3% Sodium Chloride

Generic Name: 3% sodium chloride

Over-the-Counter (OTC)

Brand Names:

3% Sodium Chloride

DESCRIPTION: 3% 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 . Table 1. *Normal physiological osmolarity range is approximately 280 to 310 mOsmol/L.

Overview

DESCRIPTION: 3% 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 . Table 1. *Normal physiological osmolarity range is approximately 280 to 310 mOsmol/L.

Uses

INDICATIONS AND USAGE: 3% Sodium Chloride Injection is indicated as a source of water and electrolytes.

Dosage

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 flexible plastic containers are intended for intravenous administration using sterile and nonpyrogenic equipment. Additives may be incompatible.

Side Effects

ADVERSE REACTIONS: Post-Marketing Adverse Reactions The following adverse reactions have not been reported with 3% Sodium Chloride Injection 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.

Interactions

Drug Interactions Caution must be exercised in the administration of 3% Sodium Chloride Injection 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% Sodium Chloride Injection. Administration of 3% Sodium Chloride Injection may, therefore, result in decreased lithium levels.

Warnings

WARNINGS: Hypersensitivity/infusion reactions, including hypotension, pyrexia, tremor, chills, urticaria, rash, and pruritus may occur with 3% Sodium Chloride Injection. Stop the infusion immediately if signs or symptoms of a hypersensitivity reaction develop, such as tachycardia, chest pain, dyspnea and flushing. Appropriate therapeutic countermeasures must be instituted as clinically indicated. Depending on the volume and rate of infusion, the intravenous administration of 3% Sodium Chloride Injection can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration/hypervolemia, congested states, pulmonary edema, or acid-base imbalance. CONTRAINDICATIONS: None known.

Pregnancy

Pregnancy There are no adequate and well controlled studies with 3% Sodium Chloride Injection in pregnant women and animal reproduction studies have not been conducted with this drug. Therefore, it is not known whether 3% Sodium Chloride Injection can cause fetal harm when administered to a pregnant woman. 3% Sodium Chloride Injection should be given during pregnancy only if the potential benefit justifies the potential risks to the fetus.

Storage

Store at 20° to 25 °C ( 68° to 77 °F) [see USP Controlled Room Temperature]; brief exposure up to 40°C/104°F does not adversely affect the product. The container closure is not made with natural rubber latex. Non-PVC, Non-DEHP, Sterile.

Frequently Asked Questions

What is 3% Sodium Chloride used for?

INDICATIONS AND USAGE: 3% Sodium Chloride Injection is indicated as a source of water and electrolytes.

What are the side effects of 3% Sodium Chloride?

ADVERSE REACTIONS: Post-Marketing Adverse Reactions The following adverse reactions have not been reported with 3% Sodium Chloride Injection 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.

Can I take 3% Sodium Chloride during pregnancy?

Pregnancy There are no adequate and well controlled studies with 3% Sodium Chloride Injection in pregnant women and animal reproduction studies have not been conducted with this drug. Therefore, it is not known whether 3% Sodium Chloride Injection can cause fetal harm when administered to a pregnant woman. 3% Sodium Chloride Injection should be given during pregnancy only if the potential benefit justifies the potential risks to the fetus.

What are the important warnings for 3% Sodium Chloride?

WARNINGS: Hypersensitivity/infusion reactions, including hypotension, pyrexia, tremor, chills, urticaria, rash, and pruritus may occur with 3% Sodium Chloride Injection. Stop the infusion immediately if signs or symptoms of a hypersensitivity reaction develop, such as tachycardia, chest pain, dyspnea and flushing. Appropriate therapeutic countermeasures must be instituted as clinically indicated. Depending on the volume and rate of infusion, the intravenous administration of 3% Sodium Chloride Injection can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration/hypervolemia, congested states, pulmonary edema, or acid-base imbalance. CONTRAINDICATIONS: None known.

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Medical Disclaimer

This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.