Depakote ER

Package insert / prescribing information
Generic name: divalproex sodium
Dosage form: tablet, extended release
Drug class: Fatty acid derivative anticonvulsants

Medically reviewed by A Ras MD.

What is Depakote ER?

Depakote comes in different dosage forms with different usages. Depakote Extended-Release Tablets are a prescription medicine used to treat manic episodes associated with bipolar disorder, alone or with other medicines to treat complex partial seizures in adults and children 10 years of age and older, simple and complex absence seizures, with or without other seizure types to prevent migraine headaches

Description

Divalproex sodium is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship and formed during the partial neutralization of valproic acid with 0.5 equivalent of sodium hydroxide. Chemically it is designated as sodium hydrogen bis(2-propylpentanoate). Divalproex sodium has the following structure:

Depakote ER: Uses, Dosage, Side effects & More

Divalproex sodium occurs as a white powder with a characteristic odor.

Depakote ER 250 and 500 mg tablets are for oral administration. Depakote ER tablets contain divalproex sodium in a once-a-day extended-release formulation equivalent to 250 and 500 mg of valproic acid.

Inactive Ingredients

Depakote ER 250 and 500 mg tablets: FD&C Blue No. 1, hypromellose, lactose, microcrystalline cellulose, polyethylene glycol, potassium sorbate, propylene glycol, silicon dioxide, titanium dioxide, and triacetin.

In addition, 500 mg tablets contain iron oxide and polydextrose.

Meets USP Dissolution Test 2.

Mechanism of Action

Divalproex sodium dissociates to the valproate ion in the gastrointestinal tract. The mechanisms by which valproate exerts its therapeutic effects have not been established. It has been suggested that its activity in epilepsy is related to increased brain concentrations of gamma-aminobutyric acid (GABA).

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

Do not stop taking Depakote ER without first talking to your healthcare provider.

Stopping Depakote ER suddenly can cause serious problems.

Depakote ER can cause serious side effects, including:

1. Serious liver damage that can cause death, especially in children younger than 2 years old. The risk of getting this serious liver damage is more likely to happen within the first 6 months of treatment.

Call your healthcare provider right away if you get any of the following symptoms:
In some cases, liver damage may continue despite stopping the drug.

nausea or vomiting that does not go away
loss of appetite
pain on the right side of your stomach (abdomen)
dark urine
swelling of your face
yellowing of your skin or the whites of your eyes

2. Depakote ER may harm your unborn baby.

If you take Depakote ER during pregnancy for any medical condition, your baby is at risk for serious birth defects that affect the brain and spinal cord and are called spina bifida or neural tube defects. These defects occur in 1 to 2 out of every 100 babies born to mothers who use this medicine during pregnancy. These defects can begin in the first month, even before you know you are pregnant. Other birth defects that affect the structures of the heart, head, arms, legs, and the opening where the urine comes out (urethra) on the bottom of the penis can also happen. Decreased hearing or hearing loss can also happen.
Birth defects may occur even in children born to women who are not taking any medicines and do not have other risk factors.
Taking folic acid supplements before getting pregnant and during early pregnancy can lower the chance of having a baby with a neural tube defect.
If you take Depakote ER during pregnancy for any medical condition, your child is at risk for having lower IQ and may be at risk for developing autism or attention deficit/hyperactivity disorder.
There may be other medicines to treat your condition that have a lower chance of causing birth defects, decreased IQ, or other disorders in your child.
Women who are pregnant must not take Depakote ER to prevent migraine headaches.
All women of childbearing age (including girls from the start of puberty) should talk to their healthcare provider about using other possible treatments instead of Depakote ER. If the decision is made to use Depakote ER, you should use effective birth control (contraception).
Tell your healthcare provider right away if you become pregnant while taking Depakote ER. You and your healthcare provider should decide if you will continue to take Depakote ER while you are pregnant.
Pregnancy Registry: If you become pregnant while taking Depakote ER, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling toll-free 1-888-233-2334 or by visiting the website, http://www.aedpregnancyregistry.org/. The purpose of this registry is to collect information about the safety of antiepileptic drugs during pregnancy.

3. Inflammation of your pancreas that can cause death.

Call your healthcare provider right away if you have any of these symptoms:

severe stomach pain that you may also feel in your back
nausea or vomiting that does not go away

4. Like other antiepileptic drugs, Depakote ER may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.

Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:

thoughts about suicide or dying
attempts to commit suicide
new or worse depression
new or worse anxiety
feeling agitated or restless
panic attacks
trouble sleeping (insomnia)
new or worse irritability
acting aggressive, being angry, or violent
acting on dangerous impulses
an extreme increase in activity and talking (mania)
other unusual changes in behavior or mood

How can I watch for early symptoms of suicidal thoughts and actions?

