Depakote contains the active ingredient divalproex sodium, which combines sodium valproate and valproic acid. It is provided as delayed-release tablets for oral administration in strengths equivalent to 125 mg, 250 mg, or 500 mg of valproic acid. Key inactive ingredients include colloidal silicon dioxide, corn starch, povidone, and hypromellose. The tablets are designed to release the medication over time after ingestion.

How should I use this medication?

Take this medication by mouth with a drink of water. Follow the directions on the prescription label. Do not cut, crush or chew this medication. You can take it with or without food. If it upsets your stomach, take it with food. Take your medication at regular intervals. Do not take it more often than directed. Do not stop taking except on your care team's advice. A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time. Talk to your care team about the use of this medication in children. While this medication may be prescribed for children as young as 10 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once. NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Where should I keep my medication?

Keep out of reach of children and pets. Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Keep container tightly closed. Throw away any unused medication after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible: -Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat -High ammonia level—unusual weakness or fatigue, confusion, loss of appetite, nausea, vomiting, seizures -Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue -Low body temperature, drowsiness, confusion -Pancreatitis—severe stomach pain that spreads to your back or gets worse after eating or when touched, fever, nausea, vomiting -Rash, fever, and swollen lymph nodes -Thoughts of suicide or self-harm, worsening mood, feelings of depression -Unusual bruising or bleeding Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome): -Change in vision -Dizziness -Drowsiness -Hair loss -Headache -Nausea -Tremors or shaking -Weight gain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions: -Frequently drink alcohol -Kidney disease -Liver disease -Low platelet counts -Mitochondrial disease -Suicidal thoughts, plans, or attempt by you or a family member -Urea cycle disorder (UCD) -An unusual or allergic reaction to divalproex sodium, sodium valproate, valproic acid, other medications, foods, dyes, or preservatives -Pregnant or trying to get pregnant -Breast-feeding

What may interact with this medication?

Do not take this medication with any of the following: -Sodium phenylbutyrate This medication may also interact with the following: -Aspirin -Certain antibiotics, such as ertapenem, imipenem, meropenem -Certain medications for depression, anxiety, or other mental health conditions -Certain medications for seizures, such as cannabidiol, carbamazepine, clonazepam, diazepam, ethosuximide, felbamate, lamotrigine, phenobarbital, phenytoin, primidone, rufinamide, topiramate -Certain medications that treat or prevent blood clots, such as warfarin -Cholestyramine -Estrogen and progestin hormones -Methotrexate -Propofol -Rifampin -Ritonavir -Tolbutamide -Zidovudine

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Tell your care team if your symptoms do not get better or they start to get worse. This medication may cause serious skin reactions. They can happen weeks to months after starting the medication. Contact your care team right away if you notice fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. Or, you might notice a red rash with swelling of the face, lips or lymph nodes in your neck or under your arms. Wear a medical ID bracelet or chain, and carry a card that describes your disease and details of your medication and dosage times. You may get drowsy, dizzy, or have blurred vision. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medication affects you. To reduce dizzy or fainting spells, do not sit or stand up quickly, especially if you are an older patient. Alcohol can increase drowsiness and dizziness. Avoid alcoholic drinks. This medication can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths. Patients and their families should watch out for new or worsening depression or thoughts of suicide. Also watch out for sudden changes in feelings such as feeling anxious, agitated, panicky, irritable, hostile, aggressive, impulsive, severely restless, overly excited and hyperactive, or not being able to sleep. If this happens, especially at the beginning of treatment or after a change in dose, call your care team. Women should inform their care team if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your care team or pharmacist for more information. Women who become pregnant while using this medication may enroll in the North American Antiepileptic Drug Pregnancy Registry by calling 1-888-233-2334. This registry collects information about the safety of antiepileptic medication use during pregnancy. This medication may cause a decrease in folic acid and vitamin D. You should make sure that you get enough vitamins while you are taking this medication. Discuss the foods you eat and the vitamins you take with your care team.

What are the most serious risks of this medication?

Babies and children younger than 2 are at a very high risk of deadly liver damage from taking this medicine. The risk is even higher in children younger than 2 who: are taking other seizure medicines; have congenital metabolic disorders; have mental retardation and severe seizure disorder; or have organic brain disease. Children age 2 and older have a much lower risk of liver damage. If this medicine must be used in a child younger than 2, it will be with extreme caution and very close monitoring. Females who can become pregnant should only take this medicine if all other medicines for her condition do not work. Effective birth control must be used while taking this medicine, because it can cause severe birth defects and a low IQ in an unborn baby. Call your healthcare provider if you become pregnant, have unprotected sex, or think your birth control has failed. This medicine may cause harm to an unborn baby. This medicine should only be used during pregnancy and in females who can get pregnant if you have a serious condition that cannot be controlled with any other medicine. If you are a female who can get pregnant, use effective birth control while taking this medicine. This medicine should not be taken by people who have a genetic liver problem caused by a mitochondrial disorder, like Alpers-Huttenlocher syndrome. Talk to your healthcare provider if you have liver problems and are not sure if the cause is a mitochondrial disorder. There is a very high risk of deadly liver damage when people with these specific liver problems take this medicine. This medicine can cause inflammation of your pancreas that can lead to death (called pancreatitis). Call your healthcare provider or get emergency medical help right away if you have: severe stomach pain; nausea or vomiting that does not go away; and/or loss of appetite. This medicine can cause serious, life-threatening liver damage.