IMPORTANT NOTE: The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.
(val-PROE-ate SOE-dee-um)
COMMON BRAND NAME(S): Depacon
WARNING: Rarely, serious (sometimes fatal) liver problems have occurred in patients using this drug. Children under 2 years of age who are using this drug are at higher risk for these liver problems, especially if they have a severe seizure disorder with mental retardation; are using more than one anti-seizure drug; have body process (metabolic) problems; or have brain disorders. If this drug is used in these patients, do not use additional anti-seizure drugs. Early signs of liver problems include: loss of seizure control, vomiting, unusual tiredness/weakness, loss of appetite, yellowing eyes or skin, or swelling of the face. Contact your doctor promptly if you develop any of these symptoms. Liver tests should be done before starting, and during the use of this drug. Rarely, severe (sometimes fatal) swelling of the pancreas (pancreatitis) has occurred in some people while taking this drug. Tell your doctor immediately if you develop severe stomach pain, vomiting, and loss of appetite. Rarely, severe (sometimes fatal) encephalopathy (decreased mental status) has occurred during use of this medication. This has occurred in patients with a specific metabolic disorder (urea cycle disorder). Symptoms may include unusual weakness, vomiting, or mental changes. Contact your doctor promptly if you develop any of these symptoms. This drug may cause birth defects (sometimes death). Consult your doctor about the use of this medication during pregnancy.
USES: Valproate sodium is used to help control seizures and treat seizure disorders (complex partial seizures, absence seizures, other seizures). It is usually used when the patient cannot take the oral form of this drug (e.g., valproic acid)
HOW TO USE: Follow all instructions for proper mixing and dilution with the correct IV fluids. If you have questions regarding the use of this medication, consult your pharmacist. Give this medication by vein (IV), usually over 60 minutes in a dextrose (D5W) or saline (NS) solution, as directed by your doctor. You will be switched to an oral form of this drug when you are able to take medication by mouth. The dosage is based on your weight, medical condition, and response to treatment. Use this medication exactly as prescribed. Do not increase your dose, give it more frequently, or use it for a longer period of time than prescribed. Doing so could increase side effects. Also, if used for an extended period of time, do not suddenly stop using this drug. Doing so could cause an increase in seizures. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard needles and medical supplies safely. Consult your pharmacist.
SIDE EFFECTS: Nausea, drowsiness, dizziness, headache, diarrhea, or pain/redness/swelling at the injection site, altered taste, sweating, or nervousness may occur. If any of these effects persist or worsen, notify your doctor promptly. Tell your doctor immediately if any of these serious side effects occur: vomiting, tingling or numbness of the hands/feet, vision changes, stomach/abdominal pain, flu-like symptoms (e.g., fever, chills, sore throat, muscle aches, unusual tiredness/weakness), tremor, loss of coordination, forgetfulness, rash, unusual hair loss, loss of appetite. Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (e.g., hallucinations, depression), trouble breathing, swelling/weight gain, ringing in the ears. Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: severe stomach pain, chest pain, yellowing eyes or skin, dark urine, swelling of the face, unusual bleeding or bruising. If you notice other effects not listed above, contact your doctor or pharmacist.
PRECAUTIONS: Tell your doctor your medical history, especially of: liver problems, pancreas problems (pancreatitis), blood problems (e.g., thrombocytopenia), metabolism problems (e.g., hyperammonemia, thyroid disorders, urea cycle disorder), seizure history/description, mental retardation, depression, brain disease, recent head trauma, upcoming surgery. This drug may make you dizzy or drowsy; use caution engaging in activities requiring alertness such as driving or using machinery. Limit alcoholic beverages. This medication should be used with caution in children, especially less than 2 years of age, because they may be more likely to have serious side effects (e.g., liver damage) from this medication. Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug. This medication is not recommended for use during pregnancy. Consult your doctor for more details. This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Tell your doctor of all prescription and nonprescription medication you may use, especially: other anti- seizure medication (e.g., phenytoin, phenobarbital, carbamazepine, felbamate, clonazepam, ethosuximide, lamotrigine, primidone), tricyclic antidepressants (e.g., amitriptyline, nortriptyline), rifamycins (e.g., rifampin, rifabutin), certain diabetes medication (e.g., tolbutamide), warfarin, aspirin, erythromycin, zidovudine. Tell your doctor if you take any drugs that cause drowsiness, such as: medicine for sleep, sedatives, tranquilizers, anti- anxiety drugs (e.g., diazepam), narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., phenothiazines such as chlorpromazine), muscle relaxants, certain antihistamines (e.g., diphenhydramine). Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain drowsiness-causing ingredients. Ask your pharmacist about the safe use of these products. This drug may interfere with certain laboratory tests (e.g., urine ketones and thyroid function tests). Make sure laboratory personnel and your doctors know you use this drug.
OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include: severe drowsiness, coma, or severe chest pain.
NOTES: Laboratory and/or medical tests (e.g., liver function tests, blood count) will be performed to monitor for side effects and response to treatment.
MISSED DOSE: If you miss a dose, contact your doctor immediately to establish a new dosing schedule.
STORAGE: Store vials at room temperature between 59 and 86 degrees F (15 to 30 degrees C) away from light and moisture. After dilution in correct IV fluids and storage in a proper container (consult your pharmacist for details), the drug is stable at room temperature for 24 hours. Discard any unused portion of the vial(s).
MEDICAL ALERT: Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (USA), or 1-800-668-1507 (Canada).
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Copyright 2004 by First DataBank, Inc.