Description and Brand Names

Drug information provided by: Micromedex

US Brand Name

  1. Depakene
  2. Depakote
  3. Depakote DR
  4. Depakote ER
  5. Depakote Sprinkles
  6. Stavzor

Canadian Brand Name

  1. Alti-Valproic

Descriptions


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.

This product is available in the following dosage forms:

  • Capsule, Delayed Release
  • Syrup
  • Capsule, Liquid Filled
  • Tablet, Extended Release
  • Tablet, Enteric Coated
  • Tablet, Delayed 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 valproic acid in children. However, safety and efficacy have not been established in children with epilepsy below 10 years of age, and in children with migraine below 12 years of age. Because of valproic acid's toxicity, use in children below 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 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.

Pregnancy

Information about this valproic-acid-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
  • Meropenem
  • Orlistat
  • Primidone
  • 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:

  • Brain disease, severe or
  • 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.
  • 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.
  • Pancreatitis (inflammation of the pancreas) or
  • Thrombocytopenia (low platelet count)—May make these conditions worse.

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.

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.

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 (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 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 below 10 years of age—Use and dose must be determined by your doctor.
  • 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.

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 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 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 adverse 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.

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