Composition, form of production and packaging
Tablets of prolonged action, covered with a cover of white color, round, biconcave.
1 tab.
sodium valproate 200 mg
valproic acid 87 mg,
which corresponds to the total content of sodium valproate 300 mg
Excipients: silicon colloidal dioxide, hydroxypropylmethylcellulose, ethylcellulose, silicon dioxide hydrate, sodium saccharin, glycerin, titanium dioxide, eudragit E-100, eudragit NE-30D, polyethylene glycol 1500, talc.
10 pieces. - Strips (10) - packs of cardboard.
The tablets of the prolonged action, covered with a cover of white color, oblong, with a notch on both sides.
1 tab.
sodium valproate 333 mg
valproic acid 145 mg,
which corresponds to the total sodium content of valproate 500 mg
Excipients: silicon colloidal dioxide, hydroxypropylmethylcellulose, ethylcellulose, silicon dioxide hydrate, sodium saccharin, glycerin, titanium dioxide, eudragit E-100, eudragit NE-30D, polyethylene glycol 1500, talc.
10 pieces. - Strips (10) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
The description of the drug was approved by the manufacturer for the 2006 print edition.
PHARMACHOLOGIC EFFECT
Anticonvulsant drug. Sodium valproate increases the content of gamma-aminobutyric acid (GABA) in the brain, which increases the GABA content in postsynaptic neurons accordingly. In addition, sodium valproate affects the transfer of potassium ions through neuronal membranes. As a result, suppression of development occurs, as well as the spread of epileptic excitation along neurons.
Sodium valproate has anticonvulsant activity in various types of epilepsy in humans. The drug does not have significant hypnotic and sedative effects, nor does it have a depressant effect on the respiratory center. Sodium valproate does not have a negative effect on blood pressure, heart rate, kidney function and body temperature.
PHARMACOKINETICS
Suction
After intake of controlled release tablets, Cmax in plasma is reached within 2-8 hours. The bioavailability of the drug is about 100%.
Therapeutic efficacy manifests itself when the concentration of valproic acid in the blood plasma is 40-100 mg / l. At the same time, the pharmacological and therapeutic effects of this controlled release drug do not always depend on its plasma concentration.
Distribution
Binding to plasma proteins is 80-90%.
V d is 0.2 l / kg.
Metabolism and excretion
Metabolized in the liver and excreted in the urine. Pre-systemic metabolism is not noted. T 1/2 is about 8-20 hours.
Pharmacokinetics in special clinical cases
In children, T 1/2 decreases.
INDICATIONS
Treatment of generalized or partial epilepsy, especially with the following types of seizures:
- Absences;
- myoclonic;
- tonic-clonic;
- Atonic.
Partial epilepsy:
- simple or combined seizures;
- Secondary generalized seizures.
Specific syndromes (Vesta, Lennox-Gastaut).
DOSING MODE
The dosage regimen is selected individually depending on the age and body weight of the patient.
For adults, the initial dose is 600 mg / day, followed by a 200 mg dose increase every 3 days until the optimal effect is achieved. Multiplicity of admission - 1-2 times / day. The maximum recommended dose is 1-2 g / day.
Tablets should be swallowed whole, washed down with a small amount of water.
In elderly patients, the mode of dosing Valparin XP is similar to the dosing regimen in adults and is selected individually.
For children weighing more than 20 kg, the initial dose is 400 mg / day. The dose should be increased gradually to achieve optimal values ​​- usually 20-30 mg / kg / day in 1 or 2 doses.
Children weighing up to 20 kg should not use Valparin XP.
SIDE EFFECT
On the part of the digestive system: rarely - nausea, vomiting, diarrhea and / or constipation, hepatitis, pancreatitis.
Allergic reactions: rarely - skin rash, itching, photosensitivity, erythema multiforme, Stevens-Johnson syndrome.
