Valproic acid
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Pratik Bahekar, MBBS [2]
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Black Box Warning
|
WARNING: LIFE THREATENING ADVERSE REACTIONS
See full prescribing information for complete Boxed Warning.
Condition Name:
Hepatotoxicity General Population: 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 [see Warnings and Precautions]. 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. 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). Depakene 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]. In patients over two years of age who are clinically suspected of having a hereditary mitochondrial disease, Depakene should only be used after other anticonvulsants have failed. This older group of patients should be closely monitored during treatment with Depakene 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 [see Warnings and Precautions]. 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 [see Warnings and Precautions]. A Medication Guide describing the risks of valproate is available for patients [see Patient Counseling Information ]. 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]. |
Overview
Valproic acid is a anticonvulsant drug that is FDA approved for the {{{indicationType}}} of absence seizure, Simple and complex, complex partial epileptic seizur, manic, bipolar I disorder, migraine; Prophylaxis. There is a Black Box Warning for this drug as shown here. Common adverse reactions include peripheral edema,alopecia, rash, increased appetite, weight increased, abdominal pain, constipation, diarrhea, indigestion, loss of appetite, nausea, vomiting, ecchymosis, sthenia, backache, amnesia, ataxia, dizziness, headache, insomnia, somnolence, tremor, amblyopia, blurred vision, diplopia, nystagmus, tinnitus, depression, disturbance in thinking, feeling nervous, mood swings, bronchitis, dyspnea, pharyngitis, respiratory tract infection, rhinitis, fever, influenza.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
- Absence seizure, simple and complex
- Initial 15 mg/kg/day PO in 2 to 3 divided doses if total daily dose exceeds 250 mg
- Maintenance increase dosage 5 to 10 mg/kg/day PO at 1-week intervals give in 2 to 3 divided doses if total daily dose exceeds 250 mg max 60 mg/kg/day or less with a therapeutic serum range of 50 to 100 mcg/mL
- Complex partial epileptic seizure
- Initial 10 to 15 mg/kg/day PO in 2 to 3 divided doses if total daily dose exceeds 250 mg, increase dosage 5 to 10 mg/kg/day at 1-week intervals to achieve optimal respons max 60 mg/kg/day or less with a therapeutic serum range of 50 to 100 mcg/mL
- Conversion to monotherapy, 10 to 15 mg/kg/day PO in 2 to 3 divided doses if total daily dose exceeds 250 mg, increase dosage 5 to 10 mg/kg/day at 1-week intervals to achieve optimal clinical response max 60 mg/kg/day or less with a therapeutic serum range of 50 to 100 mcg/mL
- Adjunct may be added to the regimen at an initial dosage of 10 to 15 mg/kg/day PO in 2 to 3 divided doses if total daily dose exceeds 250 mg, increase dosage 5 to 10 mg/kg/day at 1-week intervals to achieve optimal clinical response max 60 mg/kg/day or less.
- Manic bipolar I disorder
- Initial, delayed-release 750 mg PO daily, in divided doses; may increase dose to achieve desired clinical response max 60 mg/kg/day or less
- Migraine Prophylaxis
- Delayed-release 250 mg PO twice daily, max dose 1000 mg/day
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information about Off-Label Guideline-Supported Use of Valproic acid in adult patients.
Non–Guideline-Supported Use
- Alcohol hallucinosis
- Bipolar disorder
- Myelodysplastic syndrome
- Myoclonic seizure
There is limited information about Off-Label Non–Guideline-Supported Use of Valproic acid in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
- Risk of fatal hepatotoxicity in patients under the age of 2 years
- Absence seizure, Simple and complexfor 2.5 to 13 years
- 10 mg/kg/day for 2 weeks, 15 mg/kg/day for weeks 3 and 4, 20 mg/kg/day for weeks 5 and 6, 30 mg/kg/day for weeks 7 and 8, 40 mg/kg/day for weeks 9 and 10, 50 mg/kg/day for weeks 11 and 12, 60 mg/kg/day for weeks 13 through 16; max dose 60 mg/kg/day or 3000 mg/day, whichever lower, mean dose, 34.9 mg/kg/day
- For 10 years or older, initial, 15 mg/kg/day PO give in 2 to 3 divided doses if dose exceeds 250 mg, maintenance 5 to 10 mg/kg/day PO 1-week intervals until seizures are controlled or side effects preclude further increases in 2 to 3 divided doses if total daily dose exceeds 250 mg max 60 mg/kg/day or less with a therapeutic serum range of 50 to 100 mcg/mL
- Complex partial epileptic seizure 10 years or older
- Monotherapy, initial 10 to 15 mg/kg/day PO give in 2 to 3 divided doses if total daily dose exceeds 250 mg, may increase dosage 5 to 10 mg/kg/day at 1-week intervals to achieve optimal clinical response max 60 mg/kg/day or less
- conversion to monotherapy, 10 to 15 mg/kg/day ORALLY (give in 2 to 3 divided doses if total daily dose exceeds 250 mg), may increase dosage 5 to 10 mg/kg/day at 1-week intervals to achieve optimal clinical response max 60 mg/kg/day or less
- Adjunct, may be added to the regimen at an initial dosage of 10 to 15 mg/kg/day PO in 2 to 3 divided doses if total daily dose exceeds 250 mg, may increase dosage 5 to 10 mg/kg/day at 1-week intervals to achieve optimal clinical response max 60 mg/kg/day.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information about Off-Label Guideline-Supported Use of Valproic acid in pediatric patients.
