Is depakene the same as depakote
What is Depakote & What is It Used For?
The medication Depakote (divalproex sodium) is an anticonvulsant. Doctors prescribe it to treat seizure disorders and to prevent migraine headaches. People also use it to manage the manic phase of bipolar disorder. Depakote side effects can be serious and sometimes fatal. These include birth defects in children whose mothers take the medications while pregnant.
Depakote is an anticonvulsant. Doctors prescribe it to treat conditions that affect the brain.
Depakote contains the active ingredient divalproex sodium. This is a combination of sodium valproate and valproic acid.
The medication comes in a white powder form. Drugmaker AbbVie Inc. makes it into a tablet.
Patients take Depakote by mouth. The drug’s maker tells patients to swallow Depakote whole, not to crush or chew it.
Valproate in Depakote is effective in managing and stabilizing moods. But the chemical substance can cause serious side effects.
Depakote lawsuits blame the drug for causing birth defects in children whose mothers took Depakote during pregnancy.
Depakote (Divalproex Sodium) Uses
The U.S. Food and Drug Administration approved Depakote in 1983 to treat epilepsy. Doctors may sometimes prescribe divalproex sodium with other medications to treat types of seizures.
The FDA expanded Depakote uses to include the treatment of manic episodes associated with bipolar disorder. Divalproex sodium also helps prevent migraines headaches.
What Depakote Does for the Brain
Divalproex sodium works by increasing the amount of gamma-aminobutyric acid (GABA) in the brain. The body produces GABA naturally. It is a chemical neurotransmitter — or brain messenger.
Faster than normal electrical impulses in the brain can cause erratic impulses. These impulses overstimulate the nerves. GABA helps to calm and relax nerves. Relaxing nerves can stabilize moods.
Increasing GABA can also prevent abnormal brain signals that lead to seizures.
One 2022 clinical research trial reported on the effects of Depakote on posttraumatic irritability after traumatic brain injury.
Results showed a significant and sustained reduction of posttraumatic irritability. However, the study authors noted that treatment efficacy was not related to measures of anxiety, posttraumatic stress disorder, sedation, or veteran versus nonveteran status. Alcohol use did not change as a result of treatment.
Types of Depakote: Depakote DR vs Depakote ER vs Depakote Sprinkle Capsules
Divalproex sodium comes in Depakote tablets and Depakote ER (extended-release) tablets. It’s also available in Depakote Sprinkle Capsules (delayed-release capsules).
Depakote ER and the delayed-release formulation of Depakote are not interchangeable.
Depakote tablets are delayed release. They have a coating to keep the medication from dissolving too soon after it’s swallowed. These tablets come in three sizes: 125 mg, 250 mg and 500 mg. They are prescribed to be taken twice a day.
Depakote delayed release 250mg
Depakote delayed release 500mg
Depakote ER tablets are made to slowly deliver the medication over 24 hours.
They are taken just once a day. They come in 250 mg and 500 mg. Depakote ER does not have a coating.
Depakote extended release 250mg
Depakote extended release 500mg
Depakote Sprinkle Capsules are approved only for the treatment of epilepsy. They are available in 125 mg. They work similar to Depakote delayed release, except that they are in capsules rather than tablets. Patients who have trouble swallowing may open the capsules and sprinkle the medication on soft food.
A closely related medication, Depakene (valproic acid), comes in capsule and liquid form. Another variety of valproic acid, Stavzor, is no longer manufactured.
In 2008, the FDA approved the first generic version of Depakote. Collectively, these medications are known as valproate products.
Depakote Dosages
Depakote dosage can vary. It depends on the patient and the condition for which a doctor prescribes it.
For example, when taken to control mania, the recommended initial dose is 750 mg a day taken in divided doses for Depakote. For Depakote ER, the recommended initial dose is 25 mg once a day, up to a maximum of 60 mg a day.
The initial Depakote therapy is 10 mg to 15 mg for treating epilepsy in patients age 10 and older. Doctors can then increase the dosage by 5 mg to 10 mg each week. This continues until the doctor determines that the medication is doing what it’s supposed to.
With Depakote ER, patients ages 10 and older should start the same with a maximum dose of 60 mg a day.
If a patient forgets to take Depakote at the usual time, he or she can take it upon remembering. But if it’s close to the next dose, patients can skip the forgotten dose and resume the normal schedule. Do not double up.
Depakote Interactions
Valporic acid in Depakote may interact with a number of different medications. Depakote interactions may increase or decrease the effects of the medications.
