Generic Name: valproic acid (Oral route)
Hepatotoxicity (some cases fatal), usually occurring during the first 6 months of treatment, has been reported in patients receiving valproate and its derivatives. Children younger than 2 years and patients with hereditary mitochondrial disease are at a considerably increased risk of developing fatal hepatotoxicity. Use is contraindicated in patients with known mitochondrial disorders caused by mitochondrial DNA polymerase gamma (POLG) mutations and in children younger than 2 years in which mitochondrial disorder is clinically suspected. Failure of other anticonvulsants is the only indication for valproate use in patients older than 2 years with hereditary mitochondrial disease. Perform POLG mutation screening as clinically indicated. Monitor patients closely and perform liver function tests prior to therapy and at frequent intervals thereafter, especially during the first 6 months. Valproate can impair cognitive development with prenatal exposure and produce major congenital malformations, particularly neural tube defects (eg, spina bifida). Valproate should not be administered to a woman of childbearing potential unless the drug is essential to the management of her medical condition. Life-threatening pancreatitis has been reported in both children and adults receiving valproate. Cases have occurred shortly after initiation as well as several years after use. If pancreatitis is diagnosed, valproate should ordinarily be discontinued .Oral route(Tablet, Delayed Release;Capsule, Delayed Release;Tablet, Extended Release)
Hepatotoxicity (some cases fatal), usually occurring during the first 6 months of treatment, has been reported in patients receiving valproate and its derivatives. Children younger than 2 years and patients with hereditary mitochondrial disease are at a considerably increased risk of developing fatal hepatotoxicity. For these patients under 2 years, valproate sodium should be used with extreme caution as a sole agent. Use is contraindicated in patients with known mitochondrial disorders caused by mitochondrial DNA polymerase gamma (POLG) mutations and in children younger than 2 years in which mitochondrial disorder is clinically suspected. Failure of other anticonvulsants is the only indication for divalproex sodium in patients older than 2 years with hereditary mitochondrial disease. Perform POLG mutation screening as clinically indicated. Monitor patients closely and perform liver function tests prior to therapy and at frequent intervals thereafter, especially during the first 6 months. Valproate can impair cognitive development with prenatal exposure and produce major congenital malformations, particularly neural tube defects (eg, spina bifida). Valproate should not be administered to a woman of childbearing potential unless the drug is essential to the management of her medical condition. Life-threatening pancreatitis has been reported in both children and adults receiving valproate. Cases have occurred shortly after initiation as well as several years after use. If pancreatitis is diagnosed, valproate should ordinarily be discontinued .
Commonly used brand name(s)
In the U.S.
- Depakote DR
- Depakote ER
- Depakote Sprinkles
Available Dosage Forms:
- Capsule, Delayed Release
- Capsule, Liquid Filled
- Tablet, Extended Release
- Tablet, Enteric Coated
- Tablet, Delayed Release
Therapeutic Class: Antimanic
Pharmacologic Class: Histone Deacetylase Inhibitor
Chemical Class: Valproic Acid (class)
Uses For Depakote ER
Valproic acid is used to treat certain types of seizures (epilepsy). This medicine is an anticonvulsant that works in the brain tissue to stop seizures.
Valproic acid is also used to treat the manic phase of bipolar disorder (manic-depressive illness), and helps prevent migraine headaches.
This medicine is available only with your doctor's prescription.
Before Using Depakote ER
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of valproic acid in children. However, safety and efficacy have not been established in children with epilepsy younger than 10 years of age, and in children with migraine younger than 12 years of age. Because of valproic acid's toxicity, use in children younger than 2 years of age requires extreme caution.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of valproic acid in the elderly. However, elderly patients are more likely to have unwanted effects (eg, tremors or unusual drowsiness), which may require an adjustment in the dose for patients receiving valproic acid.
|All Trimesters||X||Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Interactions with Medicines
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Sodium Oxybate
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Interactions with Food/Tobacco/Alcohol
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Congenital metabolism disorders (born with a disease that affects metabolism) or
- Mental retardation with severe seizure disorders—Use with caution. May increase risk for more serious side effects.
