Catad_pgroup Antiepileptics
Valparin XP - official instructions by application
Instructions for medical use drug
Registration number:
P N015033/01-050210
Trade name of the drug:
VALPARINE ® XP
International nonproprietary name:
Dosage form:
extended-release film-coated tablets
Your doctor will probably tell you not to take valproic acid. If you notice that your attacks are more severe or occur more frequently, or if you experience any of the following symptoms, contact your doctor immediately: excessive tiredness, lack of energy, weakness, pain in the right side stomach, loss of appetite, nausea, vomiting, dark urine, yellowing of the skin or white eyes or swelling of the face.
Valproic acid may cause serious birth defects, especially affecting the brain and spinal cord, and may also lead to decreased intelligence in infants exposed to valproic acid before birth. Tell your doctor if you are pregnant or plan to become pregnant. Women who are pregnant should not take valproic acid to prevent migraine headaches. Women who are pregnant should only take valproic acid to treat seizures or bipolar disorder if other medications have not successfully controlled their symptoms or cannot be used.
Compound
Each 300/500 mg tablet (respectively) contains: Active ingredients: sodium valproate 200/333 mg and valproic acid 87/145 mg [eq. sodium valproate 300.27/500.11 mg]; Excipients: colloidal silicon dioxide 2.4/4 mg, hypromellose 105.4/176 mg, ethylcellulose (20 cps) 7.2/12 mg, silicon dioxide hydrate 30/50 mg, sodium saccharinate 6/10 mg; Film casing I: hypromellose 3.79/5.03 mg, glycerol 1.48/1.96 mg, titanium dioxide 0.23/0.31 mg; Film casing II: hypromellose 1.15/1.72 mg, butyl methacrylate dimethylaminoethyl methacrylate and methyl methacrylate copolymer 2.59/3.82 mg, methyl methacrylate and ethyl acrylate copolymer 1.42/2.12 mg, macrogol-1500 0.87/1.28 mg , talc 0.23/3.52 mg, titanium dioxide 0.24/0.24 mg.
Talk to your doctor about the risks of using valproic acid during pregnancy. If you can become pregnant, you should use effective birth control while taking valproic acid. Talk to your doctor about birth control methods that will work for you. If you become pregnant while taking valproic acid, contact your doctor immediately. Valproic acid may harm the fetus.
Valproic acid can cause serious or life-threatening damage to the pancreas. This can happen at any time during your treatment. If you experience any of the following symptoms, consult your doctor immediately: persistent pain that starts in the stomach area but may spread to back nausea, vomiting, or loss of appetite.
Description:
Tablets 300 mg: White, round, biconvex film-coated tablet; fractured view: the outer ring of the shell, as well as the core of the tablet white.
Tablets 500 mg: White, oblong-shaped, film-coated tablet, scored on both sides; fractured view: the outer ring of the shell, as well as the core of the tablet, are white.
Keep all appointments with your doctor and laboratory. Your doctor will order some laboratory tests to check your response to valproic acid. Talk to your doctor about the risks of taking valproic acid or giving valproic acid to your child. Your doctor or pharmacist will give you a Patient Information Sheet when you start treatment with valproic acid, and each time you refill your prescription, read the information carefully and ask your doctor or pharmacist if you have any questions.
Why are these drugs?
Food and Drug Administration website or manufacturer's website to obtain a medication guide. Valproic acid is used alone or with other drugs to treat certain types seizures. Valproic acid is also used to treat mania in people with bipolar disorder. It is also used to prevent migraine headaches, but not to relieve headaches that have already begun. Valproic acid belongs to a class of medications called anticonvulsants.
Pharmacotherapeutic group:
antiepileptic drug.
ATS code: N03F G01
Pharmacological properties
Antiepileptic drug, 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: the drug increases the content of GABA in the central nervous system (CNS) and activates GABAergic transmission.
Therapeutic effectiveness begins with a minimum concentration of 40-50 mg/l and can reach 100 mg/l. At a concentration of more than 200 mg/l, a dose reduction is necessary.
Pharmacokinetics
Bioavailability of the drug is about 100%. Distributed predominantly into the blood and extracellular fluid. Valproic acid penetrates the cerebrospinal fluid and crosses the blood-brain barrier.
