Depakine 200mg/ml Sanofi solution (40ml)

Dosage form Box x 40ml
Specifications Sodium valproate
Ingredient Epilepsy, bipolar emotional disorders

Ingredient

Composition information	Content
Sodium valproate	200mg/ml

Uses

Indications

Depakine 200mg/ml of water is indicated in the following cases:

Treatment of different epilepsy in adults and children.

Pharmacokology

Valproat causes the main pharmacological effects on the central nervous system. Anti -seizures are used to treat animal seizures and epilepsy in humans.

Clinical and laboratory studies on Valproat suggested two types of anti -seizures. The first is the direct pharmacological impact associated with the serum and brain. The second is probably the indirect impact related to Valproat metabolites that exist in the brain or with changes in neurotransmitters or directly on the cell membrane. The most widely recognized assumption is the theory of GABA, this concentration increases after using Valproat.

Valproat reduces the time of the intermediate phase of sleep and increases slow sleep.

pharmacokinetics

Different pharmacokinetics studies about Valproat shows the following:

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

The distribution is mainly limited in the blood and quickly exchanged fluid fluid. Valproat passes the cerebrospinal fence and into the brain, the concentration of valproate in cerebrospinal fluid is closely related to the free concentration of the drug in serum.

The half -life is 15 - 17 hours.

The minimum concentration of serum needed to achieve the effectiveness of treatment is 40 - 50mg/l, with amplitude between 40 and 100mg/l. When this concentration exceeds unnecessary, it is necessary to consider the risk of side effects, especially the side effects dependent. When the concentration maintains over 150mg/l requires a dose reduction.

Stable plasma concentrations achieved within 3-4 days.

Valproat connection into plasma is very high. That depends on the dose and saturation.

Valproat is excreted mainly in the country after metabolic by glucurono combined and oxidized.

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

Unlike other anti -epileptic drugs, Valproat is not an enzyme induction of the cytochrome P450 metabolic system, so Valproate does not push the degeneration of this drug itself, as well as other substances such as estrogen, progestogen and oral anticoagulant drugs.

Before taking Depakine 200mg/ml Sanofi solution (40ml)

How to use

Take oral, take diluted drug solution with a little non -gas drink.

bottle of drug solution available (with lilac color piston) used to get oral medicine. Only take cylinder oral medicine available in the box.

The lines on the cylinder do the dose only in Mg (each line corresponds to the dose of 25mg, within the scope of the dose from 50mg - 400mg).

The dose of the drug is taken by using a cylinder: pulling the piston up until the corresponding line is the dose with the indicated Mg to touch the peak of the cylinder.

Always wash the cylinder after use.

To open the bottle: press the lid down and rotate (this type of lid is safe for children).

Cover the bottle tightly immediately after each medication.

To open the bottle cap:

press the lid down.

at the same time rotate the lid.

How to use the cylinder with the dose of the dose:

full suction.

Dose adjustment.

pump out.

Treatment time:

Do not stop treating without consulting the doctor.

The risk of stopping drugs

Do not stop the treatment without consulting the doctor. The stop use of the drug must be done slowly. The consequence of sudden stop treatment or before the doctor's appointment is possible to increase the risk of seizures.

Dosage

Daily dose is determined by your doctor, and exactly for you.

The normal starting dose is 10 - 15mg/kg body weight, then may increase slowly to the optimal dose within 1-2 weeks.

Average daily dose:

Babies and children: 30mg/kg body weight (using xio, oral or oral solution for prolonged release is the best).

Teenagers and adults: from 20 - 30mg/kg body weight (using the form of tablets or long -lasting release tablets or prolonged release particle form is good).

The doctor should prescribe specific drugs equal to the number of milligrams (Mg) without the number of milliliters (ml) because the cylinder to get oral medication with the miligram dose line (Mg). If the prescription is recorded according to Mililid (ml), ask the doctor or pharmacist.

Daily dose is usually divided as follows:

Divide to drink into 2 times for patients under 1 year of age.

Divide to drink into 3 times for patients over 1 year of age.

The best medication is during meals.

