Depakote Tablets

GENERIC NAME: DIVALPROEX (dye-VAL-pro-ex)

COMMON USES: This medicine is an anticonvulsant used to control certain types of seizures. It is also used to prevent migraine headaches and to treat manic episodes associated with bipolar disorders (manic-depressive illness). It may also be used to treat other conditions as determined by your doctor.

BEFORE USING THIS MEDICINE: WARNING: LIFE-THREATENING LIVER FAILURE has occurred in patients taking this medicine. Children younger than 2 years old 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 this medicine. Be sure to keep all doctor and lab appointments. THIS MEDICINE 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 this medicine. This medicine comes with an additional patient leaflet, "lmportant Information for Women Who Could Become Pregnant." Read it carefully. CASES OF LIFE-THREATENING INFLAMMATION OF THE PANCREAS have occurred with the use of this medicine. Report any stomach pain, nausea, vomiting, or appetite loss to your doctor at once. Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking anticoagulants (e.g., warfarin), acyclovir, barbiturates (eg, phenobarbital), benzodiazepines (e.g., diazepam), cancer medicines, carbamazepine, carbapenem antibiotics (e.g., meropenem, ertapenem, imipenem), cholestyramine, clonazepam, erythromycin, ethosuximide, telbamate, fluoxetine, guanfacine, hydantoins (eg, phenytom), isomazid ketoconazole, lamotrigine, mefloquine methylphemdate, nonsteroidal antiinflammatory drugs (NSAIDs) (e.g., ibuproen), oral contraceptives (e.g., birth control pills), primidone, rifampin, risperidone, salicylates (e.g., aspirin), tolbutamide, topiramate, tricyclic antidepressants (e.g., amitriptyline), zidovudine, or other medicine for seizures. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including a history of liver problems, metabolic disease, blood disease, HIV infection, cytomegalovirus (CMV) infection, high blood levels of ammonia or glutamine, low body temperature, low levels of albumin, brain problems (e.g., organic brain disease), mental retardation, inflammation of the pancreas, kidney, problems, low levels of white blood cells, allergies, pregnancy or if you are of child-bearing age, or breast-feeding. Tell your doctor if you are scheduled for surgery or if you have a family history of urea cycle disorders or unexplained infant deaths. Tell your doctor if you have a history of ornithine transcarbamylase deficiency, unexplained coma, alcohol abuse mental or mood problems (e.g., depression), or suicidal thoughts or actions. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have liver problems or a urea cycle disorder. Contact your doctor or pharmacist if you have any questions or concerns about using this medicine.
HOW TO USE THIS MEDICINE: Follow the directions for using this medicine provided by your doctor. An additional patient information leaflet is available with this medicine. Read it carefully. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine. SWALLOW WHOLE. Do not break, crush, or chew before swallowing. THIS MEDICINE MAY BE TAKEN WITH FOOD if it upsets your stomach. DO NOT STOP TAKING THIS MEDICINE SUDDENLY, especially if you are taking this medicine to prevent seizures. Suddenly stopping this medicine may cause severe seizures to occur. If you need to stop this medicine, your doctor will gradually lower your dose. DO NOT EXCEED THE RECOMMENDED DOSE or take this medicine for longer than prescribed without checking with your doctor. STORE THIS MEDICINE between 68 and 77 degrees F (20 and 25 degrees C) away from heat, moisture, and light. Do not store in the bathroom. KEEP THIS MIDICINE out of the reach of children and away from pets. Taking this medicine at the same time each day will help you remember to take it. CONTINUE TO TAKE THIS MEDICINE even if you feel well. Do not miss any doses. THIS MEDICINE WORKS BEST when there is a constant level of this medicine in your body. IF YOU MISS A DOSE OF THIS MEDICINE, 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.

