Depakote ER

Generic name: Divalproex sodium, extended-release

What is Depakote ER?

Depakote is used to treat complex partial seizures, and simple and complex absence seizures in adults and children 10 years and older with epilepsy.

Depakote is also used for the treatment of episodes associated with bipolar disorder (manic or mixed episodes with or without psychotic features). A manic episode is a period of abnormally and persistently elevated, unreserved, or irritable mood. A mixed episode is a manic episode with a major depressive episode (depressed mood, loss of interest or pleasure in nearly all activities).

In addition, Depakote is for the prevention of migraine headaches in adults.

What is the most important information I should know about Depakote ER?

Women who can become pregnant should know Depakote is associated with birth defects such as spina bifida and other neural canal closure problems. Those taking Depakote during pregnancy may develop clotting abnormalities and should be monitored carefully. Additionally, an increased incidence of epilepsy in children born to mothers who took Depakote in their first 12 weeks of pregnancy has been reported. If you become pregnant while taking this drug, contact your doctor immediately.

Some people who take Depakote experience serious liver problems. Your doctor should check your liver function before you start this medication and continue frequently thereafter. If you experience malaise, weakness, tiredness, facial swelling, loss of appetite, or vomiting, inform your doctor immediately; this may be a sign of more serious liver problems.

Some people may experience pancreatitis, a serious and life-threatening inflammation of the pancreas. If you experience stomach pain, nausea, vomiting, and loss of appetite, contact your doctor immediately; this may be a sign of pancreatitis.

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.

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

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.

Some people taking 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.

Who should not take Depakote ER?

Women who are pregnant, planning to become pregnant, or are nursing, should not begin treatment with Depakote ER.

Depakote ER should not be given to patients with liver disease or significant liver dysfunction.

You should not take this medication if you are allergic to it, or if you have a condition called urea cycle disorder.

What should I tell my doctor before I take the first dose of Depakote ER?

Tell your doctor about all prescription, over-the-counter, and herbal medications you are taking before beginning treatment with Depakote ER. Also, talk to your doctor about your complete medical history, especially if you have a condition called urea cycle disorder, a history of liver problems or liver disease, or have been allergic to Depakote ER in the past. In addition, tell your doctor if you are pregnant, planning to become pregnant, or are nursing.

What is the usual dosage?

The information below is based on the dosage guidelines your doctor uses. Depending on your condition and medical history, your doctor may prescribe a different regimen. Do not change the dosage or stop taking your medication without your doctor's approval.

Complex Partial Seizures

Adults and children 10 years and older: The usual starting dose of Depakote is 10 milligrams (mg) to 15 mg/kg/day. This dosage should be increased by 5 to 10 mg/kg per week until optimal clinical response is achieved. Usually, the optimal clinical response is achieved at a daily dose below 60 mg/kg per day.

Bipolar Disorder

Adults: The recommended starting dose of Depakote ER is 25 mg/kg daily given once daily. The dose should increase as rapidly as possible to achieve the lowest therapeutic dose that produces the desired clinical effect. The maximum recommended dose is 60 mg/kg per day.

Migraines

Adults: The recommended starting dose for Depakote ER is 500 mg once a day for one week. After one week, the dose should be increased to 1000 mg daily. The effective dose range for patients with migraines is 500-1000 mg daily

Simple and Complex Absence Seizures

Adults and children 10 years and older: The recommended initial dose is 15 mg/kg daily, increasing by 5 to 10 mg/kg per day at one week intervals. The maximum recommended dose is 60 mg/kg daily.

Due to an increased sensitivity to Depakote, elderly patients should be started on a lower dose of the drug. Dosage should be increased more slowly with regular monitoring.

How should I take Depakote ER?

Depakote ER tablets should be swallowed whole and should not be crushed or chewed. If you experience stomach irritation, try taking Depakote ER with food or by slowly building up the dose from the initial low level. Take Depakote ER only as directed by your doctor. Try to take Depakote ER at the same time every day.

What should I avoid while taking Depakote ER?

You should avoid combining Depakote ER with alcohol, a CNS depressant, which may increase the side effects of the drug.

You may experience drowsiness when you start this medication. Avoid driving or operating dangerous machinery until you know how this medication affects you.

What are possible food and drug interactions associated with Depakote ER?

If Depakote ER is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Depakote ER with the following: alcohol, amitryptyline, aspirin, carbamazepine, carbapenem antibiotics, diazepam, ethosuximide, lamotrigine, nortryptyline, phenobarbital, phenytoin, primidone, rifampin, topiramate, warfarin, and zidovudine.

What are the possible side effects of Depakote ER?

Side effects cannot be anticipated. If any develop or change in intensity, tell your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking this drug.

Side effects may include: nausea, drowsiness, dizziness, vomiting, abdominal pain, diarrhea, increased appetite, weight gain, headache, fever, loss of appetite, constipation, flu, infection, sleepiness, nervousness

Can I receive Depakote ER if I am pregnant or breastfeeding?

The use of Depakote ER during pregnancy has been associated with birth defects such as spina bifida and other defects where the neural canal does not close normally. Women taking Depakote ER during pregnancy may develop clotting abnormalities and should be monitored carefully. Also, there has been a reported incidence of epilepsy in children born to mothers who took Depakote ER in their first 12 weeks of pregnancy If you become pregnant while on Depakote ER, notify your doctor immediately.

Depakote ER is excreted in breast milk and may harm a nursing infant. A decision between you and your doctor should be made on whether to discontinue nursing or consider an alternative drug treatment.

What should I do if I miss a dose of Depakote ER?

If you missed a dose of Depakote ER, take the dose as soon as possible unless it is almost time for the next dose. If a dose is skipped, you should not double the next dose.

How should I store Depakote ER?

Store at room temperature.