Get your patient on Sodium Chloride - Sodium Chloride injection, Solution (Sodium Chloride)
Sodium Chloride - Sodium Chloride injection, Solution prescribing information
INDICATIONS AND USAGE
3% and 5% Sodium Chloride Injection, USP is indicated as a source of water and electrolytes.
DOSAGE AND ADMINISTRATION
As directed by a physician. Dosage, rate, and duration of administration are to be individualized and depend upon the indication for use, the patient’s age, weight, clinical condition, concomitant treatment, and on the patient’s clinical and laboratory response to treatment.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Use of a final filter is recommended during administration of all parenteral solutions, where possible.
Do not administer unless solution is clear and seal is intact.
All injections in VIAFLEX plastic containers are intended for intravenous administration using sterile and nonpyrogenic equipment.
Additives may be incompatible. Complete information is not available. Those additives known to be incompatible should not be used. Consult with pharmacist, if available. If, in the informed judgment of the physician, it is deemed advisable to introduce additives, use aseptic technique. Mix thoroughly when additives have been introduced. Do not store solutions containing additives.
After opening the container, the contents should be used immediately and should not be stored for a subsequent infusion. Do not reconnect any partially used containers. Discard any unused portion.
CONTRAINDICATIONS
None known.
ADVERSE REACTIONS
Post-Marketing Adverse Reactions
The following adverse reactions have not been reported with 3% and 5% Sodium Chloride Injection, USP but may occur:
- hyperchloremia
- hyperchloremic metabolic acidosis,
- hypersensitivity/infusion reactions, including hypotension, pyrexia, tremor, chills, urticaria, rash, and pruritus,
- Infusion site reactions, such as thrombosis, phlebitis, irritation, infusion site erythema, injection site streaking, burning sensation, infusion site urticaria.
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.
Drug Interactions
Caution must be exercised in the administration of 3% and 5% Sodium Chloride Injection, USP to patients treated with drugs that may increase the risk of sodium and fluid retention, such as corticosteroids.
Caution is advised in patients treated with lithium. Renal sodium and lithium clearance may be increased during the administration of 3% and 5% Sodium Chloride Injection, USP. Administration of 3% and 5% Sodium Chloride Injection, USP may, therefore, result in decreased lithium levels.
DESCRIPTION
3% and 5% Sodium Chloride Injection, USP is a sterile, nonpyrogenic, hypertonic solution for fluid and electrolyte replenishment in single dose containers for intravenous administration. The pH may have been adjusted with hydrochloric acid. It contains no antimicrobial agents. Composition, ionic concentration, osmolarity, and pH are shown in Table 1 .
size (mL) | Composition (g/L) | Ionic Concentration (mEq/L) | Normal physiological osmolarity range is approximately 280 to 310 mOsmol/L. Osmolarity (mOsmol/L) (calc) | pH | ||
Sodium Chloride USP (NaCl) | Sodium | Chloride | ||||
3% Sodium Chloride Injection, USP | 500 | 30 | 513 | 513 | 1027 | 5.0 (4.5 to 7.0) |
5% Sodium Chloride Injection, USP | 500 | 30 | 856 | 856 | 1711 | 5.0 (4.5 to 7.0) |
The VIAFLEX plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.
CLINICAL PHARMACOLOGY
3% and 5% Sodium Chloride Injection, USP has value as a source of water and electrolytes. It is capable of inducing diuresis depending on the clinical condition of the patient.
HOW SUPPLIED
3% and 5% Sodium Chloride Injection, USP in VIAFLEX plastic container is available as follows:
| Code | Size (mL) | NDC | Product Name |
|---|---|---|---|
2B1353 | 500 | 0338-0054-03 | 3% Sodium Chloride Injection, USP |
2B1373 | 500 | 0338-0056-03 | 5% Sodium Chloride Injection, USP |
Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25°C/77°F); brief exposure up to 40°C /104°F does not adversely affect the product.