CAUTIONS: DO NOT USE THIS MEDICINE if you are allergic to any ingredient in this medicine. Lab tests may be performed while you use this medicine to monitor your condition or check for side effects. KEEP ALL DOCTOR AND LAB APPOINTMENTS. THIS MEDICINE MAY INTERFERE WITH CERTAIN LAB TESTS. Be sure your doctor and lab personnel know you are taking this medicine. BEFORE YOU HAVE ANY MEDICAL OR DENTAL TREATMENTS, EMERGENCY CARE OR SURGERY, tell the doctor or dentist that you are taking this medicine. THIS MEDICINE MAY CAUSE DROWSINESS, DIZZINESS, OR BLURRED VISION. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to this medicine. DO NOT DRINK ALCOHOL or use medicines that may cause drowsiness (e.g., sleep aids, muscle relaxers) while you are using this medicine; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness. PATIENTS WHO TAKE THIS MEDICINE 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. Patients who have bipolar illness may also have an increased risk for suicidal thoughts or actions. Watch patients who take this medicine closely. Contact the doctor right away if new, worsened, or sudden symptoms (e.g., depressed mood; anxious, restless, or irritable behavior; panic attacks; any unusual change in mood or behavior) occur or if any signs of suicidal thoughts or actions occur. THIS MEDICINE MAY REDUCE THE NUMBER OF BLOOD CELLS THAT ARE NEEDED FOR CLOTTING. Avoid activities that may cause bruising or injury. INFLAMMATION OF THE PANCREAS is a potentially life-threatening illness associated with this medicine. Contact your doctor at once if you have stomach pain, vomiting, or appetite loss. THIS MEDICINE MAY INCREASE THE AMMONIA LEVELS IN YOUR BLOOD. Contact our doctor right away if you experience unexplained sluggishness and vomiting or mental changes. BEFORE YOU BEGIN TAKING ANY NEW MEDICINES, either prescription or over-the-counter, check with your doctor or pharmacist. USE THIS MEDICINE WITH CAUTION IN THE ELDERLY; they may be more sensitive to its effects. THIS MEDICINE SHOULD BE USED WITH EXTREME CAUTION IN CHILDREN, especially children younger than 2 years old. Children younger than 2 years old may be at increased risk of serious liver problems. FOR WOMEN: THIS MEDICINE HAS BEEN SHOWN TO CAUSE HARM TO THE FETUS. Use an effective form of birth control while you take this medicine. IF YOU THINK YOU MAY BE PREGNANT OR IF YOU WISH TO BECOME PREGNANT, contact your doctor to discuss the benefits and risks of using this medicine while you are pregnant. THIS MEDICINE IS FOUND in breast milk. DO NOT breast-feed while you are taking this medicine. DIABETES PATIENTS: This medicine 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.

POSSIBLE SIDE EFFECTS: SIDE EFFECTS that may occur while taking this medicine include change in appetite, constipation, diarrhea, headache, nausea, vomiting, indigestion, stomach cramps or pain, drowsiness, dizziness, trouble sleeping, weight change, weakness or hair loss. If they continue or are bothersome, check with your doctor. THIS MEDICINE MAY CAUSE AN UNUSUAL DROP IN BODY TEMPERATURE. Contact your doctor right away if you have confusion, lack of energy, loss of coordination, shivering, slow heartbeat, slow or shallow breathing slurred speech, or unusual drowsiness. CONTACT YOUR DOCTOR IMMEDIATELY if you experience abnormal thinking; change in menstrual period; changes in behavior; chest pain; dark, tarry, or bloody stools; dark urine; difficulty speaking; difficulty urinating or other urination problems; extreme tiredness; fast or irregular heartbeat; hallucinations; hearing loss; involuntary movements of the arms and legs; involuntary movements or chewing movements of the face, jaw, mouth, or tongue; joint pain; loss of appetite; loss of seizure control; memory loss; new or worsening mental or mood changes (e.g., aggressiveness, agitation, anxiety, depression, exaggerated feeling of well-being, hostility, impulsiveness, inability to sit stilt, irritability, panic attacks, restlessness); nosebleed; pounding in the chest; red, swollen, blistered, or peeling skin; severe or persistent nausea, vomiting, or stomach pain; shortness of breath; suicidal thoughts or actions; swelling of the arms or legs; symptoms o1 infection (e.g., fever, chills, sore throat); tremor; unusual bleeding or bruising; unusual weakness; vision changes or blurred vision; yellowing of the skin or eyes. AN ALLERGIC REACTION to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue. This is not a complete list of all side effects that may occur. If you have questions about side effects contact your healthcare provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include deep sleep, irregular heartbeat, and loss of consciousness.

ADDITIONAL INFORMATION: DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. IF YOU WILL BE USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME be sure to obtain necessary refills before your supply runs out. CHECK WITH YOUR PHARMACIST about how to dispose of unused medicine.

The information in this monograph is not intended to cover all possible uses, directions, precautions, drug interactions, or adverse effects. This information is generalized and is not intended as specific medical advice. If you have questions about the medicines you are taking or would like more information, check with your doctor, pharmacist, or nurse.