Divalproex Sprinkle Capsules

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Divalproex Sprinkle Capsules


Generic Name: Divalproex Sprinkle Capsules (die-VAL-pro-ex)
Brand Name: Depakote

Life-threatening liver failure has occurred in patients taking Divalproex Sprinkle Capsules. Children younger than 2 years of age 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 Sprinkle Capsules. Be sure to keep all doctor and lab appointments. Divalproex Sprinkle Capsules can also 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 Sprinkle Capsules. Divalproex Sprinkle Capsules 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 Sprinkle Capsules. Report any stomach pain, nausea, vomiting, or appetite loss to your doctor at once.


Divalproex Sprinkle Capsules is used for:

Controlling certain types of seizures in the treatment of epilepsy. It may also be used for certain conditions as determined by your doctor.

Divalproex Sprinkle Capsules 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.

Do NOT use Divalproex Sprinkle Capsules if:

  • you are allergic to any ingredient in Divalproex Sprinkle Capsules
  • you have a history of liver conditions, low levels of the enzyme ornithine carbamoyltransferase, or a urea cycle disorder

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

Before using Divalproex Sprinkle Capsules:

Some medical conditions may interact with Divalproex Sprinkle Capsules. 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, or are breast-feeding
  • 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 metabolic disease, blood disease, HIV, high blood levels of ammonia or glutamine, 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

Some MEDICINES MAY INTERACT with Divalproex Sprinkle Capsules. 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 Sprinkle Capsules, including blurred vision or other vision problems, clumsiness or unsteadiness, drowsiness, nausea, or vomiting, may be increased
  • Acyclovir, cancer medicines, cholestyramine, hydantoins (eg, phenytoin), mefloquine, meropenem, nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen), or rifampin because they may decrease this medicine"s effectiveness
  • Anticoagulants (eg, warfarin), barbiturates (eg, phenobarbital), ethosuximide, lamotrigine, methylphenidate, primidone, tolbutamide, or tricyclic antidepressants (eg, amitriptyline) because the risk of their side effects may be increased by Divalproex Sprinkle Capsules
  • Clonazepam because the risk of seizures may be increased
  • Topiramate because the risk of high ammonium levels and brain problems may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Divalproex Sprinkle Capsules 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 Sprinkle Capsules:

Use Divalproex Sprinkle Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with Divalproex Sprinkle Capsules. Talk to your pharmacist if you have questions about this information.
  • Take Divalproex Sprinkle Capsules by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
  • Swallow Divalproex Sprinkle Capsules whole. Do not break, crush, or chew before swallowing. If you cannot swallow the capsule whole, you may open it and sprinkle the contents over a spoonful of soft food (eg, applesauce, pudding). Mix the medicine with the food and swallow the mixture right away, followed by a glass of water. Do not crush or chew the medicine before swallowing. Do not store the mixture for future use.
  • Taking Divalproex Sprinkle Capsules at the same time each day will help you to remember to take it.
  • Continue to use Divalproex Sprinkle Capsules even if you feel well. Do not miss any doses. Divalproex Sprinkle Capsules works best when there is a constant level of it in your body.
  • If you miss a dose of Divalproex Sprinkle Capsules, 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 Sprinkle Capsules.

Important safety information:

  • Divalproex Sprinkle Capsules may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Divalproex Sprinkle Capsules 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 Sprinkle Capsules; 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 Divalproex Sprinkle Capsules before you receive any medical or dental care, emergency care, or surgery.
  • You may notice undissolved parts of Divalproex Sprinkle Capsules in your stool. This is normal and not a cause for concern.
  • Inflammation of the pancreas is a potentially life-threatening illness associated with Divalproex Sprinkle Capsules. Symptoms include stomach pain, vomiting, or appetite loss. Contact your doctor at once if any of these symptoms occur.
  • Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
  • Diabetes patients - Divalproex Sprinkle Capsules 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.
  • Lab tests, including blood cell counts and liver function tests, may be performed while you use Divalproex Sprinkle Capsules. 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 Sprinkle Capsules with caution in the ELDERLY; they may be more sensitive to its effects, especially sleepiness.
  • Divalproex Sprinkle Capsules 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 of age may be at increased risk of serious liver problems.
  • PREGNANCY and BREAST-FEEDING: Divalproex Sprinkle Capsules has been shown to cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Divalproex Sprinkle Capsules while you are pregnant. Divalproex Sprinkle Capsules is found in breast milk. Do not breast-feed while you are taking Divalproex Sprinkle Capsules.

Possible side effects of Divalproex Sprinkle Capsules:

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 pain; trouble sleeping; vomiting; 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); abdominal cramps; abnormal thinking; change in menstrual period; changes in mood or behavior; chest pain; confusion; dark urine; difficulty speaking; difficulty urinating or other urination problems; extreme tiredness; fast or irregular heartbeat; fever; general body discomfort; hallucinations; hearing loss; involuntary movements of the arms and legs; involuntary movements or chewing movements of face, jaw, mouth, or tongue; joint pain; lack of energy; loss of appetite; loss of coordination; loss of seizure control; memory loss; nosebleed; pounding in the chest; severe or persistent nausea, vomiting, or stomach pain; sore throat; swelling of the arms or legs; tremor; unusual bleeding or bruising; unusual weakness; vision changes; yellowing of skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or 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/findyour.htm), or emergency room immediately. Symptoms may include deep sleep; drowsiness; irregular heartbeat; loss of consciousness.

Proper storage of Divalproex Sprinkle Capsules:

Store Divalproex Sprinkle Capsules below 77 degrees F (25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Divalproex Sprinkle Capsules out of the reach of children and away from pets.

General information:

  • If you have any questions about this medicine, please talk with your doctor, pharmacist, or other health care provider.
  • Divalproex Sprinkle Capsules 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.

This information is a summary only. It does not contain all information about Divalproex Sprinkle Capsules. 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.

Issue Date: November 1, 2006
Database Edition 06.4.1.002
Copyright © 2006 Wolters Kluwer Health, Inc.




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