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
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See full prescribing information for complete Boxed Warning.
Condition Name: (Content)
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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
- Complex partial epileptic seizure
- Manic bipolar I disorder
- Migraine; Prophylaxis
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)
There is limited information regarding Valproic acid FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
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
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See full prescribing information for complete Boxed Warning.
Condition Name: (Content)
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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
There is limited information regarding Valproic acid Drug Interactions in the drug label.
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
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.
- ↑ 1.0 1.1 1.2 "Depakene, Stavzor (valproic acid) dosing, indications, interactions, adverse effects, and more". Medscape Reference. WebMD. Retrieved 13 February 2014.