Girls, adolescents, women of reproductive age and pregnant women

Valproate needs to start treatment and closely monitored by the doctor who has experience in the treatment of epilepsy. This medication should only be used when other treatments are not effective, they cannot tolerate (see special notes, pregnant women and breastfeeding period). Balancing benefits - the risk of the drug should be carefully evaluated in each regular examination for patients. It is best to prescribe valproate in the form of single therapy and the lowest treatment dose effectively. If possible, prolonged release should be used to avoid high plasma peaks. The daily dose should be divided at least into 2 single doses.

Must take the drug regularly, do not change or stop the drug suddenly without the doctor's opinion.

Starting for treatment

If the patient has been previously treated with other anti -epileptic drugs, starting slowly with sodium valproot until the optimal dose is reached for about 2 weeks and then reducing the other anti -epileptic dose depends on the effectiveness of epilepsy control treatment.

If the patient has not taken any other anti -epileptic drugs, it is best to increase the dose of a ladder every 2-3 days until the optimal dose is about 1 week.

When needed, it is possible to treat sodium valproat combination with other anti -epileptic drugs but must start slowly.

Note: The above dose is for reference only. DEAD DEAD DEMAKINE 200mg Specifically depending 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?
What to do when forgetting a dose?

Side Effects

When using Depakine 200mg/ml, you may experience unwanted effects (ADR).

Very rare cases of liver damage (hepatitis) or pancreatic (pancreatitis), may be serious and life -threatening and it can start suddenly with fatigue, anorexia, exhaustion, drowsiness, nausea, vomiting and stomach pain.

Very rarely encounter skin rash, sometimes bulging in the mouth (diverse red skin), blistering on the skin scattered and quickly spread throughout the body and can be life-threatening (Stevens-Johnson syndrome).

Allergic reaction

The sudden swelling and neck that can lead to dyspnea and life -threatening (angioedema).

Serious allergic reactions (drug rash with eosinophilia and systemic symptoms) include a number of symptoms such as fever, skin rash, increased lymph nodes, liver damage, kidney damage and abnormal blood test results such as increased number of white blood cells (eosinophilia).

Side effects may be different

Treatment head: Nausea, vomiting, stomach pain, diarrhea. Nang).

The movement of sperm is reduced. Run, hard limbs and difficult to walk) sometimes not recover. In some cases, Parkinson's syndrome can recover. Kidney.

Reducing the number of platelets (platelets in the blood decreases abnormally).

Firinogen levels, prolonged bleeding time.

Reduces the number of red blood cells (anemia), increases the volume of red blood cells (enlarged red blood cells), reduces the number of leukemia (leukopenia, granulocytosis).

Very rare cases of reducing the number of all blood cells: leukocytes, red blood cells and platelets (anemia is not reconstructed).

Reduce the process of producing blood cells (bone marrow property).

Reducing the amount of blood sodium (abnormal hyponatremia, unsuitable anti -hormone secretion syndrome).

Hyperiac hyperactivity in the blood.

Cases of bone disorders have been reported, such as bones becomes brittle (lack of bone), reducing bone mass (osteoporosis) and fractures. Consult your doctor or pharmacist if you are treated for a long -term anti -epileptic drug, if you have a history of osteoporosis or are taking corticosteroids.

congenital deformities and intellectual development disorders (see special notes, pregnancy and lactation period).

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

Depakine 200mg/ml contraindicated drug in the following cases:

allergies to the main active ingredient of the drug (sodium valproat), or one of the ingredients of the drug.

allergies to the active ingredients of the same type as valproate (divalproat, valpromide).

Liver disease (acute or chronic hepatitis).

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

Porphyrin metabolic disorders (genetic liver disease).

Used in combination with: Mefloquine (Medication to treat malaria), St. John’s Grass (Treatment of Treatment of depression).

Precautions when using

The doctor will give blood tests to regularly monitor liver function, especially in the first 6 months of treatment. Very rarely occur, but Depakine can cause liver damage (hepatitis) or pancreatic (pancreatitis) that is critical to the patient's life.

report immediately to the doctor when the following signs appear:

Sudden fatigue, anorexia, exhaustion, sleep, leg swelling, difficulty living.

vomiting many times, epigastric pain or abdominal pain, jaundice or eyes.

