Depakene (Oral)

Valproic acid is used to treat certain types of seizures (epilepsy). This medicine is an anticonvulsant that works in the brain to stop seizures.

Valproic acid is also used to treat the manic phase of bipolar disorder (manic-depressive illness) and helps prevent migraine headaches.

This medicine is available only with a doctor's prescription.

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

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

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

Liver problems may develop while using this medicine, and some can 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.

Valproic acid may cause some people to feel agitated, irritable, or show other unusual behaviors. It may also lead to suicidal thoughts and tendencies or increased depression in some individuals. If you notice any of these side effects, inform your doctor immediately.

Valproic acid can cause serious allergic reactions that may affect multiple organs (for example, liver or kidney). Contact your doctor immediately if you have symptoms such as fever, dark urine, headache, rash, stomach pain, swollen lymph nodes in the neck, armpit, or groin, unusual tiredness, or yellow eyes or skin.

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

Contact your doctor immediately if you develop fever, sore throat, rash, mouth ulcers, nosebleeds, bleeding gums, swollen glands, or small red or purple spots on the skin. These could be signs of a serious blood problem.

Speak with your doctor right away if you are experiencing unusual drowsiness, dullness, tiredness, weakness or sluggishness, changes in mental status, low body temperature, or vomiting. These may be signs of a serious condition called hyperammonemic encephalopathy.

Valproic acid may cause some individuals to feel dizzy, lightheaded, drowsy, or less alert than usual. Avoid driving or doing anything that could be dangerous until you know how this medicine affects you.

Do not stop using this medicine without first consulting your doctor. Your doctor may want you to gradually decrease your dose before stopping completely to help prevent worsening of seizures and reduce the risk of withdrawal symptoms.

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

This medicine will enhance the effects of alcohol and other CNS depressants (medications that cause drowsiness). Examples of CNS depressants include antihistamines or medications for hay fever, other allergies, or colds, sedatives, tranquilizers, sleeping medications, prescription pain medications or narcotics, medications for seizures (such as barbiturates), muscle relaxants, or anesthetics, including some dental anesthetics. Consult your doctor before taking any of these while using this medicine.

If you plan to have children, discuss it with your doctor before using this medicine. Some men taking this medicine have experienced infertility (inability to have children).

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

In deciding to use a medicine, you need to consider the risks of taking it against the benefits it may provide. This is a decision you will make with your doctor. For this medicine, the following points should be considered:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, tell your healthcare professional about any other allergies you have, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Studies to date have not shown any specific problems in children that would limit the usefulness of valproic acid. However, safety and effectiveness have not been established in children with epilepsy younger than 10 years old and in children with migraine younger than 12 years old. Because of valproic acid's toxicity, using it in children younger than 2 years old requires extreme caution.

Geriatric

Studies to date have not shown any specific problems in elderly patients that would limit the usefulness of valproic acid. However, older patients are more likely to experience unwanted effects (e.g., tremors or unusual drowsiness), which may require a dose adjustment for patients taking valproic acid.

Breast Feeding

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

Interactions with Medicines

Some medicines should never be used together, while others may be used together even if an interaction could happen. In these cases, your doctor may want to adjust the dose, or other precautions may be needed. When taking this medicine, it is especially important for your healthcare professional to know if you are taking any of the following medicines. The interactions listed below are significant but may not include all possible interactions.

Using this medicine with any of the following is usually not recommended, but may be necessary in some cases. If both are prescribed together, your doctor may adjust the dose or frequency for one or both 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 may increase the risk of certain side effects, but using both may be the best treatment for you. If both are prescribed, your doctor may adjust the dose or frequency for one or both medicines.

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

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical conditions may affect the use of this medicine. Make sure to inform your doctor if you have any other medical conditions, especially:

• Congenital metabolism disorders (born with a disease affecting metabolism) or
• Mental retardation with severe seizure disorders—Use with caution. May increase the risk of serious side effects.

• Depression, or a history of
• Mental illness, or a history of
• Pancreatitis (inflammation of the pancreas) or
• Thrombocytopenia (low platelet count) or
• Viral infections (e.g., HIV, cytomegalovirus infection)—Use with caution. May worsen these conditions.

• Liver disease 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.

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 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
• Confusion
• Cough
• Crying
• Delusions of persecution, mistrust, suspiciousness, or combativeness
• Diarrhea
• Difficult or labored breathing
• 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
• Nervousness
• 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 in the legs, arms, hands, or feet
• Shivering
• Sleepiness or unusual drowsiness
• Sore throat
• Sweating
• Tightness in the chest
• 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
• Unusual bleeding or bruising
• Unusual tiredness or weakness
• Unusual weight gain or loss
• Vomiting

