Depakine chrono 300 side effects. Provides stable remission, but many side effects

In addition, Depakine Chrono 300 mg contains the following additional components: hypromellose 4000 , sodium saccharinate , talc , polyacrylate dispersion 30% ,ethylcellulose , macrogol 6000 , titanium dioxide , hypromellose .

Depakine Chrono 500 mg, in turn, has such auxiliary ingredients as hypromellose 4000 , silicon dioxide colloidal anhydrous , titanium dioxide , sodium saccharinate , talc , silicon dioxide colloidal hydrated , macrogol 6000 , ethylcellulose , hypromellose , polyacrylate 30% .

Release form

Coated tablets, odorless or with a slight odor. The shape is oblong.

pharmachologic effect

Anticonvulsant for.

Pharmacodynamics and pharmacokinetics

Tablets are an anticonvulsant that is effective in various forms epilepsy .

Two mechanisms of its action are known:

  • valproic acid affects GABAergic system . It increases the concentration of GABA in the CNS and stimulates GABAergic transmission ;
  • possible influence of valproate metabolites remaining in the brain. After the drug is removed, the level of GABA increases.

The bioavailability of the drug when administered orally is approximately 100%. The volume of distribution is mainly limited to the blood and extracellular fluid. The active substance enters the brain and cerebrospinal fluid .

The half-life is 15-17 hours. The minimum concentration of the drug in the blood serum is 40-50 mg / l. The maximum concentration is 200 mg / l, at a higher level it is necessary to reduce the dosage.

Stable plasma concentration - after 3-4 days of use. Strong bonds with plasma proteins, which depend on the dosage. It is excreted mainly in the urine.

Indications for use

Adult patients are prescribed this remedy for the treatment of:

  • Lennox-Gastaut syndrome ;
  • generalized and partial epileptic seizures ;
  • bipolar affective disorders .

Children are given Depakine Chrono for treatment:

  • partial and generalized epileptic seizures ;
  • Lennox-Gastaut syndrome .

Contraindications

The drug can not be used for:

  • hypersensitivity to the components of this drug;
  • chronic hepatitis ;
  • hepatic porphyria ;
  • body weight less than 17 kg;
  • acute hepatitis ;
  • admission Meflokhina and/or hypericum extract ;
  • children's age up to 6 years.

Side effects

When taking the drug, the following side effects are possible:

  • vomit;
  • Stevens-Johnson syndrome ;
  • level reduction fibrinogen ;
  • increased bleeding time;
  • light hands;
  • vasculitis ;
  • weight gain;
  • reversible Fanconi syndrome ;
  • polymorphic erythema ;
  • nausea;
  • stomach ache;
  • moderate hyperammonemia ;
  • thrombocytopenia ;
  • hair loss;

Symptoms are usually reversible and disappear after discontinuation of the drug.

In addition, in rare cases, the following side effects are possible:

  • reversible;
  • toxic epidermal;
  • lethargy , which in some cases leads to transient ;
  • macrocytosis ;
  • pancytopenia ;
  • violation of the kidneys;
  • disorders in the liver;
  • stupor;
  • reversible;
  • anemia ;
  • leukopenia ;
  • hearing loss;
  • violation of the regularity of the menstrual cycle;
  • peripheral edema.

Instructions for use Depakine Chrono

Tablets of 300 mg and 500 mg are intended for oral administration. The daily dosage is divided into 1 or 2 doses. Once a day, the drug can be used under well controlled epilepsy . Instructions for use Depakine Chrono recommends taking tablets with meals.

The dosage depends on the age and weight of the patient, as well as on his individual tolerability of the components.

Adults and children over the age of 6 years (weighing over 17 kg) are prescribed, as a rule, an initial dose of 10-15 mg / kg, gradually increasing it to the desired one. The average dosage is 20-30 mg/kg per day. If there is no therapeutic effect, it can be increased, but the patient's condition must be carefully monitored.

Tablets should not be crushed or chewed. If they are used as a substitute for other antiepileptic drugs, dosages should be introduced gradually, the average dose is thus reached within 2 weeks. Reception of the canceled drug is also reduced in stages.

If other antiepileptic drugs have not been taken before, the dosage of Depakine Chrono is increased every 2-3 days until the optimum is reached (this will take about a week).

Other anticonvulsants against the background of Depakine Chrono should also be administered in stages.

Overdose

Possible in acute overdose coma With muscle hypotension , miosis , phenomena metabolic acidosis , hyporeflexia and respiratory depression .

In addition, cases of increased intracranial pressure due to cerebral edema . A fatal outcome is also possible.

As a treatment, gastric lavage is used, the cardiovascular and respiratory systems are carefully monitored, and I maintain an effective one. In serious situations, dialysis .

Interaction

Combinations with:

  • Mefloquine ;
  • Hypericum .

Depakine Chrono should be taken with caution in conjunction with:

  • Felbamate ;
  • Phenytoin ;
  • Carbapenems ;
  • Monobactams ;
  • Phenobarbitals ;
  • Primidon ;

When combined with these drugs, strict medical supervision is required.

