Depakine Chrono 500mg Sanofi Treatment (30 tablets)

Dosage form Box of 30 tablets
Specifications Sodium valproate, Valproic acid
Ingredient Epilepsy, bipolar emotional disorders

Ingredient

Composition information	Content
Sodium valproate	333mg
Valproic acid	145mg

Uses

Indications

Depakine 500mg is indicated in the following cases:

Corruption treatment: Treatment of various epilepsy in adults and children over 6 years old and weighing over 20kg.

Renable treatment: Treatment and prevention of revival in bipolar emotional disorders.

Pharmacokology

Valproat causes the main pharmacological effect on the central nervous system.

Anti -seizure effects are used to treat seizures in animals and epilepsy in humans.

Clinical and experimental studies on Valproat have hypothesized about two types of anti -seizures. The first impact is the direct pharmacological impact associated with the plasma and brain levels in the brain. The second impact proved to be indirectly and perhaps related to Valproot's metabolites that still exist in the brain or with changes in neurotransmitters or direct effects on the cell membrane. The most widely accepted hypothesis is the hypothesis of gamma-aminobutyric acid (GABA) and this concentration increases after using Valproat.

Valproot reduces the time of intermediaries of sleep, while increasing slow sleep.

pharmacokinetics

Different pharmacokinetics studies about Valproat shows the following:

Valproat's bioavailability, after drinking, reaches nearly 100%.

The drug distribution is mainly into the bloodstream and quickly exchanged with cellular fluid. Valproat is also distributed into the cerebrospinal fluid and into the brain, the concentration of valproate in cerebrospinal fluid is closely related to the concentration of free drugs in serum.

The half -life is 15 - 17 hours.

Usually the minimum concentration of serum needed to achieve the effectiveness of treatment is 40 - 50mg/l, with amplitude between 40 and 100mg/l. If it really needs to achieve a higher level of drug concentration, the expected benefits must be superior to the risk of adultery, especially the adverse effects depending on the dose. However, the concentrations maintained higher than 150 mg/l require a dose reduction.

Stable plasma concentrations achieved within 3-4 days.

Valproat is strongly connected to plasma proteins. The cohesion with protein depends on the dose and saturation level.

Valproat is excreted mainly in urine after metabolism by glucuronide and beta-oxidation.

Valproat may be separated, but the hemorrhage only affects the freedom of Valproat (about 10%).

Contrasting with other epilepsy medications, Valproat does not touch the enzymes of the Cytochrome P450 metabolism system, so this drug does not promote the transformation of itself, or other drugs such as estrogen, progestogen and oral anticoagulants.

Comparison with the type of stomach acid resistance of sodium valproat, the type of release is prolonged with the equivalent dose with the following characteristics:

No potential absorption time.

Prolonged absorption.

Biology is the same.

Free medication concentration and peak concentration in plasma are also lower (CMAX decreases about 25% but has a relatively high concentration level from the 4th hour until the 14th after taking the drug), the maximum loss of the maximum concentration in plasma helps to achieve a stable and more uniform Valproic acid concentration during 24 hours: after using 2 times/day, the size of the drug has been reduced in the size of the plasma. Half.

Dosage and plasma concentrations (total amount of drug and free drug concentration) have a more linear correlation.

Before taking Depakine Chrono 500mg Sanofi Treatment (30 tablets)

How to use

Take oral use. Swallowing the tablet, not crushed or chewed.

Take the drug 1-2 times/day, preferably during meals.

If your disease is well controlled by treatment, your doctor may prescribe 1 time/day.

Dosage

epilepsy

is used with adults and children over 6 years old and weighs over 20kg.

This form of preparation is not suitable for children under 6 years old because of the risk of choking when taking the drug. Currently there are more appropriate types of drugs for children.

Daily dose is decided by the doctor and appointed for each individual. Use 1-2 times/day, preferably during meals.

If your disease is well controlled by treatment, your doctor may prescribe 1 time/day.

Adults:

Dosage should start with 600 mg/day and then gradually increase depakine 200mg every 3 days until the disease controls. This is usually within the dose from 1000 mg to 2000 mg, which is from 20 - 30 mg/kg/day. Cases that do not control the disease with this dose, can increase the dosage up to 2500 mg/day.

