Valproic Acid Delayed-Release CapsulesGeneric Name:
Valproic Acid (val-PROE-ik AS-id)Brand Name:
Severe and sometimes fatal liver problems have occurred with the use of Valproic Acid Delayed-Release Capsules. The risk is greater in children younger than 2 years old, especially those who have metabolic disorders, seizure disorders with mental retardation, brain disease, or who take multiple seizure medicines.
When liver problems have occurred, it usually has been during the first 6 months of treatment. Contact your doctor right away if symptoms of liver problems occur (eg, dark urine, general feeling of being unwell, loss of appetite, sluggishness, swelling of the face, vomiting, weakness, yellowing of the skin or eyes). Patients with seizure disorders may also experience worsening of seizures. Contact your doctor right away if this occurs. Liver function tests should be performed before you start Valproic Acid Delayed-Release Capsules and during treatment. Be sure to keep all doctor and lab appointments.
Valproic Acid Delayed-Release Capsules can cause severe birth defects if you take it while you are pregnant. Women who are able to become pregnant should discuss with their doctor the benefits and risks of using Valproic Acid Delayed-Release Capsules during pregnancy. Contact your doctor right away if you think you may be pregnant. An extra patient leaflet about this risk is available with Valproic Acid Delayed-Release Capsules. Read it carefully. Talk with your doctor if you have questions about this information.
Severe and sometimes fatal pancreas problems have occurred with the use of Valproic Acid Delayed-Release Capsules. These problems have occurred soon after starting Valproic Acid Delayed-Release Capsules, as well as after several years of treatment. Tell your doctor right away if you develop loss of appetite, nausea, stomach pain, or vomiting.
Valproic Acid Delayed-Release Capsules are used for:
Treating certain seizure disorders. It is used to treat mania in patients with bipolar disorder and to prevent migraine headaches. It may also be used for other conditions as determined by your doctor.
Valproic Acid Delayed-Release Capsules are an anticonvulsant. It works by increasing the amount of a certain chemical in the brain.
Do NOT use Valproic Acid Delayed-Release Capsules if:
- you are allergic to any ingredient in Valproic Acid Delayed-Release 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 Valproic Acid Delayed-Release Capsules:
Some medical conditions may interact with Valproic Acid Delayed-Release 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 liver problems, cancer, blood or bleeding problems (eg, low blood platelet levels), HIV infection, cytomegalovirus (CMV) infection, kidney problems, pancreas problems, low blood albumin levels, or high blood glycine levels
- if you have a history of metabolic problems, brain disease, coma, high blood ammonia or glutamine levels, low body temperature, mental retardation, recurring vomiting and sluggishness, or recurring extreme irritability
- if you have a history of mental or mood problems, suicidal thoughts or actions, or alcohol abuse or dependence
- if you have decreased food or fluid intake, or if you are scheduled for surgery
- if you have a family history of urea cycle disorders or unexplained infant deaths
- if you take any other medicine for seizures
Some MEDICINES MAY INTERACT with Valproic Acid Delayed-Release Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Clonazepam because the risk of seizures may be increased in certain patients
- Topiramate because the risk of high ammonium levels and brain problems may be increased
- Felbamate or salicylates (eg, aspirin) because they may increase the risk of Valproic Acid Delayed-Release Capsules's side effects
- Carbamazepine, carbapenem antibiotics (eg, imipenem), hormonal birth control (eg, birth control pills), hydantoins (eg, phenytoin), mefloquine, or rifampin because they may decrease Valproic Acid Delayed-Release Capsules's effectiveness
- Anticoagulants (eg, warfarin), barbiturates (eg, phenobarbital), benzodiazepines (eg, diazepam), ethosuximide, lamotrigine, primidone, tolbutamide, tricyclic antidepressants (eg, amitriptyline), or zidovudine because the risk of their side effects may be increased by Valproic Acid Delayed-Release Capsules
This may not be a complete list of all interactions that may occur. Ask your health care provider if Valproic Acid Delayed-Release 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 Valproic Acid Delayed-Release Capsules:
Use Valproic Acid Delayed-Release Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Valproic Acid Delayed-Release Capsules. Talk to your pharmacist if you have questions about this information.
