Depakote Sprinkle CapsulesGeneric Name: Divalproex
Life-threatening liver failure has occurred in patients taking Depakote Sprinkle Capsules. 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 Depakote Sprinkle Capsules. Be sure to keep all doctor and lab appointments.
Depakote Sprinkle Capsules can 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 Depakote Sprinkle Capsules. Depakote Sprinkle Capsules 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 Depakote Sprinkle Capsules. Report any stomach pain, nausea, vomiting, or loss of appetite to your doctor at once.
Depakote Sprinkle Capsules are 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.
Depakote Sprinkle Capsules are an anticonvulsant. It works by reducing or preventing the number of seizures by controlling the abnormal activity of nerve impulses in the brain and central nervous system.
Do NOT use Depakote Sprinkle Capsules if:
- you are allergic to any ingredient in Depakote Sprinkle Capsules
- 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 Depakote Sprinkle Capsules:
Some medical conditions may interact with Depakote Sprinkle Capsules. 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, are breast-feeding, or are of childbearing age
- 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 alcohol abuse, 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 (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
- if you have a history of mental or mood problems (eg, depression), or suicidal thoughts or actions
- if you take any other medicine for seizures
Some MEDICINES MAY INTERACT with Depakote Sprinkle Capsules. 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 Depakote Sprinkle Capsules, including blurred vision or other vision problems, clumsiness or unsteadiness, drowsiness, nausea, or vomiting, may be increased
- Clonazepam because the risk of seizures may be increased
- Topiramate because the risk of high ammonium levels, brain problems, or an unusual drop in body temperature may be increased
- Acyclovir, cancer medicines, carbapenem antibiotics (eg, ertapenem, imipenem, meropenem), cholestyramine, hydantoins (eg, phenytoin), mefloquine, nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen), oral contraceptives (eg, birth control pills), or rifampin because they may decrease Depakote Sprinkle Capsules's effectiveness
- Anticoagulants (eg, warfarin), barbiturates (eg, phenobarbital), ethosuximide, lamotrigine, methylphenidate, primidone, tolbutamide, tricyclic antidepressants (eg, amitriptyline), or zidovudine because the risk of their side effects may be increased by Depakote Sprinkle Capsules
This may not be a complete list of all interactions that may occur. Ask your health care provider if Depakote Sprinkle Capsules 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 Depakote Sprinkle Capsules:
Use Depakote Sprinkle Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Depakote Sprinkle Capsules. Talk to your pharmacist if you have questions about this information.
- Take Depakote Sprinkle Capsules by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
- Swallow Depakote Sprinkle Capsules whole. Do not break, crush, or chew before swallowing. If you cannot swallow the capsule whole, you may open it and sprinkle the contents over a spoonful of soft food (eg, applesauce, pudding). Mix the medicine with the food and swallow the mixture right away, followed by a glass of water. Do not crush or chew the medicine before swallowing. Do not store the mixture for future use.
- Do not stop taking Depakote Sprinkle Capsules suddenly. Suddenly stopping Depakote Sprinkle Capsules may cause severe seizures to occur. If you need to stop Depakote Sprinkle Capsules, your doctor will gradually lower your dose.
- Taking Depakote Sprinkle Capsules at the same time each day will help you to remember to take it.
- Continue to take Depakote Sprinkle Capsules even if you feel well. Do not miss any doses. Depakote Sprinkle Capsules works best when there is a constant level of it in your body.
- If you miss a dose of Depakote Sprinkle Capsules, 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 Depakote Sprinkle Capsules.
Important safety information:
- Depakote Sprinkle Capsules may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Depakote Sprinkle Capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Depakote Sprinkle Capsules; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
- Patients who take Depakote Sprinkle Capsules 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 (manic-depressive) illness may also have an increased risk for suicidal thoughts or actions. Watch patients who take Depakote Sprinkle Capsules closely. Contact the doctor at once if new, worsened, or sudden symptoms, such as depressed mood; anxious, restless, irritable behavior; panic attacks; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.
- Depakote Sprinkle Capsules may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
- Tell your doctor or dentist that you take Depakote Sprinkle Capsules before you receive any medical or dental care, emergency care, or surgery.
- You may notice undissolved parts of Depakote Sprinkle Capsules in your stool. This is normal and not a cause for concern.
- Inflammation of the pancreas is a potentially life-threatening illness associated with Depakote Sprinkle Capsules. Symptoms include stomach pain, vomiting, or loss of appetite. Contact your doctor at once if any of these symptoms occur.
- Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
- Diabetes patients - Depakote Sprinkle Capsules 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.
- Depakote Sprinkle Capsules may increase the ammonia levels in your blood. Contact your doctor right away if you experience unexplained sluggishness and vomiting or mental changes.
- Depakote Sprinkle Capsules may cause an unusual drop in body temperature (hypothermia). Symptoms may include confusion, lack of energy, loss of coordination, shivering, slow heartbeat, slow or shallow breathing, slurred speech, or unusual drowsiness. Contact your doctor right away if you have any of these symptoms.
- Depakote Sprinkle Capsules may interfere with certain lab tests, including thyroid function. Be sure your doctor and lab personnel know you are taking Depakote Sprinkle Capsules.
- Lab tests, including complete blood cell counts, blood ammonia levels, and liver function, may be performed while you use Depakote Sprinkle Capsules. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Depakote Sprinkle Capsules with caution in the ELDERLY; they may be more sensitive to its effects, especially drowsiness.
- Depakote Sprinkle Capsules should be used with extreme caution in CHILDREN younger than 10 years old; safety and effectiveness in these children have not been confirmed. CHILDREN younger than 2 years old may be at increased risk of serious liver problems.
- PREGNANCY and BREAST-FEEDING: Depakote Sprinkle Capsules has been shown to cause harm to the fetus. Use an effective form of birth control while you take Depakote Sprinkle Capsules. If you think you may be pregnant or if you wish to become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Depakote Sprinkle Capsules while you are pregnant. Depakote Sprinkle Capsules are found in breast milk. Do not breast-feed while you are taking Depakote Sprinkle Capsules.
Possible side effects of Depakote Sprinkle Capsules:
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:
Change in appetite; constipation; diarrhea; dizziness; drowsiness; hair loss; headache; indigestion; nausea; stomach cramps or pain; trouble sleeping; vomiting; weakness; weight changes.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; change in menstrual period; changes in behavior; chest pain; confusion; dark, tarry, or bloody stools; 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 the face, jaw, mouth, or tongue; joint pain; lack of energy; loss of appetite; loss of coordination; loss of seizure control; memory loss; new or worsening mental or mood changes (eg, aggressiveness, agitation, anxiety, depression, exaggerated feeling of well-being, hostility, impulsiveness, inability to sit still, 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 of infections (eg, fever, chills, sore throat); tremor; unusual bleeding or bruising; unusual weakness; vision changes or blurred vision; 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 deep sleep; drowsiness; irregular heartbeat; loss of consciousness.Proper storage of Depakote Sprinkle Capsules:
Store Depakote Sprinkle Capsules between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Depakote Sprinkle Capsules out of the reach of children and away from pets.
- If you have any questions about Depakote Sprinkle Capsules, please talk with your doctor, pharmacist, or other health care provider.
- Depakote Sprinkle Capsules are 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 Depakote Sprinkle Capsules. 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.