- Depression, or history of or
- Mental illness, or history of or
- Pancreatitis (inflammation of the pancreas) or
- Thrombocytopenia (low platelet count)—Use with caution. May make these conditions worse.
- Liver disease or
- Mitochondrial disorder, including Alpers-Huttenlocher syndrome (genetic disorder) or
- Urea cycle disorder (genetic disorder)—Should not be used in patients with these conditions.
Proper Use of valproic acid
This section provides information on the proper use of a number of products that contain valproic acid. It may not be specific to Depakote ER. Please read with care.
Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.
This medicine comes with a Medication Guide and patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.
Swallow the delayed-release capsules and oral capsules whole with a full glass of water. Do not split, crush, or chew it. You may take this medicine with food to decrease stomach upset.
Measure the oral liquid medicine with a marked measuring spoon, oral syringe, or medicine cup.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage forms (capsules, delayed-release capsules, and solution):
- For seizures:
- Adults and children 10 years of age or older—Dose is based on body weight and must be determined by your doctor. At first, the usual dose is 10 to 15 milligrams (mg) per kilogram (kg) of body weight per day. Your doctor may gradually increase your dose every week by 5 to 10 mg per kg of body weight if needed. However, the dose is usually not more than 60 mg per kg of body weight per day. If the total dose a day is greater than 250 mg, it is usually divided into smaller doses and taken two or more times during the day.
- Children younger than 10 years of age—Use and dose must be determined by your doctor.
- For seizures:
- For oral dosage form (delayed-release capsules):
- For mania:
- Adults—At first, 750 milligrams (mg) once a day, usually divided in smaller doses. Your doctor may increase your dose as needed.
- Children—Use and dose must be determined by your doctor.
- For migraine:
- Adults—At first, 250 milligrams (mg) two times a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 1000 mg a day.
- Children—Use and dose must be determined by your doctor.
- For mania:
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions While Using Depakote ER
It is very important that your doctor check your progress closely while you are using this medicine to see if it is working properly and to allow for a change in the dose. Blood tests may be needed to check for any unwanted effects.
Using this medicine while you are pregnant (especially during first trimester) can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.
It is very important to take folic acid before getting pregnant and during early pregnancy to lower chances of harmful side effects to your unborn baby. Ask your doctor or pharmacist for help if you are not sure how to choose a folic acid product.
Liver problems may occur while you are using this medicine, and some may be serious. Check with your doctor right away if you are having more than one of these symptoms: abdominal or stomach pain or tenderness, clay-colored stools, dark urine, decreased appetite, fever, headache, itching, loss of appetite, nausea and vomiting, skin rash, swelling of the feet or lower legs, unusual tiredness or weakness, or yellow eyes or skin.
Valproic acid may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you notice any of these side effects, tell your doctor right away.
Valproic acid may cause serious allergic reactions affecting multiple body organs (eg, liver or kidney). Check with your doctor right away if you have the following symptoms: a fever, dark urine, headache, rash, stomach pain, swollen lymph glands in the neck, armpit, or groin, unusual tiredness, or yellow eyes or skin.
Pancreatitis may occur while you are using this medicine. Tell your doctor right away if you have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.
Check with your doctor right away if fever, sore throat, rash, ulcers in the mouth, nosebleeds, bleeding gums, swollen glands, or small red or purple spots on the skin occur. These could be symptoms of a serious blood problem.
Check with your doctor right away if you are having unusual drowsiness, dullness, tiredness, weakness or feelings of sluggishness, changes in mental status, low body temperature, or vomiting. These may be symptoms of a serious condition called hyperammonemic encephalopathy.
Valproic acid may cause some people to become dizzy, lightheaded, drowsy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.
Do not stop taking this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping completely. This may help prevent worsening of seizures and reduce the possibility of withdrawal symptoms.
Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.