Some can be fatal.
Valproic acid can increase the serum concentrations of diazepam in patients taking that medication. Antacids containing magnesium and aluminum hydroxide may increase valproic acid an average of 12 percent.
Patients with urea cycle disorders who are being treated with sodium phenylbutyrate should not receive valproic acid. This interaction can be fatal.
Supplements and food can also interact with Depakote. For example, high doses of folate can decrease the effectiveness of Depakote.
High doses of the herb Ginkgo biloba also could decrease the effectiveness of Depakote.
Drugs that can interact with Depakote include:
- Alprazolam
- Amphetamine
- Benzphetamine
- Bupropion
- Butabarbital
- Carbamazepin
- Cholestyramine
- Darunavir
- Doripenem
- Ertapenem
- Fosamprenavir
- Haloperidol
- Lamotrigine
- Loxapin
- Meropenem
- Pemoline
- Propofol
- Ritonavir
- Sodium Phenylbutyrate
- Thiothixene
- Vorinostat
- Warfarin
Common Side Effects of Depakote
A common side effect of Depakote and Depakene is nausea, especially during the first month of treatment.
This can be overcome by starting on a low dosage and slowly increasing the amount. Taking the medication on a full stomach can also help.
Common side effects associated with Depakote include:
- Nausea
- Drowsiness
- Abdominal pain
- Diarrhea
- Vomiting
- Low platelet count
- Tremors
- Hair loss
These side effects may be mild or moderate. You should talk to your doctor about any side effects because they could be signs of something serious.
Depakote Serious Side Effects
Taking Depakote has been linked to some serious and even deadly side effects.
Liver damage is one of the side effects that may be fatal. This is especially true in children under 2. This risk is highest in the first months of taking the medication. The risk may still be present even after the Depakote medication is stopped.
Another potentially fatal side effect is inflammation of the pancreas, or pancreatitis. This is when digestive enzymes start digesting the pancreas itself.
When pregnant women take Depakote, their unborn babies are at risk of developing birth defects. These defects can affect the brain, spinal cord, heart, arms, legs and penis. These babies also risk developing lower intelligence. Women who are or may become pregnant should not take Depakote.
Depakote Black Box Warnings
The FDA requires that Depakote’s label have black box warnings. A black box warning is the agency’s most serious type of warning. It calls attention to serious or life-threatening risks.
Depakote’s boxed warnings are for hepatotoxicity, fetal risk and pancreatitis.
Depakote Precautions
Depakote manufacturer AbbVie warns that certain people should not take Depakote or Depakene. This includes people with liver problems, and women who are or may become pregnant.
Talk to your doctor before taking Depakote or Depakene if you:
- Have liver problems
- Have or think you have a genetic liver problem caused by a mitochondrial disorder (e.g. Alpers-Huttenlocher syndrome)
- Are allergic to divalproex sodium, valproic acid, sodium valproate, or any of the ingredients in Depakote or Depakene
- Have a genetic problem called urea cycle disorder
- Are or may become pregnant
Depakote Facts
Please seek the advice of a medical professional before making health care decisions.
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Valproic Acid Basic Seizure Medication
How to take and store Valproic Acid?
Follow the doctor's directions. Call if you have any questions. The way the medicine is taken depends, of course, on what form the doctor has prescribed.
Depakene capsules must be swallowed whole. If they're chewed, the mouth and throat may become irritated. They are best taken on a full stomach to avoid stomach upset, but they can be taken without food.
(Drink a full glass of water if taking the capsule alone.) Depakene syrup can be mixed with another liquid or food for better taste, as long as it is all consumed. Be sure to use a standard measuring spoon or dropper for accurate, consistent dosing. Because food affects the way medicine is used by the body, try to be consistent day in and day out. A person who usually takes Depakene with meals should do that all the time.
Both forms of Depakene should be stored at room temperature, away from heat, light, and dampness. (Don't keep the capsules in the bathroom if it's damp there.) Protect the syrup from freezing. Be sure to keep Depakene where children can't get it.
What if I forget?
In general, if you forget a dose, take it as soon as you remember. If it is almost time for the next dose, delay that dose for a few hours, instead of taking two doses very close together. Then go back to the regular schedule. If you're not sure about what to do, call the doctor's office for more advice.
Do your best to follow the doctor's directions. The more often a medicine must be taken, the greater the chance of forgetting, and some people need to take Depakene three times every day. This can be difficult. If you forget doses often, it may be a good idea to get a special pillbox or watch with an alarm to remind you. You also might ask the doctor about Depakote ER, a type of valproate medicine that is taken only once a day.
