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Depakine Chronospere

Release form, composition and packaging

Long-acting granules are almost white or slightly yellowish in color, waxy, easily free-flowing, without the formation of agglomerates. 1 pack sodium valproate 66.66 mg valproic acid 29.03 mg in terms of sodium valproate 100 mg. Excipients: solid paraffin, glycerol dibehenate, colloidal aqueous silicon dioxide.

Long-acting granules are almost white or slightly yellowish in color, waxy, easily free-flowing, without the formation of agglomerates. 1 pack sodium valproate 166.76 mg valproic acid 72.61 mg in terms of sodium valproate 250 mg. Excipients: solid paraffin, glycerol dibehenate, colloidal aqueous silicon dioxide.

Long-acting granules are almost white or slightly yellowish in color, waxy, easily free-flowing, without the formation of agglomerates. 1 pack sodium valproate 333.3 mg valproic acid 145.14 mg in terms of sodium valproate 500 mg. Excipients: solid paraffin, glycerol dibehenate, colloidal aqueous silicon dioxide.

Long-acting granules are almost white or slightly yellowish in color, waxy, easily free-flowing, without the formation of agglomerates. 1 pack sodium valproate 500.06 mg valproic acid 217.75 mg in terms of sodium valproate 750 mg. Excipients: solid paraffin, glycerol dibehenate, colloidal aqueous silicon dioxide.

Long-acting granules are almost white or slightly yellowish in color, waxy, easily free-flowing, without the formation of agglomerates. 1 pack sodium valproate 666.6 mg valproic acid 290.27 mg in terms of sodium valproate 1000 mg Excipients: solid paraffin, glycerol dibehenate, colloidal silicon dioxide aqueous.

Clinical and pharmacological group: Anticonvulsant drug.

pharmachologic effect

An anticonvulsant drug that has a central muscle relaxant and sedative effect. Shows antiepileptic activity in various types of epilepsy. The main mechanism of action appears to be related to the effect of valproic acid on the GABAergic system: it increases the content of GABA in the central nervous system and activates GABAergic transmission. Depakine Chronosphere is a long-acting granule that provides more uniform concentrations of the drug throughout the day.

Pharmacokinetics

Suction

The bioavailability of valproate when administered orally is close to 100%. Food intake does not affect the pharmacokinetic profile. For the development of a therapeutic effect, a minimum serum concentration of 40-50 mg/l is required, ranging from 40-100 mg/l. At concentrations of more than 200 mg/l, a reduction in the dose of the drug is required.

Distribution

Plasma protein binding is high, dose-dependent and saturable. Css in plasma is achieved by 3-4 days. Valproate penetrates the cerebrospinal fluid and the brain.

Metabolism

Valproate does not induce isoenzymes of the cytochrome P450 system: unlike most other antiepileptic drugs, valproate does not affect the degree of either its own biotransformation or other substances, such as combinations of estrogen and progestogen and vitamin K antagonists.

Removal

T1/2 is 15-17 hours. Valproate is predominantly excreted in the urine in the form of a glucuronide.

Pharmacokinetics in special clinical situations

The valproate molecule can be dialyzed, but hemodialysis only affects the free form of valproate in the blood (approximately 10%). Compared to the immediate release form of valproate in equivalent doses, Depakine Chronosphere is characterized by the following: prolonged absorption; identical bioavailability; Cmax of the drug in plasma is reached approximately 7 hours after oral administration; the total Cmax and concentration of the free form of valproate in plasma is lower (the decrease in Cmax is about 25%, but with a relatively stable plateau phase from 4 to 14 hours after administration); as a result of this decrease, the concentrations of valproic acid are more constant and have a more uniform distribution throughout the day (after using the same dose 2 times a day, the range of fluctuations in plasma concentrations is reduced by half); more linear correlation between doses and plasma concentrations (total and free form).

Indications

In adults (as monotherapy or in combination with other antiepileptic drugs):

for the treatment of generalized epileptic seizures: clonic, tonic, tonic-clonic, absence seizures, myoclonic, atonic; Lennox-Gastaut syndrome;
for the treatment of partial epileptic seizures: partial seizures with or without secondary generalization.
treatment and prevention of bipolar affective disorders;

In infants (from 6 months of age) and children (as monotherapy or in combination with other antiepileptic drugs):

for the treatment of generalized epileptic seizures: clonic, tonic, tonic-clonic, absence seizures, myoconic, atonic; Lennox-Gastaut syndrome;
for the treatment of partial epileptic seizures: partial seizures with or without secondary generalization.
prevention of seizures at high temperatures, when such prevention is necessary.

