Valproate

Generic Name: Valproate (VAL-proe-ate)Brand Name: Depacon

Life-threatening liver failure has occurred in patients taking Valproate . Children younger than 2 years old are at increased risk of developing life-threatening liver damage, especially those on more than 1 medicine to treat seizures and those with metabolic disorders, severe seizure disorders accompanied by retardation, or organic brain disease. Contact your doctor immediately if you or your child experiences a general feeling of discomfort, sluggishness, weakness, severe drowsiness, swelling of the face, loss of appetite, vomiting, or loss of seizure control. Liver function tests may be performed before and during therapy with Valproate . Be sure to keep all doctor and lab appointments.

Valproate can cause severe birth defects if it is used during pregnancy. Contact your doctor if you become pregnant or think you may be pregnant while taking Valproate . Valproate comes with an additional patient leaflet, "Important Information for Women Who Could Become Pregnant." Read it carefully.

Cases of life-threatening inflammation of the pancreas have occurred with the use of Valproate . Report any stomach pain, nausea, vomiting, or loss of appetite to your doctor at once.

Valproate is used for:

Controlling certain types of seizures in the treatment of epilepsy in patients who are unable to take the oral form of Valproate . It may also be used for other conditions as determined by your doctor.

Valproate is an anticonvulsant. It works by increasing a certain chemical in the brain.

Do NOT use Valproate if:

  • you are allergic to any ingredient in Valproate
  • 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 Valproate :

Some medical conditions may interact with Valproate . 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
  • 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 irritability
  • 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 Valproate . 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
  • 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 Valproate '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 Valproate 's effectiveness
  • Anticoagulants (eg, warfarin), barbiturates (eg, phenobarbital), benzodiazepines (eg, diazepam), ethosuximide, lamotrigine, primidone, tolbutamide, tricyclic antidepressants (eg, amitryptyline), or zidovudine because the risk of their side effects may be increased by Valproate

This may not be a complete list of all interactions that may occur. Ask your health care provider if Valproate 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 Valproate :

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

  • An additional patient leaflet is available with Valproate . Talk to your pharmacist if you have questions about this information.
  • Valproate is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Valproate at home, a health care provider will teach you how to use it. Be sure you understand how to use Valproate . Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
  • Do not use Valproate if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
  • Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
  • Do not suddenly stop using Valproate . Suddenly stopping Valproate may cause seizures to occur more often. If you need to stop Valproate , your doctor will gradually lower your dose.
  • Valproate works best if it is used at the same time each day.
  • Continue to use Valproate even if you feel well. Do not miss any doses.
  • If you miss a dose of Valproate , use 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 use 2 doses at once.

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

Important safety information:

  • Valproate may cause dizziness, drowsiness, or vision changes. These effects may be worse if you take it with alcohol or certain medicines. Use Valproate 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 Valproate ; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Patients who take Valproate 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 Valproate 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.
  • Valproate 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 use Valproate before you receive any medical or dental care, emergency care, or surgery.
  • Diabetes patients - Valproate 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.
  • Valproate may interfere with certain lab tests, including thyroid function. Be sure your doctor and lab personnel know you are taking Valproate .
  • Lab tests, including complete blood cell counts and liver function, may be performed while you use Valproate . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Valproate with caution in the ELDERLY; they may be more sensitive to its effects, especially drowsiness.
  • Valproate should be used with extreme caution in CHILDREN younger than 10 years old; safety and effectiveness in these children have not been confirmed. CHILDREN younger than 2 years old may be at increased risk of serious liver problems.
  • PREGNANCY and BREAST-FEEDING: Valproate has been shown to cause harm to the fetus. Use an effective form of birth control while you take Valproate . 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 Valproate while you are pregnant. Valproate is found in breast milk. Do not breast-feed while you are using Valproate .

Possible side effects of Valproate :

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:

Change in appetite; constipation; diarrhea; dizziness; drowsiness; hair loss; headache; indigestion; mild pain or redness at the injection site; nausea; stomach cramps or pain; trouble sleeping; vomiting; weakness; weight changes.

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; blurred vision or other vision changes; changes in behavior; change in menstrual period; chest pain; chills; confusion; dark urine; difficulty speaking; difficulty urinating or other urination problems; extreme tiredness; fast or irregular heartbeat; fever; general body discomfort; hallucinations; hearing loss; involuntary movements of the arms and legs; involuntary movements or chewing movements of the face, jaw, mouth, or tongue; joint or muscle pain or weakness; lack of energy; loss of appetite; 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); new or worsening seizures; nosebleed; pale stools; red, swollen, blistered, or peeling skin; ringing in the ears; severe or persistent nausea, vomiting, or stomach pain; severe or persistent pain; shortness of breath; sore throat; suicidal thoughts or actions; swelling of the arms or legs; swollen lymph nodes; tremor; trouble speaking or walking; unusual bleeding or bruising; unusual 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 deep sleep or coma; irregular or slow heartbeat (with possible confusion, dizziness, and fainting); loss of consciousness.

Proper storage of Valproate :

Store the undiluted solution of Valproate at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Because the product does not contain a preservative, any unused mixed portion should be discarded. Valproate is stable for 24 hours when added to compatible intravenous solutions and stored in glass or polyvinyl chloride (PVC) bags at room temperature between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Keep Valproate out of the reach of children and away from pets.

General information:

  • If you have any questions about Valproate , please talk with your doctor, pharmacist, or other health care provider.
  • Valproate 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 Valproate . 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.