Depakote (Divalproex Sodium) Patient Information

Find out why Depakote is prescribed, side effects of Depakote, Depakote warnings, effects of Depakote during pregnancy, more - in plain English.

Generic name: Divalproex sodium (Valproic acid)
Brand name: Depakote

Pronounced: DEP-uh-coat

Depakote (divalproex sodium) Full Prescribing Information

Why is Depakote prescribed?

Depakote, in both delayed-release tablet and capsule form, is used to treat certain types of seizures and convulsions. It may be prescribed alone or with other epilepsy medications.

The delayed-release tablets are also used to control the manic episodes--periods of abnormally high spirits and energy--that occur in bipolar disorder (manic depression).

An extended-release form of this drug, Depakote ER, is prescribed to prevent migraine headaches. The delayed-release tablets are also used for this purpose.

Most important fact about Depakote

Depakote can cause serious or even fatal liver damage, especially during the first 6 months of treatment. Children under 2 years of age are the most vulnerable, especially if they are also taking other anticonvulsant medicines and have certain other disorders such as mental retardation. The risk of liver damage decreases with age; but you should always be alert for the following symptoms: loss of seizure control, weakness, dizziness, drowsiness, a general feeling of ill health, facial swelling, loss of appetite, vomiting, and yellowing of the skin and eyes. If you suspect a liver problem, call your doctor immediately.

Depakote has also been known to cause life-threatening damage to the pancreas. This problem can surface at any time, even after years of treatment. Call your doctor immediately if you develop any of the following warning signs: abdominal pain, loss of appetite, nausea, or vomiting.

How should you take Depakote?

Take the tablet with water and swallow it whole (don't chew it or crush it). It has a special coating to avoid upsetting your stomach.

If you are taking the sprinkle capsule, you can swallow it whole or open it and sprinkle the contents on a teaspoon of soft food such as applesauce or pudding. Swallow it immediately, without chewing. The sprinkle capsules are large enough to be opened easily.

Depakote can be taken with meals or snacks to avoid stomach upset. Take it exactly as prescribed.

--If you miss a dose...

If you take Depakote once a day, take your dose as soon as you remember. If you don't remember until the next day, skip the missed dose and return to your regular schedule. Never take 2 doses at the same time.

If you take more than one dose a day, take your dose right away if it's within 6 hours of the scheduled time, and take the rest of the day's doses at equal intervals during the day. Never take 2 doses at the same time.

--Storage instructions...

Store at room temperature.

What side effects may occur when taking Depakote?

Side effects cannot be anticipated. If any develop or change in intensity, inform your doctor as soon as possible. Because Depakote is often used with other antiseizure drugs, it may not be possible to determine whether a side effect is due to Depakote alone. Only your doctor can determine if it is safe for you to continue taking Depakote.

• More common side effects of Depakote may include: Abdominal pain, abnormal thinking, breathing difficulty, bronchitis, bruising, constipation, depression, diarrhea, dizziness, emotional changeability, fever, flu symptoms, hair loss, headache, incoordination, indigestion, infection, insomnia, loss of appetite, memory loss, nasal inflammation, nausea, nervousness, ringing in the ears, sleepiness, sore throat, tremor, vision problems, vomiting, weakness, weight loss or gain

• Less common or rare side effects may include: Abnormal dreams, abnormal milk secretion, abnormal walk, aggression, anemia, anxiety, back pain, behavior problems, belching, bleeding, blood disorders, bone pain, breast enlargement, chest pain, chills, coma, confusion, coughing up blood, dental abscess, drowsiness, dry skin, ear inflammation, excessive urination (mainly children) or other urination problems, eye problems, feeling of illness, gas, growth failure in children, hallucinations, hearing problems, heart palpitations, high blood pressure, hostility, increased appetite, increased cough, involuntary rapid movement of eyeball, irregular or painful menstruation, itching, jerky movements, joint pain, lack of muscular coordination, leg cramps, liver problems, loss of bladder or bowel control, muscle or joint pain, muscle weakness, muscle pain, neck pain, nosebleed, overactivity, pneumonia, rapid heartbeat, rickets (mainly children), sedation, seeing "spots before your eyes", sensitivity to light, sinus inflammation, skin eruptions or peeling, skin rash, speech difficulties, stomach and intestinal disorders, swelling of arms and legs due to fluid retention, swollen glands, taste changes, tingling or pins and needles, twitching, urinary problems, vertigo, vision problems

Why should this drug not be prescribed?

