Description and Brand Names

Drug information provided by: IBM Micromedex

US Brand Name

  1. Depakote
  2. Depakote DR
  3. Depakote ER
  4. Depakote Sprinkles

Canadian Brand Name

  1. Alti-Valproic

Descriptions


Divalproex sodium is used to treat certain types of seizures (epilepsy). This medicine is an anticonvulsant that works in the brain tissue to stop seizures.

Divalproex sodium 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.

This product is available in the following dosage forms:

  • Tablet, Delayed Release
  • Capsule, Delayed Release
  • Tablet, Extended Release

Before Using

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:

Allergies

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.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of divalproex sodium in children. However, safety and efficacy have not been established for other indications in children, and to treat seizures in children younger than 10 years of age. Because of divalproex sodium's toxicity, use in children younger than 2 years of age requires extreme caution.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of divalproex sodium 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 divalproex sodium.

Pregnancy

Information about this divalproex-sodium-oral-route
Pregnancy Category Explanation
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.

Breastfeeding

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.

Drug Interactions

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 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.

  • Calcifediol
  • Cannabidiol
  • Carvedilol
  • Cisplatin
  • Doripenem
  • Ertapenem
  • Estradiol
  • Ethinyl Estradiol
  • Imipenem
  • Lamotrigine
  • Meropenem
  • Mestranol
  • Orlistat
  • Primidone
  • Propofol
  • Sodium Oxybate
  • Vorinostat
  • Warfarin

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.

  • Acyclovir
  • Aspirin
  • Betamipron
  • Carbamazepine
  • Cholestyramine
  • Clomipramine
  • Erythromycin
  • Ethosuximide
  • Felbamate
  • Fosphenytoin
  • Ginkgo
  • Lopinavir
  • Lorazepam
  • Mefloquine
  • Nimodipine
  • Nortriptyline
  • Olanzapine
  • Oxcarbazepine
  • Panipenem
  • Phenobarbital
  • Phenytoin
  • Rifampin
  • Rifapentine
  • Risperidone
  • Ritonavir
  • Rufinamide
  • Topiramate
  • Valacyclovir
  • Zidovudine

Other Interactions

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
  • Liver disease, history of or
  • Mental illness or
  • Pancreatitis (inflammation of the pancreas) or
  • Thrombocytopenia (low platelet count) or
  • Viral infection (eg, HIV, cytomegalovirus infection)—Use with caution. May make these conditions worse.
  • Liver disease or
  • Mitochondrial disorders, including Alpers-Huttenlocher syndrome (genetic disorder) or
  • Urea cycle disorder (genetic disorder)—Should not be used in patients with these conditions.
  • Pregnant women with migraine headaches—Should not be used to prevent migraine headaches in these patients.

Proper Use

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. To keep blood levels constant, take this medicine at the same time each day and do not miss any doses.

This medicine comes with a Medication Guide or patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

You may take this medicine with food to avoid stomach upset.

Swallow the sprinkle capsules whole. It may also be opened and the contents may be sprinkled onto a teaspoonful of soft food, such as applesauce or pudding. This mixture must be swallowed immediately without chewing and followed with a glass of water to ensure complete swallowing of the sprinkles.

Swallow the extended-release tablet or tablet whole with a full glass of water. Do not split, crush, or chew it.

Part of the medicine may pass into your stool after your body has absorbed the medicine. Check with your doctor right away if this happens.

Dosing

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 (delayed-release tablets or tablets):
    • For mania:
      • Adults—At first, 750 milligrams (mg) once a day, usually divided in smaller doses. Your doctor may increase your dose as needed. However, the dose is usually not more than 60 mg per kilogram (kg) of body weight per day.
      • Children—Use and dose must be determined by your doctor.
    • For migraine:
      • Adults—At first, 250 milligrams (mg) 2 times a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 1000 mg per day.
      • Children—Use and dose must be determined by your doctor.
    • 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 increase your dose gradually 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 2 or more times during the day.
      • Children younger than 10 years of age—Use and dose must be determined by your doctor.
  • For oral dosage form (extended-release tablets):
    • For mania:
      • Adults—Dose is based on body weight and must be determined by your doctor. At first, the usual dose is 25 milligrams (mg) per kilogram (kg) of body weight once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 60 mg per kg of body weight per day.
      • Children—Use and dose must be determined by your doctor.
    • For migraine:
      • Adults—At first, 500 milligrams (mg) once a day for 1 week. Your doctor may increase your dose as needed. However, the dose is usually not more than 1000 mg per day.
      • Children—Use and dose must be determined by your doctor.
    • 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 increase your dose gradually 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.
      • Children younger than 10 years of age—Use and dose must be determined by your doctor.
  • For oral dosage form (sprinkle capsules):
    • 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 a day. Your doctor may increase your dose gradually 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 2 or more times during the day.
      • Children younger than 10 years of age—Use and dose must be determined by your doctor.