Less common

• Abnormal dreams
• Absence of or decrease in body movement
• Anxiety
• Bloody nose
• Bloody or cloudy urine
• Blurred vision
• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• Change in personality
• Change in walking and balance
• Changes in patterns and rhythms of speech
• Chest pain
• Clumsiness or unsteadiness
• Cold sweats
• Constipation
• Dark urine
• Deep or fast breathing with dizziness
• Degenerative disease of the joint
• Difficulty with moving
• Discouragement
• Dizziness
• Dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• Dry mouth
• Excessive muscle tone
• Fast, irregular, pounding, or racing heartbeat or pulse
• Fear
• Feeling of warmth or heat
• Feeling sad or empty
• Flushing or redness of the skin, especially on the face and neck
• Frequent urge to urinate
• Heavy non-menstrual vaginal bleeding
• Increased need to urinate
• Indigestion
• Irritability
• Lack of appetite
• Lack of coordination
• Large, flat, blue or purplish patches in the skin
• Leg cramps
• Lip smacking or puckering
• Loss of bladder control
• Loss of interest or pleasure
• Loss of strength or energy
• Multiple swollen and inflamed skin lesions
• Muscle pain or stiffness
• Muscle tension or tightness
• Normal menstrual bleeding occurring earlier, possibly lasting longer than expected
• Numbness of the feet, hands, and around the mouth
• Pains in the stomach, side, or abdomen, possibly radiating to the back
• Passing urine more often
• Pounding in the ears
• Puffing of the cheeks
• Rapid or worm-like movements of the tongue
• Rapid weight gain
• Restlessness
• Seeing, hearing, or feeling things that are not there
• Shakiness and unsteady walk
• Slurred speech
• Small red or purple spots on the skin
• Sweating
• Swollen joints
• Tiredness
• Trouble with concentrating
• Trouble with speaking
• Twitching
• Uncontrolled chewing movements
• Uncontrolled movements of the arms and legs
• Unsteadiness, trembling, or other problems with muscle control or coordination
• Vomiting of blood or material that looks like coffee grounds
• Yellow eyes or skin

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
• 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 or muscle pain
• Loss of balance control
• Loss of consciousness
• Mask-like face
• 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

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Change in consciousness
• Fainting
• Loss of consciousness
• Slow or irregular heartbeat

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
• Body aches or pain
• Change in vision
• Congestion
• Continuing ringing or buzzing or other unexplained noise in the ears
• Hair loss or thinning of the hair
• Hearing loss
• Heartburn
• Impaired vision
• Lack or loss of strength
• Loss of memory
• Problems with memory
• Seeing double
• Tender, swollen glands in the neck
• Uncontrolled eye movements
• Voice changes
• Weight gain
• Weight loss

Less common

• Absent, missed, or irregular menstrual periods
• Burning, dry, or itching eyes
• Change in taste or bad unusual or unpleasant (after) taste
• Coin-shaped lesions on the skin
• Cough producing mucus
• Cramps
• Dandruff
• Discharge or excessive tearing
• Dry skin
• Earache
• Excess air or gas in the stomach or bowels
• Eye pain
• Feeling of constant movement of self or surroundings
• Full feeling
• Heavy bleeding
• Increased appetite
• Itching of the vagina or genital area
• Loss of bowel control
• Neck pain
• Oily skin
• Pain
• Pain during sexual intercourse
• Pain or tenderness around the eyes and cheekbones
• Passing gas
• Rash with flat lesions or small raised lesions on the skin
• Redness or swelling in the ear
• Redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid
• Redness, swelling, or soreness of the tongue
• Sensation of spinning
• Sneezing
• Stiff neck
• Stopping of menstrual bleeding
• Thick, white vaginal discharge with no odor or with a mild odor

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.

• Depakene
• Depakote
• Depakote DR
• Depakote ER
• Depakote Sprinkles
• Stavzor

In Canada

• Alti-Valproic

Available Dosage Forms:

• Syrup
• Solution
• Capsule, Liquid Filled
• Tablet, Delayed Release
• Capsule, Delayed Release
• Tablet, Extended Release

Therapeutic Class: Anticonvulsant

Pharmacologic Class: Histone Deacetylase Inhibitor

Chemical Class: Valproic Acid (class)

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a Medication Guide or patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Swallow the delayed-release capsules or oral capsules whole with a full glass of water. Do not split, crush, or chew it. You may take this medicine with food to decrease stomach upset.

If you cannot swallow the capsule whole, you may open it and sprinkle the contents onto a small amount of soft food (including applesauce or pudding).

Measure the oral liquid medicine with a marked measuring spoon, oral syringe, or medicine cup.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (capsules, delayed-release capsules, and solution):For seizures: Adults and children 10 years of age or older—Dose is based on body weight and must be determined by your doctor. At first, the usual dose is 10 to 15 milligrams (mg) per kilogram (kg) of body weight per day. Your doctor may gradually increase your dose every week by 5 to 10 mg per kg of body weight as needed. However, the dose is usually not more than 60 mg per kg of body weight per day. If the total dose a day is greater than 250 mg, it is usually divided into smaller doses and taken 2 or more times during the day. Children younger than 10 years of age—Use and dose must be determined by your doctor.
• For oral dosage form (delayed-release capsules): For mania: Adults—At first, 750 milligrams (mg) once a day, usually divided in smaller doses. Your doctor may increase your dose as needed. Children—Use and dose must be determined by your doctor. For migraine: Adults—At first, 250 milligrams (mg) 2 times a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 1000 mg a day. Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.