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Generic Name: Valproate Syrup (val-PRO-ate)
Brand Name: Depakene
Life-threatening liver failure has occurred in patients taking Valproate Syrup. Children younger than 2 years of age 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 Syrup. Be sure to keep all doctor and lab appointments. Valproate Syrup can also 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 Syrup. Valproate Syrup 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 Syrup. Report any stomach pain, nausea, vomiting, or appetite loss to your doctor at once.
Valproate Syrup is used for:
Controlling certain types of seizures in the treatment of epilepsy. It may also be used for other conditions as determined by your doctor.
Valproate Syrup is an anticonvulsant. It works by increasing 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, ornithine transcarbamylase deficiency, or 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 metabolic disease, blood disease, HIV, high blood levels of ammonia or glutamine, low levels of albumin, brain problems
(eg, organic brain disease), mental retardation, inflammation of the pancreas, kidney problems, or low levels of white blood cells, or if you are scheduled for surgery
- if you have a history of ornithine transcarbamylase deficiency or unexplained coma
- 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:
- Benzodiazepines (eg, diazepam), carbamazepine, erythromycin, felbamate, fluoxetine, guanfacine, isoniazid, ketoconazole, risperidone, or salicylates
(eg, aspirin) because the risk of serious side effects of Valproate Syrup, including blurred vision or other vision problems, clumsiness or unsteadiness, drowsiness, nausea, or vomiting, may be increased
- Acyclovir, cancer medicines, cholestyramine, hydantoins (eg, phenytoin), mefloquine, meropenem, nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen), or rifampin because they may decrease Valproate Syrup"s effectiveness
- Anticoagulants (eg, warfarin), barbiturates (eg, phenobarbital), ethosuximide, lamotrigine, methylphenidate, primidone, tolbutamide, or
(eg, amitriptyline) because the risk of their side effects may be increased by Valproate Syrup
- Clonazepam because the risk of seizures may be increased
- Topiramate because the risk of high ammonium levels and brain problems may be increased
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 additional patient leaflet is available with Valproate Syrup. Talk to your pharmacist if you have questions about this information.
- Valproate Syrup may be taken 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.
- 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 changes in vision. Use caution while driving or performing other tasks requiring alertness, coordination, or physical dexterity. Using Valproate Syrup alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous
- Avoid drinking alcohol or taking other medications that cause drowsiness
(eg, sedatives, tranquilizers) while taking Valproate Syrup. Valproate Syrup will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.
- Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Valproate Syrup.
- Diabetes patients - Valproate Syrup may cause incorrect test results with urine tests for ketones. Check with your doctor before you adjust the dose of your diabetes medicine or change your diet.
- Lab tests, including blood cell counts and liver function tests, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
- Use Valproate Syrup with caution in the ELDERLY because they may be more sensitive to its effects, especially sleepiness.
- Use Valproate Syrup with extreme caution in CHILDREN younger than 10 years of age. Safety and effectiveness in this age group have not been confirmed. CHILDREN younger than 2 years of age may be at increased risk of serious liver problems.
- PREGNANCY and BREAST-FEEDING: Valproate Syrup has been shown to cause harm to the fetus. If you think you may be pregnant, discuss with your doctor the benefits and risks of using Valproate Syrup during pregnancy. Valproate Syrup is excreted into 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:
Seek medical attention right away if any of these SEVERE side effects occur:
Change in appetite; constipation; diarrhea; dizziness; drowsiness; hair loss; headache; indigestion; nausea; stomach pain; trouble sleeping; vomiting;
Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abdominal cramps;
abnormal thinking; change in menstrual period; changes in mood or behavior; chest pain; 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 face, jaw, mouth, or tongue; joint pain; lack of energy;
loss of appetite; loss of coordination; loss of seizure control; memory loss;
nosebleed; pounding in the chest; severe or persistent nausea, vomiting, or stomach pain; sore throat; swelling of the arms or legs; tremor; unusual bleeding or bruising; unusual weakness; vision changes; yellowing of skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or 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/findyour.htm), or emergency room immediately. Symptoms may include deep sleep; irregular heartbeat; loss of consciousness.
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.
- 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.
Issue Date: November 1, 2006
Database Edition 06.4.1.002
Copyright © 2006 Wolters Kluwer Health, Inc.
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