Terms of sale

Depakine Chrono is dispensed in pharmacies strictly by prescription.

Storage conditions

Keep the drug out of the reach of children, dry place. It is advisable not to take it out of the package. The optimum temperature is not higher than 25 ° C.

Best before date

Depakine Chrono is stored for 3 years.

Reviews about Depakine Chrono

Reviews about Depakine Chrono are usually positive. Patients take 300 mg and 500 mg tablets. Regardless of the form of release, the effectiveness of the drug is noted. However, almost any forum has reports of side effects when taking this remedy. This indicates that the drug should be taken under the strict supervision of a doctor, carefully controlling the dosage.

Price Depakine Chrono

Price Depakine Chrono 300 mg 100 pieces per pack - an average of 1100 rubles.

Price Depakine Chrono 500 mg 30 pieces per pack - an average of 620 rubles.

  • Internet pharmacies in Russia Russia
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WER.RU

    Depakine Chrono tablets 300 mg 100 pcs

    Depakine Chronosphere powder 750 mg 30 pcsSanofi Aventis [Sanofi-Aventis]

    Depakine Chronosphere powder 500 mg 30 pcsSanofi Aventis [Sanofi-Aventis]

    Depakine Chronosphere powder 250 mg 30 pcsSanofi Aventis [Sanofi-Aventis]

    Depakine Chronosphere gran. prolongation for oral administration 100 Mg 30 pcsSanofi Aventis [Sanofi-Aventis]

Catad_pgroup Antiepileptic

Depakine Chrono - official * instructions for use

*registered by the Ministry of Health of the Russian Federation (according to grls.rosminzdrav.ru)

Instruction
on the medical use of the drug

DEPAKENE® CHRONO

Registration number and date:

Trade name of the drug: Depakine® Chrono.

International non-proprietary name: valproic acid.

Dosage form: film-coated tablets.

Compound

In 1 tablet Depakine®Chrono 300mg contains:
Sodium valproate - 199.8 mg and valproic acid - 87.0 mg (which corresponds to 300 mg of sodium valproate per 1 tablet).
Excipients: methylhydroxypropyl cellulose 4000 mPa.s (hypromellose), ethyl cellulose (20 mPa.s), sodium saccharinate, hydrated colloidal silicon dioxide.
Tablet shell:

In 1 tablet Depakine®Chrono 500mg contains:
Sodium valproate - 333 mg and valproic acid - 145 mg (corresponding to 500 mg of sodium valproate per 1 tablet).
Excipients: methylhydroxypropylcellulose 4000 mPa.s (hypromellose), ethylcellulose (20 mPa.s), sodium saccharinate, anhydrous colloidal silicon dioxide, hydrated colloidal silicon dioxide.
Tablet shell: methylhydroxypropyl cellulose 6 mPa.s (hypromellose), macrogol 6000, talc, titanium dioxide, 30% polyacrylate dispersion when expressed in dry extract.

Description

Film-coated oblong tablets, almost white, scored on both sides, odorless or slightly odorous.

Pharmacotherapeutic group: antiepileptic agent.

ATX code: N03AG01

Pharmacodynamic properties

An antiepileptic drug that has a central muscle relaxant and sedative effect.
It exhibits antiepileptic activity in various types of epilepsy. The main mechanism of its action seems to be associated with the effect of valproic acid on the GABAergic system: it increases the content of gamma-aminobutyric acid (GABA) in the central nervous system (CNS) and activates GABAergic transmission.
Therapeutic efficacy begins with a minimum concentration of 40-50 mg/l and can reach 100 mg/l. At concentrations above 200 mg / l, a dose reduction is necessary.

Pharmacokinetics
  • The bioavailability of valproate in the blood when administered orally is close to 100%.
  • The volume of distribution is predominantly limited to the blood and rapidly changing extracellular fluid. Valproate penetrates into the cerebrospinal fluid and into the brain.
  • The half-life is 15-17 hours.
  • For a therapeutic effect, a minimum serum concentration of 40-50 mg / l is required, ranging from 40-100 mg / l. At levels above 200 mg / l, a dose reduction is required.
  • Steady-state plasma concentration is reached by 3-4 days,
  • Protein binding is high, dose-dependent and saturable.
  • Valproate is predominantly excreted in the urine as a glucuronide and by beta-oxidation.
Valproate does not have an inducing effect on enzymes that are part of the cytochrome P450 metabolic system: unlike most other antiepileptic drugs, valproate does not affect the degree of both its own biotransformation and other substances, such as estroprogestogens and vitamin K antagonists. Compared with the form, enteric-coated, sustained release form in equivalent doses is characterized by the following:
  • no absorption delay time after ingestion;
  • prolonged absorption;
  • identical bioavailability;
  • lower Cmax, (decrease in Cmax by about 25%), but with a more stable plateau phase from 4 to 14 hours after ingestion;
  • more linear correlation between dose and plasma drug concentration.

