Brand Depakene

This medication is used to treat seizure disorders, mental/mood conditions (such as manic phase of bipolar disorder), and to prevent migraine headaches. It works by restoring the balance of certain natural substances (neurotransmitters) in the brain.

Read the Patient Information Leaflet provided by your pharmacist before you start taking valproate sodium and each time you get a refill. If you have any questions, consult your doctor or pharmacist. Take this medication by mouth as directed by your doctor. You may take it with food if stomach upset occurs. Use a specially marked device to measure the correct amount of medication. Valproate sodium syrup should not be mixed with carbonated drinks because it may irritate the mouth and throat. Dosage is based on your weight, medical condition, and response to therapy. Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time each day to keep the amount of medication in your blood constant. If this medication is used for seizures, do not stop taking it without consulting your doctor. Your condition may become worse if the drug is suddenly stopped. Your dose may need to be gradually decreased. This medication does not relieve acute migraine headaches. Take other medications as directed by your doctor for acute attacks. Inform your doctor if your condition does not improve.

See also Warning section. Before taking valproate sodium, tell your doctor or pharmacist if you are allergic to it; or to valproic acid or divalproex sodium; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. This medication should not be used if you have certain medical conditions. Before using this drug, consult your doctor or pharmacist if you have: liver disease, pancreatitis, certain metabolic disorders (urea cycle disorders). Before using this medication, tell your doctor or pharmacist your medical history, especially of: alcohol abuse, bleeding problems, brain disease (dementia), kidney disease, low body water (dehydration), poor nutrition. Before having surgery, tell your doctor or dentist that you are taking this medication. This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages. Caution is advised when using this drug in the elderly because they may be more sensitive to its side effects, especially drowsiness or tremor. This medication is not recommended for use during pregnancy. It may harm an unborn baby. However, since untreated seizures are a serious condition that can harm both a pregnant woman and her unborn baby, do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately talk to your doctor about the benefits and risks of using this medication during pregnancy. Your doctor may switch the type of medication you use during pregnancy. See also Warning section. This medication passes into breast milk. While there have been no reports of harm to nursing infants, consult your doctor before breast-feeding.

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop or change the dosage of any medicine before checking with them first. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: certain antidepressants (e.g., amitriptyline, nortriptyline, phenelzine), certain benzodiazepines (e.g., clonazepam, diazepam), certain antibiotics (carbapenems such as doripenem, imipenem), mefloquine, other medications for seizure (e.g., carbamazepine, ethosuximide, felbamate, lamotrigine, phenobarbital, phenytoin, rufinamide, topiramate), rifampin, vorinostat, warfarin, zidovudine. Low-dose aspirin, as prescribed by your doctor for specific medical reasons such as heart attack or stroke prevention (usually these dosages are 81-325 milligrams per day), should be continued. Consult your doctor or pharmacist if you are using aspirin for any reason. Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: antihistamines that cause drowsiness (e.g., diphenhydramine), medicine for sleep (e.g., sedatives), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., phenothiazines such as chlorpromazine), tranquilizers. Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about the safe use of those products. This drug may affect certain lab tests (e.g., urine ketones). Make sure laboratory personnel and your doctors know you use this medication. This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

See also Warning section. Diarrhea, dizziness, drowsiness, hair loss, blurred/double vision, change in menstrual periods, ringing in the ears, shakiness (tremor), unsteadiness, weight changes may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor immediately if any of these serious side effects occur: signs of infection (e.g., fever, persistent sore throat). Tell your doctor immediately if any of these unlikely but serious side effects occur: chest pain, easy bruising/unexplained bleeding, fast/irregular heartbeat, swelling of hands/feet, uncontrolled eye movement (nystagmus). A small number of people who take anticonvulsants for any condition (such as seizure, bipolar disorder, pain) may experience depression, suicidal thoughts/attempts, or other mental/mood problems. Tell your doctor immediately if you or your family/caregiver notice any unusual/sudden changes in your mood, thoughts, or behavior including signs of depression, suicidal thoughts/attempts, thoughts about harming yourself. Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: dark urine, persistent nausea/vomiting, severe stomach/abdominal pain, yellowing eyes or skin. Severe (sometimes fatal) brain disorder (encephalopathy) has rarely occurred, particularly in patients with certain metabolic disorders (urea cycle disorders). Tell your doctor immediately if you develop unexplained weakness and vomiting or sudden mental changes. A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Store the US product at room temperature below 86 degrees F (30 degrees C) away from light and moisture. Do not store in the bathroom. Store the Canadian product at room temperature between 59-77 degrees F (15-25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.