Valproate Sodium (Page 10 of 10)

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, USP, equivalent to 100 mg of valproic acid per mL, is a clear, colorless solution in 5 mL single dose vials, available in trays of 10 vials (NDC 0143-9785-10).

Recommended storage: Store vials at 20° to 25°C (68° to 77°F) with excursions between 15º and 30ºC (59º and 86ºF) [See USP Controlled Room Temperature].

No preservatives have been added. Unused portion of container should be discarded.

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 be told 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.

Multi-organ 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: HIKMA FARMACÊUTICA (PORTUGAL), S.A.
Estrada do Rio da Mó, 8, 8A e 8B — Fervença — 2705-906 Terrugem SNT, PORTUGAL

Distributed by: WEST-WARD PHARMACEUTICAL CORP.
Eatontown, NJ 07724 USA

Revised: 03/2015
PIN237-WES/6

PRINCIPAL DISPLAY PANEL

NDC 0143-9785-01
VALPROATE
SODIUM INJECTION, USP
500 mg/5 mL
(100 mg/mL)
FOR IV INFUSION ONLY
Rx ONLY
5 mL Single Dose Vial
Each mL contains: valproic acid 100 mg,
edetate disodium 0.4 mg, and water for
injection. pH adjusted with sodium
hydroxide and/or hydrochloric acid.
USUAL DOSAGE: See Package Insert.
CONTAINS NO PRESERVATIVES
Discard any unused solution.
Store at 20º to 25ºC (68º to 77ºF) [see USPControlled Room Temperature].

NDC 0143-9785-01 VALPROATE SODIUM INJECTION, USP 500 mg/5 mL (100 mg/mL) FOR IV INFUSION ONLY Rx ONLY 5 mL Single Dose Vial Each mL contains: valproic acid 100 mg, edetate disodium 0.4 mg, and water for injection. pH adjusted with sodium hydroxide and/or hydrochloric acid. USUAL DOSAGE: See Package Insert. CONTAINS NO PRESERVATIVES Discard any unused solution. Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature].
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0143-9785-10
VALPROATE SODIUM INJECTION, USP
500 mg/5 mL
(100 mg/mL)
Rx only
CONTAINS NO PRESERVATIVES
FOR INTRAVENOUS INFUSION ONLY
10 x 5 mL Single Dose Vials
Each mL contains: valproic acid
100 mg, edetate disodium 0.4 mg,
and water for injection. pH
adjusted with sodium hydroxide
and/or hydrochloric acid.
USUAL DOSAGE: See package
insert.
Discard any unused solution.
Store at 20º to 25ºC (68º to 77ºF)
[See USP Controlled RoomTemperature].

NDC 0143-9785-10 VALPROATE SODIUM INJECTION, USP 500 mg/5 mL (100 mg/mL) Rx only CONTAINS NO PRESERVATIVES FOR INTRAVENOUS INFUSION ONLY 10 x 5 mL Single Dose Vials Each mL contains: valproic acid 100 mg, edetate disodium 0.4 mg, and water for injection. pH adjusted with sodium hydroxide and/or hydrochloric acid. USUAL DOSAGE: See package insert. Discard any unused solution. Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature].
(click image for full-size original)
VALPROATE SODIUM valproate sodium injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0143-9785
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VALPROATE SODIUM (VALPROIC ACID) VALPROIC ACID 500 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
EDETATE DISODIUM 2 mg in 5 mL
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0143-9785-10 10 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (0143-9785-01)
1 NDC:0143-9785-01 5 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (0143-9785-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078523 02/17/2010
Labeler — West-Ward Pharmaceutical Corp (001230762)
Establishment
Name Address ID/FEI Operations
HIKMA FARMACEUTICA (PORTUGAL), S.A 452742943 ANALYSIS (0143-9785), LABEL (0143-9785), MANUFACTURE (0143-9785), PACK (0143-9785)

Revised: 06/2015 West-Ward Pharmaceutical Corp

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