Valproate Sodium (Page 12 of 12)

15 REFERENCES

  1. Meador KJ, Baker GA, Browning N, et al. Fetal antiepileptic drug exposure and cognitive outcomes at age 6 years (NEAD study): a prospective observational study. Lancet Neurology 2013; 12 (3):244-252.

16 HOW SUPPLIED/STORAGE AND HANDLING

Valproate Sodium Injection is a clear, colorless solution supplied as:

Product Code Unit of Sale Strength Each
PRX439405 NDC 63323-494-16Unit of 10 500 mg per 5 mL (100mg per mL) NDC 63323-494-415 mL Single-dose Vial

Available in packages of 10.

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Preservative Free. Unused portion of container should be discarded.

The container closure is not made with natural rubber latex.

17 PATIENT COUNSELING INFORMATION

Hepatotoxicity

Warn patients and guardians that nausea, vomiting, abdominal pain, anorexia, diarrhea, asthenia, and/or jaundice can be symptoms of hepatotoxicity and, therefore, require further medical evaluation promptly [see Warnings and Precautions (5.1)].

Pancreatitis

Warn patients and guardians that abdominal pain, nausea, vomiting, and/or anorexia can be symptoms of pancreatitis and, therefore, require further medical evaluation promptly [see Warnings and Precautions (5.5)].

Birth Defects and Decreased IQ

Inform pregnant women and women of childbearing potential (including girls beginning the onset of puberty) that use of valproate during pregnancy increases the risk of birth defects, decreased IQ, and neurodevelopmental disorders in children who were exposed in utero. Advise women to use effective contraception while using valproate. When appropriate, counsel these patients about alternative therapeutic options. This is particularly important when valproate use is considered for a condition not usually associated with permanent injury or death such as prophylaxis of migraine headache [see Contraindications (4), Warnings and Precautions (5.2, 5.3, 5.4), and Use in Specific Populations (8.1)].

Pregnancy Registry

Advise women of childbearing potential to discuss pregnancy planning with their doctor and to contact their doctor immediately if they think they are pregnant.

Encourage women who are taking Valproate to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry if they become pregnant. This registry is collecting information about the safety of antiepileptic drugs during pregnancy. To enroll, patients can call the toll free number 1-888-233-2334 or visit the website, http://www.aedpregnancyregistry.org/ [see Use in Specific Populations (8.1)].

Hyperammonemia

Inform patients of the signs and symptoms associated with hyperammonemic encephalopathy and to notify the prescriber if any of these symptoms occur [see Warnings and Precautions (5.8, 5.9)].

CNS Depression

Since valproate products may produce CNS depression, especially when combined with another CNS depressant (e.g., alcohol), advise patients not to engage in hazardous activities, such as driving an automobile or operating dangerous machinery, until it is known that they do not become drowsy from the drug.

Multiorgan Hypersensitivity Reactions

Instruct patients that a fever associated with other organ system involvement (rash, lymphadenopathy, etc.) may be drug-related and should be reported to the physician immediately [see Warnings and Precautions (5.11)].

PREMIERProRx® is a registered trademark of Premier Healthcare Alliance, L.P., used under license.

Manufactured by:

Fresenius Kabi

Lake Zurich, IL 60047

www.fresenius-kabi.com/us

451466B

PREMIERProRx Logo

PACKAGE LABEL — PRINCIPAL DISPLAY PANEL — Valproate Sodium 5 mL SIngle Dose Vial Label

NDC 63323-494-41


Valproate Sodium

Injection, USP

500 mg* per 5 mL

(100 mg per mL)

For intravenous infusion only. Preservative free.

5 mL Single-dose Vial Rx only

Vial label
(click image for full-size original)

PACKAGE LABEL — PRINCIPAL DISPLAY PANEL — Valproate Sodium 5 mL Single Dose Vial Tray Label

NDC 63323-494-16


Valproate Sodium

Injection, USP

500 mg* per 5 mL

(100 mg per mL)

For intravenous infusion only.
Preservative free.

10 x 5 mL Single-dose Vials Rx only

vial tray label
(click image for full-size original)
VALPROATE SODIUM valproate sodium injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63323-494
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VALPROATE SODIUM (VALPROIC ACID) VALPROIC ACID 100 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
EDETATE DISODIUM 0.4 mg in 1 mL
SODIUM HYDROXIDE
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63323-494-16 10 VIAL, SINGLE-DOSE in 1 TRAY contains a VIAL, SINGLE-DOSE (63323-494-41)
1 NDC:63323-494-41 5 mL in 1 VIAL, SINGLE-DOSE This package is contained within the TRAY (63323-494-16)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076539 08/18/2003
Labeler — Fresenius Kabi USA, LLC (608775388)
Establishment
Name Address ID/FEI Operations
Fresenius Kabi USA, LLC 840771732 analysis (63323-494), manufacture (63323-494)

Revised: 10/2022 Fresenius Kabi USA, LLC

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