Dosage regimen

Depakine Chronosphere is a dosage form that is particularly suitable for treating children (if they are able to swallow soft foods) or adults with difficulty swallowing. The drug is prescribed orally. The daily dose is determined depending on the age and body weight of the patient; the wide range of individual sensitivity to valproate should also be taken into account. The initial daily dose is 10-15 mg/kg body weight, then it is increased by 5-10 mg/kg per week until the optimal dose is reached. The average daily dose is 20-30 mg/kg.

In the absence of adequate antiepileptic effect, the dose of the drug can be increased under careful monitoring of the patient's condition. The average daily dose for adults is 20 mg/kg; for adolescents - 25 mg/kg; for children, incl. infants (starting from 6 months of life) - 30 mg/kg.

In elderly patients, the dose should be adjusted according to their clinical condition. A good correlation has been established between the daily dose, the concentration of the drug in the serum and the therapeutic effect: the dose should be set primarily on the basis of clinical response. Determination of plasma valproic acid concentrations may serve as an adjunct to clinical monitoring if epilepsy is uncontrolled or side effects are suspected. The range of therapeutic efficacy is usually 40-100 mg/L (300-700 µmol/L).

When switching from Depakine in the form of immediate release or sustained release of valproate, which provided disease control, to Depakine Chronosphere, it is recommended to maintain the daily dose for well-controlled epilepsy. For patients who have previously taken other antiepileptic drugs, their replacement with Depakine Chronosphere should be carried out gradually, reaching the optimal dose of valproate within approximately 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 it is necessary to combine the drug Depakine Chronosphere with other antiepileptic drugs, they should be administered gradually.

Rules for the use of the drug Depakine Chronosphere in 100 mg sachets are used only in children and infants. Depakine Chronosphere in 1 g sachets is used only in adults. The daily dose is recommended to be taken in 1 or 2 doses, preferably during meals.

Use in 1 dose is possible for well-controlled epilepsy. The contents of the sachet should be poured onto the surface of soft food or drinks at cold or room temperature (including yogurt, orange juice, fruit puree). If Depakine Chronosphere is taken with liquid, it is recommended to rinse the glass with a small amount of water and drink this water, because granules may stick to glass. The mixture should always be swallowed immediately without chewing. It should not be saved for later use.

The drug Depakin Chronosphere should not be used with hot food or drinks (such as soups, coffee, tea, etc.). The drug Depakin Chronosphere cannot be poured into a bottle with a nipple, because granules can clog the nipple opening. Considering the duration of the process of releasing the active substance and the nature of the excipients, the inert matrix of the granule is not absorbed from the digestive tract; it is excreted in feces after complete release of the active substance.

Side effect

From the side of the central nervous system: from > 0.1% to <1% - ataxia; <0.01% - cognitive impairment with progressive onset (giving a complete picture of the dementia syndrome and reversible within several weeks or months); in some cases (more often with complex treatment, especially with phenobarbital, or after a sharp increase in the dose of valproate) - stupor or lethargy, sometimes leading to transient coma (encephalopathy), these cases were isolated or associated with a paradoxical increase in the frequency of seizures during therapy, their the frequency decreased when treatment was suspended or the dose of the drug was reduced; in isolated cases - reversible parkinsonism; headache, mild postural tremor and drowsiness may occur.
From the digestive system: often (at the beginning of treatment) - nausea, vomiting, gastralgia, diarrhea (usually disappear within a few days and discontinuation of the drug is not required); <0.01% - pancreatitis, sometimes fatal (early cessation of treatment required); from > 0.01% to < 0.1% - impaired liver function.
From the hematopoietic system: often - dose-dependent thrombocytopenia; from > 0.01% to < 0.1% - suppression of bone marrow hematopoiesis, including anemia, leukopenia or pancytopenia.
From the urinary system: <0.01% - enuresis; in isolated cases - reversible Fanconi syndrome (genesis is unclear).