Non–Guideline-Supported Use
There is limited information about Off-Label Non–Guideline-Supported Use of Valproic acid in pediatric patients.
Contraindications
There is limited information regarding Valproic acid Contraindications in the drug label.
Warnings
|
WARNING: LIFE THREATENING ADVERSE REACTIONS
See full prescribing information for complete Boxed Warning.
Condition Name:
Hepatotoxicity General Population: 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 [see Warnings and Precautions]. 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. 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). Depakene 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]. In patients over two years of age who are clinically suspected of having a hereditary mitochondrial disease, Depakene should only be used after other anticonvulsants have failed. This older group of patients should be closely monitored during treatment with Depakene 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 [see Warnings and Precautions]. 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 [see Warnings and Precautions]. A Medication Guide describing the risks of valproate is available for patients [see Patient Counseling Information ]. 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]. |
There is limited information regarding Valproic acid Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Valproic acid Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Valproic acid Postmarketing Experience in the drug label.
Drug Interactions
Effects of Co-Administered Drugs on Valproate Clearance
- Drugs that affect the level of expression of hepatic enzymes, particularly those that elevate levels of glucuronosyltransferases, may increase the clearance of valproate. For example, phenytoin, carbamazepine, and phenobarbital (or primidone) can double the clearance of valproate. Thus, patients on monotherapy will generally have longer half-lives and higher concentrations than patients receiving polytherapy with antiepilepsy drugs.
- In contrast, drugs that are inhibitors of cytochrome P450 isozymes, e.g., antidepressants, may be expected to have little effect on valproate clearance because cytochrome P450 microsomal mediated oxidation is a relatively minor secondary metabolic pathway compared to glucuronidation and beta-oxidation.
- Because of these changes in valproate clearance, monitoring of valproate and concomitant drug concentrations should be increased whenever enzyme inducing drugs are introduced or withdrawn.
- The following list provides information about the potential for an influence of several commonly prescribed medications on valproate pharmacokinetics. The list is not exhaustive nor could it be, since new interactions are continuously being reported.
- (Drugs for which a potentially important interaction has been observed.)
- Aspirin
- A study involving the co-administration of aspirin at antipyretic doses (11 to 16 mg/kg) with valproate to pediatric patients (n = 6) revealed a decrease in protein binding and an inhibition of metabolism of valproate. Valproate free fraction was increased 4-fold in the presence of aspirin compared to valproate alone. The β-oxidation pathway consisting of 2-E-valproic acid, 3-OH-valproic acid, and 3-keto valproic acid was decreased from 25% of total metabolites excreted on valproate alone to 8.3% in the presence of aspirin. Caution should be observed if valproate and aspirin are to be co-administered.
- Carbapenem Antibiotics
- A clinically significant reduction in serum valproic acid concentration has been reported in patients receiving carbapenem antibiotics (for example, ertapenem, imipenem, meropenem; this is not a complete list) and may result in loss of seizure control. The mechanism of this interaction is not well understood. Serum valproic acid concentrations should be monitored frequently after initiating carbapenem therapy. Alternative antibacterial or anticonvulsant therapy should be considered if serum valproic acid concentrations drop significantly or seizure control deteriorates.
- Felbamate
- A study involving the co-administration of 1200 mg/day of felbamate with valproate to patients with epilepsy (n = 10) revealed an increase in mean valproate peak concentration by 35% (from 86 to 115 mcg/mL) compared to valproate alone. Increasing the felbamate dose to 2400 mg/day increased the mean valproate peak concentration to 133 mcg/mL (another 16% increase). A decrease in valproate dosage may be necessary when felbamate therapy is initiated.
