1.5% GLYCINE IRRIGATION SOLUTION U.S.P. _ Irrigation/Solution for

What is 1.5% GLYCINE IRRIGATION SOLUTION U.S.P. _

1.5% Glycine Irrigation Solution U.S.P. is a sterile, non-pyrogenic, and electrolyte-free aqueous solution of glycine used primarily as a urologic irrigating fluid. It is typically employed during transurethral surgical procedures, such as transurethral resection of the prostate (TURP) or bladder tumors, where it functions to irrigate, clear debris, and maintain visibility within the surgical field.

• Generic Name: Glycine 1.5%
• Form: Irrigation Solution
• Packaging: 2000 ml plastic bag, designed for continuous bladder irrigation
• Use: Specifically indicated for endoscopic urologic procedures to clear blood, tissue fragments, and maintain bladder distension
• Composition: Each 100 mL contains 1.5 g of glycine in water for injection

It is a non-conductive solution, making it suitable for use with electrosurgical devices. Glycine is a non-essential amino acid that is naturally occurring in the body and plays a role in protein synthesis and neurotransmission. Its hypotonicity facilitates distention of the bladder while reducing the risk of fluid overload from electrolyte absorption.

How to use 1.5% GLYCINE IRRIGATION SOLUTION U.S.P. _

1.5% Glycine Irrigation Solution U.S.P. is administered only for irrigation purposes and should not be used intravenously, intrathecally, or for any route other than urologic irrigation. It must be used under strict aseptic conditions by trained medical professionals, typically in operating or procedure rooms.

• Pre-procedure preparation: Ensure the bag is intact, free from particulate matter, and has not expired. Warm the solution to body temperature, if required.
• Connection: Connect the plastic bag to the irrigating system or urologic instrument using a sterile irrigation set. Ensure that the line remains closed when not actively irrigating.
• Administration: The flow rate depends on the procedure and physician’s discretion. Typically, gravity flow is used for gentle and controlled irrigation. Do not apply pressure to the bag unless the system is designed for controlled pressurized irrigation.
• During Procedure: Continuous monitoring is necessary to avoid overdistension of the bladder and signs of fluid absorption (TURP syndrome).
• Post-procedure: Discard any unused solution. Do not reuse partially used bags.

This solution is meant for short-term use during procedures. The volume used depends on the duration and extent of the surgical intervention. Strictly avoid systemic absorption or prolonged irrigation unless clinically indicated and closely monitored.

Mode of Action 1.5% GLYCINE IRRIGATION SOLUTION U.S.P. _

1.5% Glycine Irrigation Solution U.S.P. serves its purpose through mechanical and chemical actions during endoscopic surgical procedures, primarily in the genitourinary tract. Although not pharmacologically active in the conventional sense, glycine offers a range of advantages that contribute to surgical efficacy and safety.

• Non-conductive property: As an electrolyte-free solution, it does not conduct electricity, making it ideal for use with electrocautery and electrosurgical instruments. This minimizes the risk of electrical conduction injuries.
• Osmotic characteristics: Glycine is hypotonic compared to plasma, allowing it to distend the bladder gently without causing significant osmotic fluid shifts in the short term.
• Tissue compatibility: Glycine is a natural amino acid present in the body and is generally well tolerated by mucosal and urothelial tissues, reducing the risk of irritation.
• Visual clarity: Its clear, colorless solution enables enhanced visibility during surgery by flushing away blood, tissue fragments, and debris.
• Metabolism: If absorbed, glycine is metabolized primarily by the liver and kidneys, and excess amounts are excreted via the urine.

In summary, 1.5% Glycine acts as a surgical aid by maintaining a clear operative field, providing tissue distension, and minimizing electrical conduction. Its action is primarily physical, with minimal metabolic interference when used correctly.

1.5% GLYCINE IRRIGATION SOLUTION U.S.P. _ Interactions 1.5% GLYCINE IRRIGATION SOLUTION U.S.P. _

While 1.5% Glycine Irrigation Solution U.S.P. is not intended for systemic absorption, inadvertent absorption can lead to interactions and clinical consequences, especially during lengthy procedures. Hence, understanding potential drug interactions is essential.