The half-life is 15-17 hours. Therapeutic effectiveness is manifested at plasma concentrations from 40 to 100 mg/l. At levels above 200 mg/l, a dose reduction is necessary. Equilibrium concentration in plasma is achieved after 3-4 days of administration.
Bonding with plasma proteins is 90-95% (at plasma concentrations up to 50 mg/l), at concentrations of 50-100 mg/l it decreases to 80-85%; with uremia, hypoproteinemia and liver cirrhosis, binding to plasma proteins is also reduced. It is excreted mainly in the urine in the form of a glucoronide and by beta-oxidation in a conjugated form.
Valproic acid is not an inducer of enzymes of the cytochrome P450 metabolic system. Unlike most other antiepileptic drugs, it does not affect the degree of both its own biotransformation and the biotransformation of other substances, such as estrogens, progestogens and vitamin K antagonists.
The prolonged form is characterized by the absence of absorption lag time, prolonged absorption, identical bioavailability, lower (25%) but relatively more stable plasma concentration between 4 and 14 hours after administration, and a more linear correlation between the dose and the concentration of the drug in plasma.
How should I use this medicine?
It works by increasing the amount of a certain natural substance in the brain. Valproic acid comes in the form of capsule, extended-release tablet, extended-release tablet, spray capsule, and oral syrup. Syrup, capsules, extended-release tablets, and spray capsules are usually taken two or more times daily. Extended-release tablets are usually taken once daily. Take valproic acid at about the same time every day.
Indications
In adults, as monotherapy or in combination with other antiepileptic drugs:
- 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:
- treatment of generalized epileptic seizures (clonic, tonic, tonic-clonic, absence seizures, myoclonic, atonic); Lennox-Gastaut syndrome;
- treatment of partial epileptic seizures (partial seizures with or without secondary generalization).
Take valproic acid with food to help prevent stomach upset. Follow the directions on your prescription label, and ask your doctor or pharmacist to explain any part you do not understand. Take valproic acid exactly as directed. Do not take more or less of this, or take it more often than prescribed by your doctor.
Swallow regular capsules, delayed-release capsules, and extended-release tablets; do not split, chew or crush them. You can swallow the sprinkle capsules whole, or you can open the capsules and sprinkle the pellets they contain on a teaspoon of soft food such as applesauce or pudding. Swallow the food mixture and medicinal pellets immediately after preparing them. Be careful not to chew the beads. Do not store unused food and drug mixtures.
Contraindications
Hypersensitivity to valproic acid or other components of the drug; acute hepatitis; chronic hepatitis; history of liver disease, porphyria; combination with mefloquine; combination with St. John's wort; childhood up to 3 years; not recommended for use in combination with lamotrigine. With caution - Inhibition of bone marrow hematopoiesis (leukopenia, thrombocytopenia, anemia), history of organic diseases of the brain, liver and pancreas diseases; hypoproteinemia, mental retardation in children, congenital enzymopathies, renal failure.
Do not mix syrup with carbonated drink. If you need to switch from one product to another, your doctor may need to adjust your dose. Whenever you receive medication, make sure you get the product that was prescribed for you.
Ask your pharmacist if you are not sure what you have received the right medicine. Your doctor may start you on a low dose of valproic acid and gradually increase your dose. Valproic acid may help control your condition, but will not cure it. Continue taking valproic acid even if you feel well. Do not stop taking valproic acid without talking to your doctor, even if you experience side effects, such as unusual changes in behavior or mood, or if you find out you are pregnant.
Use during pregnancy and breastfeeding
Animal studies have shown teratogenic effects.
According to available data, in humans, valproic acid predominantly causes disturbances in the development of the neural tube: myelomeningocele, spina bifida (1-2%). Cases of facial dysmorphia and limb malformations (especially shortened limbs) have been described, as well as developmental defects of cardio-vascular system.
The risk of malformations is higher with combination antiepileptic therapies than with valproic acid monotherapies.
Considering the above, during pregnancy the use of the drug is possible only if the expected benefit to the mother outweighs the potential risk to the fetus.
During pregnancy, antiepileptic treatment with valproate should not be interrupted. acid if it is effective. In such cases, monotherapy is recommended; minimum effective daily dose should be divided into two doses.
