Uses^1,2

• Depakote ER is indicated for the treatment of acute manic or mixed episodes associated with bipolar disorder, with or without psychotic features.
• Depakote is indicated for the treatment of manic episodes associated with bipolar disorder.
• Depakote and Depakote ER are indicated for the treatment of complex partial seizures, and simple and complex absence seizures in adults and children 10 years of age and older with epilepsy.
• Depakote and Depakote ER are indicated for the prevention of migraine headaches in adults.

Important Safety Information^1,2

Your doctor has prescribed Depakote or Depakote ER as part of your treatment plan. However, as with any medication, serious side effects can occur during treatment. It is very important that you know about these serious side effects and talk about them with your doctor.

The following serious side effects can occur with Depakote and Depakote ER:

Some people have experienced serious liver problems while taking valproic acid*. Your doctor should check your liver function before you start this medication and at frequent intervals thereafter. You will also be monitored for symptoms that lead to liver toxicity. Before taking this medication, tell your doctor if you have liver disease. Depakote or Depakote ER should not be taken if you have liver disease. Notify your doctor immediately if you develop malaise (illness), weakness, tiredness, facial swelling, and loss of appetite or vomiting.

Before taking valproate*, women who could become pregnant should talk with their doctor, as valproic acid has been associated with birth defects in children of women who have taken it while pregnant. If you become pregnant while taking this medication, contact your doctor immediately. Your doctor should advise you of the risk and alternative treatment options. Be sure to read the Patient Information Leaflet, which appears as the last section of the full Prescribing Information.

Some people taking valproate have experienced a serious, life-threatening problem called pancreatitis, which means that the pancreas has become inflamed. Call your doctor immediately if you experience stomach pain, nausea, vomiting, and/or loss of appetite, as these can be symptoms of pancreatitis.

Elevated ammonia levels and hypothermia, an unintentional drop in body temperature, have been reported in some patients receiving valproate. Contact your doctor immediately if you experience abnormal drowsiness and vomiting or changes in mental status.

A fever associated with other symptoms such as rash or enlargement of the lymph nodes should be reported to your physician immediately.

Some people taking Depakote and Depakote ER may experience low blood platelet counts. Your doctor should order blood tests to check your platelets while you are taking this medication, as well as prior to surgery.

You may experience drowsiness when you start this medication. You should not drive or operate dangerous machinery until you know how this medication will affect you.

You should not take this medication if you are allergic to it, or if you have a condition called urea cycle disorder, which may cause too much ammonia to build up in your body. Let your doctor know if you have been diagnosed with these conditions.

Mania Pivotal Trials

The most common adverse (side) effects reported in clinical trials for mania with Depakote were nausea, vomiting, drowsiness, and dizziness.

Manic or Mixed Episodes with or without Psychotic Features Pivotal Trials

The most common side effects reported in clinical trials for mania with Depakote ER were drowsiness, stomach upset following meals, nausea, vomiting, diarrhea, dizziness, and abdominal pain.

Epilepsy Clinical Trials

The most common adverse (side) effects reported in epilepsy clinical trials with Depakote were tremor, nausea, abdominal pain, diarrhea, vomiting, low blood platelet count, weakness, drowsiness, dizziness, loss of appetite, and transient hair loss.

Migraine Prevention

The most common adverse (side) effects reported in clinical trials for migraine prevention with Depakote were nausea, stomach upset following meals, weakness, diarrhea, abdominal pain, vomiting, dizziness, and drowsiness.

The most common adverse (side) effects reported in clinical trials with Depakote ER for migraine prevention were nausea, stomach upset following meals, diarrhea, vomiting, abdominal pain, and drowsiness.

This is not a complete list of reported side effects.

Dosing Considerations

Depakote and Depakote ER tablets should be swallowed whole and should not be crushed or chewed.

 

Keep Depakote ER and all other medication where children cannot reach them.

 

* Divalproex sodium is a compound that contains sodium valproate and valproic acid.

Click Here for Full Prescribing Information

References:

1. Depakote ER package insert. Abbott Laboratories: Abbott Park, IL.
2. Depakote package insert. Abbott Laboratories: Abbott Park, IL.