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Sodium valproate

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Main article: Valproic acid

Sodium valproate chemical structure
Sodium valproate

sodium 2-propylpentanoate
IUPAC name
CAS number
1069-66-5
ATC code

N03AG01

PubChem
14047
DrugBank
[1]
Chemical formula {{{chemical_formula}}}
Molecular weight 166.20 g/mol
Bioavailability
Metabolism 75% by CYP enzymes
Elimination half-life 9–18 hours
Excretion 20% excreted as glucuronide
Pregnancy category {{{pregnancy_category}}}
Legal status {{{legal_status}}}
Routes of administration Oral, i.v.

Sodium valproate (INN) or valproate sodium (USAN) is the sodium salt of valproic acid and is an anticonvulsant used in the treatment of epilepsy and bipolar disorder, as well as other psychiatric conditions requiring the administration of a mood stabilizer. The intravenous formulations are used when oral administration is not possible.

FormulationsEdit

Trade names are in bold, followed by the manufacturer.

U.S.Edit

AustraliaEdit

UKEdit

  • Tablets – Orlept by Wockhardt and Epilim by Sanofi-Aventis.
  • Oral solution – Orlept Sugar Free by Wockhardt and Epilim by Sanofi-Aventis.
  • Syrup – Epilim by Sanofi-Aventis.
  • Intravenous injection – Epilim Intravenous by Sanofi-Aventis.
  • Extended release tablets – Epilim Chrono by Sanofi-Aventis. A combination of sodium valproate and valproic acid in a 2.3:1 ratio.
  • Enteric-coated tablets – Epilim EC200 by Sanofi-synthélabo. A 200 mg sodium valproate enteric-coated tablet.

UK onlyEdit

  • Capsules – Episenta prolonged release by Beacon.
  • Sachets – Episenta prolonged release by Beacon.
  • Intravenous solution for injection – Episenta solution for injection by Beacon.

Germany, Switzerland, NorwayEdit

  • Tablets – Orfiril by Desitin Pharmaceuticals
  • Intravenous injection – Orfiril IV by Desitin Pharmaceuticals

South AfricaEdit

  • Syrup – Convulex by Byk Madaus
  • Tablets – Epilim by sanofi~synthelabo

CanadaEdit

JapanEdit

  • Tablets – Depakene by Kyowa Hakko Kogyo.
  • Extended release tablets – Depakene-R by Kyowa Hakko Kogyo and Selenica-R by Kowa.
  • Syrup – Depakene by Kyowa Hakko Kogyo.

EuropeEdit

In much of Europe, Depakine and Depakine Chrono (tablets) are equivalent to Epilim and Epilim Chrono above.

Safety in pregnancyEdit

All antiepilepic medications have been shown to be associated with higher risks of fetal abnormalities (mostly for spina bifida) since at least 1983 with the risks being related to the strength of medication used and use of more than one drug.[1][2] Valproate has also been recognised as sometimes causing a specific facial changes ("facial phenotype") termed "fetal valproate syndrome".[3] Sodium valproate has been associated with the rare condition Paroxysmal tonic upgaze of childhood from childhood exposure(Epileptic Disord. 2007 Sep;9(3):332-6) and also fetal exposure (This condition resolved after discontinuing valproate therapy. Ouvrier-Billson syndrome (J Child Neurol. 1988 Jul;3(3):177-80) is the name used for this condition, to honor the discoverer.

Whilst developmental delay is usually associated with altered physical characterists (dysmorphic features), this may occur on its own.[4]

A 2005 study found rates of autism among children exposed to sodium valproate before birth in the cohort studied were 8.9%.[5] The normal incidence for autism in the general population is estimated at less than one percent.[6] It has been suggested that Valproate may best be avoided in women with localisation epilepsy, where there are more effective and less risky alternatives such as carbamazepine.[4]

A class action is currently underway in the United Kingdom regarding the claim that the drug used in pregnancy caused a range of problems in children, including autism, learning and social difficulties, ADHD, spinal stenosis, facial abnormalities, vision defects, dyslexia, dyspraxia, delayed speech and motor development.[7][unreliable source?]


A 2008 study [8] also suggested a correlation between higher rates of autism in children whose mothers were treated for seizure disorders during pregnancy using sodium valproate (less than 1% for children who didn't receive the drug in vitro vs. 6.3% for children who did). However, only 632 children were followed in this study, prompting criticism that this study was too small to rely on to say whether there was a definitive correlation between the use of sodium valproate in pregnant mothers and higher autism rates in their children, or whether other anti-seizure medications used during pregnancy don't cause this effect.

See alsoEdit

ReferencesEdit

  1. Koch S, Göpfert-Geyer I, Jäger-Roman E, et al (February 1983). [Anti-epileptic agents during pregnancy. A prospective study on the course of pregnancy, malformations and child development]. Dtsch. Med. Wochenschr. 108 (7): 250–7.
  2. Moore SJ, Turnpenny P, Quinn A, et al (July 2000). A clinical study of 57 children with fetal anticonvulsant syndromes. J. Med. Genet. 37 (7): 489–97.
  3. DiLiberti JH, Farndon PA, Dennis NR, Curry CJ (November 1984). The fetal valproate syndrome. Am. J. Med. Genet. 19 (3): 473–81.
  4. 4.0 4.1 Adab N, Kini U, Vinten J, et al (November 2004). The longer term outcome of children born to mothers with epilepsy. J. Neurol. Neurosurg. Psychiatr. 75 (11): 1575–83.
  5. Rasalam AD, Hailey H, Williams JH, et al (August 2005). Characteristics of fetal anticonvulsant syndrome associated autistic disorder. Dev Med Child Neurol 47 (8): 551–5.
  6. Autism Society of America: About Autism
  7. Families Sue Europe’s Largest Drug Company Over Anti-Convulsant Drug as Deadline Is Given By High Court
  8. R. L. Bromley, G. Mawer, J. Clayton-Smith, G. A. Baker, et al (December 2008). Autism spectrum disorders following in utero exposure to antiepileptic drugs. Neurology 71 (23): 1923-4.

External linksEdit


Anticonvulsants edit





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