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Divalproex Sodium
Overview
What is Depakote?
Divalproex sodium is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship and formed during the partial neutralization of valproic acid with 0.5 equivalent of sodium hydroxide. Chemically it is designated as sodium hydrogen bis(2-propylpentanoate). Divalproex sodium has the following structure:
Divalproex sodium occurs as a white powder with a characteristic odor.
Depakote tablets are for oral administration. Depakote tablets are supplied in three dosage strengths containing divalproex sodium equivalent to 125 mg, 250 mg, or 500 mg of valproic acid.
Inactive Ingredients
Depakote tablets: cellulosic polymers, diacetylated monoglycerides, povidone, pregelatinized starch (contains corn starch), silica gel, talc, titanium dioxide, and vanillin.
In addition, individual tablets contain:
125 mg tablets: FD&C Blue No. 1 and FD&C Red No. 40.
250 mg tablets: FD&C Yellow No. 6 and iron oxide.
500 mg tablets: D&C Red No. 30, FD&C Blue No. 2, and iron oxide.
What does Depakote look like?
What are the available doses of Depakote?
Tablets: 125 mg, 250 mg and 500 mg
What should I talk to my health care provider before I take Depakote?
How should I use Depakote?
Depakote (divalproex sodium) is a valproate and is indicated for the treatment of the manic episodes associated with bipolar disorder. A manic episode is a distinct period of abnormally and persistently elevated, expansive, or irritable mood. Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, poor judgment, aggressiveness, and possible hostility.
The efficacy of Depakote was established in 3-week trials with patients meeting DSM-III-R criteria for bipolar disorder who were hospitalized for acute mania
.
The safety and effectiveness of Depakote for long-term use in mania, i.e., more than 3 weeks, has not been demonstrated in controlled clinical trials. Therefore, healthcare providers who elect to use Depakote for extended periods should continually reevaluate the long-term usefulness of the drug for the individual patient.
Depakote tablets are intended for oral administration. Depakote tablets should be swallowed whole and should not be crushed or chewed.
Patients should be informed to take Depakote every day as prescribed. If a dose is missed it should be taken as soon as possible, unless it is almost time for the next dose. If a dose is skipped, the patient should not double the next dose.
What interacts with Depakote?
Sorry No Records found
What are the warnings of Depakote?
Sorry No Records found
What are the precautions of Depakote?
Sorry No Records found
What are the side effects of Depakote?
Sorry No records found
What should I look out for while using Depakote?
Hepatic disease or significant hepatic dysfunction
,
Known mitochondrial disorders caused by mutations in mitochondrial DNA polymerase γ (POLG)
,
Suspected POLG-related disorder in children under two years of age
,
Known hypersensitivity to the drug
,
Urea cycle disorders
,
Pregnant patients treated for prophylaxis of migraine headaches
Hepatotoxicity
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. The incidence of fatal hepatotoxicity decreases considerably in progressively older patient groups.
Fetal Risk
Valproate can cause major congenital malformations, particularly neural tube defects (e.g., spina bifida). In addition, valproate can cause decreased IQ scores following
exposure.
Valproate is therefore contraindicated in pregnant women treated for prophylaxis of migraine
Valproate should only be used to treat pregnant women with epilepsy or bipolar disorder if other medications have failed to control their symptoms or are otherwise unacceptable.
Valproate should not be administered to a woman of childbearing potential unless the drug is essential to the management of her medical condition. This is especially important when valproate use is considered for a condition not usually associated with permanent injury or death (e.g., migraine). Women should use effective contraception while using valproate
.
A Medication Guide describing the risks 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
.
What might happen if I take too much Depakote?
Overdosage with valproate may result in somnolence, heart block, deep coma, and hypernatremia. Fatalities have been reported; however patients have recovered from valproate levels as high as 2,120 mcg/mL.
In overdose situations, the fraction of drug not bound to protein is high and hemodialysis or tandem hemodialysis plus hemoperfusion may result in significant removal of drug. The benefit of gastric lavage or emesis will vary with the time since ingestion. General supportive measures should be applied with particular attention to the maintenance of adequate urinary output.
Naloxone has been reported to reverse the CNS depressant effects of valproate overdosage. Because naloxone could theoretically also reverse the antiepileptic effects of valproate, it should be used with caution in patients with epilepsy.
How should I store and handle Depakote?
Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing.Depakote tablets (divalproex sodium delayed-release tablets) are supplied as:125 mg salmon pink-colored tablets:Bottles of 100………………………………………..(NDC 0074-6212-13)Unit Dose Packages of 100.................………………(NDC 0074-6212-11)250 mg peach-colored tablets:Bottles of 100……………………………………….(NDC 0074-6214-13)Bottles of 500……………………………………….(NDC 0074-6214-53)Unit Dose Packages of 100................………………(NDC 0074-6214-11)500 mg lavender-colored tablets:Bottles of 100……………………………………….(NDC 0074-6215-13)Bottles of 500……………………………………….(NDC 0074-6215-53)Unit Dose Packages of 100................……………...(NDC 0074-6215-11)Recommended Storage: Store tablets below 86°F (30°C).Depakote tablets (divalproex sodium delayed-release tablets) are supplied as:125 mg salmon pink-colored tablets:Bottles of 100………………………………………..(NDC 0074-6212-13)Unit Dose Packages of 100.................………………(NDC 0074-6212-11)250 mg peach-colored tablets:Bottles of 100……………………………………….(NDC 0074-6214-13)Bottles of 500……………………………………….(NDC 0074-6214-53)Unit Dose Packages of 100................………………(NDC 0074-6214-11)500 mg lavender-colored tablets:Bottles of 100……………………………………….(NDC 0074-6215-13)Bottles of 500……………………………………….(NDC 0074-6215-53)Unit Dose Packages of 100................……………...(NDC 0074-6215-11)Recommended Storage: Store tablets below 86°F (30°C).Depakote tablets (divalproex sodium delayed-release tablets) are supplied as:125 mg salmon pink-colored tablets:Bottles of 100………………………………………..(NDC 0074-6212-13)Unit Dose Packages of 100.................………………(NDC 0074-6212-11)250 mg peach-colored tablets:Bottles of 100……………………………………….(NDC 0074-6214-13)Bottles of 500……………………………………….(NDC 0074-6214-53)Unit Dose Packages of 100................………………(NDC 0074-6214-11)500 mg lavender-colored tablets:Bottles of 100……………………………………….(NDC 0074-6215-13)Bottles of 500……………………………………….(NDC 0074-6215-53)Unit Dose Packages of 100................……………...(NDC 0074-6215-11)Recommended Storage: Store tablets below 86°F (30°C).Depakote tablets (divalproex sodium delayed-release tablets) are supplied as:125 mg salmon pink-colored tablets:Bottles of 100………………………………………..(NDC 0074-6212-13)Unit Dose Packages of 100.................………………(NDC 0074-6212-11)250 mg peach-colored tablets:Bottles of 100……………………………………….(NDC 0074-6214-13)Bottles of 500……………………………………….(NDC 0074-6214-53)Unit Dose Packages of 100................………………(NDC 0074-6214-11)500 mg lavender-colored tablets:Bottles of 100……………………………………….(NDC 0074-6215-13)Bottles of 500……………………………………….(NDC 0074-6215-53)Unit Dose Packages of 100................……………...(NDC 0074-6215-11)Recommended Storage: Store tablets below 86°F (30°C).Depakote tablets (divalproex sodium delayed-release tablets) are supplied as:125 mg salmon pink-colored tablets:Bottles of 100………………………………………..(NDC 0074-6212-13)Unit Dose Packages of 100.................………………(NDC 0074-6212-11)250 mg peach-colored tablets:Bottles of 100……………………………………….(NDC 0074-6214-13)Bottles of 500……………………………………….(NDC 0074-6214-53)Unit Dose Packages of 100................………………(NDC 0074-6214-11)500 mg lavender-colored tablets:Bottles of 100……………………………………….(NDC 0074-6215-13)Bottles of 500……………………………………….(NDC 0074-6215-53)Unit Dose Packages of 100................……………...(NDC 0074-6215-11)Recommended Storage: Store tablets below 86°F (30°C).Depakote tablets (divalproex sodium delayed-release tablets) are supplied as:125 mg salmon pink-colored tablets:Bottles of 100………………………………………..(NDC 0074-6212-13)Unit Dose Packages of 100.................………………(NDC 0074-6212-11)250 mg peach-colored tablets:Bottles of 100……………………………………….(NDC 0074-6214-13)Bottles of 500……………………………………….(NDC 0074-6214-53)Unit Dose Packages of 100................………………(NDC 0074-6214-11)500 mg lavender-colored tablets:Bottles of 100……………………………………….(NDC 0074-6215-13)Bottles of 500……………………………………….(NDC 0074-6215-53)Unit Dose Packages of 100................……………...(NDC 0074-6215-11)Recommended Storage: Store tablets below 86°F (30°C).Depakote tablets (divalproex sodium delayed-release tablets) are supplied as:125 mg salmon pink-colored tablets:Bottles of 100………………………………………..(NDC 0074-6212-13)Unit Dose Packages of 100.................………………(NDC 0074-6212-11)250 mg peach-colored tablets:Bottles of 100……………………………………….