Valproate semisodium
Encyclopedia
Valproate semisodium or divalproex sodium (USAN
) consists of a compound of sodium valproate
and valproic acid
in a 1:1 molar relationship in an enteric coated
form. It is used in the United Kingdom, Canada, and United States for the treatment of the manic
episodes of bipolar disorder
. In rare cases, it is also used as a treatment for major depressive disorder, and increasingly taken long-term for prevention of both manic and depressive phases of bipolar disorder, especially the rapid-cycling variant. It is also used in the US for the treatment of epilepsy
, certain side effects of autism
, chronic pain
associated with neuropathy, and migraine headaches. Its chemical name is sodium hydrogen bis(2-propylpentanoate). The extended release formulation allows for a single daily dose.
In the UK semisodium valproate has been sold for a few years as the proprietary drug Depakote and marketed for psychiatric conditions only. It is about five times the price of sodium valproate, which has been marketed for around 30 years as Epilim by the same company for epilepsy
and is also available from other manufacturers as a generic product.
). Risk of birth defects such as spina bifida
has been demonstrated among populations of female patients who took the medicine in childbearing age.
Otherwise, people who take this drug can experience a variety of side effects
, some of which may require immediate medical attention.
Mild side effects include:
Especially dangerous side effects include:
The above side effects suggest a possibility of liver
damage.
People taking this drug should also call their doctor if they experience other serious side effects.
Some serious side effects include:
Some people also experience:
1% to 10% of people report:
Additional brand names for this medication include Depacon, Depakene and Zalkote In the United States, generic versions of Depakote became available on July 29, 2008.
United States Adopted Name
United States Adopted Names are unique nonproprietary names assigned to pharmaceuticals marketed in the United States. Each name is assigned by the USAN Council, which is co-sponsored by the American Medical Association , the United States Pharmacopeial Convention , and the American Pharmacists...
) consists of a compound of sodium valproate
Sodium valproate
Sodium valproate or valproate sodium is the sodium salt of valproic acid and is an anticonvulsant used in the treatment of epilepsy, anorexia nervosa, panic attack, anxiety disorder, posttraumatic stress disorder, migraine and bipolar disorder, as well as other psychiatric conditions requiring...
and valproic acid
Valproic acid
Valproic acid is a chemical compound that has found clinical use as an anticonvulsant and mood-stabilizing drug, primarily in the treatment of epilepsy, bipolar disorder, and, less commonly, major depression. It is also used to treat migraine headaches and schizophrenia...
in a 1:1 molar relationship in an enteric coated
Enteric coating
An enteric coating is a barrier applied to oral medication that controls the location in the digestive system, where it is absorbed. Enteric refers to the small intestine, therefore enteric coatings prevent release of medication before it reaches the small intestine.Most enteric coatings work by...
form. It is used in the United Kingdom, Canada, and United States for the treatment of the manic
Mania
Mania, the presence of which is a criterion for certain psychiatric diagnoses, is a state of abnormally elevated or irritable mood, arousal, and/ or energy levels. In a sense, it is the opposite of depression...
episodes of bipolar disorder
Bipolar disorder
Bipolar disorder or bipolar affective disorder, historically known as manic–depressive disorder, is a psychiatric diagnosis that describes a category of mood disorders defined by the presence of one or more episodes of abnormally elevated energy levels, cognition, and mood with or without one or...
. In rare cases, it is also used as a treatment for major depressive disorder, and increasingly taken long-term for prevention of both manic and depressive phases of bipolar disorder, especially the rapid-cycling variant. It is also used in the US for the treatment of epilepsy
Epilepsy
Epilepsy is a common chronic neurological disorder characterized by seizures. These seizures are transient signs and/or symptoms of abnormal, excessive or hypersynchronous neuronal activity in the brain.About 50 million people worldwide have epilepsy, and nearly two out of every three new cases...
, certain side effects of autism
Autism
Autism is a disorder of neural development characterized by impaired social interaction and communication, and by restricted and repetitive behavior. These signs all begin before a child is three years old. Autism affects information processing in the brain by altering how nerve cells and their...
, chronic pain
Chronic pain
Chronic pain has several different meanings in medicine. Traditionally, the distinction between acute and chronic pain has relied upon an arbitrary interval of time from onset; the two most commonly used markers being 3 months and 6 months since the initiation of pain, though some theorists and...
associated with neuropathy, and migraine headaches. Its chemical name is sodium hydrogen bis(2-propylpentanoate). The extended release formulation allows for a single daily dose.
In the UK semisodium valproate has been sold for a few years as the proprietary drug Depakote and marketed for psychiatric conditions only. It is about five times the price of sodium valproate, which has been marketed for around 30 years as Epilim by the same company for epilepsy
Epilepsy
Epilepsy is a common chronic neurological disorder characterized by seizures. These seizures are transient signs and/or symptoms of abnormal, excessive or hypersynchronous neuronal activity in the brain.About 50 million people worldwide have epilepsy, and nearly two out of every three new cases...
and is also available from other manufacturers as a generic product.
Side effects
The most severe side effect is a ten times higher-than-average incidence rate of serious, irreversible birth defects (teratogenic) such as births of brainless babies (anencephalyAnencephaly
Anencephaly is a cephalic disorder that results from a neural tube defect that occurs when the cephalic end of the neural tube fails to close, usually between the 23rd and 26th day of pregnancy, resulting in the absence of a major portion of the brain, skull, and scalp...
). Risk of birth defects such as spina bifida
Spina bifida
Spina bifida is a developmental congenital disorder caused by the incomplete closing of the embryonic neural tube. Some vertebrae overlying the spinal cord are not fully formed and remain unfused and open. If the opening is large enough, this allows a portion of the spinal cord to protrude through...
has been demonstrated among populations of female patients who took the medicine in childbearing age.
