Description and Brand Names

Información sobre medicamentos proporcionada por: IBM Micromedex

US Brand Name

  1. Depacon

Canadian Brand Name

  1. Epiject Iv

Descriptions


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

This medicine is to be given only by or under the direct supervision of your doctor.

This product is available in the following dosage forms:

  • Solution

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 valproate sodium injection in children. However, safety and efficacy have not been established in children younger than 2 years of age.

Geriatric

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

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 receiving 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
  • Calcium Oxybate
  • Cannabidiol
  • Carvedilol
  • Cisplatin
  • Doripenem
  • Ertapenem
  • Estradiol
  • Ethinyl Estradiol
  • Imipenem
  • Lamotrigine
  • Lumateperone
  • Magnesium Oxybate
  • Meropenem
  • Mestranol
  • Orlistat
  • Pexidartinib
  • Potassium Oxybate
  • 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
  • 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.
  • Liver disease or
  • Head trauma, acute or
  • Migraine headache in pregnant women 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) or
  • Viral infection (eg, HIV, cytomegalovirus infection)—May make these conditions worse.

Proper Use

A nurse or other trained health professional will give you or your child this medicine in a medical facility. It is given through a needle placed into one of your veins. This medicine must be given slowly, so the needle will have to remain in place for at least 60 minutes.

Your doctor will only give you a few doses of this medicine until your condition improves. You will be switched to an oral medicine that works the same way. If you have any concerns about this, talk to your doctor.

Precautions

It is very important that your doctor check your or your child's progress closely while you are receiving 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.

Receiving 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 receiving 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 receiving 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.

Valproate sodium injection 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: 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.

Check with your doctor if you have unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness, confusion, trouble concentrating, memory problems, trouble walking, talking, or eating, or loss of consciousness while receiving this medicine.

Valproate sodium injection 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.

Before you have any medical tests, tell the medical doctor in charge that you are receiving this medicine. The results of some tests may be affected by this medicine.

This medicine may cause hypothermia (low body temperature). Tell your doctor is you have confusion, drowsiness, muscle aches, shivering, sleepiness, or tiredness.

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 receiving 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 or nurse 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. chest pain
  6. chills
  7. confusion
  8. cough
  9. crying
  10. delusions of persecution, mistrust, suspiciousness, or combativeness
  11. diarrhea
  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. painful or difficult urination
  27. pinpoint red spots on the skin
  28. poor insight and judgment
  29. problems with memory or speech
  30. quick to react or overreact emotionally
  31. rapid weight gain
  32. rapidly changing moods
  33. runny nose
  34. sense of detachment from self or body
  35. shakiness and unsteady walk
  36. shakiness in the legs, arms, hands, or feet
  37. shivering
  38. sleepiness or unusual drowsiness
  39. sore throat
  40. sweating
  41. tingling of the hands or feet
  42. trembling or shaking of the hands or feet
  43. trouble recognizing objects
  44. trouble sleeping
  45. trouble thinking and planning
  46. trouble walking
  47. unsteadiness, trembling, or other problems with muscle control or coordination
  48. unusual bleeding or bruising
  49. unusual tiredness or weakness
  50. unusual weight gain or loss
  51. vomiting

Less common

  1. Bloody nose
  2. blurred vision
  3. bruising
  4. burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  5. change in walking and balance
  6. clumsiness or unsteadiness
  7. constipation
  8. cough producing mucus
  9. dark urine
  10. difficult or labored breathing
  11. dizziness
  12. excessive muscle tone
  13. fast, pounding, or irregular heartbeat or pulse
  14. fear or nervousness
  15. increased need to urinate
  16. indigestion
  17. lack of coordination
  18. large, flat, blue or purplish patches in the skin
  19. loss of bladder control
  20. loss of strength or energy
  21. mood or mental changes
  22. muscle pain, stiffness, or weakness
  23. muscle tension or tightness
  24. pains in the stomach, side, or abdomen, possibly radiating to the back
  25. passing urine more often
  26. pounding in the ears
  27. small red or purple spots on the skin
  28. sneezing
  29. sore throat
  30. stuffy nose
  31. tightness in the chest
  32. vomiting of blood or material that looks like coffee grounds
  33. yellow eyes or skin

Rare

  1. Feeling of warmth or heat
  2. flushing or redness of the skin, especially on the face and neck
  3. lightheadedness, dizziness, or fainting

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

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. change in vision
  3. continuing ringing or buzzing or other unexplained noise in the ears
  4. double vision
  5. hair loss or thinning of the hair
  6. hearing loss
  7. heartburn
  8. impaired vision
  9. indigestion
  10. lack or loss of strength
  11. seeing double
  12. stomach discomfort, upset, or pain
  13. uncontrolled eye movements
  14. weight gain
  15. weight loss

Less common

  1. Absent, missed, or irregular menstrual periods
  2. back pain
  3. belching
  4. bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
  5. change in taste or bad unusual or unpleasant (after) taste
  6. difficulty having a bowel movement
  7. difficulty with moving
  8. dry skin
  9. earache
  10. excess air or gas in the stomach or bowels
  11. full feeling
  12. itching of the vagina or genital area
  13. leg cramps
  14. loss of memory
  15. pain
  16. pain during sexual intercourse
  17. pain or tenderness around the eyes and cheekbones
  18. passing gas
  19. problems with memory
  20. redness or swelling in the ear
  21. stopping of menstrual bleeding
  22. swollen joints
  23. thick, white vaginal discharge with no odor or with a mild odor

Rare

  1. Body aches or pain
  2. congestion
  3. voice changes

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.