Sodium Chloride

INDICATIONS AND USAGE This intravenous solution is indicated for use in adults and pediatric patients as a source of electrolytes and water for hydration. This product is designed for use as a diluent and delivery system for intermittent intravenous administration of compatible drug additives. Consult prescribing information for INDICATIONS AND USAGE of drug additives to be administered in this manner.

DOSAGE AND ADMINISTRATION This solution is for intravenous use only. Do not use plastic container in series connection. If administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result. This solution is intended for intravenous administration using sterile equipment. It is recommended that intravenous administration apparatus be replaced at least once every 24 hours. Use only if solution is clear and container and seals are intact. As directed by a physician. Dosage is dependent upon the age, weight, and clinical condition of the patient as well as laboratory determinations. 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 PRECAUTIONS, Pediatric Use . When using this product as a diluent or vehicle for administration of drug additives, consult the prescribing information of the drug to be used. Addition of medication should be accomplished using aseptic technique in order to assure sterility. Physicochemical studies have shown that the container and solution can withstand freezing. 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.

WARNINGS Solutions containing sodium ions should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency, and in clinical states in which there is sodium retention with edema. In patients with diminished renal function, administration of solutions containing sodium ions may result in sodium retention.

CONTRAINDICATIONS This solution is contraindicated where the administration of sodium or chloride could be clinically detrimental.

Drug Interactions Sodium-containing solutions should be administered with caution to patients receiving cortiscosteroids or corticotrophin. Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. Studies have not been conducted to evaluate additional drug/drug or drug/food interactions with Sodium Chloride Injection USP.

Pregnancy Teratogenic Effects Pregnancy Category C Animal reproduction studies have not been conducted with 0.9% Sodium Chloride Injection USP. It is also not known whether 0.9% Sodium Chloride Injection USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. 0.9% Sodium Chloride Injection USP should be given to a pregnant woman only if clearly needed.

Nursing Mothers Because many drugs are excreted in human milk, caution should be exercised when 0.9% Sodium Chloride Injection USP is administered to a nursing woman.

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. The physician should also be alert to the possibility of adverse reactions to drug additives diluted and administered from the plastic partial fill container. 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 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.