Sodium Chloride

These intravenous solutions are indicated for use in adults and pediatric patients as sources of electrolytes and water for hydration.

0.9% Sodium Chloride Injection USP is indicated for extracellular fluid replacement, treatment of metabolic alkalosis in the presence of fluid loss and mild sodium depletion.

0.9% Sodium Chloride Injection USP is also indicated for use as a priming solution in hemodialysis procedures and may be used to initiate and terminate blood transfusions without hemolyzing red blood cells.

0.45% Sodium Chloride Injection USP is primarily a hydrating solution and may be used to assess the status of the kidneys, since more water is provided than is required for excretion of salt. It may also be used in the treatment of hyperosmolar diabetes where the use of dextrose is inadvisable and there is a need for large amounts of fluid without an excess of sodium ions.

Sodium Chloride Injections USP are also indicated as pharmaceutic aids and diluents for the infusion of compatible drug additives. Refer to prescribing information accompanying additive drugs.

These solutions are for intravenous use only.

Dosage is to be directed by a physician and is dependent upon age, weight, clinical condition of the patient and laboratory determinations. Frequent laboratory determinations and clinical evaluation are essential to monitor changes in blood glucose and electrolyte concentrations, and fluid and electrolyte balance during prolonged parenteral therapy.

In the average adult, daily requirements of sodium and chloride are met by the infusion of one liter of 0.9% sodium chloride (154 mEq each of sodium and chloride).

There is no specific pediatric dose. The dose is dependent on weight, clinical condition and laboratory results. Follow recommendations of appropriate pediatric reference text. (See

Fluid administration should be based on calculated maintenance or replacement fluid requirements for each patient.

0.9% Sodium Chloride Injection USP may also be administered intravascularly as a priming fluid in hemodialysis procedures.

When Sodium Chloride Injections USP are used as diluents for infusion of compatible drug additives, refer to dosage and administration information accompanying additive drugs.

Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly.

Do not store.

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

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.

The physician should also be alert to the possibility of adverse reactions to drug additives. Prescribing information for drug additives to be administered in this manner should be consulted.

Symptoms may result from an excess or deficit of one or more of the ions present in the solution; therefore, frequent monitoring of electrolyte levels is essential.

Hypernatremia may be associated with edema and exacerbation of congestive heart failure due to the retention of water, resulting in an expanded extracellular fluid volume.

If infused in large amounts, chloride ions may cause a loss of bicarbonate ions, resulting in an acidifying effect.

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.

Each 100 mL of

Sodium Chloride USP 0.9 g; Water for Injection USP qs

pH: 5.6 (4.5–7.0)     Calculated Osmolarity: 310 mOsmol/liter

pH adjusted with Hydrochloric Acid NF

Concentration of Electrolytes (mEq/liter): Sodium 154     Chloride 154

Each 100 mL of

Sodium Chloride USP 0.45 g; Water for Injection USP qs

pH: 5.6 (4.5–7.0)     Calculated Osmolarity: 155 mOsmol/liter, hypotonic

pH adjusted with Hydrochloric Acid NF

Concentration of Electrolytes (mEq/liter): Sodium 77     Chloride 77

Sodium Chloride Injections USP are sterile, nonpyrogenic, isotonic and contain no bacteriostatic or antimicrobial agents.

The formula of the active ingredient is:

Not made with natural rubber latex, PVC or DEHP.

The plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers and exhibits virtually no leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration.

The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary.

Addition of medication should be accomplished using complete aseptic technique.

The closure system has two ports; the one for the administration set has a tamper evident plastic protector and the other is a medication addition site. Refer to the Directions for Use of the container.

Sodium Chloride Injections USP provide electrolytes and are a source of water for hydration. They are capable of inducing diuresis depending on the clinical condition of the patient.

Sodium, the major cation of the extracellular fluid, functions primarily in the control of water distribution, fluid balance, and osmotic pressure of body fluids. Sodium is also associated with chloride and bicarbonate in the regulation of the acid-base equilibrium of body fluid.

Chloride, the major extracellular anion, closely follows the metabolism of sodium, and changes in the acid-base balance of the body are reflected by changes in the chloride concentration.