You should not take this medication if you have liver disease or your liver is not functioning well, or if you have a genetic abnormality known as urea cycle disorder (UCD).

If you are sensitive to or have ever had an allergic reaction to Depakote, you should not take this medication.

Special warnings about Depakote

This medication can severely damage the liver (see "Most important fact about this drug"). Your doctor will test your liver function before you begin taking this medication and at regular intervals thereafter.

Also remember that the drug can damage the pancreas (see "Most important fact about this drug"). This problem can worsen very rapidly, so be sure to contact your doctor immediately if you develop any symptoms.

In people with a rare set of genetic abnormalities called urea cycle disorders, Depakote may adversely effect the brain. Signs of a developing problem include lack of energy, repeated attacks of vomiting, and mental changes. If you suspect a problem, see your doctor immediately. Depakote may have to be discontinued.

Depakote causes some people to become drowsy or less alert. You should not drive or operate dangerous machinery or participate in any hazardous activity that requires full mental alertness until you are certain the drug does not have this effect on you.

Do not abruptly stop taking this medicine without first consulting your doctor. A gradual reduction in dosage is usually required.

Depakote prolongs the time it takes blood to clot, which increases your chances of serious bleeding.

This drug can also increase the effect of painkillers and anesthetics. Before any surgery or dental procedure, make sure the doctor knows you are taking Depakote.

If you are taking Depakote to prevent migraine, remember that it will not cure a headache once it has started.

Some coated particles from the capsules may appear in your stool. This is to be expected, and need not worry you.

Possible food and drug interactions when taking Depakote

Depakote depresses activity of the central nervous system, and may increase the effects of alcohol. Do not drink alcohol while taking this medication.

If Depakote is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Depakote with the following:

Amitriptyline (Elavil)
Aspirin
Barbiturates such as phenobarbital and Seconal
Blood thinners such as Coumadin
Cyclosporine (Sandimmune, Neoral)
Notriptyline (Pamelor)
Oral contraceptives
Other seizure medications, including carbamazepine (Tegretol), clonazepam (Klonopin), ethosuximide (Zarontin), felbamate (Felbatol), lamotrigine (Lamictal), phenytoin (Dilantin), and Primidone (Mysoline)
Rifampin (Rifater)
Sleep aids such as Halcion
Tolbutamide (Orinase)
Tranquilizers such as Valium and Xanax
Zidovudine (Retrovir)

Special information if you are pregnant or breastfeeding

Depakote may produce birth defects if it is taken during pregnancy. If you are pregnant or plan to become pregnant, inform your doctor immediately. Depakote appears in breast milk and could affect a nursing infant. If Depakote is essential to your health, your doctor may advise you to discontinue breastfeeding until your treatment with this medication is finished. Read more about taking Depakote during pregnancy or breastfeeding.

Recommended dosage for Depakote

Recommended dosage

EPILEPSY

Dosage for adults and children 10 years of age or older is determined by body weight. The usual recommended starting dose is 10 to 15 milligrams per 2.2 pounds per day, depending on the type of seizure. Your doctor may increase the dose at 1-week intervals by 5 to 10 milligrams per 2.2 pounds per day until your seizures are controlled or the side effects become too severe. The most you should take is 60 milligrams per 2.2 pounds per day. If your total dosage is more than 250 milligrams a day, your doctor will divide it into smaller individual doses. Older adults usually begin taking this medication at lower dosages, and the dosage is increased more slowly.

MANIC EPISODES

The usual starting dose for those aged 18 and over is 750 milligrams a day, divided into smaller doses. Your doctor will adjust the dose for best results.

MIGRAINE PREVENTION

Delayed-Release Tablets The usual starting dose for those aged 16 and over is 250 milligrams twice a day. Your doctor will adjust the dose, up to a maximum of 1,000 milligrams a day.

Extended-Release Tablets

The usual starting dose is 500 milligrams once a day for 1 week. The dose may then be increased to 1,000 milligrams once a day.

Depakote delayed-release and extended-release tablets work differently, so you cannot substitute one type for the other.

Researchers have not established the safety and effectiveness of Depakote for prevention of migraines in children or in adults over 65.

Overdosage

Any medication taken in excess can have serious consequences. An overdose of Depakote can be fatal. If you suspect an overdose, seek medical attention immediately.

• Symptoms of Depakote overdose may include: Coma, extreme sleepiness, heart problems

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Depakote (divalproex sodium) Full Prescribing Information

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