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Drug Information: Valproic Acid

URL of this page: http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a682412.html

(val proe' ik)

IMPORTANT WARNING:

[Posted 01/31/2008] FDA informed healthcare professionals that the Agency has analyzed reports of suicidality (suicidal behavior or ideation) from placebo-controlled clinical studies of eleven drugs used to treat epilepsy as well as psychiatric disorders, and other conditions. In the FDA's analysis, patients receiving antiepileptic drugs had approximately twice the risk of suicidal behavior or ideation (0.43%) compared to patients receiving placebo (0.22%). The increased risk of suicidal behavior and suicidal ideation was observed as early as one week after starting the antiepileptic drug and continued through 24 weeks. The results were generally consistent among the eleven drugs. The relative risk for suicidality was higher in patients with epilepsy compared to patients who were given one of the drugs in the class for psychiatric or other conditions.Healthcare professionals should closely monitor all patients currently taking or starting any antiepileptic drug for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression.The drugs included in the analyses include (some of these drugs are also available in generic form): Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)Felbamate (marketed as Felbatol)Gabapentin (marketed as Neurontin) Lamotrigine (marketed as Lamictal) Levetiracetam (marketed as Keppra) Oxcarbazepine (marketed as Trileptal)Pregabalin (marketed as Lyrica) Tiagabine (marketed as Gabitril)Topiramate (marketed as Topamax) Valproate (marketed as Depakote, Depakote ER, Depakene, Depacon) Zonisamide (marketed as Zonegran) Although the 11 drugs listed above were the ones included in the analysis, FDA expects that the increased risk of suicidality is shared by all antiepileptic drugs and anticipates that the class labeling changes will be applied broadly. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Antiepileptic and http://www.fda.gov/cder/drug/InfoSheets/HCP/antiepilepticsHCP.htm.

IMPORTANT WARNING:

Valproic acid may cause serious or life threatening damage to the liver. The risk of developing liver damage is greatest in children who are younger than 2 years old and in people who are taking more than one medication to prevent seizures, or who have any of the following conditions: a severe seizure disorder and mental retardation; certain inherited diseases that prevent the body from changing food to energy normally; any condition that affects the ability to think, learn, and understand; or liver disease. Tell your doctor or your child's doctor if you or your child have any of these conditions. Your child should not take any other medications to control seizures while he or she is taking valproic acid. If you notice that your seizures are more severe or happen more often or if you experience any of the following symptoms, call your doctor immediately: excessive tiredness, lack of energy, weakness, stomach pain, loss of appetite, nausea, vomiting, or swelling of the face.Valproic acid may cause serious or life-threatening damage to the pancreas. This may occur at any time during your treatment. If you experience any of the following symptoms, call your doctor immediately: stomach pain, nausea, vomiting, or loss of appetite.Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to valproic acid.Talk to your doctor about the risks of taking valproic acid or of giving valproic acid to your child.Before you start to take valproic acid, tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking valproic acid, call your doctor immediately. Valproic acid can cause birth defects. Be sure to read the manufacturer's information for women who could become pregnant. Talk to your doctor about the risk of taking valproic acid during pregnancy.

Why is this medication prescribed?

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Valproic acid is used alone or with other medications to treat certain types of seizures. Valproic acid is also used to treat mania (episodes of frenzied, abnormally excited mood) in people with bipolar disorder (manic-depressive disorder; a disease that causes episodes of depression, episodes of mania, and other abnormal moods). It is also used to prevent migraine headaches, but not to relieve headaches that have already begun. Valproic acid is in a class of medications called anticonvulsants. It works by increasing the amount of a certain natural substance in the brain.

How should this medicine be used?

Valproic acid comes as a capsule, an extended-release (long-acting) tablet, a delayed-release (slow to begin working) tablet, a sprinkle capsule (capsule that contains small beads of medication that can be sprinkled on food), and a syrup (liquid) to take by mouth. The syrup, capsules, delayed-release tablets, and sprinkle capsules are usually taken two or more times daily. The extended-release tablets are usually taken once a day. Take valproic acid at around the same time(s) every day. Take valproic acid with food to help prevent the medication from upsetting your stomach. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take valproic acid exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the regular capsules and extended-release tablets whole; do not split, chew, or crush them.

You can swallow the sprinkle capsules whole, or you can open the capsules and sprinkle the beads they contain on a teaspoonful of soft food, such as applesauce or pudding. Swallow the mixture of food and medication beads right after you prepare it. Be careful not to chew the beads. Do not store unused mixtures of food and medication.

