Encorate Sun Pharma medicine for epilepsy (10 blisters x 10 tablets)

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

Ingredient

Composition information	Content
Sodium valproate	200mg

Uses

Indications

Encorate 200mg drug is indicated in the following cases:

Ceremony of the whole epilepsy, local epilepsy or other epilepsy. Learning

The main effect of Valproate is to inhibit the activity of Gamma Amino Butyric Acid (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 plasma valproic acid is about 40 - 100mg/l (278 - 694micromol/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 Sun Pharma medicine for epilepsy (10 blisters x 10 tablets)

How to use

Take oral use.

Dosage

Adults

Daily starting dose is 600mg divided into several times. Increase 200mg every three days until the seizure control, usually the dose of treatment is in the range of 1000 - 2000mg per day. If this dose is not enough to cut seizures, it is possible to use 2500mg daily.

children> 20kg

The starting dose should be 400mg per day, gradually increasing the dose until the epilepsy is controlled, usually the dose is 20 - 30mg/kg body weight per day. If this dose is not enough to control the seizure, you can use 35mg/kg body weight per day.

Children

The usual dose is 20mg/kg/day, some severe cases may increase the dose but only for cases of controlling valproic acid levels in plasma.

Older people

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

Renal function impairment

It is necessary to reduce the dose. Adjusting the dose should be based on clinical results because based on plasma concentrations may give misleading results. For children taking doses higher than 40mg/kg/day, should carefully monitor biochemical and hematological parameters.

combined treatment

When starting to treat patients who have used other anti -epileptic drugs, the dosage of the drug should be slowly increased to reach the destination dose of about 2 weeks. Some necessary cases may increase 510mg/kg/day when used with anti -epileptic drugs with enzyme activity such as phenytoin, phenobarbital and carbamazepine.

Once the enzyme stopped, Valproate can also maintain the effect of controlling epilepsy at a lower dose. When used simultaneously with Barbiturate, especially if the phenomenon of sedation occurs, the Barbiturate dose should be reduced.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.

What to do when overdose? Overdose with a larger threshold, 10-20 times higher than the maximum concentration of treatment, can inhibit serious central nervous system 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.

In an emergency, call the 115 emergency center immediately or go to the nearest local health station.

What to do when forgetting a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Do not drink twice as prescribed.

Side Effects

When using Encorate 200mg, you may experience unwanted effects (ADR).

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 dangerous, 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.

Instructions on how to handle ADR

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

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

Contraindicated

Encorate drug 200mg is 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 degradation, brain disease or serious epilepsy along with mental retardation.

Should check liver function 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, Italian disorders or awakening, the drug should be stopped.

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 ability to drive and operate machinery

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

Pregnancy

A ratio of birth abnormalities includes facial deformities, neural tube defects and bone deformities, especially the femur in the children of the mothers of mothers with epilepsy that have or unless treated 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 noted to reduce this risk. The dosage used for patients must be re -assessed before pregnancy, the lowest dose and division of the dose because the abnormal pregnancy rate is 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 newborn babies of mothers treated with sodium valproate during pregnancy, a syndrome related to hypoglycemia in the 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 assessment tests, fibrinogen levels and blood clotting.

Breastfeeding period

does not seem to have contraindicated use of Valproate during breastfeeding due to Valproic acid concentration found in breast milk very low, only about 1-2% of the total 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.

Special plasma phenytoin concentrations, especially free forms, 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

Store less than 30 ° C, in a cool dry place, avoid light.

Expiry date: 36 months from the date of manufacture. Do not use overdue drugs stated on the packaging.

Stay out of reach of children.

Read the user manual carefully before use.

If you need more information, please consult your doctor.

This drug is only used as prescribed by a doctor.

Manufacturer: Sun Pharmaceutical Industries Ltd.

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