Indications for use

In adults:
  • For the treatment of partial epileptic seizures (partial seizures with or without secondary generalization);
  • Treatment and prevention of bipolar affective disorders

In children: as monotherapy or in combination with other antiepileptic drugs:

  • For the treatment of generalized epileptic seizures (clonic, tonic, tonic-clonic, absences, myoconic, atonic); Lennox-Gastaut syndrome;
  • For the treatment of partial epileptic seizures (partial seizures with or without secondary generalization).

Contraindications

  • Hypersensitivity to valproate, divalproate, valpromide or any of the components of the drug;
  • Acute hepatitis;
  • chronic hepatitis;
  • Cases of severe hepatitis in the patient or in his family history, especially caused by drugs;
  • Porfiria;
  • Combination with mefloquine;
  • Combination with St. John's wort;
  • This drug is not recommended for use in combination with lamotrigine.
  • Children under 6 years of age (risk of inhalation if swallowed).

Pregnancy and breastfeeding

During pregnancy, the development of generalized tonic-clonic seizures, status epilepticus with the development of hypoxia can carry the risk of death for both the mother and the fetus.
Risk associated with valproate. Animals: Experimental studies in mice, rats and rabbits have shown teratogenic effects.
In humans, valproate has been reported to predominantly cause neural tube dysplasia: myelomeningocele, spina bifida (1-2%).
Several cases of facial dysmorphia and malformations of the limbs (particularly short limbs), as well as malformations of the cardiovascular system, have been described.
The risk of malformations is higher with combined antiepileptic therapy than with monotherapy with sodium valproate. However, it is quite 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 to the pregnant woman outweighs the possible risk to the fetus.
If a woman is planning a pregnancy, the indications for antiepileptic treatment should be reconsidered.
During pregnancy, antiepileptic treatment with valproate should not be interrupted 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 (at a dose of 5 mg per day) can be added, as they minimize the risk of neural tube defects. However, regardless of whether the patient is receiving folate or not, special antenatal monitoring of the neural tube or other malformations should be carried out in any case. newborns Valproate can cause hemorrhagic syndrome in newborns. In the case of valproate, this syndrome appears to be associated with hypofibrinogenemia. Fatal cases of afibrinogenemia have been reported. Perhaps this is due to a decrease in a number of blood clotting factors.
In a newborn, it is necessary to determine the number of platelets, the level of fibrinogen in plasma and blood clotting factors. Lactation Excretion of valproate into milk is low, with a concentration between 1% and 10% of the serum level of the drug.
Based on the literature and limited clinical experience, mothers may consider breastfeeding during treatment with this drug as monotherapy, taking into account its safety profile (especially hematological disorders).

Dosage and administration

Depakin® Chrono is a form of delayed release of the active substance of the Depakin® group of drugs, which leads to a decrease in the maximum plasma concentrations of the active substance and provides more uniform concentrations throughout the day.
This drug is intended only for adults and children weighing more than 17 kg! This dosage form is not recommended for children under 6 years of age (risk of inhalation if swallowed)!
The initial daily dose is usually 10-15 mg / kg, then it is increased until the optimal dose is reached.
The average daily dose is 20 - 30 mg/kg. However, if epilepsy is not controlled at such doses, they can be increased, with careful monitoring of the patient's condition.
For children, the usual dose is 30 mg/kg per day.
For adults, the usual dose is 20-30 mg/kg per day.
In elderly patients, the dose should be adjusted according to their clinical condition.
The daily dose is determined depending on the age and body weight of the patient; however, the wide spectrum of individual sensitivity to valproate should be taken into account.
A good correlation has been established between the daily dose, the concentration of the drug in the blood serum and the therapeutic effect: the dose should be set on the basis of the clinical response. Determination of plasma valproic acid levels may serve as an adjunct to clinical observation if epilepsy is not controlled or side effects are suspected. The range of therapeutic efficacy is usually 40-100 mg/l (300-700 µmol/l).
Depakine® Chrono is intended for oral administration. The daily dose is recommended to be taken in one or two doses, preferably with meals.
One-shot use is possible with well-controlled epilepsy.
Tablets are taken without crushing or chewing them.

Start of treatment.
When switching from immediate-release tablets of valproate, which provided the necessary control over the disease, to the sustained-release form (Depakine® Chrono), the daily dose should be maintained.
Replacement of other antiepileptic drugs with Depakine® Chrono should be carried out gradually, reaching the optimal dose of valproate within about 2 weeks. In this case, depending on the patient's condition, the dose of the previous drug is reduced.
For patients not taking other antiepileptic drugs, doses should be increased after 2-3 days in order to reach the optimal dose within about a week.
If necessary, combinations with other antiepileptic drugs should be administered gradually (see "Interaction with other medicinal substances and other forms of interaction").

