Valproate Sodium (Page 12 of 12)
15 REFERENCES
- 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
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
| VALPROATE SODIUM valproate sodium injection, solution | |||||||||||||||||
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| 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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