Glycine

1.5% Glycine Irrigation, USP is indicated for use as irrigating fluid during transurethral prostatic resection and other transurethral surgical procedures.

NOT FOR INJECTION BY USUAL PARENTERAL ROUTES. Do not use in patients with anuria.

FOR UROLOGIC IRRIGATION ONLY. Solutions for urologic irrigation must be used with caution in patients with severe cardiopulmonary or renal dysfunction. Irrigating fluids used during transurethral prostatectomy have been demonstrated to enter the systemic circulation in relatively large volumes. Thus, glycine irrigating solution must be regarded as a systemic drug. Absorption of large amounts of fluids containing glycine may significantly alter cardiopulmonary and renal dynamics. Do not heat container over 66°C (150°F).

Cardiovascular status, especially of the patient with cardiac disease, should be carefully observed before and during transurethral resection of the prostate when using glycine 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. Shift of sodium free intracellular fluid into the extracellular compartment following systemic absorption of solution may lower serum sodium concentration and aggravate pre-existing hyponatremia. Care should be exercised if impaired liver function is known or suspected. Under such conditions, ammonia resulting from metabolism of glycine may accumulate in the blood. Aseptic technique is essential with the use of sterile solutions for irrigation. The administration set should be attached promptly. Unused portions should be discarded and a fresh container of appropriate size used for the start-up of each cycle or repeat procedure. Do not administer unless solution is clear, seal is intact and container is undamaged. Discard unused portion. Carcinogenesis, Mutagenesis, Impairment of Fertility: Studies with Glycine Irrigation, USP have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility. Nursing Mothers: Caution should be exercised when Glycine Irrigation, USP is administered to a nursing woman. Pregnancy: Teratogenic Effects. Pregnancy Category C. Animal reproduction studies have not been conducted with Glycine Irrigation, USP. It is also not known whether Glycine Irrigation, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Glycine Irrigation, USP should be given to a pregnant woman only if clearly needed. Pediatric Use: The safety and effectiveness of Glycine Irrigation have not been established. Its limited use in pediatric patients has been inadequate to fully define proper dosage and limitations for use.

Adverse reactions may result from intravascular absorption of glycine. Large intravenous doses of glycine are known to cause salivation, nausea and lightheadedness. Other consequences of absorption of urologic irrigating solutions include fluid and electrolyte disturbances such as acidosis, electrolyte loss, marked diuresis, urinary retention, edema, dryness of mouth, thirst, dehydration, coma from hyponatremia, secondary hyponatremia due to fluid overload, and hyperammonemia with resultant coma and/or encephalopathy; cardiovascular disorders such as hypotension, tachycardia, angina-like pains; pulmonary disorders such as pulmonary congestion; and other general reactions such as blurred vision, convulsions, nausea, vomiting, rhinitis, chills, vertigo, backache, transient blindness and urticaria. Allergic reactions from glycine are unknown or exceedingly rare. Should any adverse reaction occur, discontinue the irrigant, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.

Teratogenic Effects. Pregnancy Category C. Animal reproduction studies have not been conducted with Glycine Irrigation, USP. It is also not known whether Glycine Irrigation, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Glycine Irrigation, USP should be given to a pregnant woman only if clearly needed.

Caution should be exercised when Glycine Irrigation, USP is administered to a nursing woman.

The safety and effectiveness of Glycine Irrigation have not been established. Its limited use in pediatric patients has been inadequate to fully define proper dosage and limitations for use.