Side effect

From the side of the central nervous system: Ataxia (>0.1 to<1%);
Cases of cognitive impairment with progressive onset (giving a complete picture of the dementia syndrome) reversible within a few weeks or months after drug withdrawal these cases were isolated or associated with a paradoxical increase in the frequency of convulsions during therapy, their frequency decreased with the suspension of the treatment process or with a decrease in the dose of the drug.The most often such cases are described in 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 often develop gastrointestinal disorders (nausea, vomiting, gastralgia, diarrhea) at the beginning of treatment, but they usually resolve without discontinuation of drug therapy within a few days.
Cases of pancreatitis, sometimes fatal (Hepatic dysfunction (> 0.01 to From the side of the hematopoietic organs: Frequent dose-dependent thrombocytopenia.
Inhibition of bone marrow hematopoiesis (from > 0.01 to From the urinary system: Enuresis ( Allergic reactions: Skin rash, urticaria, vasculitis. In some cases ( Laboratory indicators: Isolated and moderate hyperammonemia without changes in liver function tests is common, especially with polytherapy. Cancellation of the drug in this case is not required.
However, hyperammonemia associated with neurological symptoms has also been described.
This condition requires further investigation.
An increase in the level of hepatic transaminases is possible.
Isolated cases of a decrease in the level of fibrinogen 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 ( Others: Teratogenic risk (see "Pregnancy and breastfeeding").
Hair loss, rare reports of hearing loss (> 0.01 to

Overdose

Clinical manifestations of acute massive overdose usually occur in the form of a coma with muscle hypotension, hyporeflexia, miosis, respiratory depression, metabolic acidosis. Cases of intracranial hypertension associated with cerebral edema have been described.
Emergency care for overdose in the hospital should be as follows: gastric lavage, which is effective for 10-12 hours after taking the drug, monitoring the state of the cardiovascular and respiratory system and maintaining effective diuresis. In very severe cases, dialysis is performed. Usually the prognosis for overdose is favorable, but several cases of death have been described.

Interaction with other medicinal products and other forms of interaction

Contraindicated combinations:
Mefloquine The risk of epileptic seizures in patients with epilepsy due to increased metabolism of valproic acid and the convulsant effect of mefloquine.
St. John's wort Danger of reducing the concentration of valproic acid in the blood plasma. Not recommended combinations:
Lamotrigine Increased risk of severe skin reactions (toxic epidermal necrolysis). In addition, an increase in plasma concentrations of lamotrigine (its metabolism in the liver is slowed down by sodium valproate). If a combination is necessary, careful clinical and laboratory monitoring is required. Combinations requiring special precautions:
Carbamazepine An increase in the concentration of the active metabolite of carbamazepine in plasma with signs of an overdose. In addition, a decrease in plasma concentrations of valproic acid associated with an increase in hepatic metabolism of the latter under the action of carbamazepine.
Recommended: clinical observation, determination of plasma concentrations of drugs and revision of their dosage, especially at the beginning of treatment. Carbapenems, monobactams: meropenem, panipenem, and, by extrapolation, azreons, imipenem. Risk of convulsions due to a decrease in serum valproic acid concentrations.
Recommended: clinical observation, determination of plasma concentrations of drugs and, possibly, a revision of the dosage of valproic acid during treatment with an antibacterial agent and after its withdrawal. Felbamate Increasing the concentration of valproic acid in serum, with the risk of overdose.
Clinical control, laboratory control and possibly a revision of the dosage of valproic acid during treatment with felbamate and after its withdrawal. Phenobarbital, primdone Increased plasma concentrations of phenobarbital or primidone with signs of overdose, usually in children. In addition, a decrease in the concentration of valproic acid in plasma, associated with an increase in hepatic metabolism by phenobarbital or primidone.
Clinical monitoring during the first 15 days of combined treatment with an immediate reduction in the dose of phenobarbital or primidone when signs of sedation appear; determination of the level of both anticonvulsants in the blood. Phenytoin Changes in the concentration of phenytoin in plasma, the risk of a decrease in the concentration of valproic acid associated with increased hepatic metabolism of the latter by phenytoin.
Clinical monitoring is recommended, determination of the level of two antiepileptics in plasma, possibly modification of their doses. Topiramate Risk of hyperammonemia or encephalopathy commonly attributed to valproic acid when combined with topiramate.
Enhanced clinical and laboratory monitoring during the first month of treatment and in case of symptoms of ammonemia. Antipsychotics, monoamine oxidase inhibitors (MAOIs), antidepressants, benzodnazepines. Valproate potentiates the action of psychotropic drugs, such as neuroleptics, MAO inhibitors, antidepressants and benzodnazepines.
Clinical monitoring and, if necessary, dose adjustment is recommended. Cimetidine and erythromycin The serum level of valproate is increased. Zidovudine Valproate can increase the plasma concentration of zidovudine, which leads to an increase in the toxicity of the latter. Combinations to consider:
Nimodipine (oral, and by extrapolation, parenteral) Strengthening the hypotensive effect of nimodipine due to an increase in its plasma concentration (decrease in metabolism by valproic acid). Acetylsalicylic acid With the simultaneous administration of valproate and acetylsalicylic acid, an increase in the effects of valproate is observed, due to an increase in the concentration of valproate in serum. Vitamin K antagonists Careful monitoring of the prothrombin index is required when co-administered with vitamin K-dependent anticoagulants. Other forms of interaction
Oral contraceptives Valproate does not have an enzyme-inducing effect, and therefore does not affect estrogen-progesterone in women using hormonal contraceptives.

