Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Anusha Vege, M.B.B.S. [2]
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Black Box Warning
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WARNING: LIFE THREATENING ADVERSE REACTIONS
See full prescribing information for complete Boxed Warning.
Hepatotoxicity
- General Population: Hepatic failure resulting in fatalities has occurred in patients receiving valproate and its derivatives. 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.
- 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 Depacon 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.
- Patients with Mitochondrial Disease: There is an increased risk of valproate-induced acute liver failure and resultant deaths in patients with hereditary neurometabolic syndromes caused by DNA mutations of the mitochondrial DNA Polymerase γ (POLG) gene (e.g. Alpers Huttenlocher Syndrome). Depacon 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 [see Contraindications (4)]. In patients over two years of age who are clinically suspected of having a hereditary mitochondrial disease, Depacon should only be used after other anticonvulsants have failed. This older group of patients should be closely monitored during treatment with Depacon for the development of acute liver injury with regular clinical assessments and serum liver testing. POLG mutation screening should be performed in accordance with current clinical practice.
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 in utero exposure.
- Valproate should only be used to treat pregnant women with epilepsy 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.
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.
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Overview
Valproate sodium is an anticonvulsant that is FDA approved for the treatment of epilepsy. There is a Black Box Warning for this drug as shown here. Common adverse reactions include {{{adverseReactions}}}.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
There is limited information regarding Valproate sodium FDA-Labeled Indications and Dosage (Adult) in the drug label.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Valproate sodium in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Valproate sodium in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Valproate sodium FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Valproate sodium in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Valproate sodium in pediatric patients.
Contraindications
There is limited information regarding Valproate sodium Contraindications in the drug label.
Warnings
|
WARNING: LIFE THREATENING ADVERSE REACTIONS
See full prescribing information for complete Boxed Warning.
Hepatotoxicity
- General Population: Hepatic failure resulting in fatalities has occurred in patients receiving valproate and its derivatives. 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.
- 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 Depacon 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.
- Patients with Mitochondrial Disease: There is an increased risk of valproate-induced acute liver failure and resultant deaths in patients with hereditary neurometabolic syndromes caused by DNA mutations of the mitochondrial DNA Polymerase γ (POLG) gene (e.g. Alpers Huttenlocher Syndrome). Depacon 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 [see Contraindications (4)]. In patients over two years of age who are clinically suspected of having a hereditary mitochondrial disease, Depacon should only be used after other anticonvulsants have failed. This older group of patients should be closely monitored during treatment with Depacon for the development of acute liver injury with regular clinical assessments and serum liver testing. POLG mutation screening should be performed in accordance with current clinical practice.
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 in utero exposure.
- Valproate should only be used to treat pregnant women with epilepsy 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.
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.
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There is limited information regarding Valproate sodium Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Valproate sodium Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Valproate sodium Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Valproate sodium Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Valproate sodium in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Valproate sodium in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Valproate sodium during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Valproate sodium in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Valproate sodium in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Valproate sodium in geriatric settings.
Gender
There is no FDA guidance on the use of Valproate sodium with respect to specific gender populations.
Race
There is no FDA guidance on the use of Valproate sodium with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Valproate sodium in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Valproate sodium in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Valproate sodium in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Valproate sodium in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Valproate sodium Administration in the drug label.
Monitoring
There is limited information regarding Valproate sodium Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Valproate sodium and IV administrations.
Overdosage
There is limited information regarding Valproate sodium overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Valproate sodium Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Valproate sodium Mechanism of Action in the drug label.
Structure
There is limited information regarding Valproate sodium Structure in the drug label.
Pharmacodynamics
There is limited information regarding Valproate sodium Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Valproate sodium Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Valproate sodium Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Valproate sodium Clinical Studies in the drug label.
How Supplied
There is limited information regarding Valproate sodium How Supplied in the drug label.
Storage
There is limited information regarding Valproate sodium Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Valproate sodium Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Valproate sodium interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Valproate sodium Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Valproate sodium Look-Alike Drug Names in the drug label.
Price
References
The contents of this FDA label are provided by the National Library of Medicine.