
The following information is a summary about Depakene. It is not intended to replace a doctor's instructions.
What is Valproate sodium?
Valproate sodium affects chemicals in the body that may be involved in causing seizures.
Valproate sodium is used to treat various types of seizure disorders. Valproate sodium is
sometimes used together with other seizure medications.
Valproate sodium may also be used for purposes other than those listed in this medication
guide.
What is the most important information I should know about Valproate sodium?
In rare cases, Valproate sodium 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).
Valproate sodium 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 Valproate sodium for several years.
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.
Valproate sodium can cause birth defects. Do not use this medication
without your doctor's consent if you are pregnant. It could cause harm to the unborn baby. Use
an effective form of birth control, and tell your doctor if you become pregnant during treatment.
Do not stop taking the medication even if you feel better. It is important to take
Valproate sodium regularly to prevent seizures from recurring. 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 Valproate sodium.
Avoid using other drugs that make you sleepy (such as other seizure medicines, alcohol,
cold medicine, pain medication, muscle relaxers, and medicine for depression or anxiety). They
can add to sleepiness caused by Valproate sodium.
What should I discuss with my healthcare provider before taking valproic
acid?
In rare cases, Valproate sodium 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).
Valproate sodium 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 Valproate sodium for several years. Do not take Valproate sodium if you have liver disease or
a urea cycle disorder.
Before taking Valproate sodium, tell your doctor if you have:
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a bleeding or blood clotting disorder;
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a history of head injury, brain disorder, or coma;
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a family history of a urea cycle disorder;
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a family history of infant deaths with unknown cause; or
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HIV or CMV (cytomegalovirus) infection.
If you have any of these conditions, you may not be able to use
Valproate sodium, or you may need a dosage adjustment or special tests during treatment.
FDA pregnancy category D. This medication can cause harm to an unborn baby. Do
not use Valproate sodium without your doctor's consent if you are pregnant. Tell your doctor if you
become pregnant during treatment. Valproate sodium can cause birth defects.
Use an effective form of birth control while you are using this medication.
Valproate sodium passes into breast milk and could harm a nursing infant. Do not take
Valproate sodium without telling your doctor if you are breast-feeding a baby.
Valproate sodium should not be given to a child younger than 2 years of age without a
doctor's consent.
Older adults may be more sensitive to sleepiness caused by this medicine.
How should I take Valproate sodium?
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 Valproate sodium 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
Valproate sodium 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 Valproate sodium,
in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you
should know that you are taking Valproate sodium.
Store Valproate sodium 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.
Symptoms of a Valproate sodium overdose may include sleepiness or drowsiness, shallow
breathing, weak pulse, or loss of consciousness.
What should I avoid while taking Valproate sodium?
Avoid drinking alcohol, which can increase some of the side effects of Valproate sodium.
Avoid using other medicines that make you sleepy (such as cold medicine, pain
medication, muscle relaxers, and medicine for seizures, depression or anxiety). They can add to
sleepiness caused by Valproate sodium.
Valproate sodium 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.
Valproate sodium side effects
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.
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:
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unexplained weakness with vomiting and confusion or fainting;
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easy bruising or bleeding, unusual weakness;
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fever, skin rash, swollen glands;
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fever, chills, body aches, flu symptoms;
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urinating less than usual;
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blood in your urine;
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hallucinations (seeing things that aren't there);
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weakness, lack of coordination;
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a red, blistering, peeling skin rash;
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extreme drowsiness;
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unusual bleeding or bruising; or
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double vision or back-and-forth movements of the eyes.
Continue using Valproate sodium and talk with your doctor if you have any
of these less serious side effects:
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drowsiness or weakness;
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diarrhea, constipation, upset stomach;
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depression, anxiety, or other emotional changes;
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changes in your menstrual periods;
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enlarged breasts;
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tremor (shaking);
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hair loss;
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weight changes;
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a red, blistering, peeling skin rash;
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vision changes; or
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unusual or unpleasant taste in your mouth.
Side effects other than those listed here may also occur. Talk to your
doctor about any side effect that seems unusual or that is especially bothersome.
What other drugs will affect Valproate sodium?
Before taking Valproate sodium, tell your doctor if you are using any of the following drugs:
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topiramate (Topamax);
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tolbutamide (Orinase);
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a blood thinner such as warfarin (Coumadin);
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aspirin or acetaminophen (Tylenol);
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zidovudine (Retrovir);
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clozapine (Clozaril, Fazaclo);
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diazepam (Valium);
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meropenem (Merrem);
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rifampin (Rifadin, Rimactane, Rifater);
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ethosuximide (Zarontin); or
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another seizure medicine such as phenytoin (Dilantin),
carbamazepine (Tegretol, Carbatrol), phenobarbital (Luminal, Solfoton), felbamate (Felbatol),
lamotrigine (Lamictal), or clonazepam (Klonopin).
If you are using any of these drugs, you may not be able to use valproic
acid, or you may need dosage adjustments or special tests during treatment.
There may be other drugs not listed that can affect Valproate sodium. 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.
Where can I get more information?
-
Your pharmacist has additional information about Valproate sodium written for health
professionals that you may read.
What does my medication look like?
Valproate sodium is available with a prescription under the brand name Depakene in 250 mg
capsules and as a syrup. Other brand or generic formulations may also be available. Ask your
pharmacist any questions you have about this medication, especially if it is new to you.
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Depakene 250 mg--oval, orange, soft-gelatin capsules
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Depakene Syrup 250 mg per 5 mL (1 teaspoon)--red syrup
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Remember, keep this and all other medicines out of the reach of children, never share
your medicines with others, and use this medication only for the indication prescribed.