In addition to antiepileptic therapy, drugs may be added folic acid(at a dose of 5 mg/day), because they help minimize the risk of neural tube malformations.
Valproic acid may cause hemorrhagic syndrome in newborns, which appears to be associated with hypofibrinogenemia. Cases of afibrinogenemia with fatal outcomes have been reported.
Valproic acid is released from breast milk in concentrations from 1% to 10%. It is recommended to stop difficult feeding while taking the drug.
If you suddenly stop taking valproic acid, you may have severe, long-lasting, and possibly life-threatening attack. Your doctor will likely reduce your dose gradually. Valproic acid is also sometimes used to treat aggressive outbursts in children with attention deficit hyperactivity disorder. Talk to your doctor about the possible risks of using this medication for your condition.
This medicine is sometimes prescribed for other purposes. Behind additional information Consult your doctor or pharmacist. Tell your doctor and pharmacist if you are allergic to valproic acid, any other medications, or any ingredients in valproic acid that have been prescribed to you. Tell your doctor and pharmacist about the prescription and nonprescription drugs, vitamins, dietary supplements, and herbal products you take or plan to take. Be sure to mention one of the following: acyclovir, anticoagulants such as warfarin, amitriptyline, aspirin, carbamazepine, cholestyramine, clonazepam, diazepam, doripenem, ertapenem, ethosuximide, felbamate, some hormonal contraceptives, imipenem and cilastatin, lamotrigine, medications for anxiety or mental illness, meropenem, nortriptyline, phenobarbital, phenytoin, primidone, rifampin, rufinamide, sedatives, sleeping pills, tolbutamide, topiramate, tranquilizers and zidovudine. Your doctor may need to change the doses of your medications or monitor closely for side effects. Tell your doctor if you have or have ever had episodes of confusion and loss of ability to think and understand, especially during pregnancy or childbirth; coma; Difficulty coordinating your movements; AIDS virus; or cytomegalovirus. Consult your doctor if you are breastfeeding. If you are having surgery, including dental surgery, tell your doctor or dentist that you are taking valproic acid. You should be aware that valproic acid may make you drowsy. Do not drive or operate machinery until you know how this drug affects you. Remember that alcohol may add to the drowsiness caused by this medication. You should be aware that valproic acid may cause severe drowsiness, which may cause you to eat or drink less than you normally would, especially if you are older. Tell your doctor if you are unable to eat or drink as usual. You should be aware that your mental health may change unexpectedly and you may become suicidal while you are taking valproic acid to treat epilepsy. mental illness or other conditions. A small number of adults and children aged 5 years and older who took anticonvulsants such as valproic acid to treat various conditions during clinical trials became suicidal during treatment. Some of these people developed suicidal thoughts and behavior within one week of starting the medication. There is a risk that you may experience changes in your mental health, if you accept anticonvulsant medicine, such as valproic acid, but there may also be a risk that you will experience changes in your mental health if your condition is not treated. You and your doctor decide whether the risk of taking anticonvulsants than the risk of not taking medications. You, your family, or your caregiver should call your doctor immediately if you experience the following symptoms: panic attacks; agitation or disturbance; new or worsening irritability, anxiety, or depression; Acting on dangerous impulses; difficulty falling or sleeping; aggressive, angry or violent behavior; mania; talk or think about wanting to hurt yourself or end your life; withdrawal from friends and family; preoccupation with death and dying; give away valuables; or any other unusual changes in behavior or mood. Make sure your family or caregiver knows what symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own. Ask your pharmacist for a list of ingredients. . Unless your doctor tells you otherwise, continue with your normal diet.
Directions for use and doses
Valparin ® XP is intended for oral administration. The daily dose is recommended to be taken in one or two doses, preferably with meals. Use in 1 dose is possible for well-controlled epilepsy. The tablets are taken without crushing or chewing, with a small amount of water.
The initial dose for monotherapy for adults and children weighing more than 25 kg is 5-15 mg/kg/day, then this dose is gradually increased by 5-10 mg/kg/week. Maximum dose– 30 mg/kg/day (can be increased if it is possible to monitor plasma concentrations up to 60 mg/kg/day).