This medicine will add to the effects of alcohol and other CNS depressants (medicines that cause drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicine or narcotics, medicine for seizures (eg, barbiturates), muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are taking this medicine.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Depakote ER Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:More common
- Black, tarry stools
- bleeding gums
- bloating or swelling of the face, arms, hands, lower legs, or feet
- blood in the urine or stools
- cough or hoarseness
- difficult or labored breathing
- fever or chills
- general feeling of discomfort or illness
- joint pain
- loss of appetite
- lower back or side pain
- mental depression
- muscle aches and pains
- painful or difficult urination
- pinpoint red spots on the skin
- quick to react or overreact emotionally
- rapid weight gain
- rapidly changing moods
- runny nose
- shakiness in the legs, arms, hands, or feet
- sleepiness or unusual drowsiness
- sore throat
- tightness in the chest
- tingling of the hands or feet
- trembling or shaking of the hands or feet
- trouble sleeping
- unusual bleeding or bruising
- unusual tiredness or weakness
- unusual weight gain or loss
- Abnormal dreams
- absence of or decrease in body movement
- bloody nose
- bloody or cloudy urine
- blurred vision
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- change in personality
- change in walking and balance
- changes in patterns and rhythms of speech
- chest pain
- clumsiness or unsteadiness
- cold sweats
- darkened urine
- degenerative disease of the joint
- difficult, burning, or painful urination
- difficulty with moving
- dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
- dry mouth
- excessive muscle tone
- fast, irregular, pounding, or racing heartbeat or pulse
- feeling of warmth or heat
- feeling sad or empty
- flushing or redness of the skin, especially on the face and neck
- frequent urge to urinate
- heavy non-menstrual vaginal bleeding
- increased need to urinate
- lack of appetite
- lack of coordination
- large, flat, blue or purplish patches in the skin
- leg cramps
- lip smacking or puckering
- loss of bladder control
- loss of interest or pleasure
- loss of strength or energy
- multiple swollen and inflamed skin lesions
- muscle pain or stiffness
- muscle tension or tightness
- normal menstrual bleeding occurring earlier, possibly lasting longer than expected
- pains in the stomach, side, or abdomen, possibly radiating to the back
- passing urine more often
- pounding in the ears
- puffing of the cheeks
- rapid or worm-like movements of the tongue
- rapid weight gain
- seeing, hearing, or feeling things that are not there
- shakiness and unsteady walk
- slurred speech
- small red or purple spots on the skin
- swollen joints
- trouble with concentrating
- trouble with speaking
- uncontrolled chewing movements
- uncontrolled movements of the arms and legs
- unsteadiness, trembling, or other problems with muscle control or coordination
- vomiting of blood or material that looks like coffee grounds
- yellow eyes or skin
Get emergency help immediately if any of the following symptoms of overdose occur:Symptoms of overdose
- Change in consciousness
- loss of consciousness
- slow or irregular heartbeat
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:More common
- Acid or sour stomach
- body aches or pain
- change in vision
- continuing ringing or buzzing or other unexplained noise in the ears
- hair loss or thinning of the hair
- hearing loss
- impaired vision
- lack or loss of strength
- loss of memory
- problems with memory
- seeing double
- tender, swollen glands in the neck
- trouble with swallowing
- uncontrolled eye movements
- voice changes
- weight gain
- weight loss
- Absent, missed, or irregular menstrual periods
- back pain
- burning, dry, or itching eyes
- change in taste or bad unusual or unpleasant (after) taste
- coin-shaped lesions on the skin
- cough producing mucus
- discharge or excessive tearing
- dry skin
- excess air or gas in the stomach or intestines
- eye pain
- feeling of constant movement of self or surroundings
- full feeling
- heavy bleeding
- increased appetite
- itching of the vagina or genital area
- itching skin
- loss of bowel control
- neck pain
- oily skin
- pain during sexual intercourse
- pain or tenderness around the eyes and cheekbones
- passing gas
- rash with flat lesions or small raised lesions on the skin
- redness or swelling in the ear
- redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid
- redness, swelling, or soreness of the tongue
- sensation of spinning
- stiff neck
- stopping of menstrual bleeding
- thick, white vaginal discharge with no odor or with a mild odor
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
See also: Side effects (in more detail)
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