Take the medication regularly every day, do not change or stop using the drug suddenly without notice to the doctor.

Children weigh over 20kg:

The starting dose should be 400 mg/day (regardless of weight) and then gradually increase until the control of the disease; This is usually
in the dose range of 20 - 30 mg/kg/day.

Cases that do not control the disease with this dose, may increase the dose of up to 35 mg/kg/day.

Children weighs less than 20kg:

DEAP DEADKINE® CHRONO preparation form is not suitable for this patient group, due to the size of the pill as well as the need to adjust the dose. There are other forms of drugs (for example, oral solution) more appropriate.

Elderly:

Dose should be determined based on the control of seizures.

Daily dose is determined depending on the age and weight of the patient; However, it is necessary to take into account the distinct sensitivity of each person for Valproat.

Heart

The recommended starting dose is 20 mg/kg/day. Should quickly increase the dose to achieve the desired clinical effect with the lowest dose. The maintenance dose is recommended in the treatment of bipolar emotional disorders from 1000mg to 2000mg/day. In exceptions, the dose may be increased but not exceeding 3000mg/day.

Dosage should be adjusted depending on the clinical response of each patient. Preventive treatment should be established according to the response of each patient with the lowest dose level. Take medication regularly every day; Do not change or stop taking the drug suddenly without notice to the doctor.

Girls, adolescents, women of reproductive age and pregnant women:

Valproat needs to start treatment and closely monitored by the doctor who has experience in the treatment of epilepsy or bipolar disorder.

Should only use this drug when other treatments are ineffective or the patient is intolerant. Scaling
with benefits - the risk of the drug should be carefully evaluated in each regular examination for patients. It is best to prescribe valproat as a single therapy and use the lowest dose effectively. If possible, the release should be used for a long time
to avoid increasing the peak concentration in plasma. The daily dose should be divided at least into 2 single doses.

Treatment time

Must comply with the dose and therapeutic time, specifically, do not stop the treatment without consulting the doctor. Completely follow the doctor's prescription.

The risk of stopping drugs

Discontinuation of the drug must be done slowly. The consequences of sudden stop treatment (or dose reduction in large quantities) may re -occur epilepsy.

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?

Clinical manifestations of acute poisoning due to overdose are often quiet coma, can be in a deep coma, accompanied by reducing muscle tone, reducing reflexes, pupils, automatic respiratory loss and metabolic acidosis. Some cases of increased intracranial pressure related to brain edema have been described. Such poisoning cases generally have favorable prognosis. However, some deaths have been reported.

The measures to be done in the hospital are to make the stomach drum if needed, maintain the urinary tract effectively and monitor the respiratory - cardiovascular function. In very serious cases, if necessary, dialysis can be performed.

What to do when forgetting a dose?

If you find a short time before you have to take the next dose, do not use double the dose.

If you forget to use many consecutive doses, please contact the treating doctor immediately.

Side Effects

When using Depakine 500mg, you may experience unwanted effects (ADR).

Very rare cases of liver or pancreatic damage, may be serious.

Nausea, vomiting, stomach pain, diarrhea (at the beginning of the tri), fleeting hair loss, gently shaking hands, drowsiness, these side effects are only temporary but sometimes the doctor needs to adjust the dose.

Menstrual disorders, weight gain. Disorders of consciousness separately or combined with the outbreak of seizures, headaches.

Sild bleeding (nose, gums ...). Must quickly inform the doctor to get hematological tests, as there may be blood disorders.

Bloody abnormalities: thrombocytopenia (sometimes manifested as nose bleeding or mild gums), white blood cells (sometimes fever), red blood cells (sometimes expression such as shortness of breath or unusually pale) or low fibrinogen levels. Extend bleeding time, change the size of red blood cells and increase the concentration of blood ammonia may appear. Quickly inform the doctor the abnormal results of the blood test.

Reducing blood sodium levels (sometimes confused).

Rarely encounter cases of tremor, hard, cramped, difficult to perform movements or abnormal movements.

Difficulties in coordination.

Very rarely encounter cases of gradual cognitive cognitive disorders (the memory or attention, confusion, loss of orientation) requires medical examination.

