Description

A colorless solution

Pharmacodynamic properties

Sodium is the major cation of extracellular fluid and functions principally in the control of water distribution, fluid and electrolyte balance and osmotic pressure of body fluids. Chloride, the major extracellular anion, closely follows the physiological disposition of the sodium cation in maintenance of acid-base balance, isotonicity and electrodynamic characteristics of cells.

Pharmacokinetic properties

As the Sodium Chloride Intravenous preparations are directly administered to the circulation, the bioavailability of the components is 100%. Excess sodium is predominantly excreted by the kidneys, with small amounts lost in faeces and sweat.

Preclinical data on safety

Not applicable

Therapeutic indications

For the restoration and maintenance of salt and extracellular fluid levels or as a vehicle for the administration of parenteral drugs.

Posology and method of administration

To be used as directed by a physician.

Parenteral drug products should be inspected prior to administration for particulate matter and discolouration.

Dosage is dependant on the age, weight, clinical and fluid/electrolyte condition of the patient. Adult requirements are usually fulfilled by daily IV infusion of 1L 0.9% Sodium Chloride solution.

Adverse drug reactions

Thrombophlebitis may occur at the injection site during prolonged infusions.

Excess IV administration may cause hypernatraemia, hypokalaemia, or acidosis

If any adverse reactions are observed during administration, discontinue treatment and institute appropriate supportive treatment.

Hypernatraemia rarely occurs with therapeutic doses of sodium chloride, but may occur in excessive administration. A serious complication of this is dehydration of the brain causing somnolence and confusion, which may progress to convulsions, coma and ultimately respiratory failure and death. Other symptoms include thirst, reduced salivation and lachrymation, fever, tachycardia, hypertension, headache, dizziness, restlessness, weakness and irritability.

Contra-indications

congestive heart failure

severe renal impairment

conditions of sodium retention and oedema

liver cirrhosis

Precautions and warnings

Solutions containing sodium chloride should be used cautiously in patients with cardiovascular or renal disease, pregnancy associated hypertension, pulmonary or peripheral oedema, those receiving corticosteroids or corticotrophin or any condition associated with sodium retention.

Sodium chloride solutions should be used with caution in geriatric patients and infants.

Excessive administration of sodium chloride solution may result in hypokalaemia. Monitoring of fluid, electrolyte and acid-base balance may be necessary.

When used as a vehicle for intravenous drug delivery, the Product Information document of such drugs should be checked prior to use to ensure compatibility with the sodium chloride solution. Reconstitution instructions should be read carefully.

Do not use unless the solution is clear.

Carcinogenicity/Mutagenicity

The active ingredients sodium and chloride are not carcinogenic or mutagenic. They are basic cellular components.

Use in Pregnancy:

Safety in pregnancy has not been established. Use is recommended only when clearly indicated.

Use in Lactation:

Safety in lactation has not yet been established. Use of this product whilst breastfeeding is recommended only when potential benefits outweigh potential risks to the newborn.

Interactions with other pharmaceuticals and other interactions

Additives may be incompatible with sodium chloride.

Do not store solutions containing additives unless compatibility has been proven.

Do not administer such preparations unless the solution is clear.

Overdosage and other misuse

Excess Sodium Chloride within the body may produce the following general gastrointestinal effects: nausea, vomiting, diarrhoea and cramps.

Salivation and lacrimination are reduced, whilst thirst and swelling are increased.

Possible other symptoms include hypotension, tachycardia, renal failure, peripheral and pulmonary oedema and respiratory arrest.

Symptoms of the CNS include headache, dizziness, irritability, restlessness, weakness, muscle twitching or rigidity, convulsions, coma and death.

Storage

Store in a dry place below 25 °C.

Protect from light.

Keep out of reach of children.

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