Glycine 1.5 g/100mL Solution, 3000 mL — NDC 0338-0289-47 (Billing 00338-0289-47)

WARNINGS Not for injection. 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 1.5% Glycine Irrigation, USP must be regarded as a systemic drug.

Absorption of large amounts of fluids containing glycine may significantly alter cardiopulmonary and renal dynamics. Careful cardiovascular monitoring should be maintained due to the possibility of fluid overload. Should fluid overload occur, intensive fluid and electrolyte management is necessary.

Monitoring of fluid and electrolyte levels beyond the acute phase may be considered due to the possibility of delayed fluid absorption. (See ADVERSE REACTIONS, Post-Marketing Experience). The contents of an opened container should be used promptly to minimize the possibility of bacterial growth or pyrogen formation.

Discard the unused portion of irrigating solution since no antimicrobial agent has been added.

ADVERSE REACTIONS 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 adverse reactions occur, discontinue the irrigation and re-evaluate the clinical status of the patient. Post-Marketing Experience Following off-label use of 1.5% Glycine Irrigation, USP for hysteroscopic procedures in women, life-threatening adverse events related to fluid overload have been reported.

PRECAUTIONS The cardiovascular status, especially of the patient with cardiac disease, should be carefully observed before and during transurethral resection of the prostate when using 1.5% Glycine Irrigation, USP, because the quantity of fluid absorbed into the systemic circulation by opened prostatic veins may produce significant expansion of the intravascular fluid and lead to fulminating congestive heart failure. Shift of sodium-free intracellular fluid into the extracellular compartment, following systemic absorption, may lower serum sodium concentration and aggravate preexisting 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. Pregnancy Teratogenic Effects Animal reproduction studies have not been conducted with 1.5% Glycine Irrigation, USP.

It is not known whether 1.5% Glycine Irrigation, USP can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. 1.5% Glycine Irrigation, USP should be given to a pregnant woman only if clearly needed. Pediatric Use Safety and effectiveness in pediatric patients have not been established.

Geriatric Use Clinical studies of Irrigation Solutions did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from other younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Do not administer unless the solution is clear and the seal is intact.