Dextrose Injection Product Monograph

PRECAUTIONS

Electrolyte deficits, particularly in serum potassium and phosphate, may occur during prolonged use of concentrated dextrose solutions. Blood electrolyte monitoring is essential, and fluid and electrolyte imbalances should be corrected. Essential vitamins and minerals should also be provided as needed.

Hyperglycemia and consequently glycosuria may occur with excessive administration. To minimize hyperglycemia and consequent glycosuria, it is desirable to monitor blood and urine glucose and, if necessary, add insulin.

When concentrated dextrose infusion is abruptly withdrawn, it is advisable to follow with the administration of 5% or 10% dextrose injection to avoid rebound hypoglycemia.

Solutions containing dextrose should be used with caution in patients with known subclinical or overt diabetes mellitus.

Care should be exercised to insure that the needle is well within the lumen of the vein and that extravasation does not occur. If thrombosis should occur during administration, the injection should be stopped and corrective measures instituted.

Concentrated dextrose solutions should not be administered subcutaneously or intramuscularly.

Pregnancy

Animal reproduction studies have not been conducted with dextrose. It is also not known whether dextrose can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Dextrose should be given to a pregnant woman only if the benefits outweigh the risks.

ADVERSE REACTIONS

Hyperosmolar syndrome, resulting from excessively rapid administration of concentrated dextrose, may cause mental confusion and/or loss of consciousness (see WARNINGS).

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.

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.

OVERDOSAGE

In the event of overhydration or solute overload during therapy, re-evaluate the patient and institute appropriate corrective measures. See WARNINGS and PRECAUTIONS.

DOSAGE AND ADMINISTRATION

Peripheral Vein Administration

Injection of the solution should be made slowly.

The maximum rate at which dextrose can be infused without producing glycosuria is 0.5 g/kg of body weight/hour. About 95% of the dextrose is retained when infused at a rate of 0.8 g/kg/hr.

In insulin-induced hypoglycemia, intravenous injection of 10 to 25 g of dextrose (20 to 50 mL of 50% dextrose) is usually adequate. Repeated doses and supportive treatment may be required in severe cases. A specimen for blood glucose determination should be taken before injecting the dextrose. In such emergencies, dextrose should be administered promptly without awaiting pretreatment test results.

Central Venous Administration

For total parenteral nutrition, Dextrose Injection is administered by slow intravenous infusion: (a) After admixture with amino acid solutions via indwelling catheter with the tip positioned in a large central vein, preferably the superior vena cava, or (b) After dilution with sterile water for injection. Dosage should be adjusted to meet individual patient requirements.

Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation.

The maximum rate of dextrose administration which does not result in glycosuria is the same as cited above.

STORAGE RECOMMENDATIONS

Product should be stored between 15 to 25°C. Protect from freezing and excessive heat.

Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration, whenever solution and container permit.

Do not use unless solution is clear and container or seal intact. Discard if it contains a precipitate.

Single-use; discard unused portion.

AVAILABILITY

Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration, whenever solution and container permit. Do not use unless the solution is clear and seal is intact. Discard unused portion.

Dextrose Injection is a sterile nonpyrogenic, hypertonic solution of dextrose in water for injection for intravenous injection as a fluid and nutrient replenisher.

Each 100 mL of fluid contains 50 g of dextrose monohydrate which delivers 3.4 kcal/g. The solution has an osmolarity of 2526 mOsm/L (calc.), an approximate pH of 4.2 and may contain sodium hydroxide and hydrochloric acid for pH adjustment. The solution contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and is intended only for use as a single-use injection. When smaller doses are required, the unused portion should be discarded with the entire unit.

Dextrose Injection, 50% w/v, is supplied in single-use vial as follows:

REFERENCES

1. 1. 50% Dextrose Injection USP, Control No.: 186993, Prescribing Information, Hospira Healthcare Corporation.

MORE INFORMATION

If you want more information about Dextrose Injection:

• Talk to your healthcare professional
• Find the full Prescribing Information that is prepared for healthcare professionals by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the Manufacturer’s website www.omegalaboratory.com, or by calling 1-800-363-0584.

Omega Laboratories Limited

Montreal, Quebec, Canada, H3M 3E4

Last Prepared: June 15, 2021