Sodium Chloride 3% is of particular value in severe salt depletion when rapid electrolyte restoration is of paramount importance. The low salt syndrome may occur in the presence of heart failure, renal impairment, during surgery, and postoperatively. In these conditions, chloride loss frequently exceeds sodium loss.

• These hypertonic sodium chloride solutions are also indicated for the following clinical conditions.

• Hyponatremia and hypochloremia due to electrolyte and fluid loss replaced with sodium-free fluids.

Drastic dilution of extracellular body fluid following excessive water intake sometimes resulting from multiple enemas or perfusion of irrigating fluids into open venous sinuses during transurethral prostatic resections.

• Emergency treatment of severe salt depletion due to excess sweating, vomiting, diarrhea and other conditions.

Method Administrations:

Intravenous infusion route.

Concentrated Sodium Chloride infusion is hypertonic, and must be diluted before use. Inadvertent direct injection or absorption of Concentrated Sodium Chloride Injection, USP may give rise to sudden hypernatremia and such complications as cardiovascular shock, central nervous system disorders, extensive hemolysis, cortical necrosis of the kidneys and severe local tissue necrosis (if administered extravascularly).

When a hypertonic solution is to be administered peripherally, it should be slowly infused through a small bore needle, placed well within the lumen of a large vein to minimize venous irritation. Carefully avoid infiltration.

Posology:

Adults, Elderly, Adolescents and Children: Doses may be expressed in terms of mEg or mmol of sodium, mass of sodium, or mass of sodium salt (1 g NaCl contains 394 mg of sodium ion, 17.1 mEg or 17.1 mmol ofNa and Cl). The dosage and rate of administration of Sodium Chloride 3% w/v Solution for Infusion is determined by several factors including the age, weight, and clinical condition of the patient and in particular the patient's hydration state. Serum-electrolyte concentrations should be carefully monitored.

The infusion rate depends on the patient clinical condition.

Precautions for use

Caution: These are concentrated hypertonic sodium chloride solutions. Infuse very slowly with constant observation of the patient to avoid pulmonary edema.

Excessive infusion of hypertonic sodium chloride solutions may supply more sodium and chloride than normally found in serum and can exceed normal tolerance, resulting in hypernatremia. Infusion of excess chloride ions may cause a loss of bicarbonate, resulting in an acidifying effect.

4.4.1 Acid- base balance should be evaluated clinically.

4.4.2 Patients with congestive heart failure or other edematous of sodium retaining conditions.

4.4.3 Patients with severe renal insufficiency.

General precautions for IV administration

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Do not administer unless solution is clear and seal is intact.

Do not connect flexible plastic containers of intravenous solution in series, i.e., do not piggyback connections. Such use could result in air embolism due to residual air being drawn from one container before administration of the fluid from a secondary container is completed.

Pressurizing intravenous solutions contained in flexible plastic containers to increase flow rates can result in air embolism if the residual air in the container is not fully evacuated prior to administration.

Use of a vented intravenous administration set with the vent in the open position could result in air embolism. Vented intravenous administration sets with the vent in the open position should not be used with flexible plastic containers.

Interaction with other medicinal products and other forms of interaction Caution must be exercised in the administration of Sodium Chloride Injection to patients receiving corticosteroids or corticotrophin.

Pregnancy: category C

Teratogenic effects It is not recorded whether Sodium Chloride Injection can cause fatal harm when administered to a pregnant woman can affect reproduction capacity. Sodium Chloride Injection should be given to a pregnant woman only if clearly needed.

Nursing Mothers:

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Sodium Chloride Lnjection is administered to a nursing woman.

Not relevant.

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 oedema 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.

If the patient is over 65 years of age or very young he may has an increased chance of getting side effects.

To report any side effect(s):
Saudi Arabia:
The National Pharmacovigilance and Drug Safety Centre (NPC)
Fax: +966-11-205-7662
Call NPC at +966-11-2038222, Exts: 2317-2356-2353-2354-2334-2340.
Toll free phone: 8002490000
E-mail: npc.drug@sfda.gov.sa
Website: www.sfda.gov.sa/npc

Other GCC States:
Please contact the relevant competent authority.

An overdose of sodium chloride can result in side effects.

• nausea, vomiting

• cramps

• diarrhea

• decrease in saliva, tears and urination

• increase in thirst and sweating

• increase in heart rate

• dizziness, light headedness, drowsiness, restlessness or irritability increase in thirst and sweating

• swelling of hands ankles and feet

• headache

• difficulty breathing or breathlessness which may worsen when lying down

• Muscle weakness, twitching, rigidity or convulsions

Emergency measures

In the event of a fluid or solute overload during parenteral therapy, revaluate the patient's condition and initiate appropriate corrective treatment.

Pharmacotherapeutic group: Parenteral Preparation for fluid and electrolyte imbalance Sodium Chloride Injections provides electrolytes and a source of water for hydration. They are capable of inducing dieresis depending on the clinical condition of the patient. Sodium, the major action 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.

Excess sodium is mainly excreted by the kidney, and small amounts are lost in the faeces and sweat.

Special populations:

Hepatic impairment:

Select dosage with extreme caution in liver cirrhosis

Renal insufficiency:

Select dosage with extreme caution in diminished renal function or severe renal insufficiency; monitor sodium concentrations

Elderly subjects:

Select dosage with caution, usually initiating at the lower end of the usual range, because of age-related decreases in hepatic, renal, and/or cardiac function and of concomitant disease or drug therapy.

Not relevant

Water for injections

Many injectable drugs cannot be mixed together with 3%W/V Sodium Chloride, as some drugs cannot be safely diluted. Incompatibility can involve in precipitation, ionic reactions, evolution of gas and denaturation of biological molecules. Knowledge of added drug compatibility is needed before mixing drugs. If drugs mixed together, the mixture should be inspected for precipitations, turbidity or change in colour, however not all incompatibilities are visible.

Do not store above 30°C.

Before administration, the product should be visually inspected for any particulate matter and discoloration.

For single use only.

Any unused solution should be discarded.