DEPAKINE CHRONO extended-release film-coated tablets 300 mg No. 100

Severe liver damage Clinical experience shows that patients at risk include those receiving multiple antiepileptic drugs simultaneously, children under 3 years of age with severe seizures, especially in the presence of brain damage, mental retardation and/or congenital metabolic or degenerative diseases. In children over 3 years of age, the risk of liver damage is significantly reduced and decreases progressively as the patient ages. In most cases, liver damage occurs within the first 6 months of treatment. For early diagnosis of liver damage, clinical observation of patients is mandatory. In particular, you should pay attention to the appearance of the following symptoms that may precede the onset of jaundice, especially in patients at risk: nonspecific symptoms, especially sudden onset, such as asthenia, anorexia, lethargy, drowsiness, which are sometimes accompanied by repeated vomiting and abdominal pain; resumption of seizures in patients with epilepsy. Patients or their family members (when using the drug in children) should be warned that they should immediately report the occurrence of any of these symptoms to their doctor. If these symptoms occur, patients should immediately undergo clinical examination and laboratory testing of liver function tests. Liver function tests should be performed before starting treatment and then periodically during the first 6 months of treatment. Among conventional studies, the most informative are studies reflecting the state of the protein-synthetic function of the liver, especially the prothrombin index. Confirmation of deviations from the norm of the prothrombin index, especially in combination with deviations from the norm of other laboratory parameters (a significant decrease in the content of fibrinogen and blood coagulation factors, an increase in the concentration of bilirubin and an increase in transaminase activity) requires discontinuation of the use of the drug Depakin® Chrono. As a precaution, if patients were receiving salicylates concomitantly, their use should also be discontinued, because they are metabolized through the same metabolic pathway as valproic acid. Pancreatitis Children are at increased risk of developing pancreatitis, and the risk decreases as the child gets older. Severe seizures, neurological disorders, or anticonvulsant therapy may be risk factors for developing pancreatitis. Liver failure combined with pancreatitis increases the risk of death. Patients who experience severe abdominal pain, nausea, vomiting and/or anorexia should be evaluated immediately. If the diagnosis of pancreatitis is confirmed, in particular with increased activity of pancreatic enzymes in the blood, the use of valproic acid should be discontinued and appropriate treatment initiated. Suicidal thoughts and attempts Suicidal thoughts or attempts have been reported in patients receiving antiepileptic drugs for some indications. A meta-analysis of randomized placebo-controlled trials of antiepileptic drugs also showed a small increase in the risk of suicidal ideation and attempts. The mechanism of this effect is unknown. Therefore, patients receiving Depakine® Chrono should be constantly monitored for suicidal thoughts or attempts, and if they occur, appropriate treatment should be provided. Patients and caregivers are advised to seek immediate medical attention if a patient experiences suicidal thoughts or attempts. Renal failure A dose reduction of valproic acid may be required due to an increase in the concentration of its free fraction in the blood serum. If it is impossible to monitor plasma concentrations of valproic acid, the dose of the drug should be adjusted based on clinical observation of the patient. Insufficiency of carbamide cycle enzymes If a deficiency of carbamide cycle enzymes is suspected, the use of valproic acid is not recommended. Several cases of hyperammonemia with stupor or coma have been described in such patients. In these cases, metabolic studies should be performed before starting treatment with valproic acid. 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, in particular the determination of ammonemia (presence of ammonia and its compounds in the blood) on an empty stomach and after meals. Patients with systemic lupus erythematosus Although it has been shown that during treatment with Depakin® Chrono, immune system dysfunction is extremely rare, the potential benefits of its use must be compared with the potential risks when prescribing the drug to patients with systemic lupus erythematosus. Weight gain Patients should be warned of the risk of weight gain at the start of treatment and measures, mainly dietary adjustments, should be taken to minimize this phenomenon. Monitoring laboratory parameters Before starting the use of Depakine® chrono and periodically during the first 6 months of treatment, especially in patients at risk of developing liver damage, liver function tests should be performed. As with most antiepileptic drugs, a slight increase in liver enzyme activity is possible, especially at the beginning of treatment, which occurs without clinical manifestations and is transient. In these patients, a more detailed study of laboratory parameters, including the prothrombin index, is necessary, and dose adjustment of the drug may be required, and, if necessary, repeated clinical and laboratory examinations. Before starting therapy or, if surgery is necessary, in case of spontaneous occurrence of subcutaneous hematomas or bleeding, it is recommended to conduct a hematological blood test (determine the leukocyte formula of the blood, including the number of platelets; bleeding time and coagulogram). Use in pediatrics In children under 3 years of age, if it is necessary to use valproic acid, it is recommended to use the drug Depakine® as monotherapy and in a special dosage form intended for children. In this case, before starting treatment, the ratio of the potential benefit from the use of valproic acid and the risk of liver damage and the development of pancreatitis when using it should be assessed. In children under 3 years of age, concomitant use of salicylates should be avoided due to the risk of hepatotoxicity and bleeding. Ethanol During treatment, alcohol consumption is not recommended. Effect on the ability to drive vehicles and operate machinery Patients should be warned about the risk of drowsiness, especially when undergoing combination anticonvulsant therapy or when combining valproic acid with benzodiazepines. During the treatment period, you must be careful and discuss with your doctor the possibility of driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.