With combination therapy in adults - 10-30 mg/kg/day, followed by increasing the dose by 5-10 mg/kg/week.
For children weighing less than 25 kg, the average daily dose for monotherapy is 15-45 mg/kg, the maximum is 50 mg/kg. With combination therapy – 30-100 mg/kg/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, as well as taking into account individual sensitivity to valproic acid.
A good correlation has been established between the daily dose, serum concentration of the drug and the therapeutic effect: the dose should be set on the basis of clinical response. Determination of plasma valproic acid levels may be considered as an adjunct to clinical monitoring when epilepsy is uncontrolled or side effects are suspected. The concentration range at which clinical effect is observed is usually 40-100 mg/L (300-700 µmol/L).
When switching from immediate-release valproic acid tablets, which provided the necessary control over the disease, to a prolonged-release form (Valparin ® XP), the daily dose should be maintained:
Replacement of other antiepileptic drugs with Valparin ® XP should be carried out gradually, reaching the optimal dose of valproic acid 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 combinations with other antiepileptic drugs are necessary, they should be introduced gradually (see “Interaction with other drugs”).
What side effects may this medicine cause?
Take the missed dose as soon as you remember. However, if the dose is nearly full, skip the missed dose and continue with your regular dosing. Do not take a double dose to make up for a missed dose. Valproic acid may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away. Drowsiness, dizziness, dizziness, dizziness, change in appetite, change in pain, mannequins, hesitation, uncontrolled thinking, controlled shaking of a body part, problems with walking or coordination, controlled eye movements, or double alteration in loss.
Some side effects may be serious
Unusual bruising or bleeding purple or red patches on the skin that may make it difficult to breathe or swallow, flatten the glands, eyes, lips, tongue or throat, or blistering of the skin. Confusion associated with increased body temperature, weakness or swelling in the joints. Valproic acid may cause other side effects.Side effect
From the central side nervous system:
ataxia; cases of cognitive impairment with a progressive onset until the development of a full picture of dementia syndrome (reversible within several weeks or months after discontinuation of the drug); states of confusion or convulsions; stupor or lethargy, sometimes leading to transient coma (encephalopathy); reversible parkinsonism; headache, dizziness, mild postural tremor and drowsiness, changes in behavior, mood or mental state (depression, feeling tired, hallucinations, aggressiveness, hyperactivity, psychosis, unusual agitation, motor restlessness or irritability), dysarthria.
From the outside digestive system:
often at the beginning of treatment - gastrointestinal disorders (nausea, vomiting, gastralgia, decreased appetite or increased appetite, diarrhea), which usually disappear within a few days without stopping the drug; liver dysfunction; pancreatitis, up to severe injuries with a fatal outcome (in the first 6 months of treatment, more often at 2-12 weeks).
From the hematopoietic organs and hemostasis system: inhibition of bone marrow hematopoiesis (anemia, leukopenia or pancetopinia); thrombocytopenia, decreased fibrinogen content and platelet aggregation, leading to the development of hypocoagulation (accompanied by prolongation of bleeding time, petechial hemorrhages, bruises, hematomas, bleeding, etc.).
From the outside urinary system:
enuresis; cases of reversible Fanconi syndrome (of unknown origin).
From the outside endocrine system:
dysmenorrhea, secondary amenorrhea, breast enlargement, galactorrhea.
Allergic reactions:
skin rash, urticaria, vasculitis; angioedema, photosensitivity, cases, toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme.
Laboratory indicators: isolated and moderate hyperammonemia without changes in liver function tests, especially with polytherapy (drug discontinuation is not required); possible hyperammonemia associated with neurological symptoms(further examination required); possible increase: activity of “liver” transaminases; decreased fibrinogen levels or increased bleeding time, usually without clinical manifestations and especially at high doses (valproic acid has an inhibitory effect on the second stage of platelet aggregation); typonatremia.
Others: teratogenic risk (see Pregnancy and breast-feeding); diplopia, nystagmus, floaters, alopecia; reversible or irreversible hearing loss; peripheral edema; weight gain (as weight gain is a risk factor for polycystic ovary syndrome, careful monitoring of the condition of such patients is recommended); impairment menstrual cycle, amenorrhea.
