GLUCOSE 20% Solution for infusion Ref.[9426] Active ingredients: Glucose

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: hameln pharma limited, Nexus Hurricane Lane, Gloucester Business Park, Gloucester, GL3 4AG, United Kingdom

Therapeutic indications

Glucose 20% is hypertonic (in vitro tonicity, in a container) and provides a source of calories in a minimal volume of water. Glucose 20% is frequently used in both adults and children to restore blood glucose concentrations in the treatment of hypoglycaemia resulting from insulin excess or from other causes.

Glucose 20% may be used to provide temporary relief from the symptoms of cerebral oedema and from hypoglycaemic coma. Hyperosmotic Glucose with or without insulin may also correct hyperkalaemia in renal failure.

Posology and method of administration

Dosage of Glucose depends on the age, weight, clinical condition of the patient.

Fluid and acid base balance, serum glucose, serum sodium, and other electrolytes may need to be monitored before and during administration, especially in patients with increased non-osmotic vasopressin release (syndrome of inappropriate antidiuretic hormone secretion, SIADH) and in patients co-medicated with vasopressin agonists due to the risk of hyponatraemia.

Monitoring of serum sodium is particularly important for physiologically hypotonic fluids (in vivo tonicity). Glucose 20 % may become extremely hypotonic after administration due to glucose metabolism in the body (see sections 4.4, 4.5, 4.8 and 5.2).

Posology

Adults and the elderly

For the reversal of hypoglycaemic coma. Up to 125ml of a 20% w/v solution.

As an energy source and in carbohydrate depletion. Up to 3 Litres per day dependent on the needs of the patient.

Paediatric population

Only to be used under the supervision of a paediatrician

Method of administration

Glucose 20% must be administered by the intravenous route; it must not be administered by subcutaneous or intramuscular route. Except in the emergency treatment of severe hypoglycaemia, Glucose 20% should be administered via a central vein.

Glucose 20% is provided in a concentration that is ready for administration.

Overdose

Overdose of Glucose 20% may lead to hyperglycaemia and glycosuria leading to dehydration, hyperosmolar coma and death.

The blood levels of glucose can be reduced by slow infusion of insulin. Careful monitoring of blood glucose levels would be necessary.

Shelf life

Shelf life: 48 months.

Special precautions for storage

Do not store above 25°C. Keep the bottle in the outer carton in order to protect from light.

Nature and contents of container

100ml type I clear colourless glass infusion bottle with rubber stopper and cap, packed in cardboard cartons to contain 1, 10 or 25 vials x 100ml.

Not all pack sizes may be marketed.

Special precautions for disposal and other handling

Use as directed by the physician.

Glucose 20% is provided in a concentration that is ready for administration.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

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