Depakote ER extended-release tablets

Pronunciation

Generic Name: divalproex (dye-VAL-proe-ex)
Brand Name: Depakote ER

Liver failure and death from liver failure has occurred in patients taking Depakote ER extended-release tablets. This has usually occurred within the first 6 months of treatment. Tell your doctor right away if you notice symptoms of liver problems (eg, a general feeling of discomfort, sluggishness, unusual tiredness or weakness, swelling of the face, loss of appetite, vomiting, stomach pain, dark urine, pale stools, or yellowing of the skin or eyes). In patients who have seizures, loss of seizure control may occur. You should have lab tests done before and during treatment to check for liver problems. Be sure to keep all doctor and lab appointments.

Children younger than 2 years old have an increased risk of fatal liver problems, especially if they take more than 1 seizure medicine or have a metabolic disorder, a severe seizure disorder along with mental retardation, or organic brain disease. Discuss any questions or concerns with your doctor.

There is an increased risk of liver failure and death from liver failure in patients who have a genetic liver problem caused by a mitochondrial disorder (eg, Alpers-Huttenlocher syndrome). You may need to have a special genetic test to check for this condition. Certain patients who have known or suspected mitochondrial disorders should not take Depakote ER extended-release tablets. Talk with your doctor for more information.

Depakote ER extended-release tablets can cause severe birth defects if it is used during pregnancy. It can also cause the child to have a lower IQ. Do not take Depakote ER extended-release tablets to prevent migraine headaches if you are pregnant. If you are pregnant and take Depakote ER extended-release tablets for seizures or bipolar disorder, talk to your doctor to decide if you will continue to take Depakote ER extended-release tablets.

If you are able to become pregnant, you must use an effective form of birth control while you take Depakote ER extended-release tablets. Contact your doctor right away if you become pregnant or think you may be pregnant while taking Depakote ER extended-release tablets.

Depakote ER extended-release tablets comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Depakote ER extended-release tablets refilled.

Severe and sometimes fatal pancreas problems (pancreatitis) have occurred with the use of Depakote ER extended-release tablets. This has been reported shortly after starting treatment as well as after several years of use. Seek immediate medical attention if you notice any stomach pain, nausea, vomiting, or loss of appetite.


Depakote ER extended-release tablets is used for:

Controlling certain types of seizures in the treatment of epilepsy. It is also used to treat the manic phase of bipolar disorder (manic-depressive illness) and prevent migraine headaches. It may also be used for other conditions as determined by your doctor.

Depakote ER extended-release tablets is an anticonvulsant. It works by reducing or preventing the number of seizures by controlling the abnormal activity of nerve impulses in the brain and central nervous system. Exactly how it works to treat bipolar disorder and migraine headache is not known.

Do NOT use Depakote ER extended-release tablets if:

  • you are allergic to any ingredient in Depakote ER extended-release tablets
  • you have liver problems or a urea cycle disorder
  • you have a genetic liver problem caused by a mitochondrial disorder (eg, Alpers-Huttenlocher syndrome)
  • the patient is younger than 2 years old and has a mitochondrial disorder
  • you are taking Depakote ER extended-release tablets to prevent migraine headaches and you are pregnant

Contact your doctor or health care provider right away if any of these apply to you.

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Before using Depakote ER extended-release tablets:

Some medical conditions may interact with Depakote ER extended-release tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, are breast-feeding, or are of childbearing age
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of cancer, alcohol abuse or dependence, liver problems, metabolic disease, blood disease (eg, low levels of white blood cells, low blood platelet levels), HIV infection, cytomegalovirus (CMV) infection, high blood levels of ammonia or glutamine, low body temperature, low levels of albumin, brain problems (eg, organic brain disease), mental retardation, inflammation of the pancreas, kidney problems, or high blood glycine levels, or if you are scheduled for surgery
  • if you have a history of ornithine transcarbamylase deficiency or unexplained coma
  • if you have a family history of urea cycle disorders or unexplained infant deaths
  • if you have a history of mental or mood problems (eg, depression) or suicidal thoughts or actions
  • if you have recurring vomiting and sluggishness, recurring extreme irritability, or decreased food or fluid intake
  • if you take any other medicine for seizures

Some MEDICINES MAY INTERACT with Depakote ER extended-release tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Benzodiazepines (eg, diazepam), felbamate, or salicylates (eg, aspirin) because they may increase the risk of Depakote ER extended-release tablets's side effects
  • Clonazepam because the risk of seizures may be increased
  • Topiramate because the risk of high ammonium levels, brain problems, or an unusual drop in body temperature may be increased
  • Carbamazepine, carbapenem antibiotics (eg, ertapenem, imipenem, meropenem), hydantoins (eg, phenytoin), mefloquine, oral contraceptives (eg, birth control pills), or rifampin because they may decrease Depakote ER extended-release tablets's effectiveness
  • Anticoagulants (eg, warfarin), barbiturates (eg, phenobarbital, primidone), ethosuximide, lamotrigine, methylphenidate, quetiapine, rufinamide, tolbutamide, tricyclic antidepressants (eg, amitriptyline), or zidovudine because the risk of their side effects may be increased by Depakote ER extended-release tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Depakote ER extended-release tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Depakote ER extended-release tablets:

Use Depakote ER extended-release tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Depakote ER extended-release tablets comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Depakote ER extended-release tablets refilled.
  • Take Depakote ER extended-release tablets by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
  • Swallow Depakote ER extended-release tablets whole. Do not break, crush, or chew before swallowing.
  • Taking Depakote ER extended-release tablets at the same time each day will help you remember to take it.
  • Do not stop taking Depakote ER extended-release tablets suddenly, especially if you are taking Depakote ER extended-release tablets to prevent seizures. Suddenly stopping Depakote ER extended-release tablets may cause severe seizures to occur. If you need to stop Depakote ER extended-release tablets, your doctor will gradually lower your dose.
  • Continue to take Depakote ER extended-release tablets even if you feel well. Do not miss any doses. Depakote ER extended-release tablets works best when there is a constant level of it in your body.
  • If you miss a dose of Depakote ER extended-release tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Depakote ER extended-release tablets.