Taking the right amount of seizure medicine on time every single day is the most important step in preventing seizures!
How does Valproic Acid affect the brain?
Brain cells need to work (fire) at a certain rate to function normally. During a seizure, brain cells are forced to work much more rapidly than normal. Valproic acid helps prevent brain cells from working as fast as a seizure requires them to. In this way, seizures can be stopped when they are just beginning.
We don't completely understand how valproic acid works.
Doctors think that it may work in several ways at once. That could be why it works for so many different kinds of seizures.
How does the body digest Valproic Acid?
After medicine is swallowed, it must be absorbed into the blood so it can move throughout the body. The process of absorbing, digesting, and excreting a medicine or food is called metabolism. The way the body metabolizes a particular medicine affects how often it must be taken. It also determines whether it will interact with other medicines or be affected by conditions such as liver disease.
Valproic acid is quickly absorbed by the body. The medicine takes longer to reach the blood (and the brain) if it's taken with food, but in the end the amount absorbed is about the same. The delay that occurs when valproic acid is taken with food is not important during long-term treatment, but it could have some effect when treatment is first begun. That's why it's best to be consistent.
Valproic acid is broken down (digested) in the liver.
People with liver disease should not take it. Anyone who also takes other medicines that are digested in the liver (as many are) needs to be careful. How well each medicine works and how quickly it leaves the body may be changed.
This is why the doctor needs to know about everything that a person takes—not just prescription medicines but even things like vitamins, herbs, and aspirin! These things can affect how much valproic acid the doctor prescribes.
How well does the Valproic Acid work?
Doctors have studied large numbers of people to find out how well valproic acid and the other valproate medicines control seizures. (There is hardly any difference in the way the different valproate medicines work.) They have reported that these medicines are very good at completely controlling absence seizures in many people who take them. In another group, over 80% of people with new tonic-clonic seizures and related types didn't have any seizures during the period when they were given a medicine like valproic acid.
These promising results are not always matched in everyday life. Sometimes people don't take all their medicine on time. Not everyone's seizures can be controlled at a dose that can be taken without side effects. Because of individual differences, there is no "best" amount for everyone. Adjustments are often needed to reduce seizures or side effects.
In studies of seizure medicines, some people do better with valproic acid and others do better with something else. It's difficult to forecast the results for any given person. Differences in side effects may be important in deciding which medicine is best for each person.
If seizures continue, the doctor probably will change the amount of valproic acid prescribed. If that doesn't work, the next step may be either to prescribe a different seizure medicine by itself or to prescribe a combination of valproic acid and another seizure medicine. Many are available. No single combination is best for everyone. Valproic acid is often used as an "add-on" medicine for people who continue to have certain kinds of seizures while taking other seizure medicines.
What are the most common side effects of Valproic Acid?
Most people who take valproic acid don't have too much trouble with side effects. The most common complaints (usually not too severe) are:
- tiredness (sometimes with slower thinking)
- dizziness
- upset stomach
- vomiting
- tremor (shaking of the hands or other parts of the body
- hair loss
- weight gain
- changes in behavior (depression in adults, irritability in children)
If you notice any of these problems, call the doctor. Sometimes the doctor can help by changing the amount of valproic acid prescribed or prescribing a different valproate medicine. No one should stop taking valproic acid or change the amount they take without their doctor's guidance.
Stomach upset from valproic acid may be less of a problem if it is taken on a full stomach. Stomach upset is more likely when another seizure medicine with similar side effects (for example, Tegretol) is also being used.
Tremor (shaking of the hands or other body parts) tends to be worse when the level of valproate in the blood is highest, a few hours after the pills are taken. Anxiety or caffeine also may make it worse.
Weight gain affects 30% to 50% of people who take valproic acid. It is more common in adult women but can affect anyone. The average gain for adults is 15 pounds. Exercise and a reduced-calorie diet can be very helpful. It's uncertain whether weight gain is greater when higher doses of valproic acid are taken.
Hair loss occurs in 5% to 10% of people who take valproic acid. The hair almost always grows back after the valproic acid is stopped, but it often has a different texture. (For example, it may grow in curly instead of straight.)
People who have just started taking valproic acid (or who have just started taking a larger amount) should be careful during activities that might be dangerous, until they know whether they are having any side effects.
Allergic reactions
Allergic reactions such as rashes are less common with valproic acid and the other valproate medicines than with most other seizure medicines.
