Divalproex Delayed-Release Tablets

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

Life-threatening liver failure has occurred in patients taking Divalproex Delayed-Release Tablets. Children younger than 2 years old are at increased risk of developing life-threatening liver damage, especially those on more than 1 medicine to treat seizures, and those with metabolic disorders, severe seizure disorders accompanied by retardation, or organic brain disease. Contact your doctor immediately if you or your child experiences a general feeling of discomfort, sluggishness, weakness, severe drowsiness, swelling of the face, loss of appetite, vomiting, or loss of seizure control. Liver function tests may be performed before and during therapy with Divalproex Delayed-Release Tablets. Be sure to keep all doctor and lab appointments.

Divalproex Delayed-Release Tablets can cause severe birth defects if it is used during pregnancy. Contact your doctor if you become pregnant or think you may be pregnant while taking Divalproex Delayed-Release Tablets. Divalproex Delayed-Release Tablets comes with an additional patient leaflet, "Important Information for Women Who Could Become Pregnant." Read it carefully.

Cases of life-threatening inflammation of the pancreas have occurred with the use of Divalproex Delayed-Release Tablets. Report any stomach pain, nausea, vomiting, or loss of appetite to your doctor at once.

Divalproex Delayed-Release Tablets are used for:

Controlling certain types of seizures in the treatment of epilepsy. It is also used to treat the manic phase of bipolar disorders (manic-depressive illness), and to prevent migraine headaches.

Divalproex Delayed-Release Tablets are 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 Divalproex Delayed-Release Tablets if:

  • you are allergic to any ingredient in Divalproex Delayed-Release Tablets
  • you have liver problems or a urea cycle disorder

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

Before using Divalproex Delayed-Release Tablets:

Some medical conditions may interact with Divalproex Delayed-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 alcohol abuse, liver problems, metabolic disease, blood disease, 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 low levels of white blood cells, 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 take any other medicine for seizures

Some MEDICINES MAY INTERACT with Divalproex Delayed-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Benzodiazepines (eg, diazepam), carbamazepine, erythromycin, felbamate, fluoxetine, guanfacine, isoniazid, ketoconazole, risperidone, or salicylates (eg, aspirin) because the risk of serious side effects of Divalproex Delayed-Release Tablets, including changes in vision or other vision problems, clumsiness or unsteadiness, drowsiness, nausea, or vomiting, may be increased
  • 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
  • Acyclovir, cancer medicines, carbapenem antibiotics (eg, ertapenem, imipenem, meropenem), cholestyramine, hydantoins (eg, phenytoin), mefloquine, nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen), oral contraceptives (eg, birth control pills), or rifampin because they may decrease Divalproex Delayed-Release Tablets's effectiveness
  • Anticoagulants (eg, warfarin), barbiturates (eg, phenobarbital), ethosuximide, lamotrigine, methylphenidate, primidone, tolbutamide, tricyclic antidepressants (eg, amitriptyline), or zidovudine because the risk of their side effects may be increased by Divalproex Delayed-Release Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Divalproex Delayed-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 Divalproex Delayed-Release Tablets:

Use Divalproex Delayed-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with Divalproex Delayed-Release Tablets. Talk to your pharmacist if you have questions about this information.
  • Take Divalproex Delayed-Release Tablets by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
  • Swallow Divalproex Delayed-Release Tablets whole. Do not break, crush, or chew before swallowing.
  • Do not stop taking Divalproex Delayed-Release Tablets suddenly, especially if you are taking Divalproex Delayed-Release Tablets to prevent seizures. Suddenly stopping Divalproex Delayed-Release Tablets may cause severe seizures to occur. If you need to stop Divalproex Delayed-Release Tablets, your doctor will gradually lower your dose.
  • Taking Divalproex Delayed-Release Tablets at the same time each day will help you remember to take it.
  • Continue to take Divalproex Delayed-Release Tablets even if you feel well. Do not miss any doses. Divalproex Delayed-Release Tablets works best when there is a constant level of it in your body.
  • If you miss a dose of Divalproex Delayed-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 Divalproex Delayed-Release Tablets.

Important safety information:

  • Divalproex Delayed-Release Tablets may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Divalproex Delayed-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 Divalproex Delayed-Release Tablets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Inflammation of the pancreas is a potentially life-threatening illness associated with Divalproex Delayed-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 Divalproex Delayed-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 Divalproex Delayed-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.
  • Divalproex Delayed-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.
  • Tell your doctor or dentist that you take Divalproex Delayed-Release Tablets before you receive any medical or dental care, emergency care, or surgery.
  • Diabetes patients - Divalproex Delayed-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.
  • Divalproex Delayed-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.
  • Divalproex Delayed-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.
  • Divalproex Delayed-Release Tablets may interfere with certain lab tests, including thyroid function. Be sure your doctor and lab personnel know you are taking Divalproex Delayed-Release Tablets
  • Lab tests, including complete blood cell counts, blood ammonia levels, and liver function, may be performed while you use Divalproex Delayed-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 Divalproex Delayed-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially drowsiness.
  • Divalproex Delayed-Release Tablets should be used with extreme caution in CHILDREN younger than 10 years old; safety and effectiveness in these children have not been confirmed. CHILDREN younger than 2 years old may be at increased risk of serious liver problems.
  • PREGNANCY and BREAST-FEEDING: Divalproex Delayed-Release Tablets has been shown to cause harm to the fetus. Use an effective form of birth control while you take Divalproex Delayed-Release Tablets. If you think you may be pregnant or if you wish to become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Divalproex Delayed-Release Tablets while you are pregnant. Divalproex Delayed-Release Tablets are found in breast milk. Do not breast-feed while you are taking Divalproex Delayed-Release Tablets.

Possible side effects of Divalproex Delayed-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; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal thinking; change in menstrual period; changes in behavior; chest pain; confusion; dark, tarry, or bloody stools; dark urine; difficulty speaking; difficulty urinating or other urination problems; extreme tiredness; fast or irregular heartbeat; 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 appetite; loss of coordination; loss of seizure control; 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); nosebleed; pounding in the chest; red, swollen, blistered, or peeling skin; severe or persistent nausea, vomiting, or stomach pain; shortness of breath; suicidal thoughts or actions; swelling of the arms or legs; symptoms of infection (eg, fever, chills, sore throat); tremor; unusual bleeding or bruising; unusual weakness; vision changes or blurred vision; yellowing of the skin or eyes.

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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include deep sleep; drowsiness; irregular heartbeat; loss of consciousness.

Proper storage of Divalproex Delayed-Release Tablets:

Store Divalproex Delayed-Release Tablets between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Divalproex Delayed-Release Tablets out of the reach of children and away from pets.

General information:

  • If you have any questions about Divalproex Delayed-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.
  • Divalproex Delayed-Release Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If using Divalproex Delayed-Release Tablets for an extended period of time, obtain refills before your supply runs out.

This information is a summary only. It does not contain all information about Divalproex Delayed-Release Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.