Valproic

VALPROIC ACID

Manufacturer: Aphena Pharma Solutions - Tennessee, LLC

Score: 148.0

Quick Summary

Valproic acid is an antiepileptic medication used for the treatment of various seizure disorders, including complex partial seizures, simple and complex absence seizures, and as adjunctive therapy in patients with multiple seizure types. It has a boxed warning for hepatotoxicity, fetal risk, and pancreatitis. Key clinical findings indicate its efficacy in controlling seizures, but it also has important safety information, including contraindications for patients with hepatic disease, mitochondrial disorders, and hypersensitivity to the drug. Dosing recommendations vary based on the condition being treated and patient population, with initial dosing and titration details provided. Special population considerations include use during pregnancy, nursing mothers, pediatric use, and geriatric use, all of which require careful consideration due to potential risks and the need for dose adjustments.

Key Clinical Findings and Indications

Treatment of complex partial seizures
Treatment of simple and complex absence seizures
Adjunctive therapy in patients with multiple seizure types

Important Safety Information

Warning

Hepatotoxicity, fetal risk, and pancreatitis

Contraindications

Hepatic disease or significant hepatic dysfunction
Known mitochondrial disorders caused by mutations in mitochondrial DNA polymerase γ (POLG)
Known hypersensitivity to the drug
Urea cycle disorders
Pregnant women and women of childbearing potential who are not using effective contraception for prophylaxis of migraine headaches

Adverse Reactions

Hepatic failure
Birth defects
Decreased IQ following in utero exposure
Pancreatitis
Hyperammonemic encephalopathy
Suicidal behavior and ideation
Bleeding and other hematopoietic disorders
Hypothermia
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan hypersensitivity reactions
Somnolence in the elderly

Dosing Recommendations

General Guidance

Dose adjustments should be made based on clinical response and plasma concentrations, with consideration for patients with hepatic or renal impairment, as well as those taking other medications that may interact with valproic acid.

Complex partial seizures

Adult Dose

10 to 15 mg/kg/day, increasing at 1 week intervals by 5 to 10 mg/kg/week

Pediatric Dose

10 to 15 mg/kg/day, increasing at 1 week intervals by 5 to 10 mg/kg/week for children 10 years and older

Simple and complex absence seizures

Adult Dose

15 mg/kg/day, increasing at one week intervals by 5 to 10 mg/kg/day

Pediatric Dose

15 mg/kg/day, increasing at one week intervals by 5 to 10 mg/kg/day for children 10 years and older

Special Population Considerations

Pregnancy

Valproic acid is contraindicated for prophylaxis of migraine headaches in pregnant women and in women of childbearing potential who are not using effective contraception
Valproate should not be used to treat women with epilepsy or bipolar disorder who are pregnant or who plan to become pregnant unless other medications have failed to provide adequate symptom control or are otherwise unacceptable

Nursing Mothers

Valproic acid is excreted in human milk, and nursing mothers should be cautious when taking the drug

Pediatric Use

Pediatric patients under the age of two years are at a considerably increased risk of developing fatal hepatotoxicity
The safety and tolerability of valproic acid in pediatric patients were shown to be comparable to those in adults in clinical trials

Geriatric Use

No patients above the age of 65 years were enrolled in double-blind prospective clinical trials of mania associated with bipolar illness
A higher percentage of patients above 65 years of age reported accidental injury, infection, pain, somnolence, and tremor in a case review study

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