- Rifampin
- A study involving the administration of a single dose of valproate (7 mg/kg) 36 hours after 5 nights of daily dosing with rifampin (600 mg) revealed a 40% increase in the oral clearance of valproate. Valproate dosage adjustment may be necessary when it is co-administered with rifampin.
- (Drugs for which either no interaction or a likely clinically unimportant interaction has been observed.)
- Antacids
- A study involving the co-administration of valproate 500 mg with commonly administered antacids (Maalox, Trisogel, and Titralac - 160 mEq doses) did not reveal any effect on the extent of absorption of valproate.
- Chlorpromazine
- A study involving the administration of 100 to 300 mg/day of chlorpromazine to schizophrenic patients already receiving valproate (200 mg BID) revealed a 15% increase in trough plasma levels of valproate.
- Haloperidol
- A study involving the administration of 6 to 10 mg/day of haloperidol to schizophrenic patients already receiving valproate (200 mg BID) revealed no significant changes in valproate trough plasma levels.
- Cimetidine and Ranitidine
- Cimetidine and ranitidine do not affect the clearance of valproate.
Effects of Valproate on Other Drugs
- Valproate has been found to be a weak inhibitor of some P450 isozymes, epoxide hydrase, and glucuronyltransferases.
- The following list provides information about the potential for an influence of valproate co-administration on the pharmacokinetics or pharmacodynamics of several commonly prescribed medications. The list is not exhaustive, since new interactions are continuously being reported.
- (Drugs for which a potentially important valproate interaction has been observed.)
- Amitriptyline/Nortriptyline
- Administration of a single oral 50 mg dose of amitriptyline to 15 normal volunteers (10 males and 5 females) who received valproate (500 mg BID) resulted in a 21% decrease in plasma clearance of amitriptyline and a 34% decrease in the net clearance of nortriptyline. Rare postmarketing reports of concurrent use of valproate and amitriptyline resulting in an increased amitriptyline level have been received. Concurrent use of valproate and amitriptyline has rarely been associated with toxicity. Monitoring of amitriptyline levels should be considered for patients taking valproate concomitantly with amitriptyline. Consideration should be given to lowering the dose of amitriptyline/nortriptyline in the presence of valproate.
- Carbamazepine/carbamazepine-10,11-Epoxide
- Serum levels of carbamazepine (CBZ) decreased 17% while that of carbamazepine-10,11-epoxide (CBZ-E) increased by 45% upon co-administration of valproate and CBZ to epileptic patients.
- Clonazepam
- The concomitant use of valproate and clonazepam may induce absence status in patients with a history of absence type seizures.
- Diazepam
- Valproate displaces diazepam from its plasma albumin binding sites and inhibits its metabolism. Co-administration of valproate (1500 mg daily) increased the free fraction of diazepam (10 mg) by 90% in healthy volunteers (n = 6). Plasma clearance and volume of distribution for free diazepam were reduced by 25% and 20%, respectively, in the presence of valproate. The elimination half-life of diazepam remained unchanged upon addition of valproate.
- Ethosuximide
- Valproate inhibits the metabolism of ethosuximide. Administration of a single ethosuximide dose of 500 mg with valproate (800 to 1600 mg/day) to healthy volunteers (n = 6) was accompanied by a 25% increase in elimination half-life of ethosuximide and a 15% decrease in its total clearance as compared to ethosuximide alone. Patients receiving valproate and ethosuximide, especially along with other anticonvulsants, should be monitored for alterations in serum concentrations of both drugs.
- Lamotrigine
- In a steady-state study involving 10 healthy volunteers, the elimination half-life of lamotrigine increased from 26 to 70 hours with valproate co-administration (a 165% increase). The dose of lamotrigine should be reduced when co-administered with valproate. Serious skin reactions (such as Stevens-Johnson Syndrome and toxic epidermal necrolysis) have been reported with concomitant lamotrigine and valproate administration. See lamotrigine package insert for details on lamotrigine dosing with concomitant valproate administration.
- Phenobarbital
- Valproate was found to inhibit the metabolism of phenobarbital. Co-administration of valproate (250 mg BID for 14 days) with phenobarbital to normal subjects (n = 6) resulted in a 50% increase in half-life and a 30% decrease in plasma clearance of phenobarbital (60 mg single-dose). The fraction of phenobarbital dose excreted unchanged increased by 50% in presence of valproate.
