Depacon; Depakene; Depakote; Depakote ER; Depakote Sprinkles; Stavzor
Apo-Divalproex; Apo-Valproic; Depakene; Dom-Divalproex; Dom-Valproic Acid; Dom-Valproic Acid E.C.; Epival; Epival ECT; Mylan-Divalproex; Mylan-Valproic; Novo-Divalproex; Novo-Valproic; PHL-Divalproex; PHL-Valproic Acid; PHL-Valproic Acid E.C.; PMS-Divalproex; PMS-Valproic Acid; PMS-Valproic Acid E.C.; ratio-Valproic; Sandoz-Valproic
- This drug may cause very bad and sometimes deadly liver problems. This most often happens within the first 6 months of using this drug. Call your child’s doctor if your child has dark urine, is feeling tired, is not hungry, has an upset stomach, is throwing up, or has yellowing of the skin or eyes. In patients who have seizures, loss of seizure control may happen. Have your child’s blood work checked. Talk with your child’s doctor.
- Children under 2 years are at greater risk of deadly liver problems. Those who take more than 1 seizure drug or who have a metabolic disorder, a very bad seizure disorder along with mental retardation, or organic brain disease are at highest risk. Talk with the doctor.
- There is a greater risk of liver failure and death in patients who have a genetic liver problem caused by a mitochondrial disorder like Alpers–Huttenlocher syndrome. Your child may need to have a genetic test to check for this health problem. If your child has or may have mitochondrial disorders do not give this drug before talking with your child’s doctor.
- This drug may cause very bad and sometimes deadly pancreas problems (pancreatitis). This could happen in children at any time during care. Signs of pancreatitis include belly pain, upset stomach, throwing up, or not feeling hungry. Call your child’s doctor right away if your child has any of these signs.
If your child is or may be sexually active:
- If your child is able to get pregnant, she must use birth control that she can trust while taking this drug. If your child gets pregnant while taking this drug, call your child’s doctor right away.
If your child is pregnant or breast-feeding a baby:
- This drug may cause very bad birth defects if your child takes it while your child is pregnant. It can also cause the baby to have a lower IQ. Do not give this drug to prevent migraine headaches if your child is pregnant. If your child is pregnant and takes this drug for seizures or bipolar disorder, talk to your child’s doctor to see if your child needs to keep taking this drug.
- It is used to treat seizures.
- It is used to prevent migraine headaches.
- It is used to treat bipolar problems.
- It may be given to your child for other reasons. Talk with the doctor.
- If your child has an allergy to this drug or any part of this drug.
- If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
- If your child has any of these health problems: Liver disease or a urea cycle disorder.
If your child is pregnant:
- If your child is using this drug to prevent migraines.
Valproic acid capsules:
- Some brands of this drug have peanut oil in them. If your child is allergic to peanuts, check with your pharmacist to see if your child’s brand has peanut oil in it.
- Tell dentists, surgeons, and other doctors that your child is using this drug.
- Have your child’s blood work checked. Talk with your child’s doctor.
- Have your child avoid tasks or actions that call for alertness until you see how this drug affects your child. These are things like riding a bike, playing sports, or using items such as scissors, lawnmowers, electric scooters, toy cars, or motorized vehicles.
- To lower the chance of feeling dizzy or passing out, have your child get up slowly over a few minutes when sitting or lying down. Have your child be extra careful climbing stairs.
- Alcohol may interact with this drug. Be sure your child does not drink alcohol.
- Talk with the doctor before giving your child other drugs and natural products that may slow your child’s actions.
- This drug may affect certain lab tests. Be sure the doctor and lab workers know your child takes this drug.
- Your child may have more chance of getting infections. Avoid crowds and people with infections, colds, or flu.
- Some brain problems have happened with the use of valproic acid products. Sometimes, these problems have led to health problems that may not go away. Talk with the doctor.
- A very bad and sometimes deadly reaction has happened with this drug. Most of the time, this reaction has signs like fever, rash, or swollen glands with problems in body organs like the liver, kidney, blood, heart, muscles and joints, or lungs. Talk with the doctor.
If your child is or may be sexually active:
- Have your child use birth control to prevent pregnancy while taking this drug.
If your child is breast-feeding a baby:
- Tell the doctor if your child is breast-feeding a baby. You will need to talk about any risks to the baby.
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
- Chest pain.
- A heartbeat that does not feel normal.
- Very bad swelling or pain of hands or feet.
- Change in eyesight.
- Hearing loss.
- Change in thinking clearly and with logic.
- Memory problems or loss.
- Change in balance.
- If your child’s seizures are worse or not the same after starting this drug.
- Feeling very tired or weak.
- Any bruising or bleeding.
- Not able to pass urine or change in how much urine is passed.
- Swollen gland.
- Trouble controlling body movements, twitching, change in balance, trouble swallowing or speaking.
- Muscle pain or weakness.
- Joint pain or swelling.
- Patients who take this drug may be at a greater risk of having thoughts or actions of suicide. The risk may be greater in people who have had these thoughts or actions in the past. Watch people who take this drug closely. Call the doctor right away if signs like low mood (depression), nervousness, restlessness, grouchiness, panic attacks, or changes in mood or actions are new or worse. Call the doctor right away if any thoughts or actions of suicide occur.
- A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if your child has signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in the mouth, throat, nose, or eyes.
- Upset stomach or throwing up.
- Feeling sleepy.
- Hard stools (constipation).
- Loose stools (diarrhea).
- Belly pain.
- Not able to sleep.
- Feeling more or less hungry.
- Weight gain or loss.
- Hair loss.
- Feeling tired or weak.
- Irritation or swelling where the shot was given.
All oral products:
- Do not change the dose or stop your child’s drug. This could cause seizures. Talk with your child’s doctor.
- Give as you have been told, even if your child feels well.
- Give this drug at the same time of day.
- Give with or without food. Give with food if it causes your child to have an upset stomach.
Tablets and capsules:
- Have your child swallow whole. Do not let your child chew, break, or crush.
- Give this drug with a full glass of water.
- If you or your child see parts of this drug in your child’s stool, call the doctor.
- You may sprinkle contents of capsule on applesauce, pudding, or mashed potatoes. Have your child swallow without chewing.
- Measure liquid doses carefully. Use the measuring device that comes with this drug. If there is none, get an oral syringe, a dropper, a spoon, or a cup (only for older children) from your pharmacist.
- It is given as a shot into a vein.
All oral products:
- Give a missed dose as soon as you think about it.
- If it is close to the time for your child’s next dose, skip the missed dose and go back to your child’s normal time.
- Do not give 2 doses at the same time or extra doses.
- Call your child’s doctor to find out what to do.
All oral products:
- Store at room temperature.
- Protect from light.
- Store in a dry place. Do not store in a bathroom.
- The shot will be given to your child in a hospital or doctor’s office. You will not store it at home.
- Keep all drugs out of the reach of children and pets.
- Check with your pharmacist about how to throw out unused drugs.
- If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
- Do not share your child’s drug with others and do not give anyone else’s drug to your child.
- Keep a list of all your child’s drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child’s doctor.
- Talk with your child’s doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.
- Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, pharmacist, or other health care provider.
- If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
If you have any questions or concerns, talk with a member of your healthcare team. You can reach them Monday through Friday from 9:00 am to 5:00 pm at ____________________. After 5:00 pm, during the weekend, and on holidays, please call____________________. If there’s no number listed, or you’re not sure, call 212-639-2000.