Divalproex sodium

Divalproex sodium
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Pratik Bahekar, MBBS [2]

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Overview

Divalproex sodium is a mood stabilizer that is FDA approved for the {{{indicationType}}} of absence seizure, simple and complex, complex partial epileptic seizure, manic bipolar I disorder, migraine prophylaxis. Common adverse reactions include abdominal pain, diarrhea, indigestion, loss of appetite, nausea, vomiting, asthenia, dizziness, feeling nervous, headache, insomnia, somnolence, tremor, amblyopia, blurred vision, diplopia, infectious disease, 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 Divalproex sodium in adult patients.

Non–Guideline-Supported Use

There is limited information about Off-Label Non–Guideline-Supported Use of Divalproex sodium in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Divalproex sodium 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 Divalproex sodium in pediatric patients.

Non–Guideline-Supported Use

There is limited information about Off-Label Non–Guideline-Supported Use of Divalproex sodium in pediatric patients.

Contraindications

There is limited information regarding Divalproex sodium Contraindications in the drug label.

Warnings

There is limited information regarding Divalproex sodium Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Divalproex sodium Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Divalproex sodium Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Divalproex sodium Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Divalproex sodium in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Divalproex sodium in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Divalproex sodium during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Divalproex sodium in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Divalproex sodium in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Divalproex sodium in geriatric settings.

Gender

There is no FDA guidance on the use of Divalproex sodium with respect to specific gender populations.

Race

There is no FDA guidance on the use of Divalproex sodium with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Divalproex sodium in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Divalproex sodium in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Divalproex sodium in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Divalproex sodium in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Divalproex sodium Administration in the drug label.

Monitoring

There is limited information regarding Divalproex sodium Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Divalproex sodium and IV administrations.

Overdosage

There is limited information regarding Divalproex sodium overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

Valproate semisodium

Clinical data
Trade names	Depakote
AHFS/Drugs.com	Multum Consumer Information
MedlinePlus	a682412
Pregnancy category	D, X (US; depends on its indication)
Routes of administration	Oral
Legal status
Legal status	CA: ℞-only UK: POM (Prescription only) US: ℞-only
Pharmacokinetic data
Protein binding	10-18.5% (dose-dependent)
Metabolism	Hepatic (30-50% via glucuronidation; 40% via β-oxidation & 15-20% via other oxidative pathways)
Elimination half-life	9-16 hours (dose-dependent)
Excretion	Renal (<3% unchanged)
Identifiers
IUPAC name sodium 2-propylpentanoic acid 2-propylpentanoate
PubChem CID	23663956
E number	{{#property:P628}}
ECHA InfoCard	{{#property:P2566}}
Chemical and physical data
Formula	C16H31NaO4
Molar mass	310.41 g·mol−1

Mechanism of Action

There is limited information regarding Divalproex sodium Mechanism of Action in the drug label.

Structure

There is limited information regarding Divalproex sodium Structure in the drug label.

Pharmacodynamics

There is limited information regarding Divalproex sodium Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Divalproex sodium Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Divalproex sodium Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Divalproex sodium Clinical Studies in the drug label.

How Supplied

There is limited information regarding Divalproex sodium How Supplied in the drug label.

Storage

There is limited information regarding Divalproex 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 Divalproex sodium Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Divalproex 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 Divalproex sodium Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Divalproex sodium 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.