Depakote®, Depakote ER® (divalproex sodium): Headache and Migraine Drug Profile

Depakote^®, Depakote ER^® (divalproex sodium)

Depakote is a neuronal stabilizing agent (aka anticonvulsant) originally developed for the treatment of seizure disorders. Depakote ER is a time-release formula. Both Depakote and Depakote ER have now been approved by the FDA for Migraine prevention. It is also sometimes used as a mood stabilizer to treat bipolar disorder. Type of medication: Rx, neuronal stabilizing agent (aka anticonvulsant), Migraine preventive, mood stabilizer

How supplied: tablets, sprinkle capsules, time-release tablets.

Pregnancy and Breastfeeding:

• FDA pregnancy category D. Positive evidence of human fetal risk; maternal benefit may outweigh fetal risk in serious or life-threatening situations; see package insert for drug-specific recommendations .
• Breastfeeding: Limited information in animals and/or humans demonstrates no risk/minimal risk of adverse effects to infant/breast milk; caution advised.

Precautions:
Do not stop taking this medication without talking to your doctor first.

Blood tests need to be done on a regular basis if you take Depakote or Depakote ER. Anyone taking Depakote or Depakote ER should be aware of the "Black Box" warning:

BOX WARNING:
HEPATOTOXICITY:

HEPATIC FAILURE RESULTING IN FATALITIES HAS OCCURRED IN PATIENTS RECEIVING VALPROIC ACID AND ITS DERIVATIVES. EXPERIENCE HAS INDICATED THAT CHILDREN UNDER THE AGE OF TWO YEARS ARE AT A CONSIDERABLY INCREASED RISK OF DEVELOPING FATAL HEPATOTOXICITY, ESPECIALLY THOSE ON MULTIPLE ANTICONVULSANTS, THOSE WITH CONGENITAL METABOLIC DISORDERS, THOSE WITH SEVERE SEIZURE DISORDERS ACCOMPANIED BY MENTAL RETARDATION, AND THOSE WITH ORGANIC BRAIN DISEASE. WHEN DEPAKOTE IS USED IN THIS PATIENT GROUP, IT SHOULD BE USED WITH EXTREME CAUTION AND AS A SOLE AGENT. THE BENEFITS OF THERAPY SHOULD BE WEIGHED AGAINST THE RISKS. ABOVE THIS AGE GROUP, EXPERIENCE IN EPILEPSY HAS INDICATED THAT THE INCIDENCE OF FATAL HEPATOTOXICITY DECREASES CONSIDERABLY IN PROGRESSIVELY OLDER PATIENT GROUPS.

THESE INCIDENTS USUALLY HAVE OCCURRED DURING THE FIRST SIX MONTHS OF TREATMENT. SERIOUS OR FATAL HEPATOTOXICITY MAY BE PRECEDED BY NON-SPECIFIC SYMPTOMS SUCH AS MALAISE, WEAKNESS, LETHARGY, FACIAL EDEMA, ANOREXIA, AND VOMITING. IN PATIENTS WITH EPILEPSY, A LOSS OF SEIZURE CONTROL MAY ALSO OCCUR. PATIENTS SHOULD BE MONITORED CLOSELY FOR APPEARANCE OF THESE SYMPTOMS. LIVER FUNCTION TESTS SHOULD BE PERFORMED PRIOR TO THERAPY AND AT FREQUENT INTERVALS THEREAFTER, ESPECIALLY DURING THE FIRST SIX MONTHS.

TERATOGENICITY:
VALPROATE CAN PRODUCE TERATOGENIC EFFECTS SUCH AS NEURAL TUBE DEFECTS (E.G., SPINA BIFIDA). ACCORDINGLY, THE USE OF DEPAKOTE TABLETS IN WOMEN OF CHILDBEARING POTENTIAL REQUIRES THAT THE BENEFITS OF ITS USE BE WEIGHED AGAINST THE RISK OF INJURY TO THE FETUS. THIS IS ESPECIALLY IMPORTANT WHEN THE TREATMENT OF A SPONTANEOUSLY REVERSIBLE CONDITION NOT ORDINARILY ASSOCIATED WITH PERMANENT INJURY OR RISK OF DEATH (E.G., MIGRAINE) IS CONTEMPLATED. SEE WARNINGS , INFORMATION FOR PATIENTS .

AN INFORMATION SHEET DESCRIBING THE TERATOGENIC POTENTIAL OF VALPROATE IS AVAILABLE FOR PATIENTS.

PANCREATITIS:
CASES OF LIFE-THREATENING PANCREATITIS HAVE BEEN REPORTED IN BOTH CHILDREN AND ADULTS RECEIVING VALPROATE. SOME OF THE CASES HAVE BEEN DESCRIBED AS HEMORRHAGIC WITH A RAPID PROGRESSION FROM INITIAL SYMPTOMS TO DEATH. CASES HAVE BEEN REPORTED SHORTLY AFTER INITIAL USE AS WELL AS AFTER SEVERAL YEARS OF USE. PATIENTS AND GUARDIANS SHOULD BE WARNED THAT ABDOMINAL PAIN, NAUSEA, VOMITING, AND/OR ANOREXIA CAN BE SYMPTOMS OF PANCREATITIS THAT REQUIRE PROMPT MEDICAL EVALUATION. IF PANCREATITIS IS DIAGNOSED, VALPROATE SHOULD ORDINARILY BE DISCONTINUED. ALTERNATIVE TREATMENT FOR THE UNDERLYING MEDICAL CONDITION SHOULD BE INITIATED AS CLINICALLY INDICATED. (See WARNINGS and PRECAUTIONS .)

Other medical conditions:
The presence of other medical problems may affect the use of any medication. Make sure you tell your doctor if you have any other medical problems, especially those listed below.

• blood disease
• brain disease
• kidney disease
• liver disease

Other medications:
Be sure to tell your doctor if you are taking any other prescription or over-the-counter medications, especially those listed below.

• Acetaminophen (e.g., Tylenol)
• Amiodarone (e.g., Cordarone)
• anabolic steroids (nandrolone [e.g., Anabolin], oxandrolone [e.g., Anavar]
• oxymetholone [e.g., Anadrol], stanozolol [e.g., Winstrol])
• androgens (male hormones)
• barbiturates
• Carbamazepine (e.g., Tegretol)
• Carmustine (e.g., BiCNU)
• Dantrolene (e.g., Dantrium)
• Daunorubicin (e.g., Cerubidine)
• Disulfiram (e.g., Antabuse)
• Estrogens
• Methotrexate (e.g., Mexate)
• Phenothiazines (acetophenazine [e.g., Tindal]
• chlorpromazine [e.g., Thorazine]
• fluphenazine [e.g., Prolixin]
• mesoridazine [e.g., Serentil]
• perphenazine [e.g., Trilafon]
• prochlorperazine [e.g., Compazine]
•  promazine [e.g., Sparine]
• promethazine [e.g., Phenergan]
• thioridazine [e.g., Mellaril]
• trifluoperazine [e.g., Stelazine]
• triflupromazine [e.g., Vesprin]
• trimeprazine [e.g., Temaril])
• tricyclic antidepressants (medicine for depression)
• Heparin--There is an increased risk of side effects that may cause bleeding
• other anticonvulsants