Pronunciation:

VAL-proe-ate SOE-dee-um

Brand Names:

• Depacon
• Epiject Iv

Dosage Forms:

• Solution

Warnings:

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). In addition, valproate can caused decreased IQ scores and neurodevelopmental disorders following in utero exposure. Valproate is contraindicated for prophylaxis of migraine headaches in pregnant women and women of childbearing potential who are not using effective contraception. Valproate should not be administered to a woman of childbearing potential unless other medications have failed or are otherwise unacceptable. Effective contraception should be used in such situations. 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 .

Classifications:

Therapeutic—

Anticonvulsant

Pharmacologic—

Valproic Acid

Chemical—

Valproic Acid

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:

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.

Children—

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.

Older adults—

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.

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.

Other medicines—

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.

• Apixaban
• Aspirin
• Betamipron
• Calcifediol
• Calcium Oxybate
• Cannabidiol
• Cannabis
• Carbamazepine
• Carvedilol
• Celecoxib
• Cisplatin
• Clarithromycin
• Clonazepam
• Dabigatran Etexilate Mesylate
• Doripenem
• Edoxaban
• Ertapenem
• Estradiol
• Ethinyl Estradiol
• Ethosuximide
• Felbamate
• Fosphenytoin
• Imipenem
• Lamotrigine
• Levoketoconazole
• Magnesium Oxybate
• Meropenem
• Mestranol
• Methotrexate
• Orlistat
• Panipenem
• Pexidartinib
• Phenobarbital
• Phenytoin
• Potassium Oxybate
• Primidone
• Propofol
• Ritonavir
• Rivaroxaban
• Rufinamide
• Sodium Oxybate
• Topiramate
• Vorinostat
• Warfarin
• Zidovudine

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
• Amitriptyline
• Cholestyramine
• Clomipramine
• Erythromycin
• Ginkgo
• Lorazepam
• Mefloquine
• Nimodipine
• Nortriptyline
• Olanzapine
• Oxcarbazepine
• Rifampin
• Risperidone
• Valacyclovir

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 of This Medicine:

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 While Using This Medicine:

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 of This Medicine:

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

crying

delusions of persecution, mistrust, suspiciousness, or combativeness

diarrhea

dysphoria

false beliefs that cannot be changed by facts

false or unusual sense of well-being

feeling of unreality

fever

general feeling of discomfort or illness

headache

hoarseness

joint pain

loss of appetite

lower back or side pain

mental depression

muscle aches and pains

nausea

painful or difficult urination

pinpoint red spots on the skin

poor insight and judgment

problems with memory or speech

quick to react or overreact emotionally

rapid weight gain

rapidly changing moods

runny nose

sense of detachment from self or body

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 recognizing objects

trouble sleeping

trouble thinking and planning

trouble walking

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

dark 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, stiffness, or weakness

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

sneezing

sore throat

stuffy nose

tightness in the chest

vomiting of blood or material that looks like coffee grounds

yellow eyes or skin

Rare

Feeling of warmth or heat

flushing or redness of the skin, especially on the face and neck

lightheadedness, dizziness, or fainting

Incidence not known

Aggression

bladder pain

blistering, peeling, loosening of the skin

blisters on the skin

bone pain, tenderness, or aching

chest discomfort

cloudy urine

decrease in height

decreased urine output

diarrhea

difficulty swallowing

feeling that others are watching you or controlling your behavior

feeling that others can hear your thoughts

feeling, seeing, or hearing things that are not there

hives, itching, skin rash

increased sensitivity of the skin to sunlight

increased thirst

irritability

joint pain

loss of balance control

loss of consciousness

mask-like face

nausea

pain in the back, ribs, arms, or legs

pain or swelling in the arms or legs without any injury

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue red skin lesions, often with a purple center

red, irritated eyes

redness or other discoloration of the skin

seizures

severe mood or mental changes

severe sunburn

shuffling walk

slow heartbeat

slowed movements

slurred speech

sores, ulcers, or white spots in the mouth or on the lips

stiffness of the arms and legs

swelling of the face, ankles, or hands

swollen or painful glands

tic-like (jerky) movements of the head, face, mouth, and neck

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

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

seeing double

stomach discomfort, upset, or pain

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

difficulty with moving

dry skin

earache

excess air or gas in the stomach or bowels

full feeling

itching of the vagina or genital area

leg cramps

loss of memory

pain

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

Rare

Body aches or pain

congestion

voice changes

Incidence not known

Breast enlargement

changes in hair color or texture

discoloration of the fingernails or toenails

increased hair growth, especially on the face

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.