Drug Notebook

FDA Alerts

    Hepatotoxicity
  • Potentially fatal hepatic failure can occur.
  • Usually occurs during the initial 6 months of therapy.
  • Children <2 years of age are at considerably increased risk of developing fatal hepatotoxicity, especially those receiving multiple anticonvulsants and those with congenital metabolic disorders, severe seizure disorders accompanied by mental retardation, or organic brain disease.
  • Use with extreme caution in such children and only as single-agent therapy; weigh carefully benefits versus risks.
  • Above this age group, the risk of fatal hepatotoxicity decreases considerably in progressively older patient groups.
  • Serious fatal hepatotoxicity may be preceded by symptoms such as malaise, weakness, lethargy, facial edema, anorexia, and vomiting.
  • In epileptic patients, loss of seizure control also may precede its development.
  • Monitor patients closely for development of any such changes.
  • Perform liver function tests prior to and at frequent intervals during therapy, especially during the first 6 months.

    Fetal/Neonatal Morbidity and Mortality
  • Can produce teratogenic effects (e.g., neural tube defects such as spinal bifida).
  • Use in women of childbearing potential requires that potential benefits of therapy be weighed against the risk of fetal injury. (See Pregnancy under Cautions.)

    Pancreatitis
  • Life-threatening pancreatitis has occurred both in children and adults.
  • Some cases described as hemorrhagic with rapid progression from initial symptoms to death.
  • Can occur shortly after initial use as well as after several years of use.
  • Warn patients and caregivers that abdominal pain, nausea, vomiting, and/or anorexia can be symptoms of pancreatitis that require prompt medical evaluation.
  • Usually discontinue the drug and initiate alternative therapy if pancreatitis is diagnosed.

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valproic acid
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(val PRO ik A sid)

How should I take valproic acid?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor.

Take each dose with a full glass of water. Drink plenty of water while you are taking this medication. Your dose may need to be changed if you do not get enough fluids each day.

Measure the liquid form of valproic acid with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.

To be sure this medication is not causing harmful effects, your liver function will need to be tested. It is important that you not miss any scheduled visits to your doctor.

Do not stop taking the medication even if you feel better. It is important to take valproic acid regularly to prevent seizures from recurring. Get your prescription refilled before you run out of medicine completely. Call your doctor promptly if this medicine does not seem to be working as well in preventing your seizures. Swallow the capsule whole. Do not crush, chew, or break a capsule because the medicine may irritate your mouth or throat when you swallow it.

Carry an ID card or wear a medical alert bracelet stating that you are taking valproic acid, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you are taking valproic acid.

Store valproic acid at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include sleepiness or drowsiness, shallow breathing, weak pulse, or loss of consciousness.

What should I avoid while taking valproic acid?

Avoid drinking alcohol, which can increase some of the side effects of valproic acid. Valproic acid can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Valproic acid can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.
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