Divalproex sodium
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
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. There is a Black Box Warning for this drug as shown here. 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
- Initial, 15 mg/kg/day PO, increase dosage by 5 to 10 mg/kg/day at 1-week intervals max 60 mg/kg/day
- Complex partial epileptic seizure
- Monotherapy, initial, 10 to 15 mg/kg/day PO, increase dosage 5 to 10 mg/kg/day at 1-week intervals max 60 mg/kg/day
- Manic bipolar I disorder
- Initial, 25 mg/kg/day PO once dail, max 60 mg/kg/day
- Migraine; Prophylaxis
- Initial, 500 mg PO once daily for 1 week, up to 1000 mg once daily
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
- Alcohol withdrawal syndrome
- Bipolar I disorder, Maintenance
- Bipolar II disorder, Maintenance
- Headache disorder, chronicView additional information.
- Posttraumatic headache
- Schizoaffective disorder, bipolar type
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)
- Safety in children less than 10 years of age have not been established
- Absence seizure, Simple and complex for 10 years or older
- Initial, 15 mg/kg/day PO, may increase dosage 5 to 10 mg/kg/day at 1-week intervals max 60 mg/kg/day, 50 to 100 mcg/mL
- Complex partial epileptic seizure for 10 years or older monotherapy
- Initial, 10 to 15 mg/kg/day PO, increase dosage 5 to 10 mg/kg/day at 1-week intervals max 60 mg/kg/day
- Complex partial epileptic seizure for 10 years or older
- Initial, 10 to 15 mg/kg/day PO, increase dosage 5 to 10 mg/kg/day at 1-week intervals to achieve optimal clinical response max 60 mg/kg/day
- For converstion to monotherapy initial, 10 to 15 mg/kg/day PO, may increase dosage 5 to 10 mg/kg/day at 1-week intervals, 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 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
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See full prescribing information for complete Boxed Warning.
Condition Name: (Content)
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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
There is limited information regarding Divalproex sodium Pharmacology in the drug label.
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.