Missed Dose

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.

Storage

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

It is very important that your doctor check your or your child's 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 and urine tests may be needed to check for any unwanted effects.

Using this medicine while you are pregnant (especially during the first 3 months of pregnancy) can harm your unborn baby and cause serious unwanted effects (eg, brain or facial problems, heart or blood vessel problems, arm or leg problems, or intelligence or mental problems). 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.

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 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.

Divalproex sodium may cause some people to become dizzy, lightheaded, drowsy, or less alert than they are normally. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Do not stop using 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 using this medicine. The results of some tests may be affected by this medicine.

Divalproex sodium 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.

Divalproex sodium 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.

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 using this medicine.

If you plan to have children, talk with your doctor before using this medicine. Some men receiving this medicine have become infertile (unable to have children).

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.

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

  1. Black, tarry stools
  2. bleeding gums
  3. bloating or swelling of the face, arms, hands, lower legs, or feet
  4. blood in the urine or stools
  5. chills
  6. confusion
  7. cough
  8. crying
  9. delusions of persecution, mistrust, suspiciousness, or combativeness
  10. diarrhea
  11. difficult or labored breathing
  12. dysphoria
  13. false beliefs that cannot be changed by facts
  14. false or unusual sense of well-being
  15. feeling of unreality
  16. fever
  17. general feeling of discomfort or illness
  18. headache
  19. hoarseness
  20. joint pain
  21. loss of appetite
  22. lower back or side pain
  23. mental depression
  24. muscle aches and pains
  25. nausea
  26. nervousness
  27. painful or difficult urination
  28. pinpoint red spots on the skin
  29. poor insight and judgment
  30. problems with memory or speech
  31. quick to react or overreact emotionally
  32. rapid weight gain
  33. rapidly changing moods
  34. runny nose
  35. sense of detachment from self or body
  36. shakiness in the legs, arms, hands, or feet
  37. shivering
  38. sleepiness or unusual drowsiness
  39. sore throat
  40. sweating
  41. tightness in the chest
  42. tingling of the hands or feet
  43. trembling or shaking of the hands or feet
  44. trouble recognizing objects
  45. trouble sleeping
  46. trouble thinking and planning
  47. trouble walking
  48. unusual bleeding or bruising
  49. unusual tiredness or weakness
  50. unusual weight gain or loss
  51. vomiting

Less common

  1. Abnormal dreams
  2. absence of or decrease in body movement
  3. anxiety
  4. bloody nose
  5. blurred vision
  6. bruising burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  7. change in personality
  8. change in walking and balance
  9. changes in patterns and rhythms of speech
  10. chest pain
  11. cloudy urine
  12. clumsiness or unsteadiness
  13. cold sweats
  14. constipation
  15. dark urine
  16. deep or fast breathing with dizziness
  17. degenerative disease of the joint
  18. difficulty with moving
  19. dizziness
  20. dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  21. dry mouth
  22. excessive muscle tone
  23. fast, irregular, pounding, or racing heartbeat or pulse
  24. feeling of warmth or heat
  25. flushing or redness of the skin, especially on the face and neck
  26. frequent urge to urinate
  27. heavy non-menstrual vaginal bleeding
  28. increased need to urinate
  29. indigestion
  30. lack of coordination
  31. large, flat, blue or purplish patches in the skin
  32. leg cramps
  33. lip smacking or puckering
  34. loss of bladder control
  35. loss of strength or energy
  36. multiple swollen and inflamed skin lesions
  37. muscle pain or stiffness
  38. muscle tension or tightness
  39. normal menstrual bleeding occurring earlier, possibly lasting longer than expected
  40. numbness of the feet, hands and around mouth
  41. pains in the stomach, side, or abdomen, possibly radiating to the back
  42. passing urine more often
  43. pounding in the ears
  44. puffing of the cheeks
  45. rapid or worm-like movements of the tongue
  46. rapid weight gain
  47. restlessness
  48. seeing, hearing, or feeling things that are not there
  49. shakiness and unsteady walk
  50. slurred speech
  51. small red or purple spots on the skin
  52. sweating
  53. swollen joints
  54. trouble with speaking
  55. twitching
  56. uncontrolled chewing movements
  57. uncontrolled movements of the arms and legs
  58. unsteadiness, trembling, or other problems with muscle control or coordination
  59. vomiting of blood or material that looks like coffee grounds
  60. yellow eyes or skin

