SODIUM ACETATE FOR INJECTION, USP CONCENTRATE

/SODIUM ACETATE FOR INJECTION, USP CONCENTRATE
SODIUM ACETATE FOR INJECTION, USP CONCENTRATE2018-09-06T09:12:40+00:00

Prescription Drug Name:

SODIUM ACETATE FOR INJECTION, USP CONCENTRATE

ID:

0954629f-ef6f-42d1-b3c9-409597fb8a24

Code:

34391-3

DESCRIPTION


id: daa103a1-1aa9-49eb-aa35-e27e722cbfed
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Sodium Acetate for Injection, USP CONCENTRATE, 4 mEq/mL, is a sterile, nonpyrogenic, concentrated solution of Sodium Acetate (C2H3NaO2) in Water for Injection. It must be diluted prior to administration. Each 50 mL vial contains 16.4 grams of Sodium Acetate (anhydrous) which provides 200 mEq each of Sodium (Na+) and Acetate (CH3COO). The pH is adjusted with acetic acid and the solution contains no bacteriostatic agent or other preservative. The solution is intended as an alternative to Sodium Chloride to provide sodium ion (Na+) for addition to large volume infusion fluids for intravenous use. Unused portion should be discarded.

CLINICAL PHARMACOLOGY


id: cba8d554-174f-403d-a0b8-b18bcc5869d8
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1

Sodium is the principal cation of extracellular fluids. The sodium ion exerts a primary role in controlling total body water and its distribution. The acetate ion is completely metabolized in the body, providing a source of hydrogen ion acceptors.

INDICATIONS AND USAGE


id: 47efda3a-c18f-45c1-863b-3a252894549f
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

Sodium Acetate for Injection, USP CONCENTRATE is indicated as a source of sodium in patients with restricted or no oral intake. It is also useful as an additive for preparing specific intravenous fluid formulas, when the needs of the patient cannot be met by standard electrolyte or nutrient solutions.

CONTRAINDICATIONS


id: 70c64a98-1c9f-4189-8f3b-0a6e10276e47
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

Sodium Acetate for Injection, USP CONCENTRATE is contraindicated in patients with HYPERNATREMIA.

WARNINGS


id: 7e51cc92-5af4-45c5-bc70-249572245116
displayName: WARNINGS SECTION
FDA Article Code: 34071-1

Sodium Acetate for Injection, USP CONCENTRATE must be diluted before use. To avoid sodium overload and water retention, infuse sodium containing solutions slowly. Do not use unless solution is clear and seal is intact. This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

PRECAUTIONS


id: 4aca054b-9ddb-4013-9a54-8ebd4d9351a7
displayName: PRECAUTIONS SECTION
FDA Article Code: 42232-9

Sodium replacement therapy should be guided primarily by serum sodium level. Use with caution in patients with renal impairment, cirrhosis, cardiac failure or other edematous or sodium retaining states.

ADVERSE REACTIONS


id: 7c230db0-edb6-4f2a-aedd-0211fb2f027d
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4

Sodium overload can occur with intravenous infusion of excessive amounts of sodium containing compounds. See WARNINGS.

DOSAGE AND ADMINISTRATION


id: 93d607d4-60e7-40d1-899d-c5784bf18c35
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7

Sodium Acetate for Injection, USP CONCENTRATE (4 mEq/mL), is administered intravenously only after dilution. The dose and rate of administration are dependent upon the individual needs of the patient. Serum sodium should be monitored as a guide to dosage. Withdraw the calculated volume aseptically and transfer to appropriate intravenous fluids to provide the desired number of milliequivalents (mEq) of sodium (Na+) with an equal number of milliequivalents of acetate (CH3COO). Parenteral drug products should be inspected visually for particulate matter and discoloration, whenever solution and container permit.

HOW SUPPLIED


id: ccc41585-9fac-43b5-aaf3-d237f7f1027a
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Sodium Acetate for Injection, USP CONCENTRATE (4 mEq /mL) NDC 0517-5023-25     50 mL Single Dose Vial     packed in boxes of 25 Store at 20° – 25°C (68° – 77°F); excursions permitted to 15° – 30°C (59° – 86°F) (See USP Controlled Room Temperature). AMERICAN


REGENT, INC.


SHIRLEY, NY 11967 IN5023
Rev. 11/05

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


id: 1ec4d072-b4b5-4d3d-88eb-127878231fa3
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

PRINCIPLE DISPLAY PANEL – 50 mL Container NDC 0517-5023-25 SODIUM ACETATE
FOR INJECTION, USP
CONCENTRATE

200 mEq/50 mL

(4 mEq/mL) 50 mL SINGLE DOSE VIAL FOR IV USE AFTER DILUTION Rx Only AMERICAN
REGENT, INC.

SHIRLEY, NY 11967