Reappearing seizures, despite being treated properly.

Before treatment, it is necessary to tell the doctor if you have kidney disease (kidney failure), systemic erythema (rare) or a deficiency of genetic enzymes, especially the yeast deficiency of the urea cycle leads to an increase in the amount of ammonium in the blood.

When you need surgery, let the medical staff know you are taking this medication.

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

Immediately consult a treating doctor if you see the frequency of increased disease or occur attacks with other genres.

The drug can cause weight gain. The doctor will recommend diet measures with weight monitoring.

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

Inform the doctor if your child is taking anti -epileptic drugs or neurological medications or medications to treat metabolic or other types of epilepsy.

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

Valproat should not be used in girls, adolescents, women of reproductive age and pregnant women unless other treatments are not effective or the patient is not tolerated because Valproat has the potential to cause teratogenic and potential risk of development disorders in children who have been exposed to Valproat during pregnancy. The doctor should carefully assess the effectiveness and risk of the drug during each regular examination for patients, when the patient reaches puberty and immediately when women of reproductive age are being treated with Valproat planned to be pregnant or just pregnant.

Women of reproductive age are required to use effective contraceptive measures during treatment. Doctors need to notify patients with risks related to the use of valproat during pregnancy (see the section of pregnancy and nursing period).

Doctors prescribed to make sure that the patient is provided with sufficient information about the risk when using this drug. This information can be transferred to patients in the form of pocket documents for patients to help female patients better understand the risk.

Special doctors must ensure that patients understand:

Characteristics and importance of the risk of exposure to drugs during pregnancy, especially the risk of teratogenicity and the risk of fetal development disorders.

The necessity of the use of effective contraception.

The necessity of pregnancy examination.

The necessity of the doctor's consultation as soon as the female patient is suspected of being pregnant or likely to be pregnant.

Women who plan to get pregnant should try to pass to other replacement treatments before conception if possible (see the section of pregnancy and lactation period).

Should only continue treatment with Valproot after the risk balance - the benefit of the drug is assessed by an experienced doctor in the treatment of epilepsy or bipolar mental disorders.

The ability to drive and operate machinery

This drug can cause drowsiness, especially when used with other anti -epileptic drugs or drugs that can increase drowsiness.

If you've ever experienced this effect or your illness is not well controlled and you continue to have seizures, then you must not drive or operate machines.

Pregnancy

Do not use valproat -containing drugs in girls, adolescents, women of reproductive age and pregnant women unless other treatments are ineffective or intolerance patients. Women of reproductive age need to use effective contraceptive measures during the treatment process in women who plan to become pregnant, need to try to switch to other replacement treatments before conception, if possible.

Risks associated with Valproat exposure during pregnancy

The use of valproat in the form of single therapy or multiple therapy is all related to some abnormalities during pregnancy. The existing data shows the risk of congenital deformities when using a multi -therapy regimen, including a larger Valproat -containing drug than a Valproat treatment.

congenital deformity

The data obtained from a gross study (including medical record data source and from pure studies) has shown that 10.73% of children with mothers with epilepsy use Valproat single -treatment treatment during congenital malformations (95% confidence range: 8.16 - 13,29). The risk of severe malformations is greater than that of normal populations (with a rate of defects only 2-3%). This risk depends on the dose but the dose below the threshold has not yet been proven to be no harm.

Existing materials show that there is an increase in the rate of fetal defects both mild and heavy. The most common type of malformation is neural tube defects (about 2-3 %), face deformity, cleft palate, narrow skull, cardiovascular, kidney and genital urinary, limb deformities (including rotating bones on both sides) and multiple deformities of many other organs on the body.

Development disorders

The existing data indicates that Valproat exposure can lead to a disadvantage of mental and physical development of children exposed. This risk depends on the dose but the dose below the threshold still does not rule out the risk. The exact period of time during pregnancy is affected by this risk is still not determined and the risk of the risk occurs during pregnancy cannot be excluded.

Children's studies at kindergarten have been exposed to Valproat in the mother's womb during pregnancy, which has shown that 30-40% of children with developmental retardation in the beginning such as slow speech and slow walking, slow cognitive ability, language ability (reading and understanding) are poor and have memory problems.

