Valproic Acid, Oral/Injection

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KEY POINTS

• This medicine is taken by mouth to treat seizures, manic episodes in people with bipolar disorder, or to help prevent migraine headaches. Take it exactly as directed.
• This medicine may increase suicidal thoughts or actions in some people.
• This medicine is not usually given to pregnant women because it can cause severe birth defects.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause severe or life-threatening pancreatitis or liver damage or other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antiseizure

Generic and brand names: divalproex sodium, oral; valproate sodium, oral; valproic acid, injection; valproic acid, oral; Depacon; Depakene Capsules; Depakene Syrup; Depakote; Depakote ER; Depakote Sprinkle

What is this medicine used for?

This medicine may be taken by mouth or given by injection to treat:

• Seizures
• Manic episodes (periods of excitement) in people with bipolar disorder.

It may be taken by mouth to help prevent migraine headaches.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Bleeding or blood-clotting disorders
• Cytomegalovirus (CMV) infection
• Depression or other mental health problems
• HIV or AIDS
• Liver or pancreas problems
• Problems with alcohol abuse
• Thoughts of suicide
• Urea cycle disorder (too much ammonia in the blood)

Also tell your provider if anyone in your family has had urea cycle disorder or liver disease. Tell your provider if you have recently had a head injury or brain surgery.

Females of childbearing age: This medicine is not usually given to pregnant women because it can harm the baby. If you are pregnant, tell your healthcare provider. Do not become pregnant during treatment with this medicine. Use effective birth control while taking this medicine. Talk to your healthcare provider about effective birth control methods. If you become pregnant, contact your healthcare provider right away. Do not breast-feed while you are receiving this medicine.

How do I use it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes, along with any other medicine prescribed. Take it regularly to control your seizures.

Do not stop taking this medicine without your healthcare provider's approval. You may have to reduce your dosage gradually to avoid an increase in seizures.

Check with your healthcare provider before using this medicine in children. Some brands should not be used in children under a certain age. Children less than 2 years old are at risk for severe liver problems.

This medicine may be given by IV infusion (through a needle into your vein) for a few days. Usually you are switched as soon as possible to capsules, tablets, a syrup, or sprinkles to be taken by mouth. Take the medicine with food to lessen the chance that the medicine will upset your stomach.

Swallow the tablets or capsules whole with a full glass (8 ounces) of water. Do not split, chew, or crush the tablets or capsules.

If your healthcare provider has prescribed sprinkle capsules, they may be swallowed whole, or they may be opened and the contents sprinkled on soft food (for example, applesauce or pudding) and swallowed without chewing.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: drowsiness, shallow breathing, fainting, tremors.

What should I watch out for?

You will need to have blood tests regularly to see how this medicine affects you. Your healthcare provider may need to adjust your dosage. Keep all appointments for these tests.

This medicine may cause severe or life-threatening pancreatitis or liver damage. If while taking this medicine you develop weakness, tiredness, loss of appetite, severe nausea or vomiting, facial swelling, severe stomach pain, dark urine, or yellowing of your skin or eyes, contact your healthcare provider right away.

This medicine can cause serious birth defects. Make sure you understand what the risks and benefits of treatment are. Talk to your healthcare provider about effective birth control methods.

Antiseizure medicines may increase suicidal thoughts or actions in some people. Call your healthcare provider right away if you have new or worsening depression, any unusual changes in mood or behavior, or new or increased thoughts of suicide.

This medicine may make you dizzy or drowsy. Do not drive or operate machinery unless you are fully alert.

This medicine increases the effects of alcohol and other drugs that slow down your nervous system. Do not drink alcohol or take other medicines unless your healthcare provider approves.

Adults over the age of 65 may be at greater risk for side effects. Talk with your provider about this.

This medicine may interfere with results of certain lab tests. Check with your healthcare provider if you have diabetes or thyroid problems.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Clumsiness; increased seizures; severe stomach pain or severe back pain; severe nausea or vomiting; loss of appetite; facial swelling or any unexplained swelling; unusual tiredness or weakness; confusion; yellowing of skin or eyes; unusual bruising or bleeding; hallucinations (seeing or hearing things that are not there); vision problems; dark urine; light-colored bowel movements; unusual changes in mood or behavior; suicidal thoughts; new or worsening depression; fever with skin redness, blistering, or peeling; mouth sores.

Other: Diarrhea, drowsiness, trouble sleeping, mild nausea, heartburn, dizziness, trembling, fast heart rate, joint pain, hair loss, menstrual changes, weight gain or weight loss, headache, runny or stuffy nose, constipation, forgetfulness, ringing in the ears.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Antianxiety medicines such as alprazolam (Xanax), buspirone, clonazepam (Klonopin), diazepam (Valium), and hydroxyzine (Vistaril)
• Antibiotics such as clarithromycin (Biaxin), doripenem (Doribax), ertapenem (Invanz), erythromycin (E.E.S., Ery-Tab, Erythrocin), imipenem (Primaxin), isoniazid, meropenem (Merrem), rifampin (Rifadin), and telithromycin (Ketek)
• Antidepressants such as amitriptyline, desipramine (Norpramin), desvenlafaxine (Pristiq), fluoxetine (Prozac), imipramine (Tofranil), levomilnacipran (Fetzima), mirtazapine (Remeron), nortriptyline (Pamelor), trazodone, and vortioxetine (Trintellix)
• Antipsychotic medicines such as chlorpromazine, haloperidol (Haldol), paliperidone (Invega), prochlorperazine (Compro), risperidone (Risperdal), thioridazine, trifluoperazine, and ziprasidone (Geodon)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), ethosuximide (Zarontin), felbamate (Felbatol), lamotrigine (Lamictal), oxcarbazepine (Trileptal), phenytoin (Dilantin, Phenytek), primidone (Mysoline), rufinamide (Banzel), and topiramate (Qudexy, Topamax, Trokendi)
• Antiviral medicines such as ombitasvir/paritaprevir/ritonavir/dasabuvir (Viekira) and ombitasvir/paritaprevir/ritonavir (Technivie)
• Aspirin and other salicylates
• Barbiturates such as butabarbital (Butisol), pentobarbital (Nembutal), phenobarbital, and secobarbital (Seconal)
• Cholestyramine (Prevalite)
• Doxepin (Silenor)
• Guanfacine (Intuniv, Tenex)
• HIV medicines such as atazanavir (Reyataz), darunavir (Prezista), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), ritonavir (Norvir), saquinavir (Invirase), tipranavir (Aptivus), and zidovudine (Retrovir)
• Lorcaserin (Belviq)
• Natural remedies such as chaparral, comfrey, evening primrose oil, ginkgo biloba, and St. John's wort
• Nonsteroidal anti-inflammatory medicines (NSAIDs) such as diclofenac (Cambia, Voltaren, Zipsor), ibuprofen (Advil, Motrin), indomethacin (Indocin), ketoprofen, ketorolac, nabumetone (Relafen), naproxen (Aleve, Anaprox, Naprelan), oxaprozin (Daypro), piroxicam (Feldene), and sulindac (Clinoril)
• Orlistat (alli, Xenical)
• Pain medicines such as fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze), meperidine (Demerol), and tramadol (ConZip, Ultram)
• Sleeping pills such as flurazepam, temazepam (Restoril), triazolam (Halcion), zaleplon (Sonata), and zolpidem (Ambien, Edluar, Intermezzo)
• Sodium oxybate (Xyrem)
• Vorinostat (Zolinza)
• Warfarin (Coumadin)

Do not drink alcohol while taking this medicine unless your healthcare provider approves.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicines in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.