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.
There is currently no manufacturer warning information available for this drug.
1.5% Glycine Irrigation USP is indicated as an irrigant during transurethral prostatic or bladder surgery.
Each 100 mL contains:
Glycine USP …………………………………………………………………………. 1.5 g
Water for Injection USP …………………………………………………………. qs
pH: 6.1 (4.5-6.5)
Calculated Osmolarity: 200 mOsmol/liter
The formula of the active ingredient is:
| Ingredient | Molecular Formula | Molecular Weight |
|---|---|---|
| Glycine USP | NH2CH2COOH | 75.07 |
1.5% Glycine Irrigation USP is a sterile, nonpyrogenic aqueous solution suitable for urologic irrigation. This solution is slightly hypotonic.
The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers and exhibits virtually no leachability. The plastic container is also virtually impermeable to vapor transmission and therefore, requires no overwrap to maintain the proper drug concentration. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class Vl testing as specified in the U.S. Pharmacopeia for Biological Tests – Plastic Containers. These tests have shown that the container is nontoxic and biologically inert.
The PIC™ Container is PVC-free and DEHP-free.
