divalproex sodium

Generic Name: divalproex sodium (dye val PRO ex)
Brand Name: Depakote, Depakote ER, Depakote Sprinkles

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 purposes not listed in this medication guide.

What is the most important information I should know about divalproex sodium?

Divalproex sodium may cause harm to an unborn baby, but having a seizure during pregnancy could harm both the mother and the baby. Tell your doctor right away if you become pregnant while taking divalproex sodium for seizures. Do not start or stop taking divalproex sodium during pregnancy without your doctor's advice.

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Seek emergency medical attention if the person taking this medicine has nausea, vomiting, upper 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 or pancreatitis.

Report any new or worsening symptoms to your doctor, 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.

What should I discuss with my healthcare provider before taking divalproex sodium?

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?

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.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include sleepiness or drowsiness, shallow breathing, weak pulse, or loss of consciousness.

What should I avoid while taking divalproex sodium?

Drinking alcohol can increase certain side effects of divalproex sodium.

Divalproex sodium may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Avoid exposure to sunlight or tanning beds. Divalproex sodium can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Divalproex sodium side effects

Seek emergency medical attention if the person taking this medicine has nausea, vomiting, upper 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 or pancreatitis.

Report any new or worsening symptoms to your doctor, 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 other serious side effects:

• unexplained weakness with vomiting and confusion or fainting;

• easy bruising or bleeding, blood in your urine;

• fever, chills, body aches, swollen glands, flu symptoms;

• urinating less than usual;

• extreme drowsiness, lack of coordination, hallucinations;

• double vision or back-and-forth movements of the eyes; or

• severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious side effects may include:

• mild drowsiness or weakness;

• diarrhea, constipation, upset stomach;

• changes in your menstrual periods;

• enlarged breasts, weight changes;

• tremor (shaking);

• hair loss;

• vision changes; or

• unusual or unpleasant taste in your mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: divalproex sodium side effects (in more detail)

Divalproex sodium Dosing Information

Usual Adult Dose for Epilepsy:

For both delayed-release and extended-release tablets:

Complex partial seizures:
Initial Therapy: 10 to 15 mg/kg/day.
Titration: Increase by 5 to 10 mg/kg/week to achieve optimal clinical response.
Maintenance: Usually below 60 mg/kg/day. No recommendation regarding safety at doses above 60 mg/kg/day can be made.

Simple and Complex Absence Seizures:
Initial Therapy: 15 mg/kg/day.
Titration: Increase at one week intervals by 5 to 10 mg/kg/day until seizures are controlled or side effects preclude further increases.
Maximum Recommended Dose: 60 mg/kg/day.

Note: Extended-release tablets are intended for once a day oral administration. When using delayed-release tablets, total daily doses in excess of 250 mg should be given in divided doses.

Usual Adult Dose for Mania:

Delayed-release tablets:
Initial dose: 250 mg daily in divided doses.
Maintenance dose: The dose should be rapidly titrated to achieve the lowest therapeutic dose which produces the desired clinical effect.

Extended-release tablets:
Initial dose: 25 mg/kg once a day.
Titration: Increase as rapidly as possible to achieve the lowest therapeutic dose which produces the desired clinical effect or the desired range of plasma concentrations.
Maximum dose: 60 mg/kg/day

Usual Adult Dose for Migraine Prophylaxis:

Delayed-release tablets:
Initial dose: 250 mg orally twice a day.
Maintenance dose: Some patients may benefit from doses up to 1000 mg per day.

Extended-release tablets:
Initial dose: 500 mg orally once a day for 1 week
Maintenance dose: May increase to 1000 mg once daily.

Usual Pediatric Dose for Epilepsy:

>=10 years old:
For both delayed-release and extended-release tablets:

Complex partial seizures:
Initial Therapy: 10 to 15 mg/kg/day.
Titration: Increase by 5 to 10 mg/kg/week to achieve optimal clinical response.
Maintenance: Usually below 60 mg/kg/day. No recommendation regarding safety at doses above 60 mg/kg/day can be made.

Simple and Complex Absence Seizures:
Initial Therapy: 15 mg/kg/day.
Titration: Increase at one week intervals by 5 to 10 mg/kg/day until seizures are controlled or side effects preclude further increases.
Maximum Recommended Dose: 60 mg/kg/day.

Note: Extended-release tablets are intended for once a day oral administration. When using delayed-release tablets, total daily doses in excess of 250 mg should be given in divided doses.

What other drugs will affect divalproex sodium?

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.

Tell your doctor about all other medications you use, especially:

• topiramate (Topamax);

• tolbutamide (Orinase);

• a blood thinner such as warfarin (Coumadin, Jantoven);

• aspirin or acetaminophen (Tylenol);

• zidovudine (Retrovir);

• clozapine (Clozaril, FazaClo);

• diazepam (Valium);

• meropenem (Merrem) or imipenem and cilastatin (Primaxin);

• rifampin (Rifadin, Rimactane, Rifater); or

• ethosuximide (Zarontin).

This list is not complete and other drugs may interact with divalproex sodium. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about divalproex sodium.