DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Depakene (Valproic Acid) - Summary

 
 



BOX WARNING

HEPATOTOXICITY

HEPATIC FAILURE RESULTING IN FATALITIES HAS OCCURRED IN PATIENTS RECEIVING VALPROIC ACID. 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 DEPAKENE PRODUCTS ARE USED IN THIS PATIENT GROUP, THEY 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 VALPROATE PRODUCTS 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.

A PATIENT INFORMATION LEAFLET 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.)

 

DEPAKENE SUMMARY

DEPAKENE (valproic acid) is a carboxylic acid designated as 2-propylpentanoic acid. It is also known as dipropylacetic acid.

DEPAKENE (valproic acid) is indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures. DEPAKENE (valproic acid) is indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures, and adjunctively in patients with multiple seizure types which include absence seizures.

Simple absence is defined as very brief clouding of the sensorium or loss of consciousness accompanied by certain generalized epileptic discharges without other detectable clinical signs. Complex absence is the term used when other signs are also present.

SEE WARNINGS FOR STATEMENT REGARDING FATAL HEPATIC DYSFUNCTION.
See all Depakene indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Depakene (Valproic Acid)

Birth Defects Linked to Valproic Acid
Source: MedicineNet Ventricular Septal Defect Specialty [2010.06.10]
Title: Birth Defects Linked to Valproic Acid
Category: Health News
Created: 6/10/2010 10:38:00 AM
Last Editorial Review: 6/10/2010 10:38:49 AM

Mood-stabilizing drug could reduce risk of head and neck cancer
Source: Bipolar News From Medical News Today [2014.03.24]
A drug used to treat epilepsy and manic-depressive illness - valproic acid (VPA) - could be effective in reducing the risk of head and neck cancer, according to a new study.

more news >>

Published Studies Related to Depakene (Valproic Acid)

Effect of D: -cycloserine and valproic acid on the extinction of reinstated fear-conditioned responses and habituation of fear conditioning in healthy humans: a randomized controlled trial. [2011.12]
RATIONALE: Although the effects of D: -cycloserine (DCS) and valproic acid (VPA) on the facilitation of the extinction of fear-conditioned memory have been elucidated in animals, these effects have not been clearly confirmed in humans. OBJECTIVE: This study aimed to determine the effect of DCS (100 mg) and VPA (400 mg) on the facilitation of the extinction and acquisition of fear-conditioned memory in humans... CONCLUSION: A single dose of DCS or VPA might enhance exposure-based cognitive therapy of anxiety disorders by reducing the vulnerability to reinstatement and preventing relapses of fear-conditioned responses.

Prolonged survival with valproic acid use in the EORTC/NCIC temozolomide trial for glioblastoma. [2011.09.20]
OBJECTIVE: This analysis was performed to assess whether antiepileptic drugs (AEDs) modulate the effectiveness of temozolomide radiochemotherapy in patients with newly diagnosed glioblastoma... CONCLUSIONS: VPA may be preferred over an EIAED in patients with glioblastoma who require an AED during TMZ-based chemoradiotherapy. Future studies are needed to determine whether VPA increases TMZ bioavailability or acts as an inhibitor of histone deacetylases and thereby sensitizes for radiochemotherapy in vivo.

Evaluation of the subjective and reinforcing effects of diphenhydramine, levetiracetam, and valproic acid. [2011.06]
Few unscheduled sedating medications have been evaluated for their subjective and reinforcing effects in humans. To increase the information available about unscheduled sedating medications and to evaluate the ability of human laboratory measures to discriminate between scheduled and unscheduled sedating drugs, 24 subjects with a history of experience with several classes of drugs of abuse, including sedatives and/or alcohol, and who reported liking a test dose of pentobarbital 300 mg, were randomized to single doses of diphenhydramine 400 mg, levetiracetam 4000 mg, valproic acid 1500 mg, diazepam 30 mg or placebo in a double-blind, 5-way crossover study...

D-cycloserine facilitates procedural learning but not declarative learning in healthy humans: a randomized controlled trial of the effect of D-cycloserine and valproic acid on overnight properties in the performance of non-emotional memory tasks. [2011.05]
Although D-cycloserine (DCS), a partial agonist of the N-methyl-d-aspartate (NMDA) receptor, and valproic acid (VPA), a histone deacetylase inhibitor, have been investigated for their roles in the facilitation of emotional learning, the effects on non-emotional declarative and procedural learning have not been clarified...

Effect of D-cycloserine and valproic acid on the extinction of reinstated fear-conditioned responses and habituation of fear conditioning in healthy humans: a randomized controlled trial. [2011]
memory in humans... CONCLUSION: A single dose of DCS or VPA might enhance exposure-based cognitive

more studies >>

Clinical Trials Related to Depakene (Valproic Acid)

Pediatric Switch Study for Children and Adolescent Patients With Epilepsy [Completed]
To assess the tolerability of switching from Depakote Sprinkle Capsules or Depakote tablets to Depakote ER tablets in the pediatric population.

Valproate in Late Life Schizophrenia [Completed]
The purpose of this research study is to analyze the effectiveness and tolerability of a medication, valproate ( Depakote and Depakote ER), in individuals age 50 years and older who have schizophrenia.

Valproate and Etoposide for Patients With Neuronal Tumors and Brain Metastases [Recruiting]
Primary Objective:

- Determine the interindividual range and median of individual maximum tolerated doses of

valproic acid administered as one time evening dose in conjunction with a dose oral etoposide (50 mg/m2/day for children, but only 25mg/m2/day for adults to start) for four different age groups.