Even so, you should report any rash to the doctor or nurse right away, especially if treatment has just begun. It's rare for the rash to be serious, but don't ignore it. It's often necessary to switch to a different seizure medicine.
A very small number of people who take valproic acid develop life-threatening disorders. Children younger than 2 years of age and other people who are taking more than one seizure medicine have the greatest risk. See Serious side effects.
Long-term side effects
Some people who have taken valproic acid for many years have experienced bone loss and a few other disorders. Taking both calcium and vitamin D may help to prevent this kind of problem. Many doctors recommend a bone density test to identify which people need treatment for bone loss.
What are the most serious side effects of Valproic Acid?
A few people have serious reactions to valproic acid. These problems are very rare but everyone who takes this medicine should at least be aware of them because a very small number of people have died because of them.
Here's a list of warning signs that may be the start of one of these problems. If you notice any of these things, call the doctor immediately:
- weakness, sluggishness, swelling of the face, loss of appetite, vomiting, or yellowish eyes or skin, especially in a child under 2 years of age (possible liver failure)
- pain in the abdomen, upset stomach, vomiting, or loss of appetite (possible disease of the pancreas)
- easy bruising, nosebleed, or other abnormal bleeding (problems with clotting)
Tell the doctor right away if you notice any of these problems, but don't stop using the valproic acid unless the doctor says so.
The best-known and most-feared serious reaction is liver failure. This disorder usually occurs within the first 6 months of treatment. The risk of liver failure is much higher in children under 2 years of age, especially if they also take other seizure medicine or already have other serious disorders. Doctors seldom prescribe valproic acid for those with the highest risk.
The risk of liver failure is much lower in children between 2 and 10. The risk is very low in older children and adults, perhaps 1 in 50,000. There is no evidence that long-term use of valproic acid will cause gradual damage to the liver.
Another rare reaction to valproic acid is a disorder of the pancreas. Occasionally it is so severe that bleeding and death can occur. Both children and adults can be affected, even after several years of taking valproic acid. Report pain in the abdomen, upset stomach, vomiting, or loss of appetite to the doctor right away.
Problems with blood clotting are more likely in people who take large amounts of valproic acid. Sometimes the blood returns to normal without stopping the medicine. The doctor probably will order some blood tests before prescribing valproic acid, and will repeat them some time later and before any elective surgery.
A complete list of all reactions to valproic acid can be found in the package insert for brand-name Depakene, but it is important to remember that only a tiny number of people have any of these serious problems.
On July 10, 2008, an advisory panel was convened by the Food and Drug Administration (FDA) to review data that the FDA had previously collected from drug studies showing an association between many of the antiepileptic drugs (AEDs) and suicidal ideation and behavior, which together are called suicidality. According to the FDA’s Alert, among the patients with epilepsy in these drug studies, 1 out of 1000 people taking the placebo (inactive substance) showed suicidality compared to approximately 3.5 out of 1000 people who took an AED. The FDA advisory panel voted to accept the FDA's data at its meeting on July 10.
- Taking antiepileptic medicines may increase the risk of having suicidal thoughts or actions;
- Do not make any changes to the medication regimen without first talking with the responsible healthcare professional;
- Pay close attention to any day-to-day changes in mood, behavior and actions. These changes can happen very quickly so it is important to be mindful of any sudden differences.
- Be aware of common warning signs that might be a signal for risk of suicide. Some of these are:
- Talking or thinking about wanting to hurt yourself or end your life
- Withdrawing from friends and family
- Becoming depressed or having your depression get worse
- Becoming preoccupied with death and dying
- Giving away prized possessions
We again urge patients and families to contact their doctor before stopping an epilepsy medication because this may possibly lead to seizures and worsening of mood.
Impact of Valproic Acid on bone health
At this time there is no evidence to support that Gabapentin causes bone health problems. However, it might. . It is essential that if you taking this medication, that one take supplemental calcium of 1000 milligrams per day. Talk to your doctor about bone health. He/She may decide to check Vitamin D levels and other tests to check for the impact of this drug on your bones.
What else is Valproic Acid used for?
Often doctors find that medicines are useful for more than one purpose. It is legal to prescribe medicines for ""off-label uses"" even though the Food and Drug Administration (FDA) has not formally approved such use.
The only FDA-approved use of valproic acid is the treatment of epilepsy, but it also has two off-label uses:
- preventing migraine headaches (not treating headaches while they're occurring)
- treating one part of the mental illness called bipolar disorder.
