Valproic Acid

Generic Name: Valproic Acid (val-PROE-ik AS-id)Brand Name: Depakene

Severe and sometimes fatal liver problems have occurred with the use of Valproic Acid . The risk is greater in children younger than 2 years old, especially those who have metabolic disorders, seizure disorders with mental retardation, brain disease, or who take multiple seizure medicines.

When liver problems have occurred, it usually has been during the first 6 months of treatment. Contact your doctor right away if symptoms of liver problems occur (eg, dark urine, general feeling of being unwell, loss of appetite, sluggishness, swelling of the face, vomiting, weakness, yellowing of the skin or eyes). Patients with seizure disorders may also experience worsening of seizures. Contact your doctor right away if this occurs. Liver function tests should be performed before you start Valproic Acid and during treatment. Be sure to keep all doctor and lab appointments.

Valproic Acid can cause severe birth defects if you take it while you are pregnant. Women who are able to become pregnant should discuss with their doctor the benefits and risks of using Valproic Acid during pregnancy. Contact your doctor right away if you think you may be pregnant. An extra patient leaflet about this risk is available with Valproic Acid . Read it carefully. Talk with your doctor if you have questions about this information.

Severe and sometimes fatal pancreas problems have occurred with the use of Valproic Acid . These problems have occurred soon after starting Valproic Acid , as well as after several years of treatment. Tell your doctor right away if you develop loss of appetite, nausea, stomach pain, or vomiting.

Valproic Acid is used for:

Treating certain seizure disorders. It may also be used for other conditions as determined by your doctor.

Valproic Acid is an anticonvulsant. It works by increasing the amount of a certain chemical in the brain.

Do NOT use Valproic Acid if:

  • you are allergic to any ingredient in Valproic Acid
  • you have liver problems or a urea cycle disorder

Contact your doctor or health care provider right away if any of these apply to you.

Before using Valproic Acid :

Some medical conditions may interact with Valproic Acid . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, are breast-feeding, or are of childbearing age
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances (eg, peanuts)
  • if you have a history of liver problems, cancer, blood or bleeding problems (eg, low blood platelet levels), HIV infection, cytomegalovirus (CMV) infection, kidney problems, pancreas problems, low blood albumin levels, or high blood glycine levels
  • if you have a history of metabolic problems, brain disease, coma, high blood ammonia or glutamine levels, low body temperature, mental retardation, recurring vomiting and sluggishness, or recurring extreme excitability
  • if you have a history of mental or mood problems, suicidal thoughts or actions, or alcohol abuse or dependence
  • if you have decreased food or fluid intake, or if you are scheduled for surgery
  • if you have a family history of urea cycle disorders or unexplained infant deaths
  • if you take any other medicine for seizures

Some MEDICINES MAY INTERACT with Valproic Acid . Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Clonazepam because the risk of seizures may be increased in certain patients
  • Topiramate because the risk of high ammonium levels and brain problems may be increased
  • Felbamate or salicylates (eg, aspirin) because they may increase the risk of Valproic Acid 's side effects
  • Carbamazepine, carbapenem antibiotics (eg, imipenem), hormonal birth control (eg, birth control pills), hydantoins (eg, phenytoin), mefloquine, or rifampin because they may decrease Valproic Acid 's effectiveness
  • Anticoagulants (eg, warfarin), barbiturates (eg, phenobarbital), benzodiazepines (eg, diazepam), ethosuximide, lamotrigine, primidone, tolbutamide, tricyclic antidepressants (eg, amitriptyline), or zidovudine because the risk of their side effects may be increased by Valproic Acid

This may not be a complete list of all interactions that may occur. Ask your health care provider if Valproic Acid may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Valproic Acid :

Use Valproic Acid as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with Valproic Acid . Talk to your pharmacist if you have questions about this information.
  • Take Valproic Acid by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
  • Swallow Valproic Acid whole. Do not break, crush, or chew before swallowing.
  • Valproic Acid works best if it is taken at the same time each day.
  • Continue to take Valproic Acid even if you feel well. Do not miss any doses.
  • Do not suddenly stop taking Valproic Acid ; this may cause an increased risk of severe seizures. If you need to stop Valproic Acid or add a new medicine, your doctor will gradually lower your dose.
  • If you miss a dose of Valproic Acid , take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Valproic Acid .

Important safety information:

  • Valproic Acid may cause dizziness, drowsiness, or vision changes. These effects may be worse if you take it with alcohol or certain medicines. Use Valproic Acid with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Check with your doctor before you drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Valproic Acid ; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Patients who take Valproic Acid may be at increased risk for suicidal thoughts or actions. The risk may be greater in patients who have had suicidal thoughts or actions in the past. Watch patients who take Valproic Acid closely. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.
  • Valproic Acid may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
  • Tell your doctor or dentist that you take Valproic Acid before you receive any medical or dental care, emergency care, or surgery.
  • Some brands of Valproic Acid contain peanut oil. If you are allergic to peanuts, ask your pharmacist if your brand contains peanut oil.
  • Diabetes patients - Valproic Acid may cause the results of some tests for urine ketones to be wrong. Ask your doctor before you change your diet or the dose of your diabetes medicine.
  • Valproic Acid may interfere with certain lab tests, including thyroid function. Be sure your doctor and lab personnel know you are taking Valproic Acid .
  • Lab tests, including complete blood cell counts and liver function, may be performed while you use Valproic Acid . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Valproic Acid with caution in the ELDERLY; they may be more sensitive to its effects, especially drowsiness.
  • Valproic Acid should be used with extreme caution in CHILDREN, especially children younger than 2 years old; they may be at increased risk of serious and sometimes fatal liver problems.
  • PREGNANCY and BREAST-FEEDING: Valproic Acid has been shown to cause harm to the fetus. Use an effective form of birth control while you take Valproic Acid . If you think you may be pregnant or if you wish to become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Valproic Acid while you are pregnant. Valproic Acid is found in breast milk. Do not breast-feed while you are taking Valproic Acid .

Possible side effects of Valproic Acid :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; drowsiness; headache; increased or decreased appetite; mild hair loss; nausea; sore throat; stomach pain or upset; trouble sleeping; vomiting; weakness; weight gain.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal thinking; behavior changes; blurred vision or other vision changes; change in menstrual period; change in the amount of urine produced; chest pain; confusion; dark urine; fast or irregular heartbeat; fever, chills, or persistent sore throat; general feeling of being unwell; hallucinations; hearing loss; joint or muscle pain or weakness; loss of coordination; memory loss; new or worsening mental or mood changes (eg, aggressiveness, agitation, anxiety, depression, exaggerated feeling of well-being, hostility, impulsiveness, inability to sit still, irritability, panic attacks, restlessness); pale stools; red, swollen, peeling, or blistered skin; ringing in the ears; severe or persistent nausea, vomiting, or loss of appetite; severe or persistent stomach pain or cramps; shortness of breath; sluggishness; suicidal thoughts or actions; swelling of the arms or legs; swollen lymph nodes; tremor; trouble speaking or walking; uncontrolled muscle movements; unusual bleeding or bruising; unusual tiredness or weakness; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include irregular heartbeat; loss of consciousness; severe drowsiness.

Proper storage of Valproic Acid :

Store Valproic Acid between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Valproic Acid out of the reach of children and away from pets.

General information:

  • If you have any questions about Valproic Acid , please talk with your doctor, pharmacist, or other health care provider.
  • Valproic Acid is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Valproic Acid . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

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