What is divalproex sodium?

Divalproex sodium affects chemicals in the body that may be involved in causing seizures.

Divalproex sodium is used to treat various types of seizure disorders. Divalproex sodium is sometimes used together with other seizure medications.

Divalproex sodium may also be used for other purposes not listed in this medication guide.

Precautions

In rare cases, divalproex sodium has caused life-threatening liver failure, especially in children younger than 2 years old. Children of this age may be at even greater risk for liver problems if they use more than one seizure medication, if they have a metabolic disorder, or if they have a brain disease causing mental impairment (such as Creutzfeldt-Jacob disease, Huntington disease, multiple sclerosis, or a brain injury or infection).

Divalproex sodium has also caused rare cases of life-threatening pancreatitis (inflammation of the pancreas). Pancreatitis can come on suddenly and symptoms may start even after you have been taking divalproex sodium for several years.

Do not take divalproex sodium if you have liver disease or a urea cycle disorder.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely take divalproex sodium.

  • a bleeding or blood clotting disorder;
  • a history of head injury, brain disorder, or coma;
  • a family history of a urea cycle disorder;
  • a family history of infant deaths with unknown cause; or
  • HIV or CMV (cytomegalovirus) infection.

You may have thoughts about suicide while taking this medication. Tell your doctor if you have new or worsening depression or suicidal thoughts during the first several months of treatment, or whenever your dose is changed.

Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits. Do not miss any scheduled appointments.

FDA pregnancy category D. This medication can cause harm to an unborn baby. Do not use divalproex sodium without your doctor’s consent if you are pregnant. Tell your doctor if you become pregnant during treatment. Divalproex sodium can cause birth defects. Use an effective form of birth control while you are using this medication.

Divalproex sodium passes into breast milk and could harm a nursing infant. Do not take divalproex sodium without telling your doctor if you are breast-feeding a baby.

Avoid drinking alcohol, which can increase some of the side effects of divalproex sodium.

Divalproex sodium can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Divalproex sodium can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.

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Instructions

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include sleepiness or drowsiness, shallow breathing, weak pulse, or loss of consciousness.

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

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Side Effects

Seek emergency medical attention if the person taking this medicine has nausea, vomiting, stomach pain, or loss of appetite, low fever, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes). These symptoms may be early signs of liver damage. Some of these symptoms may also be early signs of pancreatitis.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • unexplained weakness with vomiting and confusion or fainting;
  • easy bruising or bleeding, blood in your urine;
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
  • fever, chills, body aches, flu symptoms;
  • urinating less than usual;
  • hallucinations (seeing things that aren't there);
  • extreme drowsiness, lack of coordination; or
  • double vision or back-and-forth movements of the eyes.

Less serious side effects may include:

  • mild drowsiness or weakness;
  • diarrhea, constipation, upset stomach;
  • depression, anxiety, or other emotional changes;
  • changes in your menstrual periods;
  • enlarged breasts;
  • tremor (shaking);
  • hair loss;
  • weight changes;
  • vision changes; or
  • unusual or unpleasant taste in your mouth.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

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Interactions

Cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for depression or anxiety can add to sleepiness caused by divalproex sodium. Tell your doctor if you regularly use any of these medicines, or any other seizure medication.

Before taking divalproex sodium, tell your doctor if you are using any of the following drugs:

  • topiramate (Topamax);
  • tolbutamide (Orinase);
  • a blood thinner such as warfarin (Coumadin);
  • aspirin or acetaminophen (Tylenol);
  • zidovudine (Retrovir);
  • clozapine (Clozaril, FazaClo);
  • diazepam (Valium);
  • meropenem (Merrem);
  • rifampin (Rifadin, Rimactane, Rifater); or
  • ethosuximide (Zarontin).

This list is not complete and there may be other drugs that can interact with divalproex sodium. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Other Names

Depakote, Depakote ER, Depakote Sprinkles, and divalproex sodium

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Disclaimer

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum'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. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum 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.

Copyright 1996-2004 Cerner Multum, Inc. Version 2.05. Revision date 8/23/04

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