Encorate 300 NSUN Pharma medicine for epilepsy (5 blisters x 10 tablets)

Dosage form Box of 5 blisters x 10 tablets
Specifications Sodium valproate

Ingredient

Composition information	Content
Sodium valproate	300mg

Uses

Indications

Encorate drug indications for treatment in the following cases:

Treatment of total epilepsy, local epilepsy or other epilepsy.

For women of reproductive age, the drug should only be used for severe cases or have resisted other drugs.

Prevent high fever in convulsions in children, mechanical mechanics in children.

Treatment and prophylaxis in bipolar emotional disorders.

Pharmacy

The main effect of Valproate is to inhibit the activity of gammaamino butyricacid (GABA) by impacting GABA's synthesis and metabolism.

pharmacokinetic

The semi -cancellation time of sodium valproate is in the range of 8-20 hours. In children the half -life is usually shorter. The treatment effect is achieved when the concentration of Valproic acid in plasma is about 40 - 100mg/l (278 - 694microml/l). This depends on the object and the used drug. About 6 - 15% of the concentration of the drug in plasma is free.

Before taking Encorate 300 NSUN Pharma medicine for epilepsy (5 blisters x 10 tablets)

How to use

Oral drugs.

Dosage

Adults

The daily daily dip dosage is 600mg divided into several times.

The starting dose should be 400mg per day, gradually increasing the dose until the seizure control, usually the dose is 20 - 30mg/kg of body every day.

The usual dose is 20mg/kg/day; Some severe cases may increase the dose, but only for cases of control of Valproic acid levels in plasma.

Although Valproate's pharmacokinetics change in the elderly, clinical symptoms are limited. Evaluation of dosage should be based on seizure control results.

It is necessary to reduce the dose. Adjusting the dose should be based on clinical results because based on plasma concentrations can give misleading results.

When starting to treat patients who have used other anti -epileptic drugs, the dosage of the drug should be slowly increased to achieve the destination dose of about 2 weeks. Men induction drugs, valproate can also maintain the effect of controlling epilepsy at lower doses. When used simultaneously with Barbiturate, especially if the sedative occurs, the Barbiturate dose should be reduced. Overdose with a larger threshold, 10-20 times higher than the maximum concentration of treatment, can inhibit the central nervous system seriously and respiratory failure.

However, diverse symptoms and reports have recorded seizures occurring at very high plasma concentrations. Many deaths due to overdose use. Treatment in hospitals includes anti -vomiting, stomach rinsing, ventilation and other supportive therapies. Dialysis and blood transfusion is also used for treatment. Naloxone veins are sometimes used in combination with oral activated carbon.

What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.

Side Effects

When using Encorate often has unwanted effects (ADR) such as:

Liver: Demonstration of fatal liver function has been recorded. Serious toxic symptoms in the liver can manifest such as loss of consciousness, uneasiness, weakness, drowsiness, sleeping, edema, anorexia, vomiting, abdominal pain, jaundice.

Nervous system: That, trembling, sedation, drowsiness, confusion, stunning, hallucinations or convulsions. Some rare cases such as encephalitis, coma and dementia have been recovered related to the recorded brain atrophy. Patients may be aggressive, agitated or destroyed. Loss of recovery or non -recovery.

Gastrointestinal gastrointestinal: Increase appetite, gain weight, stimulate the stomach in the early stages of treatment but not often. There may be nausea.

Dermatology: Bright hair loss. Some exceptions such as poisoned skin necrosis, Steven Johnson syndrome, erythema. Signs of immunosuppressive disorders are also recorded, although rare, so careful monitoring of drugs should be monitored in patients with lupus erythematosus. Vasculitis sometimes also occurs.

Hematology: People have recorded rare cases such as reducing blood cells, leukemia. Reducing blood fibrinogen can also occur. Other side effects include hyper ammonia, edema, pancreatitis, amenorrhea, inflammation of the side, fanconi syndrome.

Notice to doctors the unwanted effects when using the drug.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

Encorate drugs contraindicated in the following cases:

Acute liver disease or a history of serious liver function impairment, especially cases of drugs caused by drugs, porphyrin metabolism disorders.

Sensitive to the ingredients of the drug.