Important safety information:

  • Depakote ER extended-release tablets may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Depakote ER extended-release tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Depakote ER extended-release tablets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Tell your doctor or dentist that you take Depakote ER extended-release tablets before you receive any medical or dental care, emergency care, or surgery.
  • Inflammation of the pancreas is a potentially life-threatening illness associated with Depakote ER extended-release tablets. Symptoms include stomach pain, vomiting, or loss of appetite. Contact your doctor at once if any of these symptoms occur.
  • Patients who take Depakote ER extended-release tablets may be at increased risk for suicidal thoughts or actions. The risk may be greater in patients who have had suicidal thoughts or actions in the past. Patients who have bipolar (manic-depressive) illness may also have an increased risk for suicidal thoughts or actions. Watch patients who take Depakote ER extended-release tablets closely. Contact the doctor at once if new, worsened, or sudden symptoms, such as depressed mood; anxious, restless, irritable behavior; panic attacks; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.
  • Depakote ER extended-release tablets may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
  • You may notice undissolved parts of Depakote ER extended-release tablets in your stool with some brands of Depakote ER extended-release tablets. Contact your doctor if this occurs.
  • Diabetes patients - Depakote ER extended-release tablets may cause the results of some tests for urine ketones to be wrong. Ask your doctor before you change your diet or the dose of your diabetes medicine.
  • Depakote ER extended-release tablets may increase the ammonia levels in your blood. Contact your doctor right away if you experience unexplained sluggishness and vomiting or mental changes.
  • Depakote ER extended-release tablets may cause an unusual drop in body temperature (hypothermia). Symptoms may include confusion, lack of energy, loss of coordination, shivering, slow heartbeat, slow or shallow breathing, slurred speech, or unusual drowsiness. Contact your doctor right away if you have any of these symptoms.
  • Certain brain problems have happened with the use of valproic acid products. Sometimes, these problems have led to health problems that may not go away. Discuss any questions or concerns with your doctor.
  • Depakote ER extended-release tablets may interfere with certain lab tests, including thyroid function. Be sure your doctor and lab personnel know you are taking Depakote ER extended-release tablets.
  • Lab tests, including complete blood cell counts, blood ammonia levels, and liver function, may be performed while you use Depakote ER extended-release tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Depakote ER extended-release tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially drowsiness.
  • Depakote ER extended-release tablets has been shown to cause harm to the fetus. If you may become pregnant, discuss other possible treatment options with your doctor. If a decision is made to take Depakote ER extended-release tablets, use effective birth control while you are taking it. Talk with your doctor if you are planning to become pregnant, or if you have questions or concerns about this information.
  • PREGNANCY and BREAST-FEEDING: Depakote ER extended-release tablets has been shown to cause harm to the fetus. If you think you may be pregnant, contact your doctor right away. You will need to discuss the benefits and risks of using Depakote ER extended-release tablets while you are pregnant. You and your doctor will need to decide if you will continue to take Depakote ER extended-release tablets while you are pregnant. Depakote ER extended-release tablets is found in breast milk. Do not breast-feed while you are taking Depakote ER extended-release tablets.

Possible side effects of Depakote ER extended-release tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Change in appetite; constipation; diarrhea; dizziness; drowsiness; hair loss; headache; indigestion; nausea; stomach cramps or pain; trouble sleeping; vomiting; weakness; weight changes.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue); abnormal thinking; change in menstrual period; changes in behavior; chest pain; confusion; dark, tarry, or bloody stools; difficulty speaking; difficulty urinating or other urination problems; extreme tiredness; fast or irregular heartbeat; fainting; hallucinations; hearing loss; involuntary movements of the arms and legs; involuntary movements or chewing movements of the face, jaw, mouth, or tongue; joint pain; lack of energy; loss of coordination; memory loss; new or worsening mental or mood changes (eg, aggressiveness, agitation, anxiety, depression, exaggerated feeling of well-being, hostility, impulsiveness, inability to sit still, irritability, panic attacks, restlessness); new or worsening seizures; nosebleed; pounding in the chest; red, swollen, blistered, or peeling skin; ringing in the ears; severe or persistent nausea, vomiting, or stomach pain; shortness of breath; suicidal thoughts or actions; swelling of the arms or legs; swollen lymph nodes; symptoms of infection (eg, fever, chills, sore throat); symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, severe stomach pain, yellowing of the skin or eyes); tremor; unusual bleeding or bruising; unusual weakness; vision changes or blurred vision.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Depakote ER extended-release tablets:

Store Depakote ER extended-release tablets at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Depakote ER extended-release tablets out of the reach of children and away from pets.

General information:

  • If you have any questions about Depakote ER extended-release tablets, please talk with your doctor, pharmacist, or other health care provider.
  • Depakote ER extended-release tablets is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Depakote ER extended-release tablets or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Depakote ER extended-release tablets. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Depakote ER extended-release tablets. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Depakote ER extended-release tablets.

Issue Date: November 5, 2014
Database Edition 14.4.1.002
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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