GLUCOSE DEMOGEN

What it is

Baxter Glucose Intravenous (IV) Infusion preparations are sterile, non-pyrogenic parenteral solutions. They are supplied as clear slightly coloured solutions for intravenous infusion. Glucose 5% intravenous infusion is an isotonic solution, whereas Glucose ≥10% intravenous infusions are hypertonic.

Approved indications —

Whenever non-electrolyte fluid replacement is required (isotonic 5% glucose preparations). — As a vehicle for drug delivery, provided that the added components are compatible with glucose (isotonic 5% glucose preparations). — As a source of energy incorporated with parenteral nutrition with minimal dilution effect (hypertonic ≥10% glucose preparations). — For use with an appropriate protein (nitrogen) source in the prevention of nitrogen loss or in the treatment of negative nitrogen balance in patients where the alimentary tract cannot or should not be used, gastrointestinal absorption of protein is impaired, or metabolic requirements for protein are substantially increased, as with extensive burns (hypertonic ≥10% glucose preparations).

Dosing overview

Baxter Glucose IV Infusion is to be used for intravenous administration as directed by the physician, with infusion rate and volume dependent upon the age, weight, concomitant therapy, clinical and metabolic conditions of the patient as well as laboratory determinations. Baxter Glucose 5% Intravenous Infusion may be administered intravenously to healthy individuals at a rate of 0.5 g/kg per hour without producing glycosuria; the maximum infusion rate should not exceed 0.8 g/kg per hour. For 50% glucose injection, the usual dose is 20–50 mL administered slowly, at a rate of 3 mL/minute.

Key safety warnings

Hypersensitivity and infusion reactions, including anaphylactic and anaphylactoid reactions, have been reported with Baxter Glucose IV Infusion. The infusion must be stopped immediately if any signs or symptoms of a suspected hypersensitivity reaction develop, and appropriate therapeutic countermeasures must be instituted as clinically indicated. Administration of Baxter Glucose IV Infusion can cause fluid and solute overloading resulting in dilution of serum electrolyte concentrations, over-hydration, congested states, or pulmonary oedema. Excessive administration of high concentration Baxter Glucose IV Infusion may result in significant hypokalaemia. Depending on volume and rate of infusion and patient factors, intravenous administration of glucose can cause hyperosmolality, osmotic diuresis, dehydration, hypoosmolality, and various electrolyte disturbances including hypokalaemia, hypophosphataemia, and hypomagnesaemia. Rapid administration of glucose solutions may produce substantial hyperglycaemia and a hyperosmolar syndrome. To avoid hyperglycaemia the infusion rate should not exceed the patient's ability to utilise glucose. To reduce the risk of hyperglycaemia-associated complications, the infusion rate must be adjusted and insulin administered if blood glucose levels exceed levels considered acceptable for the individual patient. A hypertonic glucose intravenous infusion, such as Baxter Glucose 10% IV Infusion, if undiluted, is intended to be administered via intravenous catheter in a large central vein. Prolonged intravenous infusion of hypertonic glucose solutions may cause thrombophlebitis extending from the site of infusion. Unless appropriately diluted, the infusion of hypertonic glucose injection solution into a peripheral vein may result in vein irritation, vein damage, and thrombosis.

Contraindications

Infusion of hypertonic glucose (≥10%) preparations are contraindicated in patients having intracranial or intraspinal haemorrhage, with delirium tremens or those who are severely dehydrated, who are anuric, or with diabetic coma. Infusion of both isotonic and hypertonic glucose preparations are contraindicated in patients who have had head trauma within 24 hours (with blood glucose concentrations being closely monitored during intracranial hypertension), with known hypersensitivity to the product, with known allergy to corn or corn products (because cornstarch is used as raw material for glucose production), or with clinically significant hyperglycaemia. Avoid use after an ischaemic stroke episode as under this condition, the induced lactic acidosis aggravates the recovery of the brain damage tissue.

Regulatory history

Baxter Glucose IV Infusion received initial approval on 30 September 1991. Multiple ARTG registrations are held, including ARTG 29599 for Glucose 5% 25 g/500 mL injection bag first listed on 21 October 1991, ARTG 29790 for Glucose 10% 50 g/500 mL injection bag first listed on 21 October 1991, and subsequent registrations for additional pack sizes and formulations in 1994 and 2008.