Depakote ER

(Divalproex Sodium ER)

The active ingredient in Depakote ER is divalproex sodium. Once taken, divalproex sodium converts to valproic acid in the body. Valproic acid increases the amount of gamma-aminobutyric acid, or GABA, a natural chemical that helps calm brain activity. By increasing GABA levels, Depakote ER helps stabilize mood, reduce the risk of manic episodes in bipolar disorder, decrease seizure activity in epilepsy, and prevent migraine headaches.

Follow all directions given to you by your doctor and read all documents provided, including the full prescribing information, FDA-approved product labeling, instructions for use, and medication guide, before using Depakote ER. However, the following is a synopsis of the general guidelines for the use of Depakote ER:

• Depakote ER should be taken exactly as prescribed. It is usually taken once daily.
• Swallow Depakote ER tablets whole. Do not crush, chew, or split them. If swallowing tablets is difficult, speak with your healthcare provider about whether another dosage form, such as Depakote delayed-release or Depakote Sprinkle Capsules, may be more appropriate.
• Avoid drinking alcohol while taking Depakote ER, as alcohol may increase drowsiness and dizziness.
• Your healthcare provider will determine your dose based on your medical condition, age, weight, and response to treatment. The dose may be adjusted over time.
• If you miss a dose, take it as soon as you remember, unless it is almost time for your next dose. Take the next dose at your regular time. Do not take two doses at once.
• Do not stop taking Depakote ER suddenly. Stopping treatment without guidance can cause serious problems, including seizures that do not stop (status epilepticus) in people with epilepsy.

Some mild or common side effects of Depakote ER seen in clinical trials as compared to placebo include:

• Drowsiness or sleepiness
• Nausea
• Stomach pain
• Hair loss
• Asthenia or an abnormal lack of energy
• Diarrhea
• Diplopia or double vision
• Dizziness
• Headache
• Nausea
• Indigestion
• Trouble sleeping
• Constipation
• Tremor
• Weight loss or weight gain

Some individuals may experience serious side effects while using Depakote ER. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Signs of liver problems, especially within the first 6 months of treatment, such as yellowing of the skin or eyes, dark urine, swelling of the face, severe fatigue, loss of appetite, nausea, vomiting that does not stop, or right-sided stomach pain.
• Symptoms of pancreatitis such as severe stomach pain, nausea, vomiting, or loss of appetite.
• Suicidal thoughts or actions, worsening depression, severe anxiety, agitation, panic attacks, trouble sleeping, irritability, or other unusual mood or behavior changes.
• Signs of a severe allergic reaction such as skin rash, hives, swelling, trouble breathing, sores in the mouth, or blistering skin.
• Symptoms of high ammonia levels such as confusion, extreme tiredness, vomiting, or memory problems.
• Severe skin reactions like drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN). Symptoms include rash, hives, blisters, peeling skin, mouth sores, or trouble breathing.
• Thrombocytopenia (low platelet count), which can increase the risk of bleeding or bruising.

These are not all of the possible side effects of Depakote ER. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Depakote ER, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including:

• Liver problems or a history of liver disease.
• Kidney problems.
• A suspected or confirmed mitochondrial disorder such as Alpers-Huttenlocher syndrome.
• A history of pancreatitis.
• A history of depression, suicidal thoughts, or mood disorders.
• A urea cycle disorder.
• Alcohol use or a history of heavy drinking.
• Are planning to become pregnant. Depakote ER may affect fertility in some men and is not safe for women who are pregnant. Contraception is required during treatment.
• Are breastfeeding or planning to breastfeed.

Boxed Warning

• There is an increased risk for hepatotoxicity and liver damage during the first 6 months of treatment with Depakote ER. This damage can result in death, and children under 2 years of age and those with mitochondrial disorders are at a much greater risk. Regular monitoring of liver function is required.
• Depakote ER can harm the fetus, resulting in neural tube defects, malformations, and decreased IQ. This medication should not be used in pregnancy. Effective birth control should be used during treatment.
• Depakote ER may cause pancreatitis, a life-threatening inflammation or bleeding of the pancreas. Symptoms include severe abdominal pain, nausea, and vomiting.

Do not take Depakote ER if you:

• Are allergic to divalproex sodium, valproate, valproic acid, or any other ingredients in the formulation
• Have liver problems
• Have or are suspected to have a mitochondrial disorder such as Alpers-Huttenlocher syndrome
• Have a urea cycle disorder
• Are pregnant or plan to become pregnant

The time it takes to see results depends on the condition being treated. Some people may notice improvement in manic symptoms within several days, while seizure control or migraine prevention may take weeks. Your healthcare provider may adjust your dose over time to achieve the best response.

When Depakote ER is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Anticonvulsants such as phenytoin, carbamazepine, lamotrigine, felbamate, phenobarbital, or primidone
• Topiramate
• Carbapenem antibiotics
• Rifampin
• Aspirin
• Estrogen-containing contraceptives
• Methotrexate
• Cannabidiol products
• Alcohol

Depakote ER extended-release tablets are available as 250 mg and 500 mg tablets.

Other formulations, such as Depakote delayed-release tablets and Depakote Sprinkle Capsules, are also available.

Depakote ER tablets should be stored at room temperature away from moisture, heat, and light, and out of reach of children.

Depakote ER is manufactured by AbbVie Inc.

Generic versions of Depakote ER are available.

Consult your doctor or pharmacist before starting, stopping, or changing medications while taking Vermox. Do not stop taking Depakote ER without speaking to your healthcare provider. Stopping suddenly may cause serious complications, including severe seizures in people with epilepsy. Your healthcare provider will guide you on how to safely reduce your dose if needed.

Depakote ER can harm an unborn baby and cause major birth defects or long-term developmental problems. Women who are pregnant or planning to become pregnant must discuss alternative treatments with their healthcare provider. A pregnancy registry is available to track outcomes in people who take antiepileptic drugs during pregnancy.

Depakote can pass into breast milk. Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.