Dextrose  20% & 50%

Sterile, Concentrated Injection Solution (IV)

Dosage Form

50 ml single dose vial.

Drug Classification and Categories

Calorie supplier.

Dosage and Administration

The dose of dextrose depends on the age, weight, disease status, fluid status, electrolyte and acid-base balance of the patient. The usual rate of dextrose injection in children and adults is 0.5 g/kg/h and the maximum is 0.8 g/kg/h. For the treatment of hypoglycemic emergencies of any cause, in adults, 20-50 ml of 50% dextrose injection solution with a maximum rate of 3 ml/min is administered in IV form. The required dose for infants and children older than six months is 0.5-1 g/kg/dose and in infants under six months is 0.25-0.5 g/kg/dose of 20% dextrose injection solution which should be injected IV slowly.

Dextrose injection solution with a concentration of more than 10%, except in cases of severe hypoglycemia, should be diluted in an appropriate solvent. Concentrated dextrose should be administered via central vein only after suitable dilution in cases of hypoglycemic emergencies, the solution should be given slowly, preferably through a small bore needle into a large vein.

Indications

Energy supply by means of glucose, Therapy of hypoglycemia, Dextrose solution may be used to provide temporary relief from the symptoms of cerebral oedema and from hypoglycemic coma. Hyperosmotic glucose with or without insulin may also correct hyperkalemia in renal failure, 20% dextrose solution has been revealed to treat severe symptoms of hypoglycemia in infants and children.

Warnings

Under no situation should this product be injected intramuscularly (IM) or subcutaneously (SC). This product should never be injected into blood through a common infusion set.

Special care should be taken during injection to avoid leakage into the surrounding tissue.

Avoid infusion within the first 24 hours following head trauma.

Side Effects

Hypersensitivity/infusion reactions, anaphylactic reactions including reactions with mild manifestations, bronchospasm, angioedema; chills, infection at the site of injection, hyperglycemia, rash, infusion site (reactions, phlebitis, erythema). Hyponatremia (which may be symptomatic), hyponatremia, hypokalemia, hypophosphatemia, hypomagnesemia, overhydration and hypervolemia, thrombophlebitis, edema, extravasation. To reduce the risk of hyperglycemia-associated complications, the infusion rate must be adjusted to the level suitable to the patient’s ability to utilize glucose and/or insulin administered if blood glucose levels exceed levels considered acceptable for the individual patient.

Contraindications

 Glucose-galactose malabsorption syndrome, ischemic stroke, patients with delirium termenance, hyperglycemic coma, patients with hypersensitivity to any ingredient in the formulation or component of the container patients with known allergy to corn or corn products since dextrose in the product is purified from corn, patients having intracranial or intraspinal hemorrhage, patients who are severely dehydrated, patients who are anuric, patients in hepatic coma.

Pregnancy Category

Pregnancy Category C

Dextrose should be given to a pregnant woman if clearly needed.

Precautions

 Dextrose solutions should be used with precaution:

          •        In diabetic patients without clinical manifestations or with obvious symptoms, especially those patients with chronic uremia or carbohydrate intolerance, hypophosphatemia, and thiamine deficiency. Rapid injection should be avoided which may cause hyperglycemia, hyperosmolar syndrome and signs of mental confusion and loss of consciousness

          •        Prolonged use in parenteral nutrition may affect insulin production; blood and urine glucose should be monitored.

          •        Depending on the tonicity of the solution (the volume and rate of infusion) and depending on a patient's underlying clinical condition and capability to metabolize glucose, intravenous administration of glucose can cause electrolyte disturbances most importantly hypo-or hyperosmotic hypernatremia.

Drug Interactions

 Corticosteroids and corticotropins, amoxicillin, alteplase, caspofungin, co-amoxiclav, dantrolene, hydralazine, digoxin, furosemide, isoniazid, itraconazole, drugs stimulating vasopressin release such as chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors (SSRIs), 3.4-methylenedioxy-N-methamphetamine, ifosfamide, antipsychotics, and opioids.

Drugs potentiating vasopressin action such as non-steroidal anti-inflammatories (NSAIDS) and cyclophosphamide.

Vasopressin analogues such as desmopressin, oxytocin, vasopressin, terlipressin. Oxcarbazepine(antiepileptic).

Storage Conditions

 Store below 30°C and protect from freezing. The solution is clear and free of suspended particles do not use unless the solution is clear and seal is intact.

Discard unused portion. 

Packaging

Each box contains 50 vials with a volume of 50 ml and leaflets.