Sodium Chloride 5%

Sterile, Clear, Colorless, Concentrated

 Injection Solution (IV)

Dosage Form

50 ml single-dose vial for IV injection.

Drug Classification and Categories

Electrolyte replacement.

Dosage and Administration

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.

The solution should be administered into a large vein, at a rate not exceeding 100 ml per hour.

Indications

Sodium chloride 5% (hypertonic) is used to hyponatremia and hypochloremia due to electrolyte and fluid loss replaced with sodium free fluids. After dilution of body water following excessive water intake, it is emergency treatment of severe salt depletion.

Warnings

To prevent pulmonary edema, neurologic complications, pain and local inflammation, this product should be injected slowly.

Stop the infusion immediately if signs or symptoms of a hypersensitivity reaction, such as tachycardia, chest pain, dyspnea and flushing are developed.

Side Effects

Hyperchloremia, hyperchloremic metabolic acidosis, hypersensitivity/infusion reactions, including hypotension, pyrexia, tremor, chills, urticaria, rash, and pruritus, thrombosis, phlebitis, hypokalemia, excessive consumption of 5% sodium chloride may lead to decreased serum potassium level.

Contraindications

 Hypernatremia, fluid retention when administration of sodium chloride could be clinically detrimental.

Pregnancy and Lactation

 Pregnancy Category C

There is not enough information and evidence on the use of this product during pregnancy and lactation.

Precautions

          •        Administration cautiously to patients with decompensated cardiovascular, cirrhotic and nephritis disease, circulatory insufficiency hypoproteinemia, hypervolemia, urinary track obstruction, CHF, and no patients with concurrent edema and sodium retention, receiving corticosteroids or corrticotropin, and those patients treated with lithium and NSIADs.

          •        Do not mix or administer 5% sodium chloride injection solutions through the same administration set with whole blood or cellular blood components.

          •        Dosage, rate, and duration of administration should be determined by a physician experienced in intravenous fluid therapy.

Drug Interactions

 This product is incompatible with dantrolene, tolvaptan, amphotericin, amiodarone, mycophenolate, streptomycin, mannitol and filgrastim.

Caution is advised in patients treated with lithium and corticosteroids.

Storage Conditions

 Store below 30°C and protect from freezing. The solution is clear, colorless and free of suspended particles, do not use unless the solution is clear and seal is intact. Discard unused portion. 

Packaging

Each box contains 50 vials with a volume of 50 ml and leaflets.