Glycine

INDICATIONS AND USAGE 1.5% Glycine Irrigation USP is indicated as an irrigant during transurethral prostatic or bladder surgery.

DOSAGE AND ADMINISTRATION As required for irrigation. 1.5% Glycine Irrigation USP should be administered only by the appropriate transurethral urologic instrumentation. It has been reported that absorption is significantly increased if the container is higher than 60 cm (24 inches) above the patient. This drug product should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

CONTRAINDICATIONS 1.5% Glycine Irrigation USP is not for injection. It is contraindicated in patients with anuria.

WARNINGS Solutions for urologic irrigation must be used with caution in patients with severe cardiopulmonary or renal dysfunction. The amount of fluid absorbed during a transurethral resection is a function of the volume and hydrostatic pressure of the irrigant used, the number and size of venous sinuses opened, and the duration of the procedure. Since irrigating fluids used during transurethral prostatectomy have been demonstrated to enter the systemic circulation in relatively large volumes, any irrigation solution must be regarded as a systemic drug. Absorption of large amounts of fluids containing glycine and the resultant osmotic diuresis may significantly affect cardiopulmonary and renal dynamics. Absorption of large amounts of irrigating solution can also result in pronounced hyponatremia and water intoxication. After opening container, the contents should be used promptly to minimize the possibility of bacterial growth or pyrogen formation. Discard unused portion of irrigating solution since it contains no preservative.

ADVERSE REACTIONS Adverse reactions may include fluid and electrolyte disorders such as acidosis, electrolyte loss, marked diuresis, urinary retention, edema and dehydration; cardiovascular/pulmonary disorders such as pulmonary congestion, hypotension, tachycardia, angina-like pain and thrombophlebitis; other possible reactions include visual disturbances, convulsions, nausea, vomiting, diarrhea, vertigo and urticaria. Literature includes reports on hyponatremia, hyperammonemia, transient blindness, coma (immediate or delayed), and digitalis toxicity in digitalized patients. If an adverse reaction occurs, discontinue the irrigant and reevaluate the clinical status of the patient.