Otherwise, people who take this drug can experience a variety of side effects
Adverse drug reaction
An adverse drug reaction is an expression that describes harm associated with the use of given medications at a normal dosage. ADRs may occur following a single dose or prolonged administration of a drug or result from the combination of two or more drugs...
, some of which may require immediate medical attention.
Mild side effects include:
- dizziness
- decreased coordination
- misbalance
Especially dangerous side effects include:
- vomiting
- loss of appetite
- fever
- dark urine
- jaundiceJaundiceJaundice is a yellowish pigmentation of the skin, the conjunctival membranes over the sclerae , and other mucous membranes caused by hyperbilirubinemia . This hyperbilirubinemia subsequently causes increased levels of bilirubin in the extracellular fluid...
The above side effects suggest a possibility of liver
Liver
The liver is a vital organ present in vertebrates and some other animals. It has a wide range of functions, including detoxification, protein synthesis, and production of biochemicals necessary for digestion...
damage.
People taking this drug should also call their doctor if they experience other serious side effects.
Some serious side effects include:
- unusual bleeding (especially in the urine)
- hallucinations
- drowsiness
Some people also experience:
- constipation
- diarrhea
1% to 10% of people report:
- weight gain
- increased appetite
- abnormal dreams
Branded formulations
- BrazilBrazilBrazil , officially the Federative Republic of Brazil , is the largest country in South America. It is the world's fifth largest country, both by geographical area and by population with over 192 million people...
– Depakote by Abbott LaboratoriesAbbott LaboratoriesAbbott Laboratories is an American-based global, diversified pharmaceuticals and health care products company. It has 90,000 employees and operates in over 130 countries. The company headquarters are in Abbott Park, North Chicago, Illinois. The company was founded by Chicago physician, Dr.... - CanadaCanadaCanada is a North American country consisting of ten provinces and three territories. Located in the northern part of the continent, it extends from the Atlantic Ocean in the east to the Pacific Ocean in the west, and northward into the Arctic Ocean...
– Epival by Abbott LaboratoriesAbbott LaboratoriesAbbott Laboratories is an American-based global, diversified pharmaceuticals and health care products company. It has 90,000 employees and operates in over 130 countries. The company headquarters are in Abbott Park, North Chicago, Illinois. The company was founded by Chicago physician, Dr....
. - MexicoMexicoThe United Mexican States , commonly known as Mexico , is a federal constitutional republic in North America. It is bordered on the north by the United States; on the south and west by the Pacific Ocean; on the southeast by Guatemala, Belize, and the Caribbean Sea; and on the east by the Gulf of...
– Epival and Epival ER (Extended Release) by Abbott LaboratoriesAbbott LaboratoriesAbbott Laboratories is an American-based global, diversified pharmaceuticals and health care products company. It has 90,000 employees and operates in over 130 countries. The company headquarters are in Abbott Park, North Chicago, Illinois. The company was founded by Chicago physician, Dr....
. - United KingdomUnited KingdomThe United Kingdom of Great Britain and Northern IrelandIn the United Kingdom and Dependencies, other languages have been officially recognised as legitimate autochthonous languages under the European Charter for Regional or Minority Languages...
– Depakote by Sanofi-AventisSanofi-AventisSanofi S.A. is a multinational pharmaceutical company headquartered in Paris, France, the world's fourth-largest by prescription sales. Sanofi engages in the research and development, manufacturing and marketing of pharmaceutical products for sale principally in the prescription market, but the... - United StatesUnited StatesThe United States of America is a federal constitutional republic comprising fifty states and a federal district...
– Depakote and Depakote ER (Extended Release) by Abbott LaboratoriesAbbott LaboratoriesAbbott Laboratories is an American-based global, diversified pharmaceuticals and health care products company. It has 90,000 employees and operates in over 130 countries. The company headquarters are in Abbott Park, North Chicago, Illinois. The company was founded by Chicago physician, Dr....
and generics - IndiaIndiaIndia , officially the Republic of India , is a country in South Asia. It is the seventh-largest country by geographical area, the second-most populous country with over 1.2 billion people, and the most populous democracy in the world...
– Valance and Valance OD by Abbott Healthcare Pvt Ltd - GermanyGermanyGermany , officially the Federal Republic of Germany , is a federal parliamentary republic in Europe. The country consists of 16 states while the capital and largest city is Berlin. Germany covers an area of 357,021 km2 and has a largely temperate seasonal climate...
– Ergenyl Chrono by Sanofi-Aventis and generics - ChileChileChile ,officially the Republic of Chile , is a country in South America occupying a long, narrow coastal strip between the Andes mountains to the east and the Pacific Ocean to the west. It borders Peru to the north, Bolivia to the northeast, Argentina to the east, and the Drake Passage in the far...
– Valcote and Valcote ER by Abbott LaboratoriesAbbott LaboratoriesAbbott Laboratories is an American-based global, diversified pharmaceuticals and health care products company. It has 90,000 employees and operates in over 130 countries. The company headquarters are in Abbott Park, North Chicago, Illinois. The company was founded by Chicago physician, Dr.... - FranceFranceThe French Republic , The French Republic , The French Republic , (commonly known as France , is a unitary semi-presidential republic in Western Europe with several overseas territories and islands located on other continents and in the Indian, Pacific, and Atlantic oceans. Metropolitan France...
and other European countries — Dépakine Chrono and generics
Additional brand names for this medication include Depacon, Depakene and Zalkote In the United States, generic versions of Depakote became available on July 29, 2008.