Chemical Name: Sodium chloride Empirical Formula: NaCl Molecular Weight: 58.44 CAS registry number: 7647-14-5 Structure: Na Cl
Sodium Chloride Injection 20% is a sterile hypertonic solution of sodium chloride in Water for Injections, pH 4.5 to 7.0, containing no preservatives.
As an additive to parenteral fluids in patients who have specific electrolyte needs. As a sclerosing agent for small symptomatic varicose veins.
*CONTRAINDICATIONS
Congestive heart failure Severe renal impairment
Conditions of sodium retention and oedema Liver cirrhosis
Sodium Chloride Injection 20% is hypertonic and must be diluted before use. Do not use unless the solution is clear. The entire contents of the ampoule should be used promptly. Any solution remaining should be discarded. Excessive administration of sodium chloride causes hypernatraemia, resulting in dehydration of internal organs, hypokalaemia and acidosis. *Monitoring of fluid, electrolyte and acid-base balance may be necessary. Congestive heart failure and pulmonary oedema may be precipitated, particularly in patients with cardiovascular disease or those receiving corticosteroids, *corticotrophin or other drugs that may give rise to sodium retention. Sodium chloride should be administered with care to patients with congestive heart failure, *hypertension, peripheral or pulmonary oedema, *hypoproteinaemia, impaired renal function, *urinary tract obstruction, pre-eclampsia and very young or elderly patients.
*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 drugs
Sodium Chloride Injection 20% may be incompatible with other solutions and drugs, the product information document of each solution or drug should be checked prior to use to ensure compatibility with the sodium chloride solution.
Co medication of drugs inducing sodium retention may exacerbate any systemic effects.
Proper use of hypertonic saline as an additive to parenteral fluids for electrolyte replacement is unlikely to result in adverse effects. Inadvertent administration of hypertonic sodium chloride solutions may result in sudden hypernatraemia and potential complications such as cardiovascular shock, CNS disorders, extensive haemolysis and cortical necrosis of kidney.
*A serious complication of hypernatraemia is dehydration of the brain causing somnolence and confusion, which may progress to convulsions, coma and ultimately respiratory failure and death. Pulmonary embolism or pneumonia may also result. Other symptoms include thirst, reduced salivation and lacrimation, fever, tachycardia, hypertension, headache, dizziness, restlessness, weakness and irritability.
If any adverse experience is observed during administration, discontinue infusion, evaluate the patient *and institute appropriate supportive treatment.
The dosage of sodium chloride as an additive in intravenous fluids must be calculated after consideration of clinical and laboratory data. The correct volume of sodium chloride 20% is then aseptically withdrawn and diluted to the required concentration by addition to an appropriate IV solution such as 5% dextrose. The final solution should be administered within 4 hours. Sclerotherapy: inject required volume and concentration of hypertonic sodium chloride solution into the affected vein and apply a compression bandage.
Excess sodium chloride in the body produces general gastrointestinal effects of nausea, vomiting, diarrhoea and cramps. Salivation and lacrimation are reduced, while thirst and sweating are increased. Hypotension, tachycardia, renal failure, peripheral and pulmonary oedema and respiratory arrest may occur. CNS symptoms include headache, dizziness, restlessness, irritability, weakness, muscular twitching and rigidity, convulsions, coma and death.
Normal plasma sodium concentrations should be carefully restored at a rate not greater than 10 - 15 mmol/day using IV hypotonic saline. Dialysis may be necessary if there is significant renal impairment, the patient is moribund or plasma sodium levels are greater than 200 mmol/L. Convulsions are to be treated with IV diazepam.
Polyamp DuoFit: 20% w/v, 10 mL x 50
Store below 30C.
Unscheduled
AstraZeneca Pty Ltd ABN 54 009 682 311 Alma Road North Ryde NSW 2113 Australia Polyamp DuoFit(r) is a trade mark of the AstraZeneca group of companies 19 February 1993 Date of safety related notification 22 May 2003 Date of most recent amendment 16 February 2004
* Please note changes in Product Information