated and temporary increase in transaminase levels may be observed, especially at the beginning of treatment, in the absence of any clinical symptoms.

In this case, it is recommended to conduct a more complete laboratory examination (including, in particular, determination of the prothrombin index) in order to revise the dosage, if necessary, and repeat the tests depending on changes in parameters.

Before starting therapy or surgery, in the case of hematomas or spontaneous bleeding, it is recommended to conduct a hematological blood test (determine the blood count, including platelet count, bleeding time and coagulation tests).

In patients with renal failure, it is recommended to take into account the increased concentration of free form of valproic acid in the serum and reduce the dose.

In case of acute abdominal pain and gastrointestinal symptoms such as nausea, vomiting and/or anorexia, it is necessary to be able to recognize pancreatitis and, if the level of pancreatic enzymes is elevated, discontinue the drug, taking alternative therapeutic measures.

Sodium valproate is not recommended for patients with carbamide cycle enzyme deficiency. In such patients, several cases of hyperammonemia accompanied by stupor and/or coma have been described.

Although it has been shown that during treatment with Depakine® Chronosphere™, dysfunction of the immune system is extremely rare, the potential benefits of its use must be compared with the potential risks when prescribing the drug to patients suffering from systemic lupus erythematosus.

Patients should be warned about the risk of weight gain at the beginning of treatment, and measures, mainly dietary, should be taken to minimize this phenomenon.

Use in pediatrics

For children under 3 years of age, the use of valproate (in the recommended dosage form) as monotherapy is recommended, but before starting treatment, the potential benefits of treatment with the drug should be assessed in relation to the risk of developing liver disease or pancreatitis.

Combination use with salicylates should be avoided in children under 3 years of age due to the risk of hepatotoxicity.

In children with unexplained gastrointestinal symptoms (anorexia, vomiting, cases of cytolysis), a history of lethargy or coma, with mental retardation, or a family history of death of a newborn or child, metabolic studies, especially ammonemia with fasting and after eating.

Impact on the ability to drive vehicles and operate machinery

During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Overdose

An overdose of the drug is fraught with the appearance of coma , accompanied by muscle hypotonia , metabolic acidosis , hyporeflexia , and respiratory depression . There are known cases of intracranial hypertension and seizures. In general, overdose symptoms can vary. At very large doses, death is possible.

As an emergency, gastric lavage is performed, effective diuresis , and the functioning of the cardiovascular and respiratory systems is monitored. , hemodialysis and hemoperfusion are effective .

Features of using the medicine

Depakine Chronosphere with a dosage of 100 mg is used to treat small children and infants.

The drug in a dose of 1 g is prescribed to relieve epileptic seizures in adults.

It is recommended to take the prescribed daily dose 1-2 times, best combined with meals. One-time use of the medicine per day is allowed only for controlled seizures.

The contents of the sachets should be poured over soft food or mixed with drinks (warmed to room temperature). After the medicine is drunk, the glass will need to be rinsed and the water drunk; this action is due to the fact that the granules may stick to the surface of the cup or glass.

The granules will need to be swallowed immediately, without preliminary chewing. The diluted drug should not be saved for the next dose. Drugs in granules should not be added to infant formula, as the granules can clog the hole in the nipple. It is best to give the medicine in a spoon, controlling the flow of the drug.

It is worth noting that the granulate is not absorbed by the mucous membranes of the gastrointestinal tract; metabolic products are excreted in the feces immediately after the main component is completely released.

Use during pregnancy, GW

It is worth noting that taking this medication is not recommended during pregnancy and breastfeeding. In the event of epileptic seizures, confirmation of epistatus and insufficient oxygen supply, death may occur; this risk exists for both the woman and the child herself.

Risks caused by valproate

There is evidence that when taking medications based on valproate, disturbances in the formation of the neural tube can be diagnosed (signs of spina bifida, development of myelomeningocele). In rare cases, underdevelopment of the limbs and the occurrence of facial dysmorphia were diagnosed. Disturbances in the development of the cardiovascular system cannot be excluded.

It is worth noting that the likelihood of various defects increases during complex antiepileptic therapy in comparison with monotherapy with sodium valproate. Difficulties arise in establishing the cause and complications that arise between intrauterine development disorders and other factors.

The use of drugs is possible only when the possible benefits of antiepileptic treatment for the expectant mother significantly outweigh the likely risks for the baby.

It is necessary to pay attention to the fact that during pregnancy you should not complete antiepileptic therapy if it is effective. It will be necessary to continue monotherapy; the optimal daily dose is indicated; it is taken several times.