special instructions

liver dysfunction :
There are rare reports of severe and fatal cases of liver disease. 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, are at increased risk. At the age of over 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 must be taken into account, especially in patients at risk.
On the one hand, non-specific general symptoms, usually appearing suddenly, such as asthenia, anorexia, extreme fatigue, drowsiness, sometimes accompanied by recurrent vomiting and abdominal pain.
On the other hand, recurrence of epileptic seizures against the background of antiepileptic therapy It is recommended to inform the patient, and if this is a child, then his family, that if such clinical symptoms develop, you should immediately consult a doctor. In addition to a clinical examination, an urgent analysis of liver function should be carried out.
During the first 6 months of treatment, liver function should be checked periodically. Among the classical tests, the most important tests reflect protein synthesis by the liver, and especially the prothrombin index. In the event of an abnormally low level of prothrombin, a significant decrease in the level of fibrinogen and coagulation factors, an increase in the level of bilirubin and hepatic transaminases, Depakine® Chrono treatment should be suspended. It is also necessary to interrupt treatment with salicylates if they were included in the treatment regimen, since they share the same metabolic pathways as valproate.

pancreatitis
In rare cases, severe forms of pancreatitis, sometimes fatal, have been reported. These cases were observed regardless of the age of the patient and the duration of treatment, although the risk of developing pancreatitis decreased with increasing age of the patients.
Liver failure in pancreatitis increases the risk of death.
Liver function testing should be performed prior to initiation of treatment and periodically during the first 6 months of treatment, especially in patients at risk.
It should be emphasized that in the treatment of both Depakine® Chrono and other antiepileptic drugs, a slight, isolated and temporary increase in transaminase levels can 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, the determination of the prothrombin index) in order to revise the dosage, if necessary, and repeat the tests depending on the change in parameters.
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 benefit of treatment with the drug should be assessed in relation to the risk of developing liver disease or pancreatitis.
Before starting therapy or surgery, in case of hematomas or spontaneous bleeding, it is recommended to perform a hematological blood test (determine the blood count, including platelet count, bleeding time and coagulation tests).
Combined use with salicylates should be avoided in children under 3 years of age due to the risk of hepatotoxicity.
In patients with renal insufficiency, it is recommended to take into account the increased concentration of the free form of valproic acid in serum and reduce the dose.
In acute abdominal pain and gastrointestinal symptoms such as nausea, vomiting and/or anorexia, it is necessary to be able to recognize pancreatitis and, with an elevated level of pancreatic enzymes, stop the drug by taking alternative therapeutic measures.
Sodium valproate is not recommended for patients with urea cycle enzyme deficiency. In such patients, several cases of hyperammonemia accompanied by stupor and/or coma have been described.
In children with unexplained gastrointestinal symptoms (anorexia, vomiting, episodes of cytolysis), a history of lethargy or coma, mental retardation, or a family history of neonatal or child death, metabolic studies, especially ammonemia, should be performed prior to treatment with sodium valproate. fasting and after meals.
Although it has been shown that during the treatment of Depakin® Chrono, violations of the immune system are extremely rare, the potential benefit of its use must be compared with the potential risk when prescribing the drug to patients suffering from systemic lupus erythematosus.
Patients should be warned about the risk of weight gain at the start of treatment, and measures, mainly dietary, should be taken to minimize this phenomenon.

Influence on the ability to drive vehicles or other mechanisms.
During the period of treatment, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require an increased concentration of attention and speed of psychomotor reactions.

Release form

Depakine Chrono - tablets of prolonged action, film-coated 300 mg.
50 tablets in a polypropylene bottle with a polyethylene stopper with a desiccant.
2 bottles with instructions for use in a cardboard box.
Depakine Chrono - tablets of prolonged action, film-coated 500 mg. 30 tablets in a polypropylene bottle with a polyethylene stopper with a desiccant.
1 bottle with instructions for use in a cardboard box.

Storage conditions

At temperatures below +25C in a dry place. Keep out of the reach of children.

Best before date

3 years. Do not take the medicine after the expiry date which is stated on the package.

Terms of dispensing from pharmacies

On prescription

Manufacturer
Sanofi Winthrop Industry - 82 avenue Raspail, 94250 Gentilly, France

Claims of consumers should be sent to the address in Russia:
115035, Moscow, st. Sadovnicheskaya, house 82, building 2

Thanks

The use of Depakine Chrono 500, as well as other dosage forms of the drug, can provoke a number of side effects.

