Depacon (Intravenous)

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.

It is very important for your doctor to monitor your or your child's progress closely while receiving this medicine to ensure it is working properly and to adjust the dose if needed. Blood and urine tests may be necessary to check for any unwanted effects.

Taking this medicine during pregnancy (especially in the first 3 months) can harm your unborn baby and cause serious unwanted effects (for example, brain or facial issues, heart or blood vessel problems, limb issues, or intelligence or mental problems). Use an effective form of birth control to prevent pregnancy. If you think you might be pregnant while taking this medicine, inform your doctor immediately.

It is very important to take folic acid before becoming pregnant and during early pregnancy to reduce the chances of harmful side effects to your unborn baby. Ask your doctor or pharmacist for guidance if you are unsure how to choose a folic acid product.

Liver problems may occur while you are receiving this medicine, and some may be serious. Contact your doctor right away if you experience 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 that can affect multiple organs (for example, liver or kidney). Contact your doctor right away if you have any 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.

Pancreatitis may occur while using this medicine. Inform your doctor immediately if you have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.

Contact your doctor right away if you experience fever, sore throat, rash, ulcers in the mouth, nosebleeds, bleeding gums, swollen glands, or small red or purple spots on the skin. These could indicate a serious blood problem.

Inform your doctor right away if you experience 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 experience unusual drowsiness, dullness, tiredness, weakness, or feelings of sluggishness, confusion, trouble concentrating, memory problems, difficulty walking, talking, or eating, or loss of consciousness while receiving this medicine.

Valproate sodium injection may cause some people to feel dizzy, lightheaded, drowsy, or less alert than usual. Do not drive or engage in any activities that could be dangerous until you know how this medicine affects you.

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

This medicine may cause hypothermia (low body temperature). Inform your doctor if you experience confusion, drowsiness, muscle aches, shivering, sleepiness, or tiredness.

This medicine will increase the effects of alcohol and other CNS depressants (medicines that cause drowsiness). Some examples of CNS depressants include antihistamines or medicines for allergies or colds, sedatives, tranquilizers, sleeping medicines, prescription pain medications or narcotics, seizure medications (for example, barbiturates), muscle relaxants, or anesthetics, including some dental anesthetics. Consult your doctor before taking any of these while receiving this medicine.

If you plan to have children, discuss this with your doctor before using this medicine. Some men taking this medicine have become infertile (unable to have children).

Do not take other medicines unless you have discussed them with your doctor. This includes prescription and nonprescription (over-the-counter [OTC]) medicines, as well as herbal or vitamin supplements.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the benefits it will provide. This is a decision you and your doctor will make together. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also inform your healthcare 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

Studies so far have not shown any specific problems that would limit the use of valproate sodium injection in children. However, safety and effectiveness have not been established for children younger than 2 years of age.

Geriatric

Studies have not shown any specific problems that would limit the use of valproate sodium injection in the elderly. However, older patients are more likely to experience unwanted effects (for example, tremors or unusual drowsiness), which may require a dose adjustment for patients receiving valproate sodium injection.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might happen. In these situations, 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 knows if you are taking any of the medicines listed below. The following interactions have been chosen based on 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 necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you take one or both of the medicines.

• Apixaban
• Aspirin
• Betamipron
• Calcifediol
• Calcium Oxybate
• Cannabidiol
• Cannabis
• Carbamazepine
• Carvedilol
• Cisplatin
• 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 increase the 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 take one or both of the medicines.

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

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken at or around the time of eating food or certain types of food because interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect the use of this medicine. Make sure to tell your doctor if you have any other medical issues, 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
• Acute head trauma or
• Migraine headaches in pregnant women or
• Mitochondrial disorders, including Alpers-Huttenlocher syndrome (genetic disorder) or
• Urea cycle disorders (genetic disorder)—Should not be used in patients with these conditions.

• Pancreatitis (inflammation of the pancreas) or
• Thrombocytopenia (low platelet count) or
• Viral infections (for example, HIV, cytomegalovirus infection)—May make these conditions worse.

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, 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. 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.

In the U.S.

• Depacon

In Canada

• Epiject Iv

Available Dosage Forms:

• Solution

Therapeutic Class: Anticonvulsant

Pharmacologic Class: Valproic Acid

Chemical Class: Valproic Acid

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.