Who should not take Valproic Acid?
People with liver disease should not take valproic acid. Neither should anyone who has shown an allergy to valproic acid or another valproate medicine in the past. Make sure the doctor knows about any liver problems, so a different medicine can be prescribed instead.
Can Valproic Acid be taken with other medicines?
Sometimes one kind of medicine changes the way another kind of medicine works in the body.
This is true not only for prescription medicines, but also for medicines you just pick up off the shelf at the store. For instance, aspirin (ASA) may increase the side effects from taking valproic acid.
If someone who is taking valproic acid—especially a child—also starts to take the seizure medicine called Lamictal, the chances of a very dangerous rash will be increased. Adding the Lamictal slowly reduces this danger.
Taking both valproic acid and another seizure medicine, Klonopin, sometimes causes absence seizures to be much longer.
Any time a doctor suggests a new prescription, be sure to talk about what other medicines you are already using. If two kinds of medicine affect each other, the doctor may want to prescribe something else or change the amount to be taken.
How does valproic acid affect other medicines?
Valproic acid affects the way the body handles many other seizure medicines. Some of these are:
- Felbatol (felbamate)
- Lamictal (lamotrigine)
- Mysoline (primidone)
- phenobarbital
If a person taking one of these medicines starts taking valproic acid, the first medicine will stay in the body longer.
If the person keeps taking the same amount as before, soon there will be too much of it. This may cause side effects like extreme tiredness and slurred speech. The person might seem to be drunk.
A similar thing could happen with several other seizure medicines, but the effects for people taking these would probably not be too noticeable:
- Tegretol or Carbatrol (carbamazepine)
- Zarontin (ethosuximide)
- Ativan (lorazepam)
- Dilantin or Phenytek (phenytoin)
All of these effects mean that if a person taking another seizure medicine starts taking valproic acid too, the amount of the first medicine may need to be changed. Or if a person has been taking valproic acid along with another seizure medicine, stopping either one of them means that the amount of the other one probably will have to be changed.
How do other medicines affect valproic acid?
Some other medicines do affect the way valproic acid works in the body. Make sure that the doctor is aware of all the medicines being used.
What are the effects of Valproic Acid on Children?
Valproic acid can be effective against many types of seizures common in children:
- absence seizures (this is one of the most effective medicines for these brief staring spells)
- myoclonic seizures
- tonic-clonic seizures, such as those in Lennox-Gastaut syndrome.
- infantile spasms
- seizures triggered by flashing lights
Children under 2 or 3 years of age who take valproic acid have a much higher risk of liver failure than adults or older children. (The risk is very low for children over 10, perhaps 1 in 50,000.) The risk is even higher for very young children who also take other seizure medicines, and it's highest of all for those with certain other serious disorders. Usually the doctor will not prescribe valproic acid or other valproate medicines for children at very high risk. Liver damage usually occurs within the first 6 months of treatment. The first signs of it are vomiting, loss of appetite, sluggishness, and perhaps loss of seizure control, yellow skin and eyes, or swelling.
Higher-than-usual levels of the hormone testosterone have been found in many girls who take valproic acid when they're older than about age 10. No symptoms are apparent, but the doctor may want to watch for later problems, perhaps related to weight gain.
A few children who take valproic acid seem to become more irritable but this is seldom a serious problem.
To reduce side effects, the doctor probably will prescribe a low dose of valproic acid to start and will increase it slowly. Children usually start with a dose of 5 to 10 milligrams (mg) for each kilogram (kg, about 2.2 pounds) of their body weight per day. This is usually given in one to three equal doses per day.
Most children do best at about 15 to 60 mg/kg per day. Children taking a combination of valproic acid and another seizure medicine usually need the higher doses because of interactions between the medicines.
Valproic acid syrup is an easy way to give a valproate medicine to small children who cannot swallow capsules.
The medicine is absorbed by the body a bit more quickly than when Depakote sprinkle capsules are used, but the amount absorbed is the same.
If a woman takes Valproic Acid during pregnancy will it hurt the baby?
In the United States, the Food and Drug Administration (FDA) assigns each medication to a Pregnancy Category according to whether it has been proven to be harmful in pregnancy. Valproic acid is listed in Pregnancy Category D. This means that there is a risk to the baby, but the benefits may outweigh the risk for some women.
In fact, a large majority of women who use valproic acid during pregnancy have normal, healthy babies. Certain types of defects are increased (especially if valproic acid is taken during the first 3 months of pregnancy) but they are still relatively uncommon. The risk of defects is higher for women who take more than one seizure medicine. Women with a family history of birth defects also have a higher risk.
