valproic acid

Pronunciation

Generic Name: valproic acid (val PRO ik A sid)
Brand Name: Depakene, Stavzor, Depacon, Valproate Sodium

What is valproic acid?

Valproic acid affects chemicals in the body that may be involved in causing seizures.

Valproic acid is used to treat various types of seizure disorders. Valproic acid is sometimes used together with other seizure medications.

Valproic acid is also used to treat manic episodes related to bipolar disorder (manic depression), and to prevent migraine headaches.

Valproic acid may also be used for purposes not listed in this medication guide.

What is the most important information I should know about valproic acid?

Do not use valproic acid to prevent migraine headaches if you are pregnant.

If you take valproic acid for seizures or manic episodes: Do not start or stop taking the medicine during pregnancy without your doctor's advice. Valproic acid may cause harm to an unborn baby, but having a seizure during pregnancy could harm both the mother and the baby.

Slideshow: Can Prescription Drugs Lead to Weight Gain?

You should not use valproic acid if you have liver disease, a urea cycle disorder, or a genetic disorder such as Alpers' disease or Alpers-Huttenlocher syndrome (especially in a child younger than 2 years old).

Valproic acid can cause liver failure that may be fatal, especially in children under age 2 and in people with liver problems caused by a genetic mitochondrial (MYE-toe-KON-dree-al) disorder.

Call your doctor at once if the person taking this medicine has early signs of liver damage, such as: loss of appetite, upper stomach pain, ongoing nausea or vomiting, dark urine, swelling in the face, or jaundice (yellowing of the skin or eyes).

Valproic acid can also cause serious harm to the pancreas, which may get worse quickly. Call your doctor at once if you have symptoms such as: severe pain in your upper stomach spreading to your back, or ongoing nausea or vomiting.

What should I discuss with my healthcare provider before taking valproic acid?

You should not use valproic acid if you are allergic to it, or if you have:

  • liver disease;

  • a urea cycle disorder; or

  • a genetic mitochondrial (MYE-toe-KON-dree-al) disorder such as Alpers' disease or Alpers-Huttenlocher syndrome, especially in a child younger than 2 years old.

Valproic acid can cause liver failure that may be fatal, especially in children under age 2 and in people with liver problems caused by a genetic mitochondrial disorder.

If you take valproic acid to prevent migraine headaches: FDA pregnancy category X. Do not use valproic acid to prevent migraine headaches if you are pregnant.

To make sure valproic acid is safe for you, tell your doctor if you have:

  • liver problems caused by a genetic mitochondrial disorder;

  • a history of depression, mental illness, or suicidal thoughts or actions;

  • a family history of a urea cycle disorder or infant deaths with unknown cause; or

  • HIV or CMV (cytomegalovirus) infection.

Some young people have thoughts about suicide when first taking valproic acid. Your doctor will need to check your progress at regular visits while you are using this medicine. Your family or other caregivers should also be alert to changes in your mood or symptoms.

If you take valproic acid for seizures or manic episodes: FDA pregnancy category D. Do not start or stop taking the medicine during pregnancy without your doctor's advice. Valproic acid can harm an unborn baby or cause birth defects, and may affect cognitive ability (reasoning, intelligence, problem-solving) later in the child's life. However, having a seizure during pregnancy could harm both the mother and the baby.

Use effective birth control while using valproic acid, and tell your doctor right away if you become pregnant.

Seizure control is very important during pregnancy. The benefit of preventing seizures may outweigh any risks posed by taking valproic acid. There may be other seizure medications that can be more safely used during pregnancy. Follow your doctor's instructions about taking valproic acid while you are pregnant.

Valproic acid can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.

How should I take valproic acid?

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Drink plenty of water while you are taking this medication. Your dose may need to be changed if you do not get enough fluids each day.

Take with food if this medicine upsets your stomach.

Measure liquid medicine with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Do not crush, chew, break, or open a delayed-release capsule. Swallow it whole.

While using valproic acid, you may need frequent blood tests.

Wear a medical alert tag or carry an ID card stating that you take valproic acid. Any doctor, dentist, or emergency medical care provider who treats you should know that you are taking a seizure medication.

Do not stop using valproic acid suddenly, even if you feel fine. Stopping suddenly may cause a serious, life-threatening type of seizure. Follow your doctor's instructions about tapering your dose.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking valproic acid?

Drinking alcohol may increase certain side effects of valproic acid.

Valproic acid may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Avoid exposure to sunlight or tanning beds. Valproic acid can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Valproic acid side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; fever, swollen glands, mouth sores, difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if the person taking this medicine has early signs of liver damage, such as: loss of appetite, upper stomach pain, ongoing nausea or vomiting, dark urine, swelling in the face, or jaundice (yellowing of the skin or eyes).

