Hepatic failure resulting in fatalities has occurred in patients receiving valproic acid and its derivatives. Children under the age of two years are at a considerably increased risk of developing fatal hepatotoxicity. Patients should be monitored closely and liver function tests should be performed prior to therapy and at frequent intervals thereafter, especially during the first six months. Life-threatening pancreatitis has been reported in both children and adults receiving valproate. If pancreatitis is diagnosed, valproate should ordinarily be discontinued. Valproate can produce teratogenic effects such as neural tube defects (eg, spina bifida). Accordingly, the use of valproate products in women of childbearing potential requires that the benefits of its use be weighed against the risk of injury to the fetus v.
Commonly used brand name(s):
In the U.S.
Available Dosage Forms:
Therapeutic Class: Anticonvulsant
Pharmacologic Class: Valproic Acid
Chemical Class: Valproic Acid
Valproate sodium injection is used alone or together with other medicines to control certain types of seizures (convulsions) in the treatment of epilepsy. valproate sodium is an anticonvulsant that works in the brain tissue to stop seizures.
valproate sodium is available only with your doctor's prescription.
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 valproate sodium, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to valproate sodium 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 below 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 (e.g., tremors or unusual drowsiness), which may require an adjustment in the dose for patients receiving valproate sodium injection.
|All Trimesters||D||Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.|
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.
Using valproate sodium 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 valproate sodium 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.
The presence of other medical problems may affect the use of valproate sodium. Make sure you tell your doctor if you have any other medical problems, especially:
A nurse or other trained health professional will give you valproate sodium in a hospital. valproate sodium is given through a needle placed in one of your veins. valproate sodium is given slowly, so the needle will remain in place for about an hour.
Your doctor will only give you a few doses of valproate sodium 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.
valproate sodium should come with a medication guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
It is very important that your doctor check your progress closely while you are using valproate sodium 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 valproate sodium while you are pregnant (especially during your 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 valproate sodium. Stop using valproate sodium and 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.
Pancreatitis may occur while you are using valproate sodium. 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, or vomiting. These may be symptoms of a serious condition called hyperammonemic encephalopathy.
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 valproate sodium before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.
Do not stop receiving valproate sodium without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping completely.
Before you have any medical tests, tell the medical doctor in charge that you are taking valproate sodium. The results of some tests may be affected by valproate sodium.
Valproate sodium injection may cause serious allergic reactions that affect several parts of the body (e.g., liver or kidney). Check with your doctor right away if you have more than one of 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.
valproate sodium will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates or medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using valproate sodium.
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.
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
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
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.
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