Valproate sodium Intravenous

VAL-proe-ate SOE-dee-um

Intravenous routeSolution
  • HEPATOTOXICITY
    • Hepatic failure resulting in fatalities has occurred in patients receiving valproic acid and its derivatives. Experience has indicated that children under the age of two years are at a considerably increased risk of developing fatal hepatotoxicity, especially those on multiple anticonvulsants, those with congenital metabolic disorders, those with severe seizure disorders accompanied by mental retardation, and those with organic brain disease. When valproate sodium is used in this patient group, it should be used with extreme caution and as a sole agent. The benefits of therapy should be weighed against the risks. Above this age group, experience in epilepsy has indicated that the incidence of fatal hepatotoxicity decreases considerably in progressively older patient groups.
    • These incidents usually have occurred during the first six months of treatment. Serious or fatal hepatotoxicity may be preceded by non-specific symptoms such as malaise, weakness, lethargy, facial edema, anorexia, and vomiting. In patients with epilepsy, a loss of seizure control may also occur. Patients should be monitored closely for appearance of these symptoms. Liver function tests should be performed prior to therapy and at frequent intervals thereafter, especially during the first six months.
  • PANCREATITIS
    • Cases of life-threatening pancreatitis have been reported in both children and adults receiving valproate. Some of the cases have been described as hemorrhagic with a rapid progression from initial symptoms to death. Cases have been reported shortly after initial use as well as after several years of use. Patients and guardians should be warned that abdominal pain, nausea, vomiting, and/or anorexia can be symptoms of pancreatitis that require prompt medical evaluation. If pancreatitis is diagnosed, valproate should ordinarily be discontinued. Alternative treatment for the underlying medical condition should be initiated as clinically indicated .
  • TERATOGENICITY
    • 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. This is especially important when the treatment of a spontaneously reversible condition not ordinarily associated with permanent injury or risk of death (eg, migraine) is contemplated .

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.

  • Depacon

In Canada

  • Epiject Iv

Available Dosage Forms:

  • Solution

Therapeutic Class: Anticonvulsant

Pharmacologic Class: Valproic Acid

Chemical Class: Valproic Acid

Uses For valproate sodium

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.

Before Using valproate sodium

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:

Allergies

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.

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 below 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 (e.g., tremors or unusual drowsiness), which may require an adjustment in the dose for patients receiving valproate sodium injection.

Pregnancy

Pregnancy CategoryExplanation
All TrimestersDStudies 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.

Breast Feeding

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.

Interactions with Medicines

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.

  • Doripenem
  • Ertapenem
  • Imipenem
  • Lamotrigine
  • Meropenem
  • Primidone
  • Vorinostat

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.

  • 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
  • Zidovudine

Interactions with Food/Tobacco/Alcohol

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 valproate sodium. 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.
  • Head injury, acute or
  • Liver disease, history of 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 valproate sodium

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.

Precautions While Using valproate sodium

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.

valproate sodium 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
  • 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
  • chills
  • confusion
  • cough or hoarseness
  • crying
  • delusions
  • dementia
  • depersonalization
  • diarrhea
  • dysphoria
  • euphoria
  • fever or chills
  • general feeling of discomfort or illness
  • headache
  • joint pain
  • loss of appetite
  • lower back or side pain
  • mental depression
  • muscle aches and pains
  • nausea
  • painful or difficult urination
  • paranoia
  • 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
  • shivering
  • sleepiness or unusual drowsiness
  • sore throat
  • sweating
  • tingling of the hands or feet
  • trembling or shaking of the hands or feet
  • trouble with sleeping
  • unsteadiness, trembling, or other problems with muscle control or coordination
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • unusual weight gain or loss
  • vomiting
Less common
  • Bloody nose
  • blurred vision
  • bruising
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • change in walking and balance
  • clumsiness or unsteadiness
  • constipation
  • cough producing mucus
  • darkened urine
  • difficult or labored breathing
  • dizziness
  • excessive muscle tone
  • fast, pounding, or irregular heartbeat or pulse
  • fear or nervousness
  • increased need to urinate
  • indigestion
  • 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
  • shortness of breath
  • small red or purple spots on the skin
  • sneezing
  • sore throat
  • stuffy nose
  • tightness in the chest
  • vomiting of blood or material that looks like coffee grounds
  • wheezing
  • yellow eyes or skin
Rare
  • 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

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
  • Acid or sour stomach
  • belching
  • 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
  • heartburn
  • impaired vision
  • indigestion
  • lack or loss of strength
  • loss of appetite
  • seeing double
  • sleeplessness
  • stomach discomfort, upset, or pain
  • unable to sleep
  • uncontrolled eye movements
  • weight gain
  • weight loss
Less common
  • Absent, missed, or irregular menstrual periods
  • back pain
  • belching
  • 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
  • earache
  • 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
  • pain during sexual intercourse
  • pain or tenderness around the eyes and cheekbones
  • passing gas
  • problems with memory
  • rash
  • redness or swelling in the ear
  • stopping of menstrual bleeding
  • swollen joints
  • thick, white vaginal discharge with no odor or with a mild odor
Rare
  • Body aches or pain
  • congestion
  • tender, swollen glands in the neck
  • trouble with swallowing
  • voice changes

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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