Depakote DR (Oral)

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

Divalproex sodium 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 your doctor's prescription.

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

Using this medicine while pregnant (especially in the first 3 months) can harm your unborn baby and lead to serious unwanted effects (such as brain or facial issues, heart or blood vessel problems, arm or leg issues, or intelligence or mental problems). Use an effective form of birth control to prevent pregnancy. If you think you might be pregnant while using this medicine, inform your doctor right away.

Taking folic acid before 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 help if you are unsure about which folic acid product to choose.

Liver problems can occur while using this medicine, and some may be serious. Contact your doctor immediately if you have 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.

Pancreatitis may develop while using this medicine. Tell 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 experience unusual drowsiness, dullness, tiredness, weakness or sluggishness, changes in mental status, low body temperature, or vomiting. These may indicate a serious condition called hyperammonemic encephalopathy.

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

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

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

Divalproex sodium may cause serious allergic reactions affecting multiple organs (like the liver or kidney). Contact your doctor immediately if you experience: fever, dark urine, headache, rash, stomach pain, swollen lymph glands in the neck, armpit, or groin, unusual tiredness, or yellow eyes or skin.

Divalproex sodium may make some people feel agitated, irritable, or exhibit other abnormal behaviors. It may also lead some people to have suicidal thoughts or become more depressed. If you notice any of these side effects, inform your doctor right away.

This medicine will enhance the effects of alcohol and other CNS depressants (medications that cause drowsiness). Examples of CNS depressants include antihistamines or medicine for hay fever, other allergies, or colds, sedatives, tranquilizers, sleeping medications, prescription pain medications or narcotics, seizure medications (like 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 become infertile (unable to have children).

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

In deciding to use a medicine, you and your doctor need to consider the risks of taking the medicine compared to its benefits. The following points should be taken into account for this medicine:

Allergies

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

Pediatric

Current studies have not shown any specific problems in children that would limit the usefulness of divalproex sodium. However, safety and effectiveness have not been established for other uses in children, and caution is needed when treating seizures in children younger than 10 years old. Due to the toxicity of divalproex sodium, extreme caution is required when using it in children younger than 2 years old.

Geriatric

Current studies have not shown any specific problems in the elderly that would limit the usefulness of divalproex sodium. However, older patients are more likely to experience side effects (such as tremors or unusual drowsiness), which may require a dose adjustment for those taking divalproex sodium.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. You should consider the potential benefits and 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 need to adjust the dose or take other precautions. It is especially important for your healthcare professional to know if you are taking any of the following medicines while on this medicine. The following interactions are based on their potential significance and are not an exhaustive list.

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 the frequency of use 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 medicines may increase the risk of certain side effects, but using both drugs may be the best treatment option for you. If both medicines are prescribed together, your doctor may adjust the dose or frequency of use 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 used around the time of eating certain foods due to potential interactions. Drinking alcohol or using 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 issues, especially:

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

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

• Liver disease or
• Mitochondrial disorders, including Alpers-Huttenlocher syndrome (genetic disorder) or
• Urea cycle disorder (genetic disorder)—Should not be used in patients with these conditions.

• Pregnant women with migraine headaches—Should not be used to prevent migraine headaches in these patients.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may happen, if they do, they may require medical attention.

Check with your doctor right away 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
• Chills
• 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
• Blurred vision
• Bruising, 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
• Cloudy urine
• Clumsiness or unsteadiness
• Cold sweats
• Constipation
• Dark urine
• Deep or fast breathing with dizziness
• Degenerative disease of the joint
• Difficulty with moving
• 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
• Feeling of warmth or heat
• 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
• Lack of coordination
• Large, flat, blue or purplish patches in the skin
• Leg cramps
• Lip smacking or puckering
• Loss of bladder control
• 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
• 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.

• Depakote
• Depakote DR
• Depakote ER
• Depakote Sprinkles

In Canada

• Alti-Valproic

Available Dosage Forms:

• Tablet, Delayed Release
• Capsule, Delayed Release
• Tablet, Extended Release

Therapeutic Class: Anticonvulsant

Pharmacologic Class: Valproic Acid

Chemical Class: Valproic Acid

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. To keep blood levels constant, take this medicine at the same time each day and do not miss any doses.

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.

You may take this medicine with food to avoid stomach upset.

Swallow the sprinkle capsules whole. It may also be opened and the contents may be sprinkled onto a teaspoonful of soft food, such as applesauce or pudding. This mixture must be swallowed immediately without chewing and followed with a glass of water to ensure complete swallowing of the sprinkles.

Swallow the extended-release tablet or tablet whole with a full glass of water. Do not split, crush, or chew it.

Part of the medicine may pass into your stool after your body has absorbed the medicine. Check with your doctor right away if this happens.

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 (delayed-release tablets or tablets): For mania: Adults—At first, 750 milligrams (mg) once a day, usually divided in smaller doses. Your doctor may increase your dose as needed. However, the dose is usually not more than 60 mg per kilogram (kg) of body weight per day. 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 per day. Children—Use and dose must be determined by your doctor. 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 increase your dose gradually every week by 5 to 10 mg per kg of body weight if 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 (extended-release tablets): For mania: Adults—Dose is based on body weight and must be determined by your doctor. At first, the usual dose is 25 milligrams (mg) per kilogram (kg) of body weight once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 60 mg per kg of body weight per day. Children—Use and dose must be determined by your doctor. For migraine: Adults—At first, 500 milligrams (mg) once a day for 1 week. Your doctor may increase your dose as needed. However, the dose is usually not more than 1000 mg per day. Children—Use and dose must be determined by your doctor. 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 increase your dose gradually every week by 5 to 10 mg per kg of body weight if needed. However, the dose is usually not more than 60 mg per kg of body weight per day. Children younger than 10 years of age—Use and dose must be determined by your doctor.
• For oral dosage form (sprinkle capsules):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 a day. Your doctor may increase your dose gradually every week by 5 to 10 mg per kg of body weight if 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.

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.