Secondary Objectives:

- Determine the qualitative and quantitative toxicity and reversibility of toxicity of

valproic acid in conjunction with oral etoposide,

- To investigate the clinical pharmacokinetics of valproic acid when given in conjunction

with oral etoposide,

- To describe quality of life of patients with relapsed, or progressive central and

peripheral nervous system tumors when treated with oral valproic acid and etoposide,

- To observe and describe the response pattern of progressive central nervous system

tumors treated with oral valproic acid and etoposide,

- To observe and describe event free survival time and overall survival time of patients

with relapsed, or progressive central nervous system tumors when treated with oral valproic acid and etoposide,

- To determine if histone deacetylase activity and topoisomerase expression in

lymphocytes of patients is related to valproic acid levels, and

- To determine, if the individual maximal tolerated dose (iMTD) depends on the initial

performance status of the patient in the beginning of the treatment.

Effectiveness of Divalproex Sodium (Depakote) in Treating Disruptive Behavior Disorder and Explosive Tempers in Adolescents and Adults [Recruiting]

Valproic Acid and Bevacizumab in Patients With Advanced Cancer [Recruiting]
The goal of this clinical research study is to find the highest tolerable dose of bevacizumab in combination with valproic acid that can be given to patients with advanced cancer that has not responded to standard treatment or where there is no standard treatment for the disease. The safety of this drug combination will also be studied.

more trials >>

Reports of Suspected Depakene (Valproic Acid) Side Effects

Convulsion (57)Pyrexia (46)Epilepsy (46)Somnolence (42)Thrombocytopenia (29)Drug Ineffective (27)Intentional Overdose (27)Suicide Attempt (27)Sopor (26)Confusional State (25)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 2 ratings/reviews, Depakene has an overall score of 5. The effectiveness score is 6 and the side effect score is 5. The scores are on ten point scale: 10 - best, 1 - worst.
 

Depakene review by care giver of 14 year old female patient

  Rating
Overall rating:  
Effectiveness:   Moderately Effective
Side effects:   Moderate Side Effects
  
Treatment Info
Condition / reason:   Tonic clonic seizures
Dosage & duration:   500mg PM 375 mg AM taken twice a day for the period of 12 years
Other conditions:   autism, developmental delay
Other drugs taken:   clonazepam, nitrazepam
  
Reported Results
Benefits:   Moderate seizure control, seizures controlled during the awake hours, however, still uncontrolled during sleep. Patient has multiple, short seizures, nightly.
Side effects:   Side effects were at first loss of appetite, then later, increased appetite. Also some irritability which we cannot be sure but may be related to the drug. However, it could be due to the nighttime seizures which are still occurring.
Comments:   Take 500 mg of Valproic Acid before bed, daily, and 375 mg at breakfast, daily. This dose was titrated up slowly and eventually stopped at this level. Blood work is done to check the blood trough level. We are instructed to contact the physician should the seizure pattern change.

 

Depakene review by 25 year old female patient

  Rating
Overall rating:  
Effectiveness:   Moderately Effective
Side effects:   Severe Side Effects
  
Treatment Info
Condition / reason:   Bipolar Disorder
Dosage & duration:   500 mg taken two times per day for the period of 5 months
Other conditions:   Post Traumatic Stress
Other drugs taken:   None
  
Reported Results
Benefits:   Initial benefits were comparable to the brand name version of this drug, Depakote. I had been taking Depakote for several months and experienced great results. When I went to my psychiatrist for an evaluation and re-fill, he accidently prescribed the generic version, Depakene. When I discovered the error, I was told by this doctor that I would experience the same results as Depakote. The positive side effects of the Depakene: balanced mood, improved concentration, improved logical cognition, mental clarity, lessened anxiety and irritability, improved sleep, increase in pleasure about activities
Side effects:   Depakene has a very thin coating, which caused severe heart burn and stomach upset. The discomfort was so unpleasant that it made me not want to take my meds, so I was not taking them consistently as prescribed. This caused my mood to fluctuate again. Even after I switched to the Depakote, my stomach was still uncomfortable for several weeks afterwards. My appetite decreased and food was very unappetizing. Certain foods that I normally enjoy, such as chicken or fish, made me feel extremely queasy when I ate them. I did not like the physical side effect of the drug, and decided to quit my psychiatric drugs altogether - because I was no longer stable anymore!
Comments:   Depakote was prescribed to me by a Kaiser psychiatrist in Pleasant Hill, CA in 2006. The medication was given to help treat the diagnosis of Bipolar Disorder, Type II. My disease was misdiagnosed for several years as depression, since I was never seen by a professional during hypomanic episodes, and when I did see a professional, I did not think that my manic symptoms were signs of a serious psychiatric problem. Anti-depressant drugs were prescribed: Prozac in 2001, which had minimal effect and I stopped taking them a few months later. Wellbutrin was prescribed again for "chronic depression" in the spring of 2006, but this medication slowly spun me into an intense manic period. After the manic episode, I fell very hard into a severe, suicidal depressive state. I was voluntarily admitted to a psychiatric ward in June 2006 to keep me safe and to properly diagnose my condition. The symptoms I was experiencing before being prescribed the Depakote/Depakene: rapidly cycling mood swings between intense activation and irritablity/excitement and crashing lows and depression, suicidal thoughts, poor logic and decision making, racing thoughts, anxiety, poor concentration, and poor sleep.

See all Depakene reviews / ratings >>

Page last updated: 2014-03-24

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2014