Precautions when used

Valproate is excreted mainly through the kidney, partly in the form of ceton. This can produce false positive results in urine tests of diabetes.

impaired liver function, including the case of liver failure, leading to death has been recorded in some patients using Valproic acid or sodium valproate. The object is susceptible to this risk of children, especially cases under 3 years of age or cases of congenital disease, metabolic disorders or degraded disorders, brain disease or serious seizures along with mental retardation. Liver function should be checked regularly before treatment and periodically every 6 months, especially in patients with many risks. Stop treatment if prothrombin time lasts abnormally, especially when occurring with other disorders.

If the ammonia concentration increases with clinical signs such as vomiting, ventricular, conscious disorders, should stop the drug.

There have been reports on cases of pancreatitis, rarely causing death, usually occurring within the first 6 months of treatment. Patients with acute abdominal pain should be taken to assess pancreatic enzymes including blood amylase tests, if the concentration increases due to drugs, they should stop treatment.

Valproic acid inhibits the secondary phase of platelet aggregation process that prolongs the bleeding time and reduces platelets. The above effects are often related to the dose and recovery.

The effect of the drug on the ability to drive and operate machinery

Persons who often drive or operate machinery should use drugs?

The drug can cause drowsiness. Therefore, patients are driving or operating machinery should be cautious when taking this drug.

Use drugs for women during pregnancy and lactation

Pregnant women

It is recognized that an increase in congenital abnormalities including facial deformities, neural tube defects and bone deformities, especially the femur in the children of the mothers of mothers with epilepsy with or without treatment with sodium valproate.

The rate of neural tube defects of children of women who are treated with valproate in the first 3 months of pregnancy under the region is estimated to be 1-2%. Folate supplementation is recognized as helping to reduce this risk.

Dosage used for patients must be re -evaluated before pregnancy, lowest doses and dosage breakdown because abnormal pregnancy rates are often associated with high doses. Pregnant women should be carefully monitored the development of pregnancy, women of reproductive age should be notified of the risk and benefits of long -term epilepsy treatment during pregnancy. Rarely occurs bleeding syndrome on newborns of mothers treated with sodium valproate during pregnancy, a syndrome related to fibrin reduction in blood due to reduced coagulation factors. Plasma fibrin disorders are also recorded and may cause death. However, it should be noted that phenobarbital and other enzyme drugs can also cause bleeding syndrome.

Should do platelet evaluation tests, blood fibrinogen levels and blood clotting status.

breastfeeding women

There is no contraindication to use Valproate during breastfeeding due to the low -level Valproic acid level found in breast milk very low, only about 1-2% of the total number of plasma concentrations. The decision allows patients to breastfeed or not should rely on all known data.

Medicinal interaction

Valproate less enzyme than other anti -epileptic drugs and the effects of birth control pills do not seem to be affected. Treatment in combination with valproate can affect the effects of some drugs so carefully monitoring is essential, especially in the early stages of combined therapy.

The effect of sedatives, Monoamine inhibitors, Anti -Depression and Benzodiazepine may increase.

Plasma concentrations of phenobarbital and primidone may increase and the sedative effect may occur, then a rapid dose should be reduced quickly. Clinical monitoring carefully during the first two weeks of combined therapy. Phenytoin concentration in plasma especially free form can also increase. The toxic effect of carbamazepine may increase. Adjust the appropriate dose.

The metabolism of lamotrigine may be inhibited and the half -life is further canceled so the dose adjustment is necessary. Treatment drugs can increase the risk of rash.

Plasma zidovudine concentration may increase, resulting in zidovudine poisoning effect.

Mount with protein of warfarin and anticoagulants can decrease. Prothrombin should be followed carefully. Anti -epilepsy drugs can reduce the level of Valproate in plasma.

cimetidine and erythromycin can cause a semi -cancellation time and reduce valproate clearance due to metabolism in the liver decreases. Mefloquine increases the metabolism of valproic acid and can cause seizures.

cholestyramine reduces the absorption of valproate.

Salicylate like aspirin can replace the valproate plasma bond position. Felbamate increases the plasma valproate levels.

Storage

Leave a cool place, avoid light, temperature below 30⁰C.

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