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Drugs & Medications

Depakote ER

GENERIC NAME(S): DIVALPROEX SODIUM

WARNINGS:

Rarely, this medication has caused serious (sometimes fatal) liver problems, usually within the first 6 months of starting treatment. Laboratory tests should be performed before you start treatment and periodically during treatment, especially within the first 6 months, to monitor this side effect.

The risk of serious liver problems is increased in children younger than 2 years, especially if they have an inherited metabolic disorder, severe seizure disorder with mental retardation, organic brain disease, or if they take more than one seizure medication. Talk with the doctor about the risks and benefits of using this medication in children younger than 2 years.

Due to an increased risk for liver problems, people with certain inherited metabolic disorders (such as Alpers-Huttenlocher syndrome) should not use this medication. Children younger than 2 years who might have these disorders should not use this medication. Children older than 2 years who might have these disorders should be closely monitored during treatment with divalproex sodium. Talk to your doctor for details.

This medication has rarely caused severe (sometimes fatal) disease of the pancreas (pancreatitis). This may occur at any time during treatment and can quickly worsen.

Tell your doctor right away if you develop symptoms of liver problems or pancreatitis such as unusual tiredness, weakness, swelling of the face, stomach/abdominal pain, loss of appetite, dark urine, yellowing eyes/skin, or persistent nausea/vomiting.

Taking this medication during pregnancy can cause birth defects and may lower your child's IQ. Women of childbearing age should discuss the risks and benefits of this medication, other treatment options, and use of reliable forms of birth control with their doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately talk to your doctor. If you are taking divalproex sodium only to prevent migraine headaches, this medication must not be used during pregnancy. If you are taking divalproex sodium to treat seizures or mental/mood problems (such as bipolar disorder), do not stop taking this medication unless directed by your doctor. Untreated seizures and mental/mood problems (such as bipolar disorder) are serious conditions that can harm both a pregnant woman and her unborn baby.

Who should not take Depakote ER?
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Uses

This medication is used to treat seizure disorders, mental/mood conditions (such as manic phase of bipolar disorder), and to prevent migraine headaches. It works by restoring the balance of certain natural substances (neurotransmitters) in the brain.

How to use Depakote ER

Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start taking divalproex sodium and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth once daily or as directed by your doctor. You may take it with food if stomach upset occurs. Do not crush or chew extended-release tablets. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split the tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing.

Dosage is based on your age, weight, medical condition, and response to therapy. Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time each day to keep the amount of medication in your blood constant.

If this medication is used for seizures, do not stop taking it without consulting your doctor. Your condition may become worse if the drug is suddenly stopped. Your dose may need to be gradually decreased.

Divalproex sodium does not relieve acute migraine headaches. Take other medications as directed by your doctor for acute attacks.

Inform your doctor if your condition does not improve.

Side Effects

See also Warning section.

Diarrhea, dizziness, drowsiness, hair loss, blurred/double vision, change in menstrual periods, ringing in the ears, shakiness (tremor), unsteadiness, weight changes may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: signs of infection (e.g., fever, persistent sore throat, swollen lymph nodes), chest pain, easy bruising/unexplained bleeding, fast/slow/irregular heartbeat, swelling of hands/feet, uncontrolled eye movement (nystagmus), feeling cold/shivering, rapid breathing, loss of consciousness.

A small number of people who take anticonvulsants for any condition (such as seizure, bipolar disorder, pain) may experience depression, suicidal thoughts/attempts, or other mental/mood problems. Tell your doctor immediately if you or your family/caregiver notice any unusual/sudden changes in your mood, thoughts, or behavior including signs of depression, suicidal thoughts/attempts, thoughts about harming yourself.

Severe (sometimes fatal) brain disorder (encephalopathy) has rarely occurred, particularly in patients with certain metabolic disorders (urea cycle disorders). Tell your doctor immediately if you develop unexplained weakness, vomiting, or sudden mental/mood changes (such as confusion).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

See also Warning section.

Before taking divalproex sodium, tell your doctor or pharmacist if you are allergic to it; or to valproic acid or valproate sodium; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, pancreatitis, certain metabolic disorders (such as urea cycle disorders, Alpers-Huttenlocher syndrome), alcohol abuse, bleeding problems, brain disease (dementia), kidney disease, low body water (dehydration), poor nutrition.

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.

Older adults may be more sensitive to the side effects of this drug, especially drowsiness, dizziness, unsteadiness, or tremor. Drowsiness, dizziness, unsteadiness can increase the risk of falling.

This medication is not recommended for use during pregnancy. It may harm an unborn baby. See also Warning section.

This medication passes into breast milk. While there have been no reports of harm to nursing infants, consult your doctor before breast-feeding.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: certain antidepressants (e.g., amitriptyline, nortriptyline, phenelzine), certain benzodiazepines (e.g., clonazepam, diazepam), certain antibiotics (carbapenems such as doripenem, imipenem), mefloquine, other medications for seizure (e.g., carbamazepine, ethosuximide, felbamate, lamotrigine, phenobarbital, phenytoin, rufinamide, topiramate), rifampin, vorinostat, warfarin, zidovudine.

Low-dose aspirin, as prescribed by your doctor for specific medical reasons such as heart attack or stroke prevention (usually these dosages are 81-325 milligrams per day), should be continued. Consult your doctor or pharmacist if you are using aspirin for any reason.

Tell your doctor or pharmacist if you are taking other products that cause drowsiness including alcohol, antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), and narcotic pain relievers (such as codeine, hydrocodone).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

This drug may affect certain lab tests (e.g., urine ketones). Make sure laboratory personnel and your doctors know you use this medication.

Overdose

If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: excessive drowsiness, coma, irregular/slow heartbeat.

Notes

Do not share this medication with others.

Laboratory and/or medical tests (such as drug levels, liver function tests, complete blood counts, clotting tests) should be performed before you start treatment, periodically to monitor your progress, or to check for side effects. Consult your doctor for more details.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

Information last revised March 2015. Copyright(c) 2015 First Databank, Inc.

Images

DEPAKOTE ER 250 MG TABLET
DEPAKOTE ER 250 MG TABLET
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DEPAKOTE ER 500 MG TABLET
DEPAKOTE ER 500 MG TABLET
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DEPAKOTE ER 250 MG TABLET
DEPAKOTE ER 250 MG TABLET

Identification

color
white
shape
oval
imprint
logo and HF
This medicine is a white, oval tablet imprinted with "logo and HF".
DEPAKOTE ER 500 MG TABLET
DEPAKOTE ER 500 MG TABLET

Identification

color
gray
shape
oval
imprint
logo and HC
This medicine is a gray, oval tablet imprinted with "logo and HC".

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, expect as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

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