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What should I discuss with my healthcare provider before taking divalproex sodium (Depakote, Depakote ER, Depakote Sprinkles)?

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.

You should not take this medication if you are allergic to divalproex sodium, or if you have liver disease or a urea cycle disorder.

To make sure you can safely take divalproex sodium, tell your doctor if you have any of these other conditions:

• liver disease;
• a bleeding or blood clotting disorder;
• a history of head injury, brain disorder, or coma;
• a family history of a urea cycle disorder or 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. Divalproex sodium can cause birth defects. Do not start taking divalproex sodium without telling your doctor if you are pregnant or planning to become pregnant. Use effective birth control while you are taking divalproex sodium.

Divalproex sodium may also affect cognitive development in children born to mothers who take this medication during pregnancy. Studies have shown that these children may score lower on cognitive tests (reasoning, intelligence, and problem-solving) than children whose mothers took other seizure medications during pregnancy.

Although divalproex sodium may harm an unborn baby, having a seizure during pregnancy could harm both mother and baby. If you become pregnant while taking divalproex sodium, do not stop taking the medicine without your doctor's advice.

Seizure control is very important during pregnancy. The benefit of preventing seizures may outweigh any risks posed by taking divalproex sodium. There may be other seizure medications that can be more safely used during pregnancy. Follow your doctor's instructions about taking divalproex sodium while you are pregnant.

Divalproex sodium can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take divalproex sodium (Depakote, Depakote ER, Depakote Sprinkles)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Drink plenty of water while you are taking this medication. Your dose may need to be changed if you do not get enough fluids each day.

You may open the divalproex sodium sprinkle capsule and sprinkle the medicine into a spoonful of pudding or applesauce to make swallowing easier. Swallow this mixture right away.

Do not crush, chew, break, or open a delayed-release or extended-release tablet or capsule. Swallow it whole.

To be sure this medication is not causing harmful effects, your liver function will need to be tested. Visit your doctor regularly.

Do not stop using divalproex sodium without first talking to your doctor, even if you feel fine. You may have increased seizures if you stop using divalproex sodium suddenly. You may need to use less and less before you stop the medication completely.

Wear a medical alert tag or carry an ID card stating that you take divalproex sodium. Any doctor, dentist, or emergency medical care provider who treats you should know that you are taking a seizure medication.

Store at room temperature away from moisture and heat.

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