  • the drug affects the functioning of the brain: trembling of the limbs is possible, sometimes the patient's behavior changes, his psycho-emotional state is likely to appear, visions, unmotivated aggression, nervousness, impaired coordination, migraine-like pain, craving for sleep, encephalopathy, spontaneous urination, stupor, changes in the perception of reality , as well as coma,
  • the drug can affect the senses, spots appear before the eyes, nystagmus, diplopia may develop,
  • the effect on the organs of the gastrointestinal tract is manifested in vomiting, pain in the stomach, aversion to food, diarrhea, jaundice. In rare cases, there is inflammation of the pancreas ( sometimes in severe cases, provoking death, such complications usually develop in the first two to twelve weeks of treatment, sometimes up to six months), constipation,
  • blood production is disturbed, leukopenia, anemia, thrombocytopenia, deterioration of blood clotting, hemorrhages are possible,
  • the metabolism of essential substances may be disturbed: the patient may lose weight or gain weight,
  • allergic manifestations are likely: rashes on the body, angioedema, changes in reaction to light, Steven-Johnson syndrome,
  • in the test results there may be the following changes: an increase in creatinine, ammonium, glycine, bilirubin, a slight increase in the activity of liver enzymes,
  • depakine can disrupt the endocrine system, which is expressed in: galactorrhea, breast growth, amenorrhea, dysmenorrhea.
  • In addition, in the treatment of depakine, alopecia and the appearance of swelling of the extremities are possible.
Before use, you should consult with a specialist.
Reviews

I've been taking it for about 10 years. I'm 30. My hair fell out at first. There is a problem with nails. gave birth. I drank during pregnancy. I live without complaining. There were seizures without him. As soon as I started taking it, they disappeared immediately.

My son is 17 years old. We had a lot of seizures, we went to the doctors for almost two years. The epileptologist did not diagnose us. In Moscow, a cardioverter was urgently installed because the pulse reached 250 beats. It took a long time to write what and how. Ultimately, in the past We got to Cherevashchenko I., in Pyatigorsk. He prescribed Depakin 500. And for a year we live almost without seizures. I no longer believed that they would pass. There are side effects; lethargy, drowsiness and weight loss. Health to everyone.

There are people who do not want to take medicine. I myself refused ... But I really love life, give me adrenaline, high speed, parachutes, shooting. I'll tell you so, about those who are dumb to drink medicine. It is better to drink 50 tablets a day and plant the liver and plant anything, so long as these attacks do not occur. It is impossible to live a full life with this diagnosis. Therefore, drink what the doctor advised you (a competent doctor is very important, I went to St. Petersburg to some special clinic, I don’t remember now). I drink pills already with pleasure, I will drink everything so that there are no more seizures. And by the will of the Almighty they are no more. Drink and don't quit right away. You can reduce the dose, but you can not immediately take and quit these pills. This also leads to seizures. For those who are afraid to take pills: I have been drinking for five years now. I do what I want. There are no admissions. Stresses happen but pass as at normal healthy people. I look great. Good luck and don't be afraid to take your medicine. Be careful not to drink them.

At the age of 19 I had my first attack. They prescribed Depokin Chrono 500. Now I'm 25. I haven't had a single attack since the moment I took it. The doctor guaranteed that within three years I would not be able to drink medicines at all, but since I lead a lifestyle that is not supposed to be for me. I do not deny myself anything, so to speak ... Clubs, I can not sleep for days. Yes, there are no attacks, but I can not drink them. Has reduced a dose... But has not left because a way of life not the most favorable with this diagnosis.

My husband was diagnosed with epilepsy at the age of 65. Depakin was prescribed. The attacks became less, but did not go away completely. And with the constant intake of Depakine for 2 years, the composition of the blood has changed (a decrease in platelets, their characteristics), hemoptysis has opened. Now he is in the hospital in pulmonology.

My daughter is 12 years old. There was one generalized attack, frontal epilepsy. We take Depakine Chrono 300, 1 tablet 2 times. From the positive, there were no more attacks, there was no epiactivity according to the EEG. From the negative, multiple erosive-ulcerative gastritis developed in the lower part of the stomach. With any rotavirus infection, gastric bleeding opens and the pancreas becomes inflamed. The liver is still normal, as we constantly drink hepatoprotectors. Now we will have to take gastroprotectors. A very aggressive effect on the gastrointestinal tract.

At the end of the first month, the main pains began to be severe, I can’t even sleep, I fall asleep with difficulty, sweat makes me sick.
Doctors prescribed to drink two tablets for seven days and then three tablets for a long time. 16 years old 54 kilograms 500 milligrams

My daughter, 9.5 years old, has been taking Valproate 300 mg in the morning and evening for the past three years. I used to take it too, but in small doses, but there were still attacks and the doctor increased the dose. She is very short and underweight. Memory worsened, although before the attacks she was a very smart girl. Constant pain in her legs, nightmares and nausea from food

They prescribed a child, 13 years old, 500 mg at night, and zinc preparations, the result is positive, memory, behavior, thinking, our relationships improved, sleep became even, lost 7 kg, began to eat little. After the examination, positive dynamics. The first week there were pains in the stomach, chest hurt, and all the side effects on this. Then it went away.