Women with epilepsy who are pregnant or thinking about becoming pregnant should talk to their doctor about their seizure medicines. Taking more than one seizure medicine may increase the risk of birth defects, so doctors sometimes gradually reduce the number or amount of seizure medicines taken by women planning for pregnancy. This is not done routinely, however, because it increases the risk of seizures. Some kinds of seizures can injure the baby, so do not stop using seizure medicines or reduce the amount without the doctor’s OK.
All women who are capable of becoming pregnant should take at least 400 mcg (0.4 mg) of the vitamin called folic acid every day because it helps to prevent one type of birth defect. (The most well-known of these is spina bifida, in which the spinal cord is not completely enclosed.) These defects are more common in the babies of women who take valproic acid during the first 4 to 6 weeks of pregnancy. If the doctor thinks a woman is at especially high risk, a much larger dose of folic acid—4000 mcg (4 mg) per day—may be recommended.
There's no proof that the folic acid will prevent the defects, however, so the doctor may recommend a check-up later in pregnancy.
About 20% to 35% of women have seizures more often during pregnancy because of changes in hormones or changes in how their seizure medicine is handled by the body. It is helpful for the doctor to check the levels of medicine in the blood regularly during pregnancy so that the dosage can be adjusted if necessary.
Breast-feeding by mothers taking valproic acid should be safe for healthy, full-term newborns. The amount of medicine the baby gets through the milk is much less than the amount that doctors safely give to babies who take valproic acid for seizures.
The babies of women taking valproic acid have a greater than usual number of minor craniofacial abnormalities, organ malformations, limb deficiencies, or developmental delay. The risk of defects is higher for women who take more than one AED and for women with a family history of birth defects.
Moreover the NEAD study showed that children born to women who took Valproic acid, had lower IQ scores than children born to women with epilepsy who tool other seizure medications.
What are the effects of Valproic Acid on Seniors
Doctors have prescribed valproic acid to people over 65 for many years with good results. These seniors do have a few special problems, however.
Most seniors take more medicines than younger people, so there’s a greater risk that the medicines may affect each other. Usually seniors can continue to take all the medicines they need, including valproic acid, without trouble if the doctor changes the amount of some of them to make up for the way they affect each other.
Seniors also tend to be more sensitive than younger adults to medicines and their side effects. For instance, many seniors have a problem with sleepiness, depression, weight gain, or shaking of the hands even before they start taking valproic acid.
These are common side effects of this medicine, so these problems may become worse and cause real trouble.
Seniors also face more danger from some side effects because they are more likely to be seriously hurt if they fall or have another kind of accident.
To reduce side effects, the doctor probably will prescribe a very low dose of valproic acid to start and then be cautious about any increases. It’s especially important for seniors to keep the doctor informed about any changes that they notice.
What are the dose ranges for Valproic Acid?
The best amount is the amount that completely controls seizures without causing troublesome side effects. It depends on many factors, which are different for every individual. Follow the doctor's directions. Call if you have any questions.
No one should stop taking valproic acid or change the amount they take without talking to the doctor first. Stopping any seizure medicine all at once can cause a problem that may be life-threatening.
Don’t use more than the doctor prescribes. If a little extra (such as one or two extra capsules) is taken by accident, call the doctor for advice. For a larger overdose, call a poison control center or emergency room right away unless you have other specific directions from your doctor.
To avoid unwanted side effects, the doctor will prescribe a low dose to start and increase it gradually until the seizures are controlled, unless side effects get too bad first. Most people need to take valproic acid two to four times a day.
Read the package insert of Valproic Acid
In the United States, companies that manufacture medicines are required to publish certain kinds of information about each product. This document is commonly known as a “package insert” because it is usually included with each package of the medicine.
You can also read these documents (also called "prescribing information") online. The U.S. package insert for Depakene (valproic acid) is found at:
- http://www.
rxabbvie.com/pdf/depakene.pdf
Some of the information may differ in other countries.
To learn how to read and understand a package insert, see "How to read a package insert."
Read About Valproic Acid studies
Valproic acid
Valproic acid is an anticonvulsant drug. It is widely used to treat various types of epilepsy in adults and children (large and small seizures, myoclonic, tonic-clonic and bipolar forms).
Synonyms Russian
Apilepsin, depakine, orfiril, convulex.