Overdose
Symptoms: coma with muscle hypotonia, hyporeflexia, miosis, respiratory depression, metabolic acidosis; Cases of intracranial hypertension associated with cerebral edema have been described.
Treatment: in the hospital - gastric lavage if no more than 10-12 hours have passed after taking the drug; monitoring the state of cardiovascular and respiratory systems and maintaining effective diuresis. In very severe cases, dialysis is performed. The prognosis is generally good, but a few cases have been described fatal outcome.
Interaction with other drugs
Contraindicated combinations
Mefloquine: risk epileptic seizures in patients with epilepsy due to increased metabolism of valproic acid and convulsant mefloquine.
St. John's wort: the danger of reducing the concentration of valproic acid in the blood plasma.
Combinations not recommended
Lamotrigine: increased risk severe skin reactions up to the development of toxic epidermal necrolysis. In addition, the plasma concentration of lamotrigine increases (its metabolism in the liver is slowed down by valproic acid). If the 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 overdose. In addition, a decrease in the concentration of valproic acid in plasma is associated with increased metabolism of valproic acid in the liver under the influence of carbamazepine. Recommended: clinical observation, determination of drug concentrations in plasma and, possibly, dose adjustment, especially at the beginning of treatment.
Carbapenems, monobactams: meropenem, panipenem, and, by extrapolation, aztreonam and imipenem: an increased risk of seizures due to a decrease in the concentration of valproic acid in the blood plasma. Recommended: clinical observation, determination of drug concentrations in blood plasma; dose adjustment of valproic acid may be required during treatment antibacterial agent and after its cancellation.
Felbamate: increased concentration of valproic acid in blood plasma with the risk of overdose. Recommended: clinical and laboratory monitoring and possible dose revision of valproic acid during treatment with felbamate and after its discontinuation).
Phenobarbital, primidone: increased concentrations of phenobarbital and primidone in plasma with signs of overdose, usually in children. Besides; a decrease in the concentration of valproic acid in plasma associated with increased hepatic metabolism under the influence of phenobarbital or primidone. Recommended: clinical monitoring during the first 15 days of combination treatment with immediate reduction of the dose of phenobarbital or primidone at the first signs of sedation, determination of blood concentrations of both anticonvulsants.
Phenytoin: changes in the concentration of phenytoin in plasma, the risk of a decrease in the concentration of valproic acid associated with increased metabolism of valproic acid in the liver under the influence of phenytoin. Recommended: clinical monitoring with determination of plasma concentrations of both antiepileptic drugs and, if necessary, adjustment of their doses.
Topiramate: risk of developing hyperammonemia or encephalopathy. Recommended: clinical and laboratory monitoring during the first month of treatment and in case of symptoms of ammonemia.
Neuroleptics, monoamine oxidase inhibitors (MAOIs), antidepressants, benzodiazepines: Valproic acid potentiates the effect of psychotropic drugs, such as antipsychotics, MAO inhibitors, antidepressants, benzodiazepines. Recommended: clinical monitoring and, if necessary, dose adjustment of the drug.
Cimetidine and erythromycin: the concentration of valproic acid in the blood plasma increases.
Zidovudine: Valproic acid may increase plasma concentrations of zidovudine, resulting in increased zidovudine toxicity.
Combinations to Consider
Nimodipine (orally and, by extrapolation, parenterally): increased hypotensive effect of nimodipine due to a decrease in its metabolism under the influence of valproic acid and an increase in plasma concentrations.
Acetylsalicylic acid:
increased effects of valproic acid due to an increase in its concentration in the blood plasma.
When used simultaneously with anticoagulants, vitamin K antagonists require careful monitoring of the prothrombin index.
Other forms of interaction
Valproic acid does not have an enzyme-inducing effect and therefore does not affect the effectiveness of hormonal contraceptives containing combinations of estrogen and progesterone.
special instructions
Before starting treatment and during the first 6 months of therapy, it is necessary periodic control liver function, especially in patients at risk.
Among the classical tests, the most important are those reflecting protein synthesis in the liver and especially the prothrombin index. If there is a significant decrease in the concentration of prothrombin, a marked decrease in the content of fibrinogen, blood clotting factors, an increase in the concentration of bilirubin and transaminase activity, treatment with Valparin ® XP should be suspended. If the patient is receiving salicylates at the same time, they should also be discontinued immediately, since salicylates and valproic acid have common paths metabolism.
