Orfiril Treatment Report

Precautions

Instructions

Side Effects

Interactions

In rare cases, valproic acid has caused life-threatening liver failure, especially in children younger than 2 years old. Children of this age may be at even greater risk for liver problems if they use more than one seizure medication, if they have a metabolic disorder, or if they have a brain disease causing mental impairment (such as Creutzfeldt-Jacob disease, Huntington disease, multiple sclerosis, or a brain injury or infection).

Valproic acid has also caused rare cases of life-threatening pancreatitis (inflammation of the pancreas). Pancreatitis can come on suddenly and symptoms may start even after you have been taking valproic acid for several years. Do not take valproic acid if you have liver disease or a urea cycle disorder.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:

• a bleeding or blood clotting disorder;
• a history of head injury, brain disorder, or coma;
• a family history of a urea cycle disorder;
• a family history of infant deaths with unknown cause; or
• HIV or CMV (cytomegalovirus) infection.

You may have thoughts about suicide while taking this medication. Tell your doctor if you have new or worsening depression or suicidal thoughts during the first several months of treatment, or whenever your dose is changed.

Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits. Do not miss any scheduled appointments.

FDA pregnancy category D. This medication can cause harm to an unborn baby. Do not use valproic acid without your doctor’s consent if you are pregnant. Tell your doctor if you become pregnant during treatment. Valproic acid can cause birth defects. Use an effective form of birth control while you are using this medication.

Valproic acid passes into breast milk and could harm a nursing infant. Do not take valproic acid without telling your doctor if you are breast-feeding a baby.

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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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.

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Seek emergency medical attention if the person taking this medicine has nausea, vomiting, stomach pain, or loss of appetite, low fever, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes). These symptoms may be early signs of liver damage. Some of these symptoms may also be early signs of pancreatitis.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

• unexplained weakness with vomiting and confusion or fainting;
• easy bruising or bleeding;
• fever, chills, skin rash, swollen glands, flu symptoms;
• urinating less than usual;
• blood in your urine;
• weakness, lack of coordination;
• a red, blistering, peeling skin rash;
• extreme drowsiness; or
• double vision or back-and-forth movements of the eyes.

Less serious side effects may include:

• mild drowsiness;
• diarrhea, constipation, upset stomach;
• changes in your menstrual periods;
• enlarged breasts;
• tremor (shaking);
• hair loss;
• weight changes;
• vision changes; or
• unusual or unpleasant taste in your mouth.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

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Cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for depression or anxiety can add to sleepiness caused by valproic acid. Tell your doctor if you regularly use any of these medicines, or any other seizure medication.

Before taking valproic acid, tell your doctor if you are using any of the following drugs:

• topiramate (Topamax);
• tolbutamide (Orinase);
• a blood thinner such as warfarin (Coumadin);
• aspirin or acetaminophen (Tylenol);
• zidovudine (Retrovir);
• clozapine (Clozaril, Fazaclo);
• diazepam (Valium);
• meropenem (Marum);
• rifampin (Rifadin, Rimactane, Rifater); or
• ethosuximide (Zarontin).

This list is not complete and there may be other drugs that can interact with valproic acid. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Depacon, Depakene, sodium valproate, valproic acid, and Stavzor

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