Sodium Chloride

West-ward Pharmaceutical Corp.

FULL PRESCRIBING INFORMATION: CONTENTS*

• PRINCIPAL DISPLAY PANEL

FULL PRESCRIBING INFORMATION

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Sodium Chloride Injection, USP is a sterile, nonpyrogenic, isotonic solution of sodium chloride 0.9% (9 mg/mL) in Water for Injection containing no antimicrobial agent or other added substance. The pH is between 4.5 and 7.0. Its chloride and sodium ion concentrations are approximately 0.154 mEq of each per milliliter and its calculated osmolality is 0.308 milliosmols per mL.

Sodium chloride occurs as colorless cubic crystals or white crystalline powder and has a saline taste. Sodium chloride is freely soluble in water. It is soluble in glycerin and slightly soluble in alcohol.

The empirical formula for sodium chloride is NaCl, and the molecular weight is 58.44.

Sodium chloride comprises over 90% of the inorganic constituents of the blood serum. Sodium chloride in water dissociates to provide sodium (Na+) and chloride (Cl–) ions. These ions are normal constituents of the body fluids (principally extracellular) and are essential for maintaining electrolyte balance. The small volume of fluid and amount of sodium chloride provided by Sodium Chloride Injection, USP, 0.9%, when used only as a vehicle for parenteral injection of drugs, is unlikely to exert a significant effect on fluid and electrolyte balance except possibly in very small infants.

Sodium Chloride Injection is used to flush intravascular catheters or as a sterile, isotonic single dose vehicle, solvent, or diluent for substances to be administered intravenously, intramuscularly or subcutaneously and for other extemporaneously prepared single dose sterile solutions according to instructions of the manufacturer of the drug to be administered.

Sodium chloride must be used with caution in the presence of congestive heart failure, circulatory insufficiency, kidney dysfunction or hypoproteinemia.

Excessive amounts of sodium chloride by any route may cause hypokalemia and acidosis. Excessive amounts by parenteral routes may precipitate congestive heart failure and acute pulmonary edema, especially seen in patients with preexisting cardiovascular disease and those receiving corticosteroids, corticotropin or other drugs that may give rise to sodium retention.

For use in newborns, when a sodium chloride solution is required for preparation or diluting medications, or in flushing intravenous catheters, only preservative-free Sodium Chloride Injection, USP, 0.9% should be used.

Since Sodium Chloride Injection does not contain antimicrobial agents and is intended for single use, any unused amount must be discarded immediately following withdrawal of any portion of the contents of the vial.

Consult the manufacturer’s instructions for choice of vehicle, appropriate dilution or volume for dissolving the drugs to be injected, including the route and rate of injection.

TERATOGENIC EFFECTS - PREGNANCY CATEGORY C

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

Reactions which may occur because of this solution, added drugs or the technique of reconstitution or administration include febrile response, local tenderness, abscess, tissue necrosis or infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection and extravasation.

If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate countermeasures, and if possible, retrieve and save the remainder of the unused vehicle for examination.

When used as a diluent, solvent or intravascular flushing solution, this parenteral preparation is unlikely to pose a threat of sodium chloride or fluid overload except possibly in very small infants. In the event these should occur, reevaluate the patient and institute appropriate corrective measures.

Before Sodium Chloride Injection, USP, 0.9% is used as a vehicle for the administration of a drug, specific references should be checked for any possible incompatibility with sodium chloride.

The volume of the preparation to be used for diluting or dissolving any drug for injection is dependent on the vehicle concentration, dose and route of administration as recommended by the manufacturer.

Sodium Chloride Injection, USP, 0.9% is also indicated for use in flushing intravenous catheters. Prior to and after administration of the medication, the intravenous catheter should be flushed in its entirety with Sodium Chloride Injection, USP, 0.9%. Use in accord with any warnings or precautions appropriate to the medication being administered.

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

Sodium Chloride Injection, USP, 0.9%, is available in the following package:

    2 mL Single Dose vials packaged in 25s (NDC 0641-0495-25)

Store at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]. Avoid freezing.

To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceutical Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

For Product Inquiry call 1-877-845-0689.

Manufactured by:

WEST-WARD
PHARMACEUTICALS

Eatontown, NJ 07724 USA

Revised January 2012

462-019-04

PRINCIPAL DISPLAY PANEL

Sodium Chloride, USP
0.9%
2 mL Vial
NDC 0641-0495-17