Pay attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings.
Keep all follow-up visits with your healthcare provider as scheduled.

Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

Do not stop Depakote ER without first talking to a healthcare provider. Stopping Depakote ER suddenly can cause serious problems. Stopping a seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus).

Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

Who should not take Depakote ER?

Do not take Depakote ER if you:

have liver problems
have or think you have a genetic liver problem caused by a mitochondrial disorder (e.g. Alpers-Huttenlocher syndrome)
are allergic to divalproex sodium, valproic acid, sodium valproate or any of the ingredients in Depakote ER. See the end of this leaflet for a complete list of ingredients in Depakote ER.
have a genetic problem called urea cycle disorder
are taking it to prevent migraine headaches and are either pregnant or may become pregnant because you are not using effective birth control (contraception)

What should I tell my healthcare provider before taking Depakote ER?

Before you take Depakote ER, tell your healthcare provider if you:

have a genetic liver problem caused by a mitochondrial disorder (e.g. Alpers-Huttenlocher syndrome)
drink alcohol
are pregnant or breastfeeding. Depakote ER can pass into breast milk. Talk to your healthcare provider about the best way to feed your baby if you take Depakote ER.
have or have had depression, mood problems, or suicidal thoughts or behavior
have any other medical conditions

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, herbal supplements and medicines that you take for a short period of time.

Taking Depakote ER with certain other medicines can cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider.

Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist each time you get a new medicine.

How should I take Depakote ER?

Take Depakote ER exactly as your healthcare provider tells you. Your healthcare provider will tell you how much Depakote ER to take and when to take it.
Your healthcare provider may change your dose.
Do not change your dose of Depakote ER without talking to your healthcare provider.
Do not stop taking Depakote ER without first talking to your healthcare provider. Stopping Depakote ER suddenly can cause serious problems.
Swallow Depakote ER tablets whole. Do not crush or chew Depakote ER tablets. Tell your healthcare provider if you cannot swallow Depakote ER whole. You may need a different medicine.
If you take too much Depakote ER call your healthcare provider or local Poison Control Center right away.

What should I avoid while taking Depakote ER?

Depakote ER can cause drowsiness and dizziness. Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking Depakote ER until you talk with your doctor. Taking Depakote ER with alcohol or drugs that cause sleepiness or dizziness may make your sleepiness or dizziness worse.
Do not drive a car or operate dangerous machinery until you know how Depakote ER affects you. Depakote ER can slow your thinking and motor skills.

What are the possible side effects of Depakote ER?

See “What is the most important information I should know about Depakote?”

Depakote ER can cause serious side effects including:

Bleeding problems: red or purple spots on your skin, bruising, pain and swelling into your joints due to bleeding or bleeding from your mouth or nose.
High ammonia levels in your blood: feeling tired, vomiting, changes in mental status.
Low body temperature (hypothermia): drop in your body temperature to less than 95°F, feeling tired, confusion, coma.
Allergic (hypersensitivity) reactions: fever, skin rash, hives, sores in your mouth, blistering and peeling of your skin, swelling of your lymph nodes, swelling of your face, eyes, lips, tongue, or throat, trouble swallowing or breathing.
Drowsiness or sleepiness in the elderly. This extreme drowsiness may cause you to eat or drink less than you normally would. Tell your doctor if you are not able to eat or drink as you normally do. Your doctor may start you at a lower dose of Depakote ER.

Call your healthcare provider right away, if you have any of the symptoms listed above.

The common side effects of Depakote ER include:

nausea
headache
sleepiness
vomiting
weakness
tremor
dizziness
stomach pain
blurry vision
double vision
diarrhea
increased appetite
weight gain
hair loss
loss of appetite
problems with walking or coordination

These are not all of the possible side effects of Depakote ER. For more information, ask your healthcare provider or pharmacist.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of Depakote ER

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Depakote ER for a condition for which it was not prescribed. Do not give Depakote ER to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about Depakote ER. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Depakote ER that is written for health professionals.

For more information, go to www.rxabbvie.com or call 1-800-633-9110.

How should I store Depakote ER?

Store Depakote Extended-Release Tablets between 59°F to 86°F (15°C to 30°C).

Keep Depakote ER and all medicines out of the reach of children.

What are the ingredients in Depakote ER?

Active ingredient: divalproex sodium

Inactive ingredients: FD&C Blue No. 1, hypromellose, lactose, microcrystalline cellulose, polyethylene glycol, potassium sorbate, propylene glycol, silicon dioxide, titanium dioxide, and triacetin. The 500 mg tablets also contain iron oxide and polydextrose.