Particularly dangerous when encountering cases of kidney damage and deafness.

Environment (urine flows out especially at night) and cannot help urinating.

Appears the spread of the body. Especially, this case is accompanied by blistering, fever, oral oral organs, need to go to the emergency department immediately.

Very rarely encounter cases of edema (swelling of the legs and feet).

Allergic reactions such as fever, decrease in general condition, skin rash, liver or kidney damage, increased number of white blood cells (eosinophilia). If these signs appear, need to report immediately to the doctor.

The face and neck are suddenly swollen due to allergies. If these signs appear, need to report immediately to the doctor.

Instructions for handling ADR

If any side effects become serious, or if you record any side effects that are not stated in the prescription of this drug, notify your doctor or pharmacist.

Warnings

Before using Depakine 500mg, you need to read the instructions carefully and refer to the information below.

Contraindications

Depakine 500mg is not used in the following cases:

Hepatitis, like hepatitis.

Personal history or families with severe liver disease, especially when related to drugs.

allergies to Valproat, Divalproat, Valpromide or one of the ingredients of the drug.

Porphyrin metabolic disorders (genetic diseases associated with the abnormal creation of pigments called porphyrin).

Used in combination with Mefloquine (Medication to treat malaria), St. John's (see drug interaction).

Precautions when using

Special note

When starting treatment, the doctor will check to make sure you are not pregnant and will prescribe birth control pills if needed (see pregnancy and lactation period).

When starting to treat, the frequency of disease increases or occurring attacks with other categories: if any, immediately must ask the doctor's treatment.

Very rarely occur, but Depakine 500mg can cause liver or pancreatic damage to the patient. This can happen, especially in the first 6 months of treatment.

report immediately to the doctor when the following signs appear:

Sudden fatigue, anorexia, exhaustion, sleeping chicken.

vomiting many times, epigastric pain.

Reappearing seizures, despite being properly treated.

The treatment doctor will make the necessary decision or give you blood tests or stop or adjust treatment.

It is important:

never stop treatment without a doctor.

Compliance with the prescription dose.

Must be monitored by the doctor regularly, the doctor may ask you to do blood tests to monitor the liver function, especially in the first 6 months of treatment.

inform the doctor that all the drugs you are taking, even the drugs only occasionally use or non -prescribing drugs.

There have been a few cases of patients who have thoughts on self -destruction or suicide when taking anti -epileptic drugs such as Depakine 500mg. If you also have such thoughts, immediately have to see a treating doctor.

Other caution

Children must avoid taking aspirin -containing drugs during treatment.

inform the doctor if you have kidney disease.

When you need surgery, notify the surgeon and anesthetist know you are taking this medication.

Because the drug can cause weight gain, diet measures along with weight monitoring.

The ability to drive and operate machinery

If your disease is not controlled, that is, if you continue to have seizures, it is dangerous when you drive or operate machines that are likely to be dangerous. In addition, this drug can cause drowsiness, especially when used with drugs that affect the central nervous system.

Pregnancy

should not use Depakine 500mg during pregnancy or for women who are reproductive age without contraception. If this medication is used for pregnant women, the drug can cause defects to the fetus, infant coagulation disorders, and developmental disorders or universal disorders in children.

Inform the doctor if you want to get pregnant before stopping the medication, which allows your doctor to adjust the dose of treatment and plan a special plan to monitor your pregnancy.

If you find you pregnant during the time you are taking this medication, you should immediately notify the doctor for adjustment to suit your condition.

In all cases you can never stop taking the medication without being allowed by your doctor.

Breastfeeding period

Drug interaction

Do not use Mefloquine (Malaria Treatment) and St. John's grass during the use of this drug (see contraindications).

Avoid using Lamotrigine (epilepsy medicine) during treatment with Depakine 500mg.

inform the doctor that all the medications you or your child are using or just used, including those without prescription medications.

Storage

Leave the medicine out of children's vision and reach.

Do not take the drug over the shelf life with the outside of the drug box. Store drugs at temperatures below 30 ° C and avoid moisture.

Do not throw medicine to wastewater or family trash. Ask the pharmacist how to cancel unused drugs, this will help protect the environment.

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