• Diuretics: The use of loop or thiazide diuretics may exacerbate electrolyte imbalances if glycine is absorbed in significant quantities, potentially causing hyponatremia or fluid overload.
• Antihypertensive agents: Patients on beta-blockers or ACE inhibitors may experience exacerbated hypotension if glycine absorption leads to fluid or cardiovascular disturbances.
• Nephrotoxic drugs: Concomitant use of nephrotoxic medications (e.g., aminoglycosides, NSAIDs) may impair renal clearance of glycine and increase the risk of toxicity.
• Sodium-containing solutions: Co-use with sodium-rich IV infusions may require electrolyte monitoring to prevent sudden sodium shifts if glycine is absorbed.
• General anesthesia agents: Systemic absorption of glycine during procedures may alter fluid balance and influence the pharmacokinetics of anesthetic agents.

Though local irrigation solutions rarely interact directly with systemic drugs, significant absorption (e.g., in TURP syndrome) can provoke systemic symptoms. Monitor closely in at-risk patients or prolonged exposure.

Dosage of 1.5% GLYCINE IRRIGATION SOLUTION U.S.P. _

As an irrigation fluid, 1.5% Glycine Irrigation Solution U.S.P. does not have a fixed dose. Its administration is procedural-dependent and is governed by the type and length of the surgery. However, certain guidelines help ensure safe and effective use.

• Typical procedure use: Used during endoscopic urologic procedures (e.g., TURP, bladder tumor resections) for continuous bladder irrigation.
• Volume: The volume used may range from 500 ml to several liters, depending on procedural duration. A 2000 ml bag may be used in its entirety or partially.
• Flow rate: Controlled by gravity or an irrigation pump system. The rate should be adjusted based on surgical field visibility and patient response.
• Monitoring: Continuous observation for signs of overdistension, fluid absorption (especially during TURP), or changes in serum sodium levels is recommended.
• Duration: Use should be limited to the duration of the surgical procedure. Post-operative irrigation should be guided by clinical assessment.

The solution is not meant for systemic administration. Inadvertent absorption can lead to dilutional hyponatremia, fluid overload, and glycine toxicity. Hence, careful volume and patient monitoring is essential.

Possible side effects of 1.5% GLYCINE IRRIGATION SOLUTION U.S.P. _

Although 1.5% Glycine Irrigation Solution is generally safe when used correctly, inadvertent systemic absorption—particularly during prolonged procedures—can result in complications known as TURP syndrome. Understanding these risks is crucial for intraoperative monitoring.

• Neurological effects: Visual disturbances, confusion, headache, seizures, or even coma can occur due to glycine’s central nervous system depressant properties when absorbed systemically.
• Electrolyte imbalances: Absorption can cause dilutional hyponatremia, leading to hypotonicity and cerebral edema.
• Cardiovascular effects: Bradycardia, hypertension, arrhythmias, or hypotension may occur, especially in fluid overload states.
• Gastrointestinal symptoms: Nausea and vomiting may present post-operatively in cases of minor systemic exposure.
• Respiratory distress: In rare instances, pulmonary edema may occur due to volume overload.

Most side effects are associated with excessive absorption of the solution during procedures. Prompt identification and intervention can prevent progression to severe TURP syndrome. Close intraoperative monitoring and use in experienced settings are essential to mitigate risk.

1.5% GLYCINE IRRIGATION SOLUTION U.S.P. _ Contraindications 1.5% GLYCINE IRRIGATION SOLUTION U.S.P. _

Though generally safe when used appropriately, 1.5% Glycine Irrigation Solution U.S.P. should be avoided or used with caution in certain patient populations or clinical situations.

• Hypersensitivity: Patients with known hypersensitivity to glycine or any component of the formulation should not receive this solution.
• Severe renal impairment: Patients with compromised renal function may not efficiently eliminate absorbed glycