AHFS Class:

28:12.28 GABA-mediated Anticonvulsants

Valproate sodium is available in 5-mL single-dose (preservative-free) vials.³⁴²³ Each mL of solution contains valproate sodium equivalent to valproic acid 100 mg and edetate disodium 0.4 mg in water for injection.³⁴²³ Sodium hydroxide and/or hydrochloric acid are used to adjust pH during manufacture.³⁴²³ The solution should be diluted for use.³⁴²³

pH

Adjusted to 7.6.³⁴²³

Trade Name(s)

Depacon

Valproate sodium is intended for intravenous use only.³⁴²³ The manufacturer recommends that the drug be administered as an intravenous infusion over 60 minutes at a rate that does not exceed 20 mg/min following dilution of the appropriate dose in at least 50 mL of a compatible infusion solution.³⁴²³ (See Solution Compatibility.) For many indications, the manufacturer also recommends that total daily dosages exceeding 250 mg be administered in divided doses.³⁴²³

The manufacturer states that there is limited experience with infusion of valproate sodium over less than 60 minutes or at rates of infusion exceeding 20 mg/min.³⁴²³ In a safety study, a more rapid infusion of a single dose of the drug over 5 to 10 minutes (1.5 to 3 mg/kg/min) was used.³⁴²³ More rapid infusion rates (e.g., 3 to 6 mg/kg/min) of sometimes larger doses (e.g., loading dose) also have been used in other studies or are recommended in some guidelines for certain indications.³⁴³⁸; ³⁴³⁹; ³⁴⁴⁰; ³⁴⁴¹; ³⁴⁴²; ³⁴⁴³ While patients in such studies generally tolerated such infusions well,³⁴²³; ³⁴³⁹; ³⁴⁴⁰; ³⁴⁴¹; ³⁴⁴²; ³⁴⁴³ the manufacturer states that rapid infusion of valproate sodium has been associated with an increase in adverse reactions.³⁴²³

Valproate sodium injection is a clear, colorless solution.³⁴²³ Intact vials should be stored at controlled room temperature of 15 to 30°C.³⁴²³ Because no antibacterial preservatives are present in the formulation, any unused solution remaining in a vial after entry should be discarded.³⁴²³

Syringes

Valproate sodium (Sanofi) 20 mg/mL in sodium chloride 0.9% packaged in 40-mL polypropylene syringes (BD) was physically and chemically stable for 30 days stored at 2 to 8°C protected from light.³⁵²³

Valproate sodium (Mylan) 600 mg/50 mL in sodium chloride 0.9% in a 50-mL polypropylene syringe (BD) was physically stable for 48 hours at room temperature.³⁵⁴⁵

Solution Compatibility

Additive Compatibility

Y-Site Injection Compatibility (1:1 Mixture)

For a list of references cited in the text of this monograph, search the monograph titled References.

ASHP^® Injectable Drug Information^TM. Selected Revisions December 5, 2024. © Copyright, 2024. American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.