Valproate Syrup

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

Severe and sometimes fatal liver problems have occurred with the use of Valproate Syrup. 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 Valproate Syrup and during treatment. Be sure to keep all doctor and lab appointments.

Valproate Syrup may 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 Valproate Syrup during pregnancy. Contact your doctor right away if you think you may be pregnant. An extra patient leaflet about this risk is available with Valproate Syrup. 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 Valproate Syrup. These problems have occurred soon after starting Valproate Syrup, as well as after several years of treatment. Tell your doctor right away if you develop loss of appetite, nausea, stomach pain, or vomiting.

Valproate Syrup is used for:

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

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

Do NOT use Valproate Syrup if:

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

Some medical conditions may interact with Valproate Syrup. 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, or are breast-feeding
  • 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, 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

Some MEDICINES MAY INTERACT with Valproate Syrup. 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 Valproate Syrup'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 Syrup'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 Valproate Syrup

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

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

  • An extra patient leaflet is available with Valproate Syrup. Talk to your pharmacist if you have questions about this information.
  • Take Valproate Syrup by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
  • Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
  • Valproate Syrup works best if it is taken at the same time each day.
  • Continue to use Valproate Syrup even if you feel well. Do not miss any doses.
  • Do not suddenly stop taking Valproate Syrup; this may cause an increased risk of severe seizures. If you need to stop Valproate Syrup or add a new medicine, your doctor will gradually lower your dose.
  • If you miss a dose of Valproate Syrup, 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 Valproate Syrup.

Important safety information:

  • Valproate Syrup may cause dizziness, drowsiness, or vision changes. These effects may be worse if you take it with alcohol or certain medicines. Use Valproate Syrup 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 Syrup; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Tell your doctor or dentist that you take Valproate Syrup before you receive any medical or dental care, emergency care, or surgery.
  • Diabetes patients - Valproate Syrup 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 Syrup may interfere with certain lab tests, including thyroid function tests. Be sure your doctor and lab personnel know you are taking Valproate Syrup.
  • Lab tests, including blood cell counts and liver function, may be performed while you use Valproate Syrup. 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 Syrup with caution in the ELDERLY; they may be more sensitive to its effects, especially drowsiness.
  • Valproate Syrup 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: Valproate Syrup has been shown to cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Valproate Syrup while you are pregnant. Valproate Syrup is found in breast milk. Do not breast-feed while you are taking Valproate Syrup.

Possible side effects of Valproate Syrup:

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; 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; mental or mood changes (eg, depression, nervousness); pale stools; red, swollen, or blistered skin; ringing in the ears; severe or persistent nausea, vomiting, or loss of appetite; severe or persistent stomach pain or cramps; 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; or severe drowsiness.

Proper storage of Valproate Syrup:

Store Valproate Syrup at room temperature, below 86 degrees F (30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Valproate Syrup out of the reach of children and away from pets.

General information:

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