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

Method of administration:
1.5% Glycine Irrigation, B.P should be administered only by transurethral instillation with
appropriate urologic instrumentation. A disposable irrigation set should be used. The total volume
of solution used for irrigation is solely at the discretion of the surgeon.
Height of container(s) above the operating table in excess of 60 cm (approx. 2 ft.) has been
reported to increase intravascular absorption of the irrigating fluid.

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.

PRECAUTIONS
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.

•  Additives may be incompatible with Sodium Chloride Irrigation Solution 0.9%.
•  Product Information documents of intended medications for mixing should be checked

beforehand to avoid incompatibility.

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.
Use in Lactation
Safety in lactation has not been established. Use of this product during breast feeding is
recommended only when potential benefits outweigh potential risks to the newborn.
Caution should be exercised when Glycine Irrigation, USP is administered to a nursing woman.
 

Not relevant.

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.

In the event of over hydration or solute overload, re-evaluate the patient and institute appropriate
corrective measures. See WARNINGS, PRECAUTIONS and ADVERSE REACTIONS.

Glycine is an amino acid and a nonelectrolyte. A solution of glycine in water is therefore
nonconductive and suitable for urologic irrigation during electrosurgical procedures.
A 1.5% concentration of glycine in water (200 mOsmol/liter calc.) is sufficient to minimize the
risk of intravascular hemolysis which can occur from absorption of plain water through open
prostatic veins during transurethral resection (TUR). It is hypotonic in relation to the extracellular
fluid (280 mOsmol/liter). Any solution absorbed intravascularly during transurethral prostatic or
bladder surgery, although variable in amount depending primarily on the extent of surgery, will be
excreted by the kidney. Studies have shown that the absorption of glycine does not cause
significant hemolysis (increase of free hemoglobin) or release significant amounts of free ammonia
in the blood. Glycine is rapidly degraded in the liver by glycine oxidase.
Water is an essential constituent of all body tissues and accounts for approximately 70% of total
body weight. Average normal adult daily requirement ranges from two to three liters (1.0 to 1.5
liters each for insensible water loss by perspiration and urine production).
Water balance is maintained by various regulatory mechanisms. Water distribution depends
primarily on the concentration of electrolytes in the body compartments and sodium (Na+) plays a
major role in maintaining physiologic equilibrium.

Group: solvents and diluting agents including irrigating solutions
Pharmacotherapeutic group Code: B05CX03

Any solution absorbed intravascularly during transurethral prostatic or bladder surgery, although
variable in amount depending primarily on the extent of surgery, will be excreted by the kidney.

Not relevant

Not applicable .

• Additives may be incompatible.
•  Product Information documents of intended medications for mixing should be checked

beforehand to avoid incompatibility.

• Additives may be incompatible. Consult with pharmacist, if available. When

introducing additives, use aseptic technique, mix thoroughly and do not store.

Do not store above 30°C.

2000 or 3000 ml NON-PVC bag.

Before use, the product should be visually inspected for any particulate matter and discoloration.
For single use only.
Any unused solution should be discarded.