- There is evidence for severe CNS depression, with or without significant elevations of barbiturate or valproate serum concentrations. All patients receiving concomitant barbiturate therapy should be closely monitored for neurological toxicity. Serum barbiturate concentrations should be obtained, if possible, and the barbiturate dosage decreased, if appropriate.
Primidone, which is metabolized to a barbiturate, may be involved in a similar interaction with valproate.
- Phenytoin
- Valproate displaces phenytoin from its plasma albumin binding sites and inhibits its hepatic metabolism. Co-administration of valproate (400 mg TID) with phenytoin (250 mg) in normal volunteers (n = 7) was associated with a 60% increase in the free fraction of phenytoin. Total plasma clearance and apparent volume of distribution of phenytoin increased 30% in the presence of valproate. Both the clearance and apparent volume of distribution of free phenytoin were reduced by 25%.
- In patients with epilepsy, there have been reports of breakthrough seizures occurring with the combination of valproate and phenytoin. The dosage of phenytoin should be adjusted as required by the clinical situation.
- Tolbutamide
- From in vitro experiments, the unbound fraction of tolbutamide was increased from 20% to 50% when added to plasma samples taken from patients treated with valproate. The clinical relevance of this displacement is unknown.
- Warfarin
- In an in vitro study, valproate increased the unbound fraction of warfarin by up to 32.6%. The therapeutic relevance of this is unknown; however, coagulation tests should be monitored if valproate therapy is instituted in patients taking anticoagulants.
- Zidovudine
- In six patients who were seropositive for HIV, the clearance of zidovudine (100 mg q8h) was decreased by 38% after administration of valproate (250 or 500 mg q8h); the half-life of zidovudine was unaffected.
- (Drugs for which either no interaction or a likely clinically unimportant interaction has been observed.)
- Acetaminophen
- Valproate had no effect on any of the pharmacokinetic parameters of acetaminophen when it was concurrently administered to three epileptic patients.
- Clozapine
- In psychotic patients (n = 11), no interaction was observed when valproate was co-administered with clozapine.
- Lithium
- Co-administration of valproate (500 mg BID) and lithium carbonate (300 mg TID) to normal male volunteers (n = 16) had no effect on the steady-state kinetics of lithium.
- Lorazepam
- Concomitant administration of valproate (500 mg BID) and lorazepam (1 mg BID) in normal male volunteers (n = 9) was accompanied by a 17% decrease in the plasma clearance of lorazepam.
- Olanzapine
- No dose adjustment for olanzapine is necessary when olanzapine is administered concomitantly with valproate. Co-administration of valproate (500 mg BID) and Olanzapine (5 mg) to healthy adults (n=10) caused 15% reduction in Cmax and 35% reduction in AUC of olanzapine.
- Oral Contraceptive Steroids
- Administration of a single-dose of ethinyloestradiol (50 mcg)/levonorgestrel (250 mcg) to 6 women on valproate (200 mg BID) therapy for 2 months did not reveal any pharmacokinetic interaction.
Topiramate
- Concomitant administration of valproate and topiramate has been associated with hyperammonemia with and without encephalopathy. Concomitant administration of topiramate with valproate has also been associated with hypothermia in patients who have tolerated either drug alone. It may be prudent to examine blood ammonia levels in patients in whom the onset of hypothermia has been reported.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Valproic acid in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Valproic acid in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Valproic acid during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Valproic acid in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Valproic acid in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Valproic acid in geriatric settings.
Gender
There is no FDA guidance on the use of Valproic acid with respect to specific gender populations.
Race
There is no FDA guidance on the use of Valproic acid with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Valproic acid in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Valproic acid in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Valproic acid in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Valproic acid in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Valproic acid Administration in the drug label.
Monitoring
There is limited information regarding Valproic acid Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Valproic acid and IV administrations.
Overdosage
There is limited information regarding Valproic acid 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 Valproic acid Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Valproic acid Mechanism of Action in the drug label.
Structure
There is limited information regarding Valproic acid Structure in the drug label.
Pharmacodynamics
There is limited information regarding Valproic acid Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Valproic acid Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Valproic acid Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Valproic acid Clinical Studies in the drug label.
How Supplied
There is limited information regarding Valproic acid How Supplied in the drug label.
Storage
There is limited information regarding Valproic acid 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 Valproic acid Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Valproic acid 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 Valproic acid Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Valproic acid Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.