Valproate sodium (Intravenous route)
- Epiject Iv
Hepatotoxicity (some cases fatal), usually occurring during the first 6 months of treatment, has been reported in patients receiving valproate and its derivatives. Loss of seizure control may also occur in patients with epilepsy. Children younger than 2 years, especially receiving multiple anticonvulsants, those with congenital metabolic disorders, severe seizure disorders with mental retardation, with organic brain disease, and patients with hereditary mitochondrial disease are at a considerably increased risk of developing fatal hepatotoxicity. For 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) gene 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 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 and effective contraception is used during treatment. 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 .
Uses of This Medicine:
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.
Before Using This Medicine:
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 valproate sodium injection in children. However, safety and efficacy have not been established in children younger than 2 years of age.
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.
|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.
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.
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.
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
- 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 of This Medicine:
A nurse or other trained health professional will give you or your child this medicine in a hospital. This medicine is given through a needle placed in one of your veins. This medicine is given slowly, so the needle will remain in place for about an hour.
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 While Using This Medicine:
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.
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: 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.
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 using this medicine.
Valproate sodium injection 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.
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.
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 using 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 of This Medicine:
- 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
- chest pain
- cough or hoarseness
- 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 and unsteady walk shakiness in the legs, arms, hands, or feet
- sleepiness or unusual drowsiness
- sore throat
- tingling of the hands or feet
- trembling or shaking of the hands or feet
- trouble sleeping
- unsteadiness, trembling, or other problems with muscle control or coordination
- unusual bleeding or bruising
- unusual tiredness or weakness
- unusual weight gain or loss
- Less common
- Bloody nose
- blurred vision
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- change in walking and balance
- clumsiness or unsteadiness
- cough producing mucus
- darkened urine
- difficult or labored breathing
- excessive muscle tone
- fast, pounding, or irregular heartbeat or pulse
- fear or nervousness
- increased need to urinate
- lack of coordination
- large, flat, blue or purplish patches in the skin
- loss of bladder control
- loss of strength or energy
- mood or mental changes
- muscle pain or weakness
- muscle stiffness
- muscle tension or tightness
- pains in the stomach, side, or abdomen, possibly radiating to the back
- passing urine more often
- pounding in the ears
- small red or purple spots on the skin
- sore throat
- stuffy nose
- tightness in the chest
- vomiting of blood or material that looks like coffee grounds
- yellow eyes or skin
- False or unusual sense of well-being
- feeling faint, dizzy, or lightheadedness
- feeling of warmth or heat
- flushing or redness of the skin, especially on the face and neck
- More common
- Acid or sour stomach
- change in vision
- continuing ringing or buzzing or other unexplained noise in the ears
- double vision
- hair loss or thinning of the hair
- hearing loss
- impaired vision
- lack or loss of strength
- loss of appetite
- seeing double
- stomach discomfort, upset, or pain
- uncontrolled eye movements
- weight gain
- weight loss
- Less common
- Absent, missed, or irregular menstrual periods
- back pain
- 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
- change in taste or bad unusual or unpleasant (after) taste
- difficulty having a bowel movement (stool)
- difficulty with moving
- dry skin
- excess air or gas in the stomach or intestines
- full feeling
- itching of the vagina or genital area
- leg cramps
- loss of memory
- muscle pains or stiffness
- pain during sexual intercourse
- pain or tenderness around the eyes and cheekbones
- passing gas
- problems with memory
- redness or swelling in the ear
- stopping of menstrual bleeding
- swollen joints
- thick, white vaginal discharge with no odor or with a mild odor
- Body aches or pain
- tender, swollen glands in the neck
- trouble swallowing
- voice changes
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:
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:
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.
Last Updated: 9/15/2016