SODIUM CHLORIDE injection, solution

Sodium Chloride by

Drug Labeling and Warnings

Sodium Chloride by is a Prescription medication manufactured, distributed, or labeled by American Regent, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Osmolarity 0.3 mOsm/mL

Rx Only

DESCRIPTION

Sodium Chloride Injection, USP 0.9%, is a sterile, nonpyrogenic, isotonic solution. Each mL contains Sodium Chloride 9 mg, Water for Injection q.s. pH (range 4.5 - 7.0) adjusted with Hydrochloric Acid and/or Sodium Hydroxide when necessary. Preservative Free.

CLINICAL PHARMACOLOGY

Sodium chloride in water dissociates to provide sodium (Na+) and chloride (Cl¯) ions. Sodium (Na+) is the principal cation of the extracellular fluid and plays a large part in the therapy of fluid and electrolyte disturbances. Chloride (Cl¯) has an integral role in buffering action when oxygen and carbon dioxide exchange occurs in the red blood cells. The distribution and excretion of sodium (Na+) and chloride (Cl¯) are largely under the control of the kidney which maintains a balance between intake and output.

Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult daily requirements range from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production).

Water balance is maintained by various regulatory mechanisms. Water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na+) plays a major role in maintaining physiologic equilibrium.

INDICATIONS AND USAGE

Intravenous solutions containing sodium chloride are indicated for parenteral replenishment of fluid and sodium chloride as required by the clinical condition of the patient.

CONTRAINDICATIONS

None known.

WARNINGS

Excessive amounts of Sodium Chloride by any route may cause hypopotassemia and acidosis. Excessive amounts by the parenteral route may precipitate congestive heart failure and acute pulmonary edema, especially in patients with cardiovascular disease and in patients receiving corticosteroids or corticotropin or drugs that may give rise to sodium retention.

PRECAUTIONS

Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation. Caution must be exercised in the administration of parenteral fluids, especially those containing sodium ions to patients receiving corticosteroids or corticotropin.

Do not administer unless solution is clear and container is undamaged. Discard unused portion.

Pregnancy

Teratogenic Effects

Pregnancy Category C. Animal reproduction studies have not been conducted with Sodium Chloride. It is also not known whether Sodium Chloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Chloride should be given to a pregnant woman only if clearly needed.

Drug Interactions

Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store.

ADVERSE REACTIONS

Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia.

If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.

OVERDOSAGE

In the event of overhydration or solute overload, reevaluate the patient and institute appropriate corrective measures. (See WARNINGS, PRECAUTIONS, AND ADVERSE REACTIONS.)

DOSAGE AND ADMINISTRATION

The dose is dependent upon the age, weight and clinical condition of the patient.

Parenteral drug products should be inspected visually for particulate matter prior to administration whenever solution and container permit.

HOW SUPPLIED

Sodium Chloride Injection, USP 0.9%

NDC: 0517-2802-25                 2 mL Single Dose Vials                 packed in boxes of 25.

NDC: 0517-2810-25                 10 mL Single Dose Vials               packed in boxes of 25.

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature).

AMERICAN
REGENT, INC.
SHIRLEY, NY 11967

IN2802
Rev. 1/09

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - Container

NDC: 0517-2810-25

SODIUM CHLORIDE
INJECTION, USP
0.9%

10 mL
SINGLE DOSE VIAL
FOR DRUG DILUENT USE
PRESERVATIVE FREE

Rx Only

AMERICAN REGENT, INC.
SHIRLEY, NY 11967

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - Carton

SODIUM CHLORIDE
INJECTION, USP
0.9%

NDC: 0517-2810-25
25 x 10 mL
SINGLE DOSE VIALS

FOR DRUG DILUENT USE
PRESERVATIVE FREE

Rx Only

Each mL contains: Sodium Chloride 9 mg, Water for Injection q.s. pH adjusted with Hydrochloric Acid and/or Sodium Hydroxide.
0.3 mOsmol/mL. Sterile, nonpyrogenic.
WARNING: DISCARD UNUSED PORTION.
Store at 20°-25°C (68°-77°F);excursions permitted to 15°-30°C (59°-86°F) (See USP Controlled Room Temperature).
Directions for Use: See Package Insert.

AMERICAN REGENT, INC.
SHIRLEY, NY 11967

Rev. 11/05

INGREDIENTS AND APPEARANCE

SODIUM CHLORIDE 
sodium chloride injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0517-2810
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	9 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYDROCHLORIC ACID (UNII: QTT17582CB)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0517-2810-25	25 in 1 TRAY	09/30/1990
1		10 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		09/30/1990

Labeler - American Regent, Inc. (002033710)

Establishment
Name	Address	ID/FEI	Business Operations
American Regent, Inc.		002033710	ANALYSIS(0517-2810) , MANUFACTURE(0517-2810)