Synonyms English
Acidum valproicum, Valproate, Valproic Acid, Depakote.
Test method
Immunochemiluminescent assay.
Units
μg/mL (micrograms per milliliter).
What biomaterial can be used for research?
Venous blood.
How to properly prepare for an examination?
- Do not eat for 2-3 hours before the examination, you can drink pure non-carbonated water.
- Do not smoke for 30 minutes before the test. nine0040
General information about the study
Valproic acid inhibits the enzyme GABA transferase and, as a result, increases the content of the inhibitory neurotransmitter - gamma-aminobutyric acid (GABA) - in the nervous system. Under conditions of accumulation of GABA in the central structures of the brain, the threshold of excitability and the level of convulsive readiness decrease.
It is prescribed for patients suffering from epilepsy in all its manifestations (major and small seizures, myoclonic, tonic-clonic and bipolar form), behavioral changes inherent in epilepsy, affective disorders, as well as in the treatment of mania accompanied by bipolar disorders, with febrile convulsions in children, children's tics. Recently, it has also been used for neurological and mental disorders, for the prevention and treatment of migraine, neuropathic pain, behavioral disorders with panic episodes, aggression, etc.
In addition, according to the results of studies, the antitumor activity of valproic acid, which is used in myelodysplastic syndromes, has been revealed. and acute monocytic leukemia. nine0003
Valproic acid preparations are rapidly and almost completely absorbed in the gastrointestinal tract, reaching a maximum concentration in the blood after 1.5-4 hours. Moreover, they are characterized by non-linear (dose-dependent) pharmacokinetics, when the concentration of the drug in the blood increases or decreases faster than the increased or reduced dose. If the upper limit of their average therapeutic level is exceeded, one must take into account the greater likelihood of side effects, in some cases up to intoxication. nine0003
Valproic acid is primarily metabolized in the liver and may cause liver damage, especially during the first 6 months after starting treatment. Therefore, before therapy with valproic acid, each patient must pass a series of tests to assess liver function.
Valproic acid is characterized by low toxicity, severe side effects may occur during prolonged treatment.
These include weight gain, nausea, ovarian cysts, tremors, dizziness, mental depression, manifestations of pancreatitis, and liver damage (severe abdominal pain and vomiting, lethargy, yellow discoloration of the skin or eyes). Side effects are more common in infants and young children, especially when treated in combination with other antiepileptic drugs. Poisoning with valproic acid drugs in most cases is not severe, serious overdoses, when the patient's life is in danger, are extremely rare. Most often, overdoses are associated with depression of the central nervous system. A significant excess of the dose of the drug can cause coma and respiratory failure. In this regard, in the course of treatment, it is required to determine the concentration of the drug in the blood of patients in order to assess the level of toxicity and control the excretion of drugs from the body. nine0003
Individual dosage, based on therapeutic control of the drug concentration in the blood serum, increases the effectiveness and safety of therapy and allows you to achieve success in each case.
Blood is taken twice for analysis (this is the standard method): 1st sample - immediately before taking the drug by the patient (residual concentration after the last dose), 2nd sample - 2-3 hours after administration (reaching the maximum concentration in the blood) . At the same time, the procedure for taking blood is determined by the attending physician and may differ significantly from the standard method. nine0003
What is research used for?
- To determine the most effective concentration of valproic acid and the regimen of its administration in the treatment of certain diseases.
- To prevent the toxic effects of valproic acid preparations.
When is the test ordered?
- In violation of the function of the liver, kidney or gastrointestinal tract, which affect the pharmacokinetics of valproic acid preparations. nine0040
- If there is doubt about the correctness of the drug intake by the patient.
- If acute poisoning with valproic acid is suspected (depression of consciousness, disorientation, increased drowsiness, tachycardia, pulmonary edema, manifestations of pancreatitis and liver damage).
- When prescribing the drug after reaching its stable concentration (minimum equal to five half-lives).
- When the patient is less than a year old - due to rapidly changing body weight (every 1-3 months). nine0040
- With positive dynamics of the disease against the background of ongoing therapy, in general, 1-2 times a year.
- When pregnancy is confirmed, at the 8-10th week of pregnancy, then 1 time in 2 months, at 34-36 weeks, after childbirth for 8 weeks twice, and with ongoing seizures - at each visit to a neurologist (epileptologist) .
- After prescribing or discontinuing other combination anticonvulsant drugs.
What do the results mean? nine0006
Reference values: 50 - 100 µg/ml.