The risk of side effects from the liver is increased during combined anticonvulsant therapy, as well as in children.
Early diagnosis based primarily on clinical examination. In particular, two factors that may precede jaundice should be taken into account, especially in patients at risk:
- nonspecific general symptoms, usually appearing suddenly, such as asthenia, anorexia, extreme fatigue, drowsiness, sometimes accompanied by repeated vomiting and abdominal pain;
- recurrence of epileptic seizures during antiepileptic therapy.
You should: warn the patient, and if it is a child, then his family, about the need to immediately notify the doctor about the occurrence of specified symptoms.
In addition to clinical examination, liver function testing should be performed immediately in such cases.
In rare cases, there were severe forms pancreatitis, sometimes with fatal outcome.
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. Insufficiency of liver function in pancreatitis increases the risk of death.
It should be emphasized that during treatment with both Valparin ® XP and other antiepileptic drugs, a slight isolated and temporary increase in transaminase activity may be observed, especially at the beginning of treatment, in the absence of any clinical symptoms. In this case, it is recommended to spend more full examination(including, in particular, determination of the prothrombin index) in order to, if necessary, revise the dose and repeat the tests depending on changes in parameters.
Before starting therapy, before surgical intervention, if hematomas or spontaneous bleeding occur, it is necessary general analysis blood (including determination of platelet count, bleeding time and coagulogram parameters).
If, during treatment, symptoms of “acute” abdomen and such gastrointestinal symptoms such as nausea, vomiting and/or anorexia, it is necessary to determine the activity of amylase in the blood to exclude acute pancreatitis. If there is increased activity of pancreatic enzymes, the drug should be discontinued and alternative therapeutic measures.
When using Valparin ® XP in patients with renal failure It is recommended to take into account the increased concentration of the free form of valproic acid in the blood plasma and reduce the dose.
If necessary, prescribing the drug to patients with systemic lupus erythematosus and other diseases immune system the expected therapeutic effect and the possible risk of therapy should be assessed, since when using Valparin ® XP, in extremely rare cases, disorders of the immune system were observed.
It is not recommended to prescribe the drug to patients with carbamide cycle enzyme deficiency. In such patients, several cases of hyperammonemia accompanied by stupor and/or coma have been described.
During treatment, drinking drinks containing ethanol is not allowed.
Patients should be warned of the risk of weight gain early in treatment and advised to follow a diet to minimize this effect.
Impact on the ability to drive vehicles and operate machinery
During the treatment period, patients must be careful when driving vehicles and other activities that require high concentration and speed of psychomotor reactions.
Release form
Extended-release film-coated tablets, 300 mg, 500 mg. 10 tablets per aluminum foil strip. 3, 5 or 10 strips along with instructions for use in a cardboard box.
Storage conditions
List B.
Store in a dry place at a temperature not exceeding 30 °C.
Keep out of the reach of children.
Best before date
3 years. Do not use too late indicated on the packaging.
Vacation conditions:
On prescription
Manufacturer
Torrent Pharmaceuticals Ltd.
Torrent House, Off Ashram Road, Ahmedabad 380 009, India
Manufacturing address:
Torrent Pharmaceuticals Ltd.
Indrad-3 82721, Diet. Mehsana, India
or
Torrent Pharmaceuticals Ltd.
Village: Bhood and Makhnu Majra, Tehsil: Baddi-173205, Diet: Solan. (H.P.), India
For more information contact:
Representative office of Torrent Pharmaceuticals Ltd.:
Moscow 117418 st. Novocheremushkinskaya, 61
Valproic Acid is derived from essential oil valerian officinalis. Sodium valproate is the same valproic acid combined with sodium salt.
Valproic acid is known primarily for its antiepileptic effect. Many clinical researches have proven the effectiveness of the substance in the fight against. Considered vital medicine. Chemical formula— C8H16O2.
Properties of matter
In medicines presented on the shelves of pharmacies, the substance can be found both in the form of acid and in the form sodium salt called sodium valproate. The acid has a liquid consistency, but in combination with sodium hydroxide it forms solid. Easily absorbed by the body. The highest dose of the substance in the blood plasma is observed two hours after administration.