Incidence not known

  1. Aggression
  2. bladder pain
  3. blistering, peeling, loosening of the skin
  4. blisters on the skin
  5. bone pain, tenderness, or aching
  6. chest discomfort
  7. cloudy urine
  8. decrease in height
  9. decreased urine output
  10. difficulty swallowing
  11. feeling that others are watching you or controlling your behavior
  12. feeling that others can hear your thoughts
  13. feeling, seeing, or hearing things that are not there
  14. hives, itching, skin rash
  15. increased sensitivity of the skin to sunlight
  16. increased thirst
  17. irritability
  18. joint or muscle pain
  19. loss of balance control
  20. loss of consciousness
  21. mask-like face
  22. pain in the back, ribs, arms, or legs
  23. pain or swelling in the arms or legs without any injury
  24. puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  25. red skin lesions, often with a purple center
  26. red, irritated eyes
  27. redness or other discoloration of the skin
  28. seizures
  29. severe mood or mental changes
  30. severe sunburn
  31. shuffling walk
  32. slow heartbeat
  33. slowed movements
  34. slurred speech
  35. sores, ulcers, or white spots in the mouth or on the lips
  36. stiffness of the arms and legs
  37. swelling of the face, ankles, or hands
  38. swollen or painful glands
  39. tic-like (jerky) movements of the head, face, mouth, and neck
  40. unusual behavior

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

  1. Change in consciousness
  2. fainting
  3. loss of consciousness
  4. 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

  1. Belching
  2. body aches or pain
  3. change in vision
  4. congestion
  5. continuing ringing or buzzing or other unexplained noise in the ears
  6. hair loss or thinning of the hair
  7. hearing loss
  8. heartburn
  9. impaired vision
  10. lack or loss of strength
  11. loss of memory
  12. problems with memory
  13. seeing double
  14. tender, swollen glands in the neck
  15. uncontrolled eye movements
  16. voice changes
  17. weight gain
  18. weight loss

Less common

  1. Absent, missed, or irregular menstrual periods
  2. burning, dry, or itching eyes
  3. change in taste or bad unusual or unpleasant (after) taste
  4. coin-shaped lesions on the skin
  5. cough producing mucus
  6. cramps
  7. dandruff
  8. discharge or excessive tearing
  9. dry skin
  10. earache
  11. excess air or gas in the stomach or bowels
  12. eye pain
  13. feeling of constant movement of self or surroundings
  14. full feeling
  15. heavy bleeding
  16. increased appetite
  17. itching of the vagina or genital area
  18. loss of bowel control
  19. neck pain
  20. oily skin
  21. pain
  22. pain during sexual intercourse
  23. pain or tenderness around the eyes and cheekbones
  24. passing gas
  25. rash with flat lesions or small raised lesions on the skin
  26. redness or swelling in the ear
  27. redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid
  28. redness, swelling, or soreness of the tongue
  29. sensation of spinning
  30. sneezing
  31. stiff neck
  32. stopping of menstrual bleeding
  33. thick, white vaginal discharge with no odor or with a mild odor

Incidence not known

  1. Breast enlargement
  2. changes in hair color or texture
  3. discoloration of the fingernails or toenails
  4. increased hair growth, especially on the face
  5. unexpected or excess milk flow from the breasts

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.