Causes of an increase in the level of valproic acid:
- overdose and / or incorrect regimen of administration of valproic acid preparations;
- acute poisoning with valproic acid preparations.
Causes of a decrease in the level of valproic acid:
- excretion of valproic acid preparations from the body.
The generally accepted therapeutic concentration range for valproic acid is 50-100 µg/mL. The toxic effect develops at concentrations above 100 µg/ml. nine0003
What can influence the result?
- Reduced liver function in a number of liver diseases can cause an increase in the concentration of valproic acid in the blood serum even in the absence of an increase in the doses of the administered drug.
Important Notes
- Before starting treatment with valproic acid, each patient should undergo a series of tests to evaluate liver function.
- Doses of drugs are selected by the attending physician for each patient individually, they cannot be changed independently. nine0040
- Simultaneous use of other anticonvulsants increases the toxic effect of valproic acid and increases the risk of side effects, so it is necessary to control the concentration in the blood serum of these drugs.
Also recommended
- Alanine aminotransferase (ALT)
- Aspartate aminotransferase (AST)
- Alkaline phosphatase, total
- Gamma-glutamyl transpeptidase (gamma-GT)
- Carbamazepine
- Lamotrigine
- Topiramate
Who orders the examination?
Neurologist, psychiatrist, psychotherapist, narcologist, toxicologist, general practitioner.
Literature
- Smirnova O.Yu., Sitnikov I.Yu., Savinov SV Drug monitoring as the most important factor in the correct approach in the treatment of epilepsy and convulsive syndromes.
- Sokolov A. V. Therapeutic drug monitoring. // Qualitative clinical practice, 2002, No. 1, p. 78-88. nine0040
- Problems of Forensic Science 2007, LXXll, 416-432: Toxicological analysis of valproic acid in blood by FPIA in comparison to GC-MS.
- Lacy, Charles F. Drug Information Handbook.
Lexi Comp, Inc. 2002. - Hirschfeld, Robert. "Safety and Tolerability of Oral Loading Divalproex Sodium in Acutely Manic Bipolar Patients". Journal of Clinical Psychiatry. 60 (1999): 815-818.
- Lagace DC, Obrien WT, Gurvich N, Nachtigal MW, Klein PS. Valproic acid: How it works. Or not. Clin Neurosci Res 2004; 4:215-225. nine0040
Epilepsy drug caused congenital diseases in 450 children in France - Vademecum magazine
Olga Chesnokova
February 24, 2016, 22:37 trade names such as Depakin, Depakot, Depamid and Micropakin. According to the report of the department, the drug caused the development of congenital diseases in at least 450 children born in 2006-2014. nine0003
Valproate is used as an anticonvulsant in epilepsy and bipolar disorder. The production of the original anticonvulsant drug Depakine was started by the pharmaceutical company Sanofi in 1967, after the appearance of generics, the drug became available to residents of more than 120 countries.
For the first time, the risk of fetal developmental anomalies (defects in the development of the facial and cerebral parts of the skull, heart, kidneys, urinary tract, genital organs, and limbs) when taking Depakine by pregnant women was discovered back in the 80s of the XX century, however, Depakine therapy then was mandatory for patients with epilepsy. In the 2000s, it became known that the drug was associated with a slow development of the nervous system in children, and in 2013 its connection with autism was suspected. In 2015, it was found that the IQ was reduced in 40% of children taking valproate. nine0003
Valproate attracted the attention of the French authorities after it became known that one of the inhabitants of the country, who had suffered from epilepsy since the age of six, took Depakine during two pregnancies. Doctors did not tell the woman about the risks of taking the medicine during this period, and her two sons were born with severe congenital diseases.
As a result, the Frenchwoman sued Sanofi, and also founded APESAC, a support association for parents of children suffering from serious illnesses due to Depakine. During the five years of its existence, the parents of 500 affected children have joined the association. nine0003
In this high-profile case, French Minister of Health Marisol Touraine commissioned IGAS to prepare a reassessment of the risk-benefit ratio of valproate during pregnancy and for women of reproductive age (15-49 years). The document also provides an overview of the measures that have been taken regarding the anticonvulsant drug in other European countries.
The head of the French Ministry of Health also plans to establish a compensation fund for residents of the country affected by Depakine, Figaro reports, and to further reduce the number of women taking this drug during pregnancy. nine0003
In 2015, Sanofi issued new recommendations for the use of valproate and its derivatives in women of childbearing age and pregnant women, stating that they should not use this drug "unless other treatments have failed or are not well tolerated by the patient.