(NDC 0074-6214-13)Bottles of 500……………………………………….(NDC 0074-6214-53)Unit Dose Packages of 100................………………(NDC 0074-6214-11)500 mg lavender-colored tablets:Bottles of 100……………………………………….(NDC 0074-6215-13)Bottles of 500……………………………………….(NDC 0074-6215-53)Unit Dose Packages of 100................……………...(NDC 0074-6215-11)Recommended Storage: Store tablets below 86°F (30°C).Depakote tablets (divalproex sodium delayed-release tablets) are supplied as:125 mg salmon pink-colored tablets:Bottles of 100………………………………………..(NDC 0074-6212-13)Unit Dose Packages of 100.................………………(NDC 0074-6212-11)250 mg peach-colored tablets:Bottles of 100……………………………………….(NDC 0074-6214-13)Bottles of 500……………………………………….(NDC 0074-6214-53)Unit Dose Packages of 100................………………(NDC 0074-6214-11)500 mg lavender-colored tablets:Bottles of 100……………………………………….(NDC 0074-6215-13)Bottles of 500……………………………………….(NDC 0074-6215-53)Unit Dose Packages of 100................……………...(NDC 0074-6215-11)Recommended Storage: Store tablets below 86°F (30°C).Depakote tablets (divalproex sodium delayed-release tablets) are supplied as:125 mg salmon pink-colored tablets:Bottles of 100………………………………………..(NDC 0074-6212-13)Unit Dose Packages of 100.................………………(NDC 0074-6212-11)250 mg peach-colored tablets:Bottles of 100……………………………………….(NDC 0074-6214-13)Bottles of 500……………………………………….(NDC 0074-6214-53)Unit Dose Packages of 100................………………(NDC 0074-6214-11)500 mg lavender-colored tablets:Bottles of 100……………………………………….(NDC 0074-6215-13)Bottles of 500……………………………………….(NDC 0074-6215-53)Unit Dose Packages of 100................……………...(NDC 0074-6215-11)Recommended Storage: Store tablets below 86°F (30°C).Depakote tablets (divalproex sodium delayed-release tablets) are supplied as:125 mg salmon pink-colored tablets:Bottles of 100………………………………………..(NDC 0074-6212-13)Unit Dose Packages of 100.................………………(NDC 0074-6212-11)250 mg peach-colored tablets:Bottles of 100……………………………………….(NDC 0074-6214-13)Bottles of 500……………………………………….(NDC 0074-6214-53)Unit Dose Packages of 100................………………(NDC 0074-6214-11)500 mg lavender-colored tablets:Bottles of 100……………………………………….(NDC 0074-6215-13)Bottles of 500……………………………………….(NDC 0074-6215-53)Unit Dose Packages of 100................……………...(NDC 0074-6215-11)Recommended Storage: Store tablets below 86°F (30°C).Depakote tablets (divalproex sodium delayed-release tablets) are supplied as:125 mg salmon pink-colored tablets:Bottles of 100………………………………………..(NDC 0074-6212-13)Unit Dose Packages of 100.................………………(NDC 0074-6212-11)250 mg peach-colored tablets:Bottles of 100……………………………………….(NDC 0074-6214-13)Bottles of 500……………………………………….(NDC 0074-6214-53)Unit Dose Packages of 100................………………(NDC 0074-6214-11)500 mg lavender-colored tablets:Bottles of 100……………………………………….(NDC 0074-6215-13)Bottles of 500……………………………………….(NDC 0074-6215-53)Unit Dose Packages of 100................……………...(NDC 0074-6215-11)Recommended Storage: Store tablets below 86°F (30°C).Depakote tablets (divalproex sodium delayed-release tablets) are supplied as:125 mg salmon pink-colored tablets:Bottles of 100………………………………………..(NDC 0074-6212-13)Unit Dose Packages of 100.................………………(NDC 0074-6212-11)250 mg peach-colored tablets:Bottles of 100……………………………………….(NDC 0074-6214-13)Bottles of 500……………………………………….(NDC 0074-6214-53)Unit Dose Packages of 100................………………(NDC 0074-6214-11)500 mg lavender-colored tablets:Bottles of 100……………………………………….(NDC 0074-6215-13)Bottles of 500……………………………………….(NDC 0074-6215-53)Unit Dose Packages of 100................……………...(NDC 0074-6215-11)Recommended Storage: Store tablets below 86°F (30°C).Depakote tablets (divalproex sodium delayed-release tablets) are supplied as:125 mg salmon pink-colored tablets:Bottles of 100………………………………………..(NDC 0074-6212-13)Unit Dose Packages of 100.................………………(NDC 0074-6212-11)250 mg peach-colored tablets:Bottles of 100……………………………………….(NDC 0074-6214-13)Bottles of 500……………………………………….(NDC 0074-6214-53)Unit Dose Packages of 100................………………(NDC 0074-6214-11)500 mg lavender-colored tablets:Bottles of 100……………………………………….(NDC 0074-6215-13)Bottles of 500……………………………………….(NDC 0074-6215-53)Unit Dose Packages of 100................……………...(NDC 0074-6215-11)Recommended Storage: Store tablets below 86°F (30°C).
