Valparin XP sustained release pills 500mg, 30pcs

Composition

of 1 tab. sodium valproate 333 mg

valproic acid 145 mg which corresponds to a total sodium valproate content of 500 mg

Auxiliary substances:

colloidal silicon dioxide,

hydroxypropylmethylcellulose,

ethylcellulose,

silicon dioxide hydrate,

sodium saccharin,

glycerin,

titanium dioxide,

eudragite E-100,

eudragite NE-30D,

polyethylene glycol 1500,

talc.

Pharmacological action

Sodium valproate has anticonvulsant activity in various types of epilepsy in humans. The drug does not have pronounced hypnotic and sedative effects, and also does not have a depressing effect on the respiratory center. Sodium valproate has no negative effect on blood pressure, heart rate, kidney function and body temperature.

Sodium valproate increases the content of gamma-aminobutyric acid (GABA) in the brain, which accordingly increases the content of GABA in postsynaptic neurons. In addition, sodium valproate affects the transport of potassium ions across the membranes of neurons. As a result, there is a suppression of the development, as well as the spread of epileptic arousal through neurons.

Pharmacokinetics

 Suction

After oral use of controlled-release tablets, Cmax in plasma is reached within 2-8 hours. Bioavailability of the drug is about 100%.

Therapeutic effectiveness is shown when the concentration of valproic acid in blood plasma is 40-100 mg/l. 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%.

Vd is 0.2 l/kg.

Metabolism and elimination

It is metabolized in the liver and excreted in the urine. Presystemic metabolism is not observed. T1 / 2 is approximately 8-20 hours.

Pharmacokinetics in special clinical cases

In children, T1 / 2 decreases.

Indications

Treatment of generalized or partial epilepsy, especially in the following types of seizures:

• absences;
• myoclonic;
• tonic-clonic;
• atonic.

Partial epilepsy:

• simple or combined seizures;
• secondary generalized seizures.

Specific syndromes (West, Lennox-Gastaut).

Use during pregnancy and lactation

Prescribing the drug during pregnancy is possible only if the intended benefit to the mother exceeds the potential risk to the fetus. In the case of taking the drug during pregnancy, it is mandatory to conduct specialized prenatal monitoring of the fetus.

 The use of the drug during breastfeeding is not recommended.

Use in children

 The drug is contraindicated in children under 3 years of age.

For children weighing more than 20 kg, the initial dose is 400 mg / day. The dose should be increased gradually until optimal values are reached-usually 20-30 mg / kg / day in 1 or 2 doses.

Valparin XP should not be used in children weighing less than 20 kg.

Contraindications

• • severe pancreatic dysfunction;
  • acute or chronic hepatitis, cases of active hepatitis in the family history (primarily of drug origin);
  • porphyria;
  • thrombocytopenia;
  • pregnancy;
  • lactation (breastfeeding);
  • children under 3 years of age;
  • hypersensitivity to valproic acid and other components of the drug.

 It is contraindicated in acute or chronic hepatitis, cases of active hepatitis in the family history (primarily of drug origin

In elderly patients), the dosage regimen of Valparin XP is similar to the dosage regimen in adults and is selected individually.

Side effects

From the digestive system:  rarely – nausea, vomiting, diarrhea and / or constipation, hepatitis, pancreatitis.

Allergic reactions:  rarely – skin rash, pruritus, photosensitization, erythema multiforme, Stevens-Johnson syndrome.

From the central nervous system:  rarely – ataxia, tremor, impaired consciousness, coma.

From the side of the reproductive system:  rarely-violation of the menstrual cycle, secondary amenorrhea.

From the hematopoietic system:  rarely-anemia, thrombocytopenia, neutropenia, leukopenia, decreased fibrinogen content, inhibition of platelet aggregation.

Other services:  2-12% – hair loss; rarely-weight gain, hyperammonemia, creatininemia.

Interaction

Sodium valproate enhances the effect of antipsychotic drugs, anticonvulsants and antidepressants. Unlike other anticonvulsants, sodium valproate does not induce 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 acetylsalicylic acid derivatives, the antiplatelet effect is enhanced.

How to take, course of use and dosage

The dosage regimen is selected individually depending on the patient’s age and body weight.

For adults, the initial dose is 600 mg / day, followed by increasing the dose by 200 mg every 3 days until optimal effect is achieved. The frequency of reception is 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 dosage regimen of Valparin XP is similar to the dosage 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 until optimal values are reached-usually 20-30 mg / kg / day in 1 or 2 doses.

Valparin XP should not be used in children weighing less than 20 kg.

Overdose

Rare cases of accidental or intentional overdose of the drug have been reported.

Symptoms:  nausea, vomiting, dizziness, diarrhea, respiratory depression, hyporeflexia, coma.

Treatment:  gastric lavage, taking activated charcoal. If necessary – inpatient treatment with symptomatic therapy, hemodialysis.

Special instructions

It is necessary to regularly monitor the activity of transaminases, bilirubin, blood platelets, and amylase (every 3 months).

Valproic acid inhibits platelet aggregation, which increases the risk of increased blood clotting time during bleeding. Consideration should be given to the possibility of postoperative bleeding complications in patients receiving sodium valproate. With prolonged use of sodium valproate, spontaneous hematomas and bleeding may develop. In this case, you should immediately stop taking the drug.

Sodium valproate can cause drug-induced pancreatitis and impaired liver function (usually in the first 6 months of use). In this regard, it is necessary to monitor the condition of the pancreas, conduct liver tests, and monitor the level of prothrombin during the first 23 months of treatment. Impaired liver function, liver failure on the background of sodium valproate therapy are sometimes observed in children with epilepsy and combined metabolic and degenerative diseases, organic pathology of brain tissue and delayed mental development. If symptoms such as severe weakness, lethargy, swelling, vomiting and jaundice occur, the drug should be discontinued immediately.

Influence on the ability to drive motor vehicles and manage mechanisms

The patient should be careful when working with mechanisms, because the drug reduces the ability to concentrate attention.

Form of production

Tablets

Storage conditions

In a dry place, at a temperature not exceeding 30 °C

Shelf life

3 years

Active ingredient

Valproic Acid

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Description

For adults as directed by your doctor

Indications

Epilepsy