INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo DEXTROSE-FRESENIUS 50% (20 mL)
DEXTROSE-FRESENIUS 50% (50 mL)

SCHEDULING STATUS:
S1

PROPRIETARY NAME
(and dosage form):

DEXTROSE-FRESENIUS 50% (20 mL)
DEXTROSE-FRESENIUS 50% (50 mL)
Injection

COMPOSITION:
Each 20 mL contains 10 g of
Dextrose anhydrous
Each 50 mL contains 25 g of Dextrose anhydrous

PHARMACOLOGICAL CLASSIFICATION:
A. 24 Mineral substitutes, electrolytes.

PHARMACOLOGICAL ACTION:
Dextrose may be used to adjust the osmotic pressure of dialysis fluids and injections.

INDICATIONS:
Acute management of hypoglycaemia or insulin induced hypoglycaemic coma.

CONTRA-INDICATIONS:
The use of hyperosmotic glucose solutions is contra-indicated in patients with anuria, intracranial or intraspinal haemorrhage and in delirium tremens where there is dehydration.
It has been suggested that glucose solutions should not be used after acute ischaemic strokes as hyperglycaemia has been implicated in increasing cerebral ischaemic brain damage and in impairing recovery.
Dextrose should be administered with care to patients with diabetes insipidus.
It is contra-indicated in patients with the glucose-galactose malabsorption syndrome. Dextrose tolerance may be impaired in patients with renal failure or kidney damage.
Safety in pregnancy and lactation has not been established.

WARNINGS:

DOSAGE AND DIRECTIONS FOR USE:
Dextrose should not be mixed with whole blood - haemolysis and clumping have occurred. Do not add certain medicaments to the injection with which it is incompatible e.g. warfarin sodium, Vit B
12, sodium bicarbonate, kanamycin sulphate and novobiocin sodium. The amount of dextrose required can be determined only by continued observation of the patient and repeated checking of the indicators (systemic arterial and venous pressures, urinary output, etc.). Dosage may (where time permits) be estimated by measuring the concentration of one of the extracellular fluid constituents (e.g. serum protein) and taking the increment over the normal value as an indication to the water deficit. The usual dose is 50 mL of a 50% m/v solution, which may be repeated if indicated, at a rate of 10 mL per minute given by central venous catheter.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Intravenous infusions of concentrated dextrose injections may cause local pain, vein irritation and thrombophlebitis. Tissue necrosis may occur following extravasation.
Intravenous infusion can lead to the development of fluid and electrolyte disturbances including hypokalaemia, hypomagnesaemia and hypophosphataemia.
Rapid intravenous administration of solutions of glucose may lead to glycosuria. Use only very large veins and administer slowly. 50% m/v Dextrose can be a sclerosing agent and will cause thrombosis. Monitor blood glucose, potassium and sodium levels. When administered slowly, in small doses, acidosis, alkalosis, hypoglycaemia (after infusion), hyperglycaemia (during infusion), hyperosmolar syndrome (mental confusion loss of consciousness), hypokalaemia, hypovitaminosis and thrombosis may occur.
Prolonged and rapid administration of hyperosmotic solutions may result in dehydration as a consequence of the induced hyperglycaemia.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See under side-effects and special precautions. Treatment is symptomatic and supportive.

IDENTIFICATION:
Clear, colourless to straw-coloured solution for injections.

PRESENTATION:
Containers containing ten 20 mL clear glass ampoules.
Containers containing five 50 mL clear glass ampoules.
Containers with sixty plastic bags (50 mL in 100 mL bags)

STORAGE INSTRUCTIONS:
Store below 25°C.
Keep out of reach of children.

REGISTRATION NUMBER:
V/24/222 - 20 mL
V/24/223 - 50 mL

NAME AND BUSINESS ADDRESS OF APPLICANT:
BODENE (PTY) LIMITED trading as Intramed, 6 Gibaud Road,
Port Elizabeth, 6001, South Africa

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
September 1989

        12-144/12-01
        Pro-Print

Updated on this site: March 2005
Source: State Pharmacy

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