When taking a drug against epilepsy, the use of a folic acid-based product may be prescribed; thanks to this treatment, it is possible to reduce the likelihood of developing intrauterine defects, in particular, the formation of the neural tube. In this case, there is a need to conduct antenatal monitoring of the neural tube and other developmental pathologies.

Risks in Infants

Taking valproate can provoke skin hemorrhage in infants. The development of this pathology can be triggered by hypofibrinogenemia. Cases of afibrinogenemia have been reported, with a high mortality rate. It is possible that this may be caused by a decrease in a number of coagulation factors.

In infants, platelet cell levels will need to be monitored, and plasma fibrinogen levels as well as clotting factors will need to be monitored.

Lactation

The active ingredient passes into breast milk in small quantities. According to some data, breastfeeding is possible during monotherapy, and the safety profile must be taken into account.

Interaction

The active substance Depakine Chronosphere activates other psychotropic drugs when used simultaneously, so doses need to be adjusted if necessary.

In addition, Depakine Chronosphere increases plasma concentrations of Phenobarbital , Primidone , Zidovudine , enhancing some of their effects, including the sedative effect of Phenobarbital . The drug also reduces total plasma concentrations of phenytoin .

Valproic acid activates the toxicity of Carbamazepine and Amotrigine . Drugs should be taken together only under the strict supervision of a specialist. In addition, Depakine Chronosphere complicates the metabolism of Lamotrigine in the liver and increases its half-life by almost 2 times.

Valproic acid reduces the average clearance of Felbamate and enhances the hypotensive effect of Nimodipine .

Antiepileptic drugs that induce microsomal liver enzymes reduce the content of the active component Depakine Chronosphere in plasma. Felbamate has the same effect when combined with this drug.

It is not advisable to combine mefloquine and valproic acid , otherwise there is a high risk of an epileptic seizure. The effectiveness of Depakine Chronosphere is also reduced with simultaneous use of St. John's wort and rifampicin . Its concentration, on the contrary, increases when combined with drugs that are known to have a high degree of binding to plasma proteins. The serum concentration of the drug also increases with the use of cimetidine or erythromycin .

It is not recommended to combine Depakine Chronosphere with Carbapenems and Topiramate . If this cannot be avoided, medications should be taken under the strict supervision of a physician.

Ethanol and other potentially hepatotoxic drugs combined with valproic acid enhance the hepatotoxic effect of the latter. And in combination with Clonazepam, it is possible to increase the severity of absence status .

Myelotoxic drugs when used simultaneously with Depakine Chronosphere increase the risk of suppression of bone marrow hematopoiesis.

Contraindications

Due to the peculiarities of the composition and action of the drug “Depakine Chronosphere”, therapy often must be carried out with extreme caution. Special monitoring and dosage reduction may be necessary when

lesions of the liver and pancreas, chronic enzymopathies, disruption of the hematopoietic cycle in the bone marrow, renal failure. The high chemical activity of the product leads to its interaction with many medications. Any combination of medications must be agreed with your doctor.

The use of the product is prohibited in the following cases:

intolerance to the main or auxiliary ingredients of the composition;
acute or chronic inflammation of the liver;
serious liver pathologies, fatal cases of valproic acid use due to a family history of liver pathologies;
hepatic porphyria;
low performance of the pancreas;
infancy up to six months, some mitochondrial pathologies in children under 2 years of age;
decreased platelet count in the blood, hemorrhagic diathesis;
drug treatment with compositions based on St. John's wort, taking Mefloquine.

Combining pregnancy and taking the drug "Depakine Chronosphere" can expose the fetus to serious risk. The teratogenic effect of the composition manifests itself in the form of mental and physical development disorders in children.

When planning a pregnancy, it is advisable to at least temporarily switch the expectant mother to less aggressive means. Doctors generally try to refrain from prescribing the product to females of childbearing potential. Therapy is resorted to only in cases where alternative approaches do not provide the desired effect or are poorly tolerated by the patient.

Reviews of Depakin Chronosphere

Reviews of Depakine Chronosphere report the effectiveness of the drug. This is a new form of Depakine, which is enjoying great success. Many parents are scared by the unusual form of the well-known drug, but in this case there is no need to be afraid. This remedy can also be given to children. This is just a new form for the treatment of epilepsy , which makes it easier for young patients to take the drug.

Many also note that, thanks to its improved shape, Depakine Chronosphere is very convenient to carry.

Analogues of the drug according to ATC codes:

VALPARINE VALPARINE HR DEPAKINE CHRONO CONVULEX CONVULEX CONVULEX CONVULEX CONVULSOFIN ENCORATE ENCORATE CHRONO All

Before using the drug DEPAKINE CHRONOSPHERE, you should consult your doctor. These instructions for use are for informational purposes only. For more complete information, please refer to the manufacturer's instructions.