Generic Name: valproate (val-PROE-ate)
Brand Name: Depacon
Liver failure and death from liver failure has occurred in patients taking valproate. This has usually occurred within the first 6 months of treatment. Tell your doctor right away if you notice symptoms of liver problems (eg, a general feeling of discomfort, sluggishness, unusual tiredness or weakness, swelling of the face, loss of appetite, vomiting, stomach pain, dark urine, pale stools, or yellowing of the skin or eyes). In patients who have seizures, loss of seizure control may occur. You should have lab tests done before and during treatment to check for liver problems. Be sure to keep all doctor and lab appointments.
Children younger than 2 years old have an increased risk of fatal liver problems, especially if they take more than 1 seizure medicine or have a metabolic disorder, a severe seizure disorder along with mental retardation, or organic brain disease. Discuss any questions or concerns with your doctor.
There is an increased risk of liver failure and death from liver failure in patients who have a genetic liver problem caused by a mitochondrial disorder (eg, Alpers-Huttenlocher syndrome). You may need to have a special genetic test to check for this condition. Certain patients who have known or suspected mitochondrial disorders should not take valproate. Talk with your doctor for more information.
Valproate can cause severe birth defects if it is used during pregnancy. It can also cause the child to have a lower IQ. Do not take valproate to prevent migraine headaches if you are pregnant. If you are pregnant and take valproate for seizures or bipolar disorder, talk to your doctor to decide if you will continue to take valproate.
If you are able to become pregnant, you must use an effective form of birth control while you take valproate. Contact your doctor right away if you become pregnant or think you may be pregnant while taking valproate.
Valproate comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get valproate refilled.
Severe and sometimes fatal pancreas problems (pancreatitis) have occurred with the use of valproate. This has been reported shortly after starting treatment as well as after several years of use. Seek immediate medical attention if you notice any stomach pain, nausea, vomiting, or loss of appetite.
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
- you have a genetic liver problem caused by a mitochondrial disorder (eg, Alpers-Huttenlocher syndrome)
- the patient is younger than 2 years old and has a mitochondrial disorder
- you are taking valproate to prevent migraine headaches and you are pregnant
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 disease (eg, low levels of white blood cells, 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, ornithine transcarbamylase deficiency, brain problems (eg, organic 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
- Benzodiazepines (eg, diazepam), 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, rifampin, or ritonavir because they may decrease valproate's effectiveness
- Anticoagulants (eg, warfarin), barbiturates (eg, phenobarbital, primidone), ethosuximide, lamotrigine, methylphenidate, quetiapine, rufinamide, tolbutamide, tricyclic antidepressants (eg, amitriptyline), 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.
- 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 away from 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.
- Inflammation of the pancreas is a potentially life-threatening illness associated with valproate. Symptoms include stomach pain, vomiting, or loss of appetite. Contact your doctor at once if any of these symptoms occur.
- A very bad and sometimes deadly reaction has happened with this drug. Most of the time, this reaction has signs like fever, rash, or swollen glands with problems in body organs like the liver, kidney, blood, heart, muscles and joints, or lungs. Talk with the doctor.
- 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.
- Certain brain problems have happened with the use of valproic acid products. Sometimes, these problems have led to health problems that may not go away. Discuss any questions or concerns with your doctor.
- 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 has been shown to cause harm to the fetus. If you may become pregnant, discuss other possible treatment options with your doctor. If a decision is made to take valproate, use effective birth control while you are taking it. Talk with your doctor if you are planning to become pregnant, or if you have questions or concerns about this information.
- PREGNANCY and BREAST-FEEDING: Valproate has been shown to cause harm to the fetus. If you think you may be pregnant, contact your doctor right away. You will need to discuss the benefits and risks of using valproate while you are pregnant. You and your doctor will need to decide if you will continue to take 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:
Seek medical attention right away if any of these SEVERE side effects occur:
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.
Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue); abnormal thinking; blurred vision or other vision changes; changes in behavior; change in menstrual period; chest pain; chills; confusion; difficulty speaking; difficulty urinating or other urination problems; extreme tiredness; fainting; 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 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; 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; symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, severe stomach pain, yellowing of the skin or eyes); tremor; unusual bleeding or bruising; unusual weakness.
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. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.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. Do not store in the bathroom. Keep valproate out of the reach of children and away from pets.
- 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.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take valproate or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about valproate. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to valproate. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using valproate.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.
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