DEPAKOTE XR (Divalproex Sodium EC) 250 mg – 150 tablet

Divalproex sodium Information

Pronunciation

val PROE ik AS id & dah RIV ah tives

What is this drug used for?

• It is used to treat seizures.

• It is used to prevent migraine headaches.

• It is used to treat bipolar problems.

• It may be given to you for other reasons. Talk with the doctor.

Frequently reported side effects of this drug

• Headache

• Nausea

• Vomiting

• Dizziness

• Fatigue

• Constipation

• Diarrhea

• Abdominal pain

• Trouble sleeping

• Lack of appetite

• Increased hunger

• Weight gain

• Weight loss

• Anxiety

• Flu-like signs

• Hair loss

Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:

• Infection

• Liver problems like dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or yellow skin.

• Pancreatitis like severe abdominal pain, severe back pain, severe nausea, or vomiting.

• Depression like thoughts of suicide, anxiety, emotional instability, or confusion.

• High ammonia level like abnormal heartbeat, abnormal breathing, confusion, pale skin, slow heartbeat, seizures, vomiting, or twitching.

• Chest pain

• Swelling of arms or legs

• Vision changes

• Trouble with memory

• Severe loss of strength and energy

• Change in balance

• Abnormal gait

• Bruising

• Bleeding

• Purple or red spots on skin

• Unable to pass urine

• Change in amount of urine passed

• Swollen glands

• Agitation

• Panic attacks

• Irritability

• Mood changes

• Behavioral changes

• Muscle pain

• Muscle weakness

• Joint pain

• Joint swelling

• Tremors

• Seizures

• Involuntary eye movements

• Noise or ringing in the ears

• Cold sensation

• Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.

Medication Safety Issues

Sound-alike/look-alike issues:

Storage and Stability

Oral capsules:

Immediate release: Store at 15°C to 25°C (59°F to 77°F).

Delayed release: Store at 25°C (77° F); excursions are permitted between 15°C and 30°C (59°F and 86°F).

Oral sprinkle capsules: Delayed release: Store below 25°C (77°F).

Oral solution: Immediate release: Store below 30°C (86°F).

Oral tablets:

Delayed release: Store below 30°C (86°F).

24-hour extended release: Store tablets at 25°C (77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F).

Immediate release [Canadian product]: Store at 15°C and 25°C (59°F and 77°F). Protect from light.

IV: Store at controlled room temperature 15°C to 30°C (59°F to 86°F). Stable in D5W, NS, and LR for at least 24 hours when stored in glass or PVC.

Adverse Reactions

As reported with oral administration, unless otherwise noted.

Cardiovascular: Chest pain, edema, facial edema, hypertension, hypotension, orthostatic hypotension, palpitations, peripheral edema, tachycardia, vasodilation (more common in oral)

Central nervous system: Abnormal dreams, abnormal gait, abnormality in thinking, agitation, amnesia, anxiety, ataxia, catatonia, chills, confusion, depression, dizziness (more common in oral), drowsiness (more common in oral), emotional lability, hallucination, headache (more common in oral), hyperreflexia, hypertonia, insomnia, malaise, myasthenia, nervousness (more common in oral), pain (more common in oral), paresthesia, personality disorder, sleep disorder, speech disturbance, tardive dyskinesia, twitching, vertigo

Dermatologic: Alopecia, diaphoresis, erythema nodosum, furunculosis, maculopapular rash, pruritus, seborrhea, skin rash, vesiculobullous dermatitis, xeroderma

Endocrine & metabolic: Amenorrhea, menstrual disease, weight gain, weight loss

Gastrointestinal: Abdominal pain (more common in oral), anorexia, constipation, diarrhea (more common in oral), dysgeusia, dyspepsia, dysphagia, eructation, fecal incontinence, flatulence, gastroenteritis, gingival hemorrhage, glossitis, hematemesis, hiccups, increased appetite, nausea (more common in oral), oral mucosa ulcer, pancreatitis, periodontal abscess, stomatitis, vomiting (more common in oral), xerostomia

Genitourinary: Cystitis, dysmenorrhea, dysuria, urinary frequency, urinary incontinence, vaginal hemorrhage, vaginitis

Hematologic & oncologic: Ecchymoses, hypoproteinemia, petechia, prolonged bleeding time, thrombocytopenia (dose related)

Hepatic: Increased serum alanine aminotransferase, increased serum aspartate aminotransferase

Infection: Fungal infection, infection, viral infection

Local: Injection site reaction, pain at injection site

Neuromuscular & skeletal: Arthralgia, asthenia, back pain, discoid lupus erythematosus, dysarthria, hypokinesia, lower limb cramps, myalgia, neck pain, neck stiffness, osteoarthritis, tremor

Ophthalmic: Conjunctivitis, diplopia, dry eye syndrome, eye pain, nystagmus disorder, photophobia, visual disturbance (amblyopia, blurred vision)

Otic: Deafness, otitis media, tinnitus

Respiratory: Bronchitis, cough, dyspnea, epistaxis, flu-like symptoms, pharyngitis (more common in oral), pneumonia, rhinitis, sinusitis

Miscellaneous: Accidental injury, fever