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Divalproex sodium dissociates to the valproate ion in the gastrointestinal tract. The mechanisms by which valproate exerts its therapeutic effects have not been established. It has been suggested that its activity in epilepsy is related to increased brain concentrations of gamma-aminobutyric acid (GABA).
Non-Clinical Toxicology
Hepatic disease or significant hepatic dysfunction ,Known mitochondrial disorders caused by mutations in mitochondrial DNA polymerase γ (POLG) ,
Suspected POLG-related disorder in children under two years of age ,
Known hypersensitivity to the drug ,
Urea cycle disorders ,
Pregnant patients treated for prophylaxis of migraine headaches
Hepatotoxicity
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. The incidence of fatal hepatotoxicity decreases considerably in progressively older patient groups.
Fetal Risk
Valproate can cause major congenital malformations, particularly neural tube defects (e.g., spina bifida). In addition, valproate can cause decreased IQ scores following exposure.
Valproate is therefore contraindicated in pregnant women treated for prophylaxis of migraine Valproate should only be used to treat pregnant women with epilepsy or bipolar disorder if other medications have failed to control their symptoms or are otherwise unacceptable.
Valproate should not be administered to a woman of childbearing potential unless the drug is essential to the management of her medical condition. This is especially important when valproate use is considered for a condition not usually associated with permanent injury or death (e.g., migraine). Women should use effective contraception while using valproate .
A Medication Guide describing the risks 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 .
No specific drug interactions have been demonstrated.
General Information on Hepatotoxicity
Hepatic failure resulting in fatalities has occurred in patients receiving valproate. 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. Serum liver tests should be performed prior to therapy and at frequent intervals thereafter, especially during the first six months of valproate therapy. However, healthcare providers should not rely totally on serum biochemistry since these tests may not be abnormal in all instances, but should also consider the results of careful interim medical history and physical examination.
Caution should be observed when administering valproate products to patients with a prior history of hepatic disease. Patients on multiple anticonvulsants, children, those with congenital metabolic disorders, those with severe seizure disorders accompanied by mental retardation, and those with organic brain disease may be at particular risk. See below, “Patients with Known or Suspected Mitochondrial Disease.”
Experience has indicated that children under the age of two years are at a considerably increased risk of developing fatal hepatotoxicity, especially those with the aforementioned conditions. 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. In progressively older patient groups experience in epilepsy has indicated that the incidence of fatal hepatotoxicity decreases considerably.
Patients with Known or Suspected Mitochondrial Disease
Depakote is contraindicated in patients known to have mitochondrial disorders caused by POLG mutations and children under two years of age who are clinically suspected of having a mitochondrial disorder . Valproate-induced acute liver failure and liver-related deaths have been reported in patients with hereditary neurometabolic syndromes caused by mutations in the gene for mitochondrial DNA polymerase γ (POLG) (e.g., Alpers-Huttenlocher Syndrome) at a higher rate than those without these syndromes. Most of the reported cases of liver failure in patients with these syndromes have been identified in children and adolescents.
POLG-related disorders should be suspected in patients with a family history or suggestive symptoms of a POLG-related disorder, including but not limited to unexplained encephalopathy, refractory epilepsy (focal, myoclonic), status epilepticus at presentation, developmental delays, psychomotor regression, axonal sensorimotor neuropathy, myopathy cerebellar ataxia, ophthalmoplegia, or complicated migraine with occipital aura. POLG mutation testing should be performed in accordance with current clinical practice for the diagnostic evaluation of such disorders. The A467T and W748S mutations are present in approximately 2/3 of patients with autosomal recessive POLG-related disorders.
In patients over two years of age who are clinically suspected of having a hereditary mitochondrial disease, Depakote should only be used after other anticonvulsants have failed. This older group of patients should be closely monitored during treatment with Depakote for the development of acute liver injury with regular clinical assessments and serum liver test monitoring.
The drug should be discontinued immediately in the presence of significant hepatic dysfunction, suspected or apparent. In some cases, hepatic dysfunction has progressed in spite of discontinuation of drug .
The following serious adverse reactions are described below and elsewhere in the labeling:
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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