Depakote is a popular brand name of divalproex sodium which is comprised of sodium valproate and valproic avid. Depakote ER (Extended Releases) and Depakote Sprinkles are other brand names of divalproex sodium.

Depakote has been approved by the US Food and Drug Administration (FDA) for the medical treatment of different types of seizures (convulsions), such as complex partial seizures and absence seizures. Depakote has been also approved for treatment of manic episodes associated with bipolar disorder and prevention of migraine (severe attacks of headache on one side of the head).
Complex partial seizures are caused by transient alternation in the electrical activity of a specific area in the brain. This type of seizures is characterized by a change in awareness and thought, sensory, or physical disturbances. After recovery from the attack, the patients can not remember those events.
Absence seizures are characterized by sudden and transient loss of consciousness, which is usually accompanied by blinking or mouth twitching. This type of seizures is more common in children than in adults.
Bipolar disorder is a mood disorder characterized by alternating periods of depression and mania (abnormal or irritable mood). It is often called “manic-depressive disorder”.

For treatment of complex partial seizures in adult patients, Depakote is usually given in an initial dose of 10 to 15 mg/kg, orally twice daily. The dose may be increased after a week to obtain an optimal response.

For treatment of manic episodes associated with bipolar disorder in adult patient, Depakote is usually started at a dose of 250 to 500 mg, orally three times daily.

The most commonly reported Depakote side effects are headache, nausea, vomiting, diarrhea, abdominal pain, hair loss, nervousness, depression and blurring of vision.

If Depakote is given in a dose larger than recommended, the patient may experience any of the following symptoms:
Somnolence (sensation of sleepiness or drowsiness)
Deep coma
Heart block (serious disorder characterized by delayed transmission of electrical impulses that cause the heart to heart)

Black Box Warnings:
Liver toxicity: Fatal liver failure has been reported usually in the first 6 months of treatment with Depakote. Warning symptoms and signs of liver toxicity include weakness, vomiting, decreased appetite, edema of the face and weakness. The risk of liver toxicity increases if Depakote is used in children below the age of 2 years.

Life-threatening pancreatitis (inflammation of the pancreas): Patients receiving Depakote are advised to notify their healthcare professional immediately if they feel symptoms suggestive of pancreatitis, such as abdominal pain, nausea, vomiting or decreased appetite. Depakote should be discontinued if diagnosis of pancreatitis is confirmed.

Teratogenicity (ability of producing congenital fetal malformations): Administration of Depakote during pregnancy can increase the risk of developing congenital fetal malformations, such as neural tube defects (serious malformations which may lead to paralysis or death).

Common Depakote Side Effects:
Central Nervous System (CNS):
Headache
Somnolence (sensation of sleepiness or drowsiness)
Insomnia
Dizziness
Tremors (involuntary movements of the hands or feet)
Abnormal gait
Paresthesia (uncomfortable sensation of needles and pins in the hands and or feet)
Vertigo (false sensation of movement)
Nervousness
Depression
Amnesia (loss of memory)
Emotional instability
Hostility
Abnormal dreams
Abnormalities in thinking

Gastrointestinal Tract (GIT):
Nausea
Vomiting
Dyspepsia (disorders of digestion)
Diarrhea or constipation
Abdominal pain
Taste perversion
Change in appetite
Change in body weight
Gastroenteritis (inflammation of the stomach and intestine)
Glossitis (inflammation of the tongue)
Dyspepsia (disorders of digestion)
Pharyngitis (inflammation of the muscular tube that carries foods and liquids from the mouth to the stomach)
Swelling of the parotid gland (the gland located in front of the ear)
Elevation of liver enzymes (ASL & ALT)

Eyes:
Blurring of vision
Conjunctivitis (inflammation of the membrane that lines the eye lids & covers the white of the eye)
Nystagmus (rapid involuntary movements of the eyeball)
Diplopia (visual disorder characterized by double vision)
Photosensitivity (increased sensitivity of eyes to light)

Skin and hair:
Rash
Alopecia (loss of hair)
Dry skin
Peripheral edema (swelling of hands and or feet)
Petechiae and ecchymosis (small areas of hemorrhage in the skin)