Valproic acid can also cause serious harm to the pancreas, which may get worse quickly. Call your doctor at once if you have symptoms such as: severe pain in your upper stomach spreading to your back, or ongoing nausea or vomiting.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, depression, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have any of these other side effects:

  • confusion, tiredness, cold feeling, vomiting, change in your mental state;

  • easy bruising, unusual bleeding (nose, mouth, or gums), purple or red pinpoint spots under your skin;

  • severe drowsiness;

  • worsening seizures; or

  • severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

  • nausea, vomiting, stomach pain, indigestion, constipation, diarrhea;

  • fever, flu symptoms, cough, sore throat, sneezing, runny nose;

  • nervousness, depression, sleep problems (insomnia);

  • headache, dizziness, drowsiness, memory problems, unusual thoughts;

  • rash, hair loss, bruising;

  • weakness, tremors, problems with balance or walking;

  • swelling in your hands or feet;

  • vision problems, ringing in your ears; or

  • changes in appetite, weight gain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Valproic acid dosing information

Usual Adult Dose for Epilepsy:

Complex partial seizures:
Initial dose: 10 to 15 mg/kg orally or intravenously per day as an IV infusion in divided doses, increased by 5 to 10 mg/kg per week if necessary according to clinical response
Maintenance dose: 10 to 60 mg/kg per day in divided doses
Maximum dose: 60 mg/kg per day

Simple and complex absence seizures:
Initial dose: 15 mg/kg orally or intravenously per day as an IV infusion in divided doses, increased at one week intervals by 5 to 10 mg/kg/day according to seizure control and tolerability
Maximum dose: 60 mg/kg per day

Comments:
-If the total daily dose exceeds 250 mg, it should be given in 2 to 3 divided doses.
-Use of IV valproate sodium for periods longer than 14 days has not been studied; patients should be converted to oral valproate as soon as clinically feasible.
-When switching from oral to IV valproate, the total daily dose of IV valproate should be equivalent to the total daily dose of oral valproate, and administered at the same frequency as the oral product.
-Equivalence between IV and oral valproate products at steady state has only been evaluated in a 6-hourly dosing regimen. Trough plasma level monitoring may be required if IV valproate is administered 2 to 3 times a day.
-Complex partial seizures: When converting patients to valproate monotherapy, concomitant antiepileptic drug dosage can generally be reduced by approximately 25% every 2 weeks, commencing either at the start of valproate therapy or delayed by 1 to 2 weeks. Patients should be monitored closely during this period for increased seizure frequency.

Uses: Monotherapy and adjunctive therapy in the treatment of complex partial seizures; sole and adjunctive therapy for simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures.

Usual Adult Dose for Mania:

Delayed-release capsules :
Initial dose: 750 mg orally per day in divided doses
Maximum dose: 60 mg/kg orally per day
Duration: Safety and efficacy beyond 3 weeks has not been established

Comments:
-The dose should be increased as rapidly as possible to achieve the lowest therapeutic dose which produces the desired clinical effect or the desired range of plasma concentrations.
-In placebo-controlled clinical trials of acute mania, patients were dosed to a clinical response with a trough plasma concentration of 50 to 125 mcg/mL.
-Maximum concentrations were generally achieved within 14 days.
-Safety and efficacy for longer term use in the maintenance of the initial response and prevention of new manic episodes has not been systematically evaluated in clinical trials. Use for extended periods should be accompanied by regular review for the long-term usefulness of the drug for the individual patient.

Use: Treatment of manic episodes associated with bipolar disorder.

Usual Adult Dose for Migraine Prophylaxis:

Delayed release oral capsules:
Initial dose: 250 mg orally twice a day

Comments:
-Some patients may benefit from doses up to 1000 mg per day.
-In clinical trials, there was no evidence that higher doses led to greater efficacy.

Usual Pediatric Dose for Epilepsy:

10 years of age or older:
Complex partial seizures:
Initial dose: 10 to 15 mg/kg orally or intravenously per day as an IV infusion in divided doses, increased by 5 to 10 mg/kg per week if necessary according to clinical response
Maintenance dose: 10 to 60 mg/kg per day in divided doses
Maximum dose: 60 mg/kg per day

Simple and complex absence seizures:
Initial dose: 15 mg/kg orally or intravenously per day as an IV infusion in divided doses, increased at one week intervals by 5 to 10 mg/kg/day according to seizure control and tolerability
Maximum dose: 60 mg/kg per day

Comments:
-If the total daily dose exceeds 250 mg, it should be given in 2 to 3 divided doses.
-Use of IV valproate sodium for periods longer than 14 days has not been studied; patients should be converted to oral valproate as soon as clinically feasible.
-When switching from oral to IV valproate, the total daily dose of IV valproate should be equivalent to the total daily dose of oral valproate, and administered at the same frequency as the oral product.
-Equivalence between IV and oral valproate products at steady state has only been evaluated in a 6-hourly dosing regimen. Trough plasma level monitoring may be required if IV valproate is administered 2 to 3 times a day.
-Complex partial seizures: When converting patients to valproate monotherapy, concomitant antiepileptic drug dosage can generally be reduced by approximately 25% every 2 weeks, commencing either at the start of valproate therapy or delayed by 1 to 2 weeks. Patients should be monitored closely during this period for increased seizure frequency.

Uses: Monotherapy and adjunctive therapy in the treatment of complex partial seizures; sole and adjunctive therapy for simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures.

What other drugs will affect valproic acid?

Other drugs may interact with valproic acid, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

  • Your pharmacist can provide more information about valproic acid.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 15.01. Revision Date: 2014-07-29, 11:14:34 AM.

Hide
(web5)