From the side of the central nervous system: rarely - ataxia, tremor, impaired consciousness, coma.
On the part of the reproductive system: rarely - a violation of the menstrual cycle, secondary amenorrhea.
On the part of the hematopoiesis system: rarely - anemia, thrombocytopenia, neutropenia, leukopenia, decrease in fibrinogen content, inhibition of platelet aggregation.
Other: 2-12% - hair loss; rarely - weight gain, hyperammonia, creatinine.
CONTRAINDICATIONS
- severe disorders of the pancreas;
- Acute or chronic hepatitis, cases of active hepatitis in a family history (primarily of medicinal origin);
- porphyria;
- thrombocytopenia;
- Pregnancy;
- lactation (breastfeeding);
- children's age till 3 years;
- Hypersensitivity to valproic acid and other components of the drug.
PREGNANCY AND LACTATION
The purpose of the drug during pregnancy is possible only if the intended benefit for the mother exceeds the potential risk to the fetus. In the case of taking the drug during pregnancy, special prenatal monitoring of the fetus is mandatory.
The use of the drug during breast-feeding is not recommended.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Contraindicated in acute or chronic hepatitis, cases of active hepatitis in a family history (primarily drug origin
APPLICATION FOR CHILDREN
The drug is contraindicated for children under 3 years.
For children weighing more than 20 kg, the initial dose is 400 mg / day. The dose should be increased gradually to achieve optimal values ​​- usually 20-30 mg / kg / day in 1 or 2 doses.
Children weighing up to 20 kg should not use Valparin XP.
APPLICATION IN ELDERLY PATIENTS
In elderly patients, the mode of dosing Valparin XP is similar to the dosing regimen in adults and is selected individually.
SPECIAL INSTRUCTIONS
It is necessary to regularly monitor the activity of transaminases, bilirubin, blood platelets, amylase (every 3 months).
Valproic acid inhibits platelet aggregation, which increases the risk of prolonged clotting time in bleeding. One should take into account the possibility of developing complications associated with bleeding in the postoperative period in patients receiving sodium valproate. With prolonged intake of sodium valproate, the development of spontaneous hematomas and bleeding may occur. In this case, stop taking the medication immediately.
Sodium valproate can cause drug pancreatitis and impaired liver function (usually in the first 6 months of use). In this regard, it is necessary during the first 23 months of treatment to monitor the pancreas, carry out liver tests, monitor the level of prothrombin. Violation of liver function, liver failure on the background of sodium therapy with valproate is sometimes observed in children with epilepsy and associated metabolic and degenerative diseases, organic pathology of the brain tissue and delayed mental development. If symptoms such as severe weakness, lethargic state, swelling, vomiting and jaundice occur, discontinue use immediately.
Impact on the ability to drive vehicles and manage mechanisms
The patient should be careful when working with the mechanisms, because the drug reduces the ability to concentrate.
OVERDOSE
There have been reports of rare cases of accidental or deliberate drug overdose.
Symptoms: nausea, vomiting, dizziness, diarrhea, respiratory depression, hyporeflexia, coma.
Treatment: gastric lavage, reception of activated charcoal. If necessary - inpatient treatment with symptomatic therapy, hemodialysis.
DRUG INTERACTION
Sodium valproate enhances the effect of antipsychotics, anticonvulsants and antidepressants. Unlike other anticonvulsants, sodium valproate does not induce the induction of liver enzymes, so it does not reduce the effectiveness of oral contraceptives.
With the combined use of sodium valproate and warfarin, the percentage of binding to plasma proteins of the latter decreases.
Sodium valproate changes the plasma concentrations of phenytoin and lamotrigine. In combination with anticoagulants and derivatives of acetylsalicylic acid, antiaggregant effect is enhanced.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored at a temperature below 30 В° C in a place protected from moisture, inaccessible to children.
Shelf life - 3 years.
Conditions of leave from pharmacies
The drug is released by prescription.