Hello. I have been taking Depakine Chrono 300 for 7 months, 2 times a day. Menstruation stopped going, sometimes dizziness bothers me, it throws me into a fever very often. Everything is fine in gynecology. Tell me how to establish menstruation. I am 36 years old.

I am 24, I have been taking it for 6 years, one attack at the age of 16 with loss of consciousness, then for a long time there were myoclonuses of the arms and legs. Dorziovka was 1000, then 800, now I drink 600 at night, we are trying to equalize the EEG.
After the first year of taking it, my hair began to fall out a lot, which of course was sad, but I didn’t go bald, I took care of it with all my might, and after 6-7 months everything got better, they began to grow. The menstrual cycle was initially disturbed, and did not improve, due to the appearance of a cyst, hormones were prescribed, in short, another preparation. Hands do not shake, but the memory is very deteriorated.
It is much easier for me to understand that I am a little slow (because there are healthy people who are much more slow) than waking up in the morning to wait for these twitches in all parts of the body.

Good afternoon, tell me please, I have been taking Depakine Chrono 300 for a week already. Almost from the first days, my hands began to shake a little, my attentiveness worsened. And the last two days such a state as with a long lack of sleep. This is fine? They were attributed to me after one seizure was recorded. It was when I drank a lot of coffee and slept little. I went to bed at 24-1 at night and woke up at 5:30 on weekdays. Can you tell me if this is a normal condition at the beginning of the reception?

I am 22 years old. I have been taking Depakine 300 for 9 years now. Once a day at night. Hands are shaking a lot. Memory is deteriorating. The mood changes often by 100 degrees. I have problems with my nails. The rest is all right.

And at the age of 13, my daughter was prescribed Suxilep 20. The diagnosis was Childhood absence epilepsy. She had fading, memory lapses for 2-3 seconds or even more. A year later, an epileptic attack began. She takes Depakine chrono. For almost 17 months she has not had her period. A year and no seizures. Her EEG is excellent! There were 2 of these attacks in total .. Can the gradual cancellation of Depakine and menstruation normalize?

Good afternoon! my son is 22 years old, 11 months ago he had an accident with a head injury, there was a coma, despite the fact that there were no seizures and epilepsy, the doctor prescribed Depakine Chrono 500, 250 ml g in the morning and 500 ml g in the evening, I am worried about all the side effects ..... there are no packs ... well, there is a little bit of irritation but not significant, I'm worried about the fact of infertility, and in general: will those side effects that are listed after taking them pass or not ??? thanks in advance

Tell me, I used to take depakine 3 times a day. I now have an enkarat chrono. how do i take it?

In general, we drink for 3 years. Epilepsy, as it was, and is, well, together with Depakine 500, using it, we also degrade memory in full swing, there is no perception of reality, well, just a child, somewhere but not with us, more often goes into himself, sleeps just on the go ... .. How to live and how to study further for 15 years she has no desires
And everyone is talking about transitional age. Everyone would go like this...

What to take to improve memory? We have been accepting for over 10 years. 1500 per day.

I am 28 years old, had several seizures with loss of consciousness (I don’t know what they are called correctly). The doctor prescribed 2.5 tablets a day, and if the seizures do not recur within 3 years, then the diagnosis can be removed. I have been taking the pills themselves for almost 3 months, at first I had headaches and nausea, they disappeared, now my hair has begun to fall out, but judging by the instructions, this is a temporary effect. I saw an increase in body weight in side effects - I try to eat less and play sports, I believe in the best !!

Started taking in September 2014 due to loss of consciousness (transitional age). They said to take about a year. If it doesn't help, another year. And I've been taking it for 4 months now. During the reception, I have already recovered by 10 kg, although I am only 17 (!) years old. According to the parents, lethargy appeared and mood changes dramatically ... I drink 3.5 tablets a day.

Depakine is a synthetic drug used in the treatment of generalized epileptic seizures.

pharmachologic effect

Valproic acid, which is the active substance of Depakine, exhibits antiepileptic activity against various types of epilepsy. The main mechanism of action is associated with the effect of the drug on the GABAergic system. Also, the drug has a central sedative and muscle relaxant effect.

Composition, form of release and analogues of Depakine

Depakine is released in the form of:

  • Syrup containing 1 ml of 50 μg of the active substance (valproic acid), in 150 ml vials;
  • Lyophilisate for solution for injection in vials containing 400 mg of active ingredient;
  • Long-acting tablets (Depakine Chrono) 300 mg and 500 mg;
  • Granules of prolonged action for oral administration (Depakine Chronosphere) 100 mg, 250 mg, 500 mg, 750 mg, 1 g.

