Valproic acid delayed-release capsules

Pronunciation

Generic Name: valproic acid (val-PROE-ik AS-id)
Brand Name: Stavzor

Liver failure and death from liver failure has occurred in patients taking valproic acid delayed-release capsules. This has usually occurred within the first 6 months of treatment. Tell your doctor right away if you notice symptoms of liver problems (eg, a general feeling of discomfort, sluggishness, unusual tiredness or weakness, swelling of the face, loss of appetite, vomiting, stomach pain, dark urine, pale stools, or yellowing of the skin or eyes). In patients who have seizures, loss of seizure control may occur. You should have lab tests done before and during treatment to check for liver problems. Be sure to keep all doctor and lab appointments.

Children younger than 2 years old have an increased risk of fatal liver problems, especially if they take more than 1 seizure medicine or have a metabolic disorder, a severe seizure disorder along with mental retardation, or organic brain disease. Discuss any questions or concerns with your doctor.

There is an increased risk of liver failure and death from liver failure in patients who have a genetic liver problem caused by a mitochondrial disorder (eg, Alpers-Huttenlocher syndrome). You may need to have a special genetic test to check for this condition. Certain patients who have known or suspected mitochondrial disorders should not take valproic acid delayed-release capsules. Talk with your doctor for more information.

Valproic acid delayed-release capsules can cause severe birth defects if it is used during pregnancy. It can also cause the child to have a lower IQ. Do not take valproic acid delayed-release capsules to prevent migraine headaches if you are pregnant. If you are pregnant and take valproic acid delayed-release capsules for seizures or bipolar disorder, talk to your doctor to decide if you will continue to take valproic acid delayed-release capsules.

If you are able to become pregnant, you must use an effective form of birth control while you take valproic acid delayed-release capsules. Contact your doctor right away if you become pregnant or think you may be pregnant while taking valproic acid delayed-release capsules.

Valproic acid delayed-release capsules comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get valproic acid delayed-release capsules refilled.

Severe and sometimes fatal pancreas problems (pancreatitis) have occurred with the use of valproic acid delayed-release capsules. This has been reported shortly after starting treatment as well as after several years of use. Seek immediate medical attention if you notice any stomach pain, nausea, vomiting, or loss of appetite.


Valproic acid delayed-release capsules is 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 is 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
  • you have a genetic liver problem caused by a mitochondrial disorder (eg, Alpers-Huttenlocher syndrome)
  • the patient is younger than 2 years old and has a mitochondrial disorder
  • you are taking valproic acid delayed-release capsules to prevent migraine headaches and you are pregnant

Contact your doctor or health care provider right away if any of these apply to you.

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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 disease (eg, low levels of white blood cells, 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, ornithine transcarbamylase deficiency, brain problems (eg, organic 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
  • Benzodiazepines (eg, diazepam), 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, primidone), ethosuximide, lamotrigine, methylphenidate, quetiapine, rufinamide, 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.

  • Valproic acid delayed-release capsules comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get valproic acid delayed-release capsules refilled.
  • 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.
  • Inflammation of the pancreas is a potentially life-threatening illness associated with valproic acid delayed-release capsules. Symptoms include stomach pain, vomiting, or loss of appetite. Contact your doctor at once if any of these symptoms 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.
  • You may notice undissolved parts of valproic acid delayed-release capsules in your stool with some brands of valproic acid delayed-release capsules. Contact your doctor if this occurs.
  • 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.
  • Certain brain problems have happened with the use of valproic acid products. Sometimes, these problems have led to health problems that may not go away. Discuss any questions or concerns with your doctor.
  • 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 has been shown to cause harm to the fetus. If you may become pregnant, discuss other possible treatment options with your doctor. If a decision is made to take valproic acid delayed-release capsules, use effective birth control while you are taking it. Talk with your doctor if you are planning to become pregnant, or if you have questions or concerns about this information.
  • PREGNANCY and BREAST-FEEDING: Valproic acid delayed-release capsules has been shown to cause harm to the fetus. If you think you may be pregnant, contact your doctor right away. You will need to discuss the benefits and risks of using valproic acid delayed-release capsules while you are pregnant. You and your doctor will need to decide if you will continue to take valproic acid delayed-release capsules while you are pregnant. Valproic acid delayed-release capsules is 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 or swallowing; tightness in the chest; swelling of the mouth, face, lips, throat, 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; fainting; 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); new or worsening seizures; 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; symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, severe stomach pain, yellowing of the skin or eyes); tremor; trouble speaking or walking; uncontrolled muscle movements; unusual bleeding or bruising; unusual tiredness or weakness.

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, or emergency room immediately.

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.

General information:

  • 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 is 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.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take valproic acid delayed-release capsules or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about valproic acid delayed-release capsules. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to valproic acid delayed-release capsules. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using valproic acid delayed-release capsules.

Issue Date: December 3, 2014
Database Edition 14.4.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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