Glycine, aminoacetic acid is an amino acid and a nonelectrolyte solution indicated for use as an irrigating fluid during transurethral prostatic resection and other transurethral surgical procedures. As a nonconductive solution in water, glycine, aminoacetic acid is suitable for urologic irrigation during electrosurgical procedures. Glycine, aminoacetic acid solution is hypotonic (200 mOsmol/L) in relation to the extracellular fluid (280 mOsmol/L). When used during a transurethral resection of the prostate, glycine, aminoacetic acid instillation minimizes the risk of intravascular hemolysis, which can occur from absorption of plain water through open prostatic veins. Systemic absorption is minimal but poses a greater risk in patients with cardiopulmonary, renal, or hepatic disease.
General Administration Information
For storage information, see the specific product information within the How Supplied section.
Route-Specific Administration
Other Administration Route(s)
Transurethral Instillation
-Visually inspect product prior to administration; do not administer unless solution is clear, seal is intact, and container is undamaged.
-Administer only by transurethral instillation with appropriate urologic instrumentation; a disposable irrigation set should be used.
-Aseptic technique is essential with the use of sterile solutions for irrigation. The administration set should be attached promptly.
-Placing the irrigation container at a height in excess of 60 cm (approximately 2 feet) above the operating table has been associated with an increase in intravascular absorption of the irrigation fluid.
-Do not heat container over 66 degrees C (150 degrees F).
-Storage: Discard unused portion. Use a fresh container of appropriate size for the start-up of each cycle or repeat procedure.
Fluid and electrolyte disturbances such as metabolic acidosis, electrolyte loss, marked diuresis, urinary retention, edema, dehydration, coma from hyponatremia, secondary hyponatremia due to fluid retention, and hyperammonemia with resultant coma and/or encephalopathy may result from intravascular absorption of glycine, aminoacetic acid. Discontinue glycine, aminoacetic acid, evaluate the patient, and institute appropriate therapeutic countermeasures if any adverse reaction occurs.
Cardiovascular disorders such as angina-like pain, hypotension, and sinus tachycardia may result from intravascular absorption of glycine, aminoacetic acid. Discontinue glycine, aminoacetic acid, evaluate the patient, and institute appropriate therapeutic countermeasures if any adverse reaction occurs.
Large intravenous doses of glycine are known to cause lightheadedness. Other central nervous system or special senses adverse reactions such as blurred vision, transient blindness, seizures, and vertigo may result from intravascular absorption of glycine, aminoacetic acid. Discontinue glycine, aminoacetic acid, evaluate the patient, and institute appropriate therapeutic countermeasures if any adverse reaction occurs.
Large intravenous doses of glycine, aminoacetic acid are known to cause hypersalivation and nausea. Other gastrointestinal system adverse reactions such as polydipsia, vomiting, and xerostomia may result from intravascular absorption of glycine, aminoacetic acid. Discontinue glycine, aminoacetic acid, evaluate the patient, and institute appropriate therapeutic countermeasures if any adverse reaction occurs.
General adverse reactions such as pulmonary congestion, back pain, chills, rhinitis, and urticaria may result from intravascular absorption of glycine, aminoacetic acid. Allergic reactions from glycine are unknown or exceedingly rare. Discontinue glycine, aminoacetic acid, evaluate the patient, and institute appropriate therapeutic countermeasures if any adverse reaction occur.
Glycine, aminoacetic acid is for irrigation use only. Parenteral administration of glycine, aminoacetic acid is contraindicated.
Glycine, aminoacetic acid is contraindicated in patients with anuria. Use glycine, aminoacetic acid with caution in patients with severe renal impairment or renal failure. Relatively large volumes of irrigating fluids enter the systemic circulation when used during transurethral prostatectomy. Accumulation of large volumes of fluids containing glycine may significantly alter renal dynamics.
Use glycine, aminoacetic acid with caution in patients with severe cardiac disease or severe pulmonary disease. Relatively large volumes of irrigating fluids enter the systemic circulation when used during transurethral prostatectomy. Accumulation of large volumes of fluids containing glycine, aminoacetic acid may significantly alter cardiopulmonary dynamics. Monitor cardiovascular status, especially in the patient with cardiac disease, before and during transurethral resection of the prostate when using glycine, aminoacetic acid irrigating solution, because the quantity of fluid absorbed into the systemic circulation by opened prostatic veins may produce significant expansion of the extracellular fluid and lead to fulminating congestive heart failure.
Use glycine, aminoacetic acid with caution in patients with hepatic disease. In such patients, ammonia resulting from metabolism of glycine, aminoacetic acid may accumulate in the blood.
Shift of sodium free intracellular fluid into the extracellular compartment after systemic absorption of glycine, aminoacetic acid solution may lower serum sodium concentration and aggravate preexisting hyponatremia.
Use glycine, aminoacetic acid irrigation during pregnancy only if clearly needed. It is not known whether glycine, aminoacetic acid irrigation has the potential to cause fetal harm when administered to a pregnant woman or if it can affect reproduction capacity. Animal reproduction studies have not been conducted with glycine, aminoacetic acid irrigation.
Use glycine, aminoacetic acid with caution in a breast-feeding woman.
For use as urologic irrigation solution during transurethral prostatic resection and other transurethral surgical procedures:
Irrigation dosage:
Adults: Total volume of solution used for irrigation is at the discretion of the surgeon.
Maximum Dosage Limits:
-Adults
Total volume of solution used for irrigation is at the discretion of the surgeon.
-Geriatric
Total volume of solution used for irrigation is at the discretion of the surgeon.
-Adolescents
Safety and efficacy have not been established.
-Children
Safety and efficacy have not been established.
-Infants
Safety and efficacy have not been established.
-Neonates
Safety and efficacy have not been established.
Patients with Hepatic Impairment Dosing
Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.
Patients with Renal Impairment Dosing
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.
*non-FDA-approved indication
There are no drug interactions associated with Glycine, Aminoacetic Acid products.
Glycine, aminoacetic acid is an amino acid and a nonelectrolyte. As a nonconductive solution in water, glycine, aminoacetic acid is suitable for urologic irrigation during electrosurgical procedures. Glycine, aminoacetic acid solution is hypotonic (200 mOsmol/L) in relation to the extracellular fluid (280 mOsmol/L). When used during a transurethral resection of the prostate, glycine, aminoacetic acid instillation minimizes the risk of intravascular hemolysis, which can occur from absorption of plain water through open prostatic veins. Systemic absorption of glycine during bladder surgery does not cause significant hemolysis (increase of free hemoglobin) or release significant amounts of free ammonia into the blood.
Glycine, aminoacetic acid is administered by transurethral instillation. Glycine is rapidly degraded in the liver by glycine oxidase, and ammonia is produced as a result of this metabolism. Any glycine, aminoacetic acid absorbed intravascularly during an urologic surgical procedure is excreted by the kidney.
Affected cytochrome P450 isoenzymes and drug transporters: none
-Route-Specific Pharmacokinetics
Other Route(s)
Intravascular absorption of glycine, aminoacetic acid is expected during transurethral instillation in prostatic or bladder surgery, although amounts are variable and are largely dependent on the extent of surgery. Absorption of glycine, aminoacetic acid does not cause significant hemolysis (increase of free hemoglobin) or release significant amounts of free ammonia into the blood.
-Special Populations
Hepatic Impairment
Ammonia resulting from the hepatic metabolism of glycine, aminoacetic acid may accumulate in patients with hepatic impairment.
Renal Impairment
Absorption of large amounts of fluids containing glycine, aminoacetic acid can significantly alter renal dynamics.