- Take Valproic Acid Delayed-Release Capsules by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
- Swallow Valproic Acid Delayed-Release Capsules whole. Do not break, crush, or chew before swallowing.
- Valproic Acid Delayed-Release Capsules works best if it is taken at the same time each day.
- Continue to take Valproic Acid Delayed-Release Capsules even if you feel well. Do not miss any doses.
- If you are taking Valproic Acid Delayed-Release Capsules to treat seizures, do not suddenly stop taking it; this may cause an increased risk of severe seizures. If you need to stop Valproic Acid Delayed-Release Capsules or add a new medicine, your doctor will gradually lower your dose.
- If you miss a dose of Valproic Acid Delayed-Release 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 Valproic Acid Delayed-Release Capsules.
Important safety information:
- Valproic Acid Delayed-Release Capsules may cause dizziness, drowsiness, or vision changes. These effects may be worse if you take it with alcohol or certain medicines. Use Valproic Acid Delayed-Release Capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Check with your doctor before you drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Valproic Acid Delayed-Release Capsules; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
- Patients who take Valproic Acid Delayed-Release 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 Valproic Acid Delayed-Release Capsules closely. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood; anxious, restless, or 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.
- Valproic Acid Delayed-Release 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 Valproic Acid Delayed-Release Capsules before you receive any medical or dental care, emergency care, or surgery.
- Diabetes patients - Valproic Acid Delayed-Release 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.
- Valproic Acid Delayed-Release Capsules may interfere with certain lab tests, including thyroid function. Be sure your doctor and lab personnel know you are taking Valproic Acid Delayed-Release Capsules.
- Lab tests, including complete blood cell counts and liver function, may be performed while you use Valproic Acid Delayed-Release 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 Valproic Acid Delayed-Release Capsules with caution in the ELDERLY; they may be more sensitive to its effects, especially drowsiness.
- Valproic Acid Delayed-Release Capsules should be used with extreme caution in CHILDREN, especially children younger than 2 years old; they may be at increased risk of serious and sometimes fatal liver problems.
- PREGNANCY and BREAST-FEEDING: Valproic Acid Delayed-Release Capsules has been shown to cause harm to the fetus. Use an effective form of birth control while you take Valproic Acid Delayed-Release 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 Valproic Acid Delayed-Release Capsules while you are pregnant. Valproic Acid Delayed-Release Capsules are found in breast milk. Do not breast-feed while you are taking Valproic Acid Delayed-Release Capsules.
Possible side effects of Valproic Acid Delayed-Release 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:
Constipation; diarrhea; dizziness; drowsiness; headache; increased or decreased appetite; mild hair loss; nausea; sore throat; stomach pain or upset; trouble sleeping; vomiting; weakness; weight gain.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; behavior changes; blurred vision or other vision changes; change in menstrual period; change in the amount of urine produced; chest pain; confusion; dark urine; fast or irregular heartbeat; fever, chills, or persistent sore throat; general feeling of being unwell; hallucinations; hearing loss; joint or muscle pain or weakness; loss of coordination; 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); pale stools; red, swollen, peeling, or blistered skin; ringing in the ears; severe or persistent nausea, vomiting, or loss of appetite; severe or persistent stomach pain or cramps; shortness of breath; sluggishness; suicidal thoughts or actions; swelling of the arms or legs; swollen lymph nodes; tremor; trouble speaking or walking; uncontrolled muscle movements; unusual bleeding or bruising; unusual tiredness or weakness; 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 irregular heartbeat; loss of consciousness; severe drowsiness.Proper storage of Valproic Acid Delayed-Release Capsules:
Store Valproic Acid Delayed-Release Capsules at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Valproic Acid Delayed-Release Capsules out of the reach of children and away from pets.
- If you have any questions about Valproic Acid Delayed-Release Capsules, please talk with your doctor, pharmacist, or other health care provider.
- Valproic Acid Delayed-Release 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 Valproic Acid Delayed-Release 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.