Description and Brand Names

Drug information provided by: 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, Extended Release
  • Tablet, Enteric Coated
  • Tablet, Delayed Release
  • Capsule, Delayed Release
  • Syrup

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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Amifampridine

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.

  • Amitriptyline
  • Cisplatin
  • Desvenlafaxine
  • Doripenem
  • Ertapenem
  • Fentanyl
  • Fluoxetine
  • Hydroxytryptophan
  • Imipenem
  • Ketorolac
  • Lamotrigine
  • Levomilnacipran
  • Lorcaserin
  • Meperidine
  • Meropenem
  • Orlistat
  • Primidone
  • Sodium Oxybate
  • Tramadol
  • Trazodone
  • Vorinostat
  • Vortioxetine
  • 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
  • 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)—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 and a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

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

The sprinkle capsules may be opened and the contents may be sprinkled onto 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.

If you are taking the sprinkle capsules, part of the capsules may pass into your stool after your body has absorbed the medicine. This is normal and not something to worry about.

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) two 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 two 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 if 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 two 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 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 the 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.

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. 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.

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 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.

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. confusion
  6. cough or hoarseness
  7. crying
  8. delusions
  9. dementia
  10. depersonalization
  11. diarrhea
  12. difficult or labored breathing
  13. dysphoria
  14. euphoria
  15. fever or chills
  16. general feeling of discomfort or illness
  17. headache
  18. joint pain
  19. loss of appetite
  20. lower back or side pain
  21. mental depression
  22. muscle aches and pains
  23. nausea
  24. nervousness
  25. painful or difficult urination
  26. paranoia
  27. pinpoint red spots on the skin
  28. quick to react or overreact emotionally
  29. rapid weight gain
  30. rapidly changing moods
  31. runny nose
  32. shakiness in the legs, arms, hands, or feet
  33. shivering
  34. sleepiness or unusual drowsiness
  35. sore throat
  36. sweating
  37. tightness in the chest
  38. tingling of the hands or feet
  39. trembling or shaking of the hands or feet
  40. trouble sleeping
  41. unusual bleeding or bruising
  42. unusual tiredness or weakness
  43. unusual weight gain or loss
  44. 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. chills
  12. cloudy urine
  13. clumsiness or unsteadiness
  14. cold sweats
  15. constipation
  16. darkened urine
  17. degenerative disease of the joint
  18. difficulty with moving
  19. dizziness
  20. dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
  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. hyperventilation
  29. increased need to urinate
  30. indigestion
  31. lack of coordination
  32. large, flat, blue or purplish patches in the skin
  33. leg cramps
  34. lip smacking or puckering
  35. loss of bladder control
  36. loss of strength or energy
  37. multiple swollen and inflamed skin lesions
  38. muscle pain or stiffness
  39. muscle tension or tightness
  40. normal menstrual bleeding occurring earlier, possibly lasting longer than expected
  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

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

Less common

  1. Absent, missed, or irregular menstrual periods
  2. back pain
  3. burning, dry, or itching eyes
  4. change in taste or bad unusual or unpleasant (after) taste
  5. coin-shaped lesions on the skin
  6. cough producing mucus
  7. cramps
  8. dandruff
  9. discharge or excessive tearing
  10. dry skin
  11. earache
  12. excess air or gas in the stomach or intestines
  13. eye pain
  14. feeling of constant movement of self or surroundings
  15. full feeling
  16. heavy bleeding
  17. increased appetite
  18. itching of the vagina or genital area
  19. itching skin
  20. loss of bowel control
  21. neck pain
  22. oily skin
  23. pain
  24. pain during sexual intercourse
  25. pain or tenderness around the eyes and cheekbones
  26. passing gas
  27. rash with flat lesions or small raised lesions on the skin
  28. redness or swelling in the ear
  29. redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid
  30. redness, swelling, or soreness of the tongue
  31. sensation of spinning
  32. sneezing
  33. stiff neck
  34. stopping of menstrual bleeding
  35. 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.