According to the active substance, Depakine's analogues are: Apilepsin, Valparin, Konvuleks, Enkorat, Konvulsofin. In some cases, the doctor may prescribe Aminalon - an analogue of the drug, which has a similar therapeutic effect.

Indications for the use of Depakine

Depakine is prescribed as an independent therapy or as part of a combined treatment:

  • Generalized epileptic seizures: tonic, clonic, tonic-clonic, myoclonic, atonic, absences;
  • Lennox-Gastaut syndrome;
  • Partial epileptic seizures (with or without secondary generalization).

The use of Depakine in children is also effective for the prevention of seizures at high temperatures.

Pregnant and lactating women can take Depakine only on prescription, which will correlate the risk to the mother and child with the expected benefits of the medication.

Against the background of taking Depakine, when planning a pregnancy, the regimen for using the medication should be reviewed. With the effectiveness of treatment with the drug, it is recommended:

  • Use the medicine as monotherapy, minimizing the dosage taken;
  • As an additional antiepileptic treatment, folic acid preparations (5 mg per day) can be used. This will significantly reduce the risk of developing neural tube defects.

Contraindications

According to the instructions, Depakine is contraindicated for use against the background of:

  • Acute and chronic hepatitis;
  • Porfiria;
  • Hypersensitivity to divalproate, valproate, valpromide or to auxiliary components of Depakine.

You should also avoid taking Depakin simultaneously with mefloquine, St. John's wort and lamotrigine.

How to use Depakine

The dose of Depakine is set depending on age and body weight. The medication should be taken with meals.

Depakine for children and adults from 25 kg is prescribed 10-15 mg per 1 kg, after which it is gradually increased once a week by 5-10 mg / kg until the optimal dosage is reached (no more than 60 mg / kg). In cases where the patient has previously taken antiepileptic drugs, their replacement with Depakine should be carried out gradually (over two weeks). If other medicines were not taken, the dose can be increased more quickly - every 2-3 days.

The daily dosage (average - 30 mg / kg) of Depakine for children should be taken in two (up to a year) or three (over a year) doses. For children under three years of age, the drug is recommended to be used as monotherapy, having previously assessed the potential benefit of drug treatment in relation to the risk of developing liver disease or pancreatitis. Due to the risk of hepatotoxicity, this age group of children should also not be given salicylates at the same time as Depakine.

For children, the syrup dosage form is the most preferred. In order to correctly measure Depakine for children, you should use the double-sided dosing spoon that comes with the medicine.

Side effects

Most often, Depakine, according to reviews, leads to the development of disorders of the central nervous system, which manifest themselves in the form of:

  • Changes in mood, behavior or mental state, impaired coordination of movements;
  • motor restlessness;
  • Headache;
  • Trembling of the hands or arms;
  • spots before the eyes;
  • Unusual arousal, irritability;
  • diplopia;
  • drowsiness;
  • Vertigo.

Also, Depakine, according to reviews, can cause nausea, mild abdominal cramps, constipation or diarrhea, loss of appetite, vomiting, and other digestive disorders. Of the allergic and dermatological reactions, the development of alopecia and skin rash is most likely. In some cases, when taking Depakine, according to reviews, you may experience:

  • Thrombocytopenia;
  • Increase or decrease in body weight;
  • Menstrual disorders.

Children under 3 years of age with mental retardation, epilepsy (especially associated with brain damage), congenital degenerative or metabolic diseases are at an increased risk of developing liver dysfunction when taking Depakine. Older children are less likely to develop these complications.

In some cases, against the background of the use of Depakine according to the instructions, there were cases of the development of severe forms of pancreatitis, which did not depend on the age or duration of treatment. The risk of death increases significantly against the background of insufficiency of liver function. In this regard, during therapy, the examinations necessary to detect liver failure should be carried out.

Against the background of acute abdominal pain and such gastrointestinal signs as vomiting, nausea and anorexia, it is necessary to be able to recognize pancreatitis. With an excessive level of pancreatic enzymes, Depakine is canceled using alternative medications.

Despite the fact that against the background of the use of Depakine, cases of dysfunction of the immune system were rarely recorded, against the background of systemic lupus erythematosus, the possible benefits of it and the potential risk should be assessed before taking the medication.

Depakine drug interaction

Depakin according to the instructions:

  • It is contraindicated to use: with mefloquine (increased metabolism of valproic acid) and St. John's wort (decrease in the concentration of the active substance in the blood plasma);
  • Not recommended: with lamotrigine (increased risk of severe skin reactions);
  • It should be taken with caution: with carbamazepine (increased risk of overdose of carbamazepine), with felbamate (danger of overdose of valproic acid), with phenytoin (change in plasma concentrations of drugs), with topiramate and zidovudine (danger of encephalopathy or hyperammonemia).

Storage conditions

Depakine is one of the prescription antiepileptic drugs. The shelf life of the drug is 36 months, provided that it is stored in accordance with the manufacturer's recommendations (at a temperature not exceeding 25 ° C). A bottle of syrup after opening should not be stored for more than one month.

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