Musculoskeletal System:
Weakness
Leg cramps
Arthralgia (joint pain)
Arthrosis (disorders of joint)
Myalgia (pain in the muscles)

Genitourinary System:
Urinary tract infections
Dysuria (difficulty in urination)
Cystitis (inflammation of the urinary bladder)
Dysmenorrhea (painful cramps during menstruation)
Irregular menses
Abnormal vaginal bleeding

Respiratory System:
Cough
Dyspnea (shortness of breath)
Rhinitis (inflammation of the nose)
Sinusitis (inflammation of the air-filled cavities beside the nose)

Other Common Depakote Side Effects:
Asthenia (loss of strength and energy)
Tinnitus (hearing of ringing, buzzing or whistling without external stimuli)
Chest pain
Pain and rigidity in the neck

Serious Depakote Side Effects:
Hypersensitivity reactions:
Anaphylaxis (severe and potentially fatal hypersensitivity reaction in which the patient may have skin rash, itching, difficulty breathing and swelling of the face)
Steven-Johnson’s syndrome (serious hypersensitivity reaction in which the patient may have fever, cough, sore throat, skin pain, itching and swelling of the face or tongue)
Erythema multiforme (severe allergic skin disease manifested by itching and skin rashes)
Toxic epidermal necrolysis (severe allergic skin disease characterized by detachment o the outermost layer of the skin)

Central Nervous System (CNS):
Hallucinations
Psychosis (mental disorders)
Suicidality
Dysarthria (difficulty with speech)
Encephalopathy (impairment of brain function)
Coma (prolonged loss of consciousness)

Gastrointestinal Tract (GIT):
Live toxicity
Pancreatitis
Fecal incontinence (involuntary leakage of feces from the rectum)

Blood:
Pancytopenia (reduction in all types of blood cells, including white blood cells and platelets)
Thrombocytopenia (decreased platelet count which may lead to spontaneous bleeding)
Myelosuppression (suppression of the bone marrow which produces all types of blood cells)
Aplastic anemia (inability of the bone marrow to produce new blood cells)
Bleeding

Endocrinal and metabolic:
Abnormal thyroid function tests
Syndrome of inappropriate antidiuretic hormone hypersecretion (SIADH, serious endocrinal disorder characterized by water retention, irritability, convulsions and coma)
Hyponatremia (reduced blood sodium level)
Hyperammonemia (elevated blood ammonia level)

Cardiovascular System (CVS):
Changes in blood pressure
Palpitation (awareness of heart beats)
Tachycardia (increased hearty rate)

Other Serious Depakote Side Effects:
Hypothermia (decreased body temperature)
Polycystic ovary syndrome (disorder of ovaries which may affect women’s fertility)
Urinary incontinence (involuntary leakage of urine from the bladder)

Depakote Contraindications, Cautions, and Drug Interactions:
Depakote is absolutely contraindicated for people known to be hypersensitive to it.
Depakote should be given with caution to people who have any of the following disorders:
Severe liver diseases
Severe kidney diseases
Organic brain diseases
Head injuries
Mental retardation
Seizures (convulsions)
Congenital metabolic disorders
Bone marrow suppression
Risk of bleeding
History of depression
Depakote should not be given simultaneously with any of the following medications:
Doripenem
Ertapenem
Imipenem
Meropenem
Clonazepam
Rifampins
Ginkgo biloba
Tositumomab
The above mentioned contraindications, cautions and interactions of Depakote are the most important ones. For a complete list see the manufacturer’s prescriber guidelines, and for specific concerns consult your healthcare professional.

Pharmacology:
Depakote is metabolized in the liver. Its plasma half-life is 9 to 16 hours.
Depakote is excreted mainly in the urine.

According to the FDA, Depakote is classified as a class D medication, meaning that there is a positive evidence of fetal risk if this drug is given during pregnancy.
Clinical studies have shown that taking Depakote during pregnancy is associated with congenital fetal malformations, such as neural tube defects (serious malformations which may lead to paralysis or death).

Depakote is known to be excreted in the breast milk. Caution should be exercised before giving Depakote to a breastfeeding mother.

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