Valproate Sodium (Page 10 of 10)

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 that use of valproate during pregnancy increases the risk of birth defects and decreased IQ in children who were exposed. 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 [see Warnings and Precautions ( 5.2, 5.3, 5.4) and Use in Specific Populations ( 8.1)] .

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

Hyperammonemia

Inform patients of the signs and symptoms associated with hyperammonemic encephalopathy and notify to inform 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)] .

Manufactured by:
Fresenius Kabi
Lake Zurich, IL 60047

www.fresenius-kabi.com/us

451466A

Revised: May 2019

image 4

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

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 labelvial tray label

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	manufacture (63323-494)

Revised: 05/2019 Fresenius Kabi USA, LLC