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DEPAKOTE
DIVALPROEX SODIUM - ORAL ENTERIC-COATED TABLET

Important Note

The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

DIVALPROEX SODIUM - ORAL ENTERIC-COATED TABLET

(dye-VAL-pro-ex SO-dee-um)

COMMON BRAND NAME(S): Depakote

WARNING: Rarely, serious (possibly fatal) liver problems have occurred in patients using this drug. Children using this drug who are under the age of 2 years are at higher risk to experience liver problems, especially if they also have a severe seizure disorder along with mental retardation; are using more than one seizure control drug; have body process (metabolic) problems or have brain disorders. If used in these patients, this drug must not be used with additional seizure control drugs. Early signs of liver problems include loss of seizure control, vomiting, unusual tiredness/weakness, loss of appetite, yellowing eyes/skin, or swelling of the face. Contact your doctor promptly if you develop any of these symptoms. Liver tests should be run before and during use of the drug. Rarely, severe (possibly fatal) pancreatitis (pancreas inflammation) has occurred during use of this medication. It may progress quickly and may include abdominal pain, nausea, vomiting, and loss of appetite. Contact your doctor promptly if you develop any of these symptoms. Rarely, severe (possibly fatal) encephalopathy (decreased mental status) has occurred during use of this medication. This has occurred in patients with a specific metabolic disorder (urea cycle disorder). Symptoms may include unusual weakness, vomiting, or mental changes. Contact your doctor promptly if you develop any of these symptoms. This drug may cause birth defects. Consult your doctor about the use of this medication during pregnancy.

Uses

This medication is used to treat seizure disorders, the manic stage of manic-depressive disorder (bipolar disorder) and to prevent migraine headaches.

How To Use

May be taken with food if stomach upset occurs. This medication should be swallowed whole. If chewed or crushed it may irritate the mouth or throat. It is important to take all doses on time to keep the level of medication in your blood constant. Take doses at evenly spaced intervals.

Side Effects

Mild stomach pain, loss of appetite, change in menstrual periods, diarrhea, mild hair loss, unsteadiness, dizziness, drowsiness, rash or headache might occur. If any of these effects continue or are bothersome, inform your doctor. Very unlikely but report: yellowing eye/skin, blurred or double vision, severe stomach pain, unusual bleeding or bruising. Tell your doctor immediately if any of these serious side effects occur: unusual weakness, vomiting, mood or mental changes. If you notice other effects not listed above, contact your doctor or pharmacist.

Precautions

Before you take this drug, tell your doctor if you have: a bleeding disorder, a history of a brain disorder, any allergies. This medication is not recommended for use if you have the following medical conditions: liver disease, pancreatitis, certain metabolic disorder (urea cycle disorder). Use caution driving motor vehicles or performing tasks that require alertness. Limit your consumption of alcoholic beverages. Before having surgery, including dental surgery, tell the doctor that you take this drug. Use with extreme caution in children under 2 years old as the potential for serious liver problems exist. This drug is not recommended for use during pregnancy. Consult your doctor before taking this drug. Divalproex is excreted into human breast milk. Consult your doctor before breast-feeding.

Drug Interactions

Be sure to tell your doctor of all over-the-counter and prescription drugs you are taking, especially of: other medications for seizures, aspirin, chlorpromazine, anticoagulants ("blood thinners"), cimetidine, mefloquine, drugs used for colds or allergies (antihistamines), sleeping pills, muscle relaxants, narcotic pain relievers (e.g., codeine), sedatives, tranquilizers. This drug may alter certain laboratory test results (e.g., urine ketones). Consult your doctor or pharmacist. Do not start or stop any medicine without doctor or pharmacist approval.

Overdose

If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include deep sleep, irregular heartbeat, and loss of consciousness.

Notes

It is recommended to wear or carry medication identification indicating you are taking this drug. Lab tests may be done, especially in the first few months to check if the drug is working properly. Do not allow anyone else to take this medication.

Missed Dose

If you miss a dose and your dosing schedule is 1 dose daily, take the missed dose as soon as remembered. If you do not remember until the next day, skip the missed dose and resume your usual dosing schedule. If you take 2 or more doses daily and you remember within 6 hours of the missed dose, take it immediately. Then take the remainder of the doses for that day at evenly spaced intervals. Do not "double-up" the dose to catch up.

Storage

Store at room temperature between 59 and 86 degrees F (between 15 and 30 degrees C) away from moisture and sunlight. Do not store in the bathroom.

Medical Alert

Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (USA), or 1-800-668-1507 (Canada).