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Depakin 500 Mg 40 Tablets ingredient valproic acid

FORMULA In one ml: Sodium valproate 500 mg

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PHARMACOLOGICAL CHARACTERISTICS Pharmacodynamic Properties: Valproate mainly forms on the central nervous system. It has anticonvulsant effect in many different seizure types. Experimental and clinical studies on valproate suggest two types of anticonvulsant effect. The first is the direct pharmacological effect of valproate due to plasma and brain concentrations. The second is the indirect effect, probably due to the metabolites of valproate in the brain, changes in neurotransmitters, or direct membrane effects. This hypothesis was raised due to increased concentrations of gamma-aminobutyric acid (GABA), usually after valproate use. As a result of the slow wave sleep, the continuity of the sleep intermediate phase decreases with valproate.

Pharmacokinetic Properties: - The bioavailability of sodium valproate after oral administration is close to 100%. - It is rapidly absorbed after oral administration and fixed plasma density is reached in 3-4 days. - The volume of distribution is mainly limited to blood and extracellular fluid. Valproate passes to BOS and brain. - Valproate binds highly to plasma proteins; This binding is dose-dependent and saturable. The minimum serum concentration required for the therapeutic effect is 40-50 mg / l and the range is between 40 mg / l and 100 mg / l. Dose reduction at levels above 200 mg / l is required. - In contrast to other antiepileptics, valproate does not induce cytochrome P450 enzymes and does not increase the metabolism of its own and other drugs (e. - Sodium valproate is metabolized by glucuronidation and beta-oxidation and is mainly excreted in urine (3% unchanged).

CSI: 03.10.2005 (Updated version: 10) SBA approval date: 15.10.2009 SB Demand: 05.04.2006 & 24.02.2009 20.01.2009SB circular


- The half-life of about 15-17 hours. - The valproate molecule can be dialyzed, but hemodialysis only affects the free form of valproate in the blood (about 10%).

INDICATIONS Generalized or partial epilepsies: - Primary generalized seizures: Petit goods, grand goods, myoclonic epilepsies, - Partial seizures: Simple or complex seizures, - Secondary generalized seizures, - Mixed seizures. Sodium valproate may be a viable option for women of childbearing potential, provided that an informed choice is made on the basis of the patient's careful consideration of all relevant elements with the treating physician. (see Warnings and Pregnancy).

CONTRAINDICATIONS - Patientsvalproate, divalproate, valpromide, or excipients in the drug

with a history of hypersensitivity to- Acute hepatitis - Chronic hepatitis - A history of severe hepatitis in the individual or family, particularly drug-induced (Hepatitis P) - Hepatic porphyrias It is not recommended to use the drug in combination with lamotrigine.

WARNINGS / PRECAUTIONS Warnings: After starting treatment with an antiepileptic drug, it can rarely be seen that the frequency of the crisis increases or a new type of crisis occurs regardless of the spontaneous fluctuations observed in some epileptic diseases. In treatment with valproate, these conditions are mainly based on another antiepileptic drug or a pharmacokinetic interaction (see mel Drug Interactions bkz), a toxicity condition (hepatopathy or encephalopathy: see ie Cautions olarak and see av Adverse Effects / Advers Val). Effects ileri) or overdose.

Since this medicinal product is converted to valproic acid in the body, it should not be used in combination with other medicinal products (eg divalproat, valpromide) that have been transformed in the same way to prevent a possible valproic acid overdose.

Hepatic Failure (Hepatopathy): Conditions of Condition: Severe cases of hepatic impairment, which may also result in fatality, have been rarely reported.

CSI: 03.10.2005 (Updated version: 10) SB approval date: 15.10.2009 SB demand: 05.04.2006 & 24.02.2009 SB circulars 20.01.2009