Valproic Acid Formula
In addition to the antiepileptic effect, valproate relaxes skeletal muscles and reduces anxiety and irritability.
They also improve mood and general mental condition patients.
Scope of application
Valproic acid preparations are indicated for use in:
- both generalized and;
- , which occurs when;
- children's tics.
Instructions for use
The specific medication, course of treatment, regimen of use and dosage are prescribed by the attending physician. The daily amount of valproic acid for treatment should be related to age and body weight. Treatment should begin with the lowest possible dosages. As a rule, we are talking about 10-15 mg per kilogram of weight per day.
Further, the dosage can be increased by 5-10 mg per kilogram of body weight per day until the desired therapeutic effect is achieved. The optimal dose of valproic acid is 20-30 mg per kilogram of body weight per day. If a positive effect is not observed and attacks are repeated with the same frequency, then the dose can be increased.
Small children are recommended to be prescribed relatively higher doses of the substance. If valproic acid is prescribed in combination with other drugs, the doses remain approximately the same. An exception is drugs that increase enzymatic activity. In these cases, the dose of valproate should be increased.
If the patient is prescribed more than 40 mg of the substance per kilogram of body weight per day, then it is necessary to periodically take blood tests to determine the concentration of valproic acid in the blood.
The number of doses per day is 2-3 times. The medication should be taken with food, and the medicine should be taken with a sufficient amount of clean water.
Intravenous administration of sodium valproate occurs in an amount of 400-800 mg. The drug is administered dropwise at a dosage of 25 mg per kilogram of body weight for 1-2 days.
The initial dose of the drug is 5-15 mg/kg per day, gradually the dose is increased to 20-30 mg/kg per day. Therefore, the number of tablets taken varies depending on the concentration in them active substance. Usually this is 2-3 tablets per day, taken with meals. The syrup is usually mixed with food or water. The drops can be taken regardless of food intake, the main thing is to dilute it in a sufficient amount of clean water.
For whom is it contraindicated?
Hemorrhagic diathesis is also a contraindication for taking the medication. The drug is also contraindicated in patients suffering from acute or chronic hepatitis, porphyrin disease. In addition, before starting treatment with valproic acid, it is necessary to exclude increased sensitivity To her.
Special instructions and side effects
Special instructions apply to those patients who are treated with other drugs of this pharmacological group. In this case 
Valproic Acid should be introduced into treatment gradually so that the optimal clinical dose is achieved after approximately 2 weeks. After this, slowly stop taking other medications.
When carrying out combined treatment of epilepsy, the load on the liver increases, so during the period of therapy it is necessary to regularly monitor liver function, as well as the picture of peripheral blood and the blood coagulation process.
Given the sedative effect of valproate, during treatment you should be careful when driving vehicles.
Possible adverse reactions:
- mood changes;
- appearance;
- impaired coordination of movements;
- increased;
- fatigue and drowsiness;
- stomach ache;
- weight gain;
- hair loss;
- allergic reaction.
Use in special patients
The use of valproic acid during pregnancy is strictly not recommended as it can cause various congenital anomalies, for example, spina bifida in a newborn.
We also do not recommend taking the drug during breastfeeding, since it is excreted in breast milk in an amount of 1-10%. Use is possible only as a last resort, when the lack of necessary treatment worsens the condition of the fetus. Valproic acid has a strong effect on the liver in children.
TOP 10 drugs valproic acid
The ten most popular valproates:
Doctor review
Epilepsy is one of the most common diseases of the nervous system. It is treated with long-term use of antiepileptic drugs. Valproic acid is one of the best medicines V in this case, which helps suppress or minimize seizures for almost everyone.
Despite the fact that valproic acid is one of the most effective drugs, it has its own list of side effects.
Pregnant women, children and the elderly need to be especially careful. Therefore, the first thing you need to do is see a doctor and consult with him. Only this will help you overcome the disease as effectively as possible. The doctor will conduct a diagnosis, select the drug in the required release form, prescribe the correct dose and monitor your health. Only in this case, treatment of epilepsy with valproate will be as effective and safe as possible.
Sergey Nikolaevich, neurologist