Do not mix the syrup into any carbonated drink.

Your doctor may start you on a low dose of valproic acid and gradually increase your dose, not more often than once a week.

Valproic acid may help to control your condition but will not cure it. Continue to take valproic acid even if you feel well. Do not stop taking valproic acid without talking to your doctor. If you suddenly stop taking valproic acid, you may experience a severe, long-lasting and possibly life-threatening seizure. Your doctor will probably decrease your dose gradually.

Other uses for this medicine

Valproic acid is also sometimes used to treat outbursts of aggression in children with attention deficit hyperactivity disorder (ADHD; more difficulty focusing or remaining still or quiet than other people who are the same age), chorea (a group of conditions that affect the ability to control body movements), and certain conditions that affect thinking, learning, and understanding. Talk to your doctor about the possible risks of using this medication for your condition.

This medication is sometimes prescribed for other uses. Ask your doctor or pharmacist for more information.

What special precautions should I follow?

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Before taking valproic acid,

  • tell your doctor and pharmacist if you are allergic to valproic acid any other medications, or any of the ingredients in the type of valproic acid that has been prescribed for you. Ask your pharmacist for a list of the ingredients.
  • tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: acyclovir (Zovirax); antidepressants ('mood elevators') such as amitriptyline (Elavil) and nortriptyline (Pamelor); anticoagulants ('blood thinners') such as warfarin (Coumadin); aspirin; clonazepam (Klonopin); diazepam (Valium); medications for anxiety or mental illness; other medications for seizures such as carbamazepine (Tegretol), ethosuximide (Zarontin), felbamate (Felbatol), phenobarbital, phenytoin (Dilantin), primidone (Mysoline), lamotrigine (Lamictal), mephobarbital (Mebaral), and topiramate (Topamax); meropenem (Merrem IV); rifampin (Rifadin); sedatives; sleeping pills; tolbutamide; tranquilizers;and zidovudine (Retrovir). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor if you have or have ever had a urea cycle disorder (one of a group of conditions that affect the ability to change protein from food into energy). Your doctor will probably tell you not to take valproic acid.
  • tell your doctor if anyone in your family has ever had a urea cycle disorder or has died of unknown causes in the first months of life. Also tell your doctor if you have or have ever had episodes of vomiting, extreme tiredness and/or irritability; episodes of confusion and loss of ability to think and understand, especially during pregnancy or after childbirth; coma (loss of consciousness for a period of time); mental retardation; difficulty coordinating your movements; human immunodeficiency virus (HIV); cytomegalovirus (CMV; a virus that can cause symptoms in people who have weak immune systems); hyperlipidemia (higher than normal amount of fats in the blood); or kidney disease.
  • tell your doctor if you are breast-feeding.
  • if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking valproic acid.
  • you should know that valproic acid may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
  • remember that alcohol can add to the drowsiness caused by this medication.

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet. Be sure to drink plenty of water or other liquids while you are taking valproic acid.

What should I do if I forget a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for your next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What side effects can this medication cause?

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Valproic acid may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • drowsiness
  • dizziness
  • headache
  • diarrhea
  • constipation
  • heartburn
  • changes in appetite
  • weight changes
  • back pain
  • agitation
  • mood swings
  • abnormal thinking
  • memory loss
  • uncontrollable shaking of a part of the body
  • loss of coordination
  • uncontrollable movements of the eyes
  • blurred or double vision
  • ringing in the ears
  • stuffed or runny nose
  • sore throat
  • hair loss

Some side effects can be serious. If you experience any of the following symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

  • unusual bruising or bleeding
  • tiny purple spots on the skin
  • fever
  • blisters or rash
  • itching
  • hives
  • confusion
  • difficulty breathing or swallowing
  • swollen glands
  • weakness in the joints
  • depression
  • thinking about killing yourself or planning or trying to do so

Valproic acid may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

What storage conditions are needed for this medicine?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature, away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

  • sleepiness
  • irregular heartbeat
  • coma (loss of consciousness for a period of time)

What other information should I know?

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

If you are taking the sprinkle capsules, you may notice the medication beads in your stool. This is normal and does not mean that you did not get the full dose of medication.

If you have diabetes and your doctor has told you to test your urine for ketones, tell the doctor that you are taking valproic acid. Valproic acid can cause false results on urine tests for ketones.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking valproic acid.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Brand name(s):

  • Depakene®
  • Depakote®
  • Depakote® ER
  • Depakote® Sprinkle

Other name(s):

  • Divalproex sodium
  • Valproate sodium

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