IQ's intelligence index is measured on children of school age (6 years old) who has been exposed to Valproat when a pregnant mother is 7-10 points lower than an average of children who have been exposed to other anti -epileptic drugs. Although it is not possible to rule out the role of interference factors, the above data has shown that the risk of intelligence in children can be independent of the mother's IQ.

Data for long -term consequences is still limited

Existing data indicates that children exposed to Valproat in the mother's womb during pregnancy are at risk of autism increasing by 3 times and autism increases about 5 times compared to normal populations.

Data shows that children exposed to Valproat in the mother's palace during pregnancy are more likely to suffer from symptoms of concentrated hyperactivity disorders (ADHD).

Girls, adolescents and women of reproductive age (see above and special notes).

If women plan pregnancy:

During pregnancy, seizures - vibration and epilepsy accompanied by a lack of oxygen in the mother can lead to the risk of death for both mother and fetus.

If women plan to become pregnant or are pregnant, Valproat treatment should be re -evaluated.

For female patients who plan to become pregnant, it is necessary to switch to other replacement treatments before conception, if possible.

Valproat treatment should not be stopped without the benefits and risks because doctors have experience in the treatment of epilepsy or bipolar mental disorders. In case of balancing benefits - the risk of using Valproat during pregnancy has been carefully evaluated and the treatment with Valproate can continue, should note the following recommendations:

Use the lowest doses effectively and divide the daily dose of Valproot into several smaller doses and drink several times a day, prioritizing the use of a longer -released dosage form than other cell formats to avoid the peak concentration in plasma.

Perfect skin or urticaria.

Folat supplementation before pregnancy may reduce the risk of neural tube defects that often occur during pregnancy. However, existing data does not show that this can prevent congenital defects or malformations when exposed to Valproot.

It is necessary to start prenatal monitoring to detect the appearance of neural tube defects or other malformations.

Risks for babies:

Cases of bleeding syndrome is very rare in infants whose mothers have used Valproate during pregnancy. This hemorrhage syndrome is associated with platelet deficiency, fibrinogen deficiency in the blood or related to reducing other coagulation factors. Blood condition without fibrinogen has also been reported and may be life -threatening. However, this symptom needs to be distinguished from vitamin K deficiency caused by phenobarbital and enzyme induction substances. Therefore, hematological tests should be conducted such as counting the number of platelets, measuring serum fibrinogen levels, blood clotting tests and other coagulation factors on infants.

Hemodiagia schools have been reported on infants whose mothers used to use Valproat during the last three months of pregnancy.

The cases of thyroid disabilities have also been reported in infants whose mothers used to use valproate during pregnancy.

C tracing syndrome (such as excitement, struggle, excessive irritation, fear, hyperactivity, muscle tone disorders, muscle tremor, jerk brush and eating disorders) can occur on babies whose mothers used to use Valproat during the last three months of pregnancy.

Reproduction

Menstrual loss, polycystic ovaries and increased blood testosterone levels in women using Valproot have been reported. Using Valproat can lead to decline in fertility in men (especially, the movement of sperm is reduced). This reproductive dysfunction can recover after stopping treatment with Valproate.

In any case, never stop treating epilepsy without a doctor's permission.

Breastfeeding period

Valproat is excreted into breast milk with a concentration of 1% - 10% compared to the mother's plasma concentrations. Blood disorders have also been reported on children whose mothers are being treated with Valproat (see unwanted effects).

The decision to stop breastfeeding or stop treatment with Valproat should be considered based on the benefit of breastfeeding and the benefits of the mother's treatment.

Medicinal interaction

Do not use this medication if you are taking the following drugs:

Mefloquine (Malaria medicine).

St. John’s grass (Treatment of depression).

Need to tell the doctor if you are taking Lamotrigine (epilepsy medication) or penems (antibiotic to treat infections).

Special for children under 3 years old, it is necessary to avoid taking drugs containing aspirin during treatment.

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

Used with food and drink.

Do not use alcoholic drinks during treatment with Depakine.

Storage

Store drugs at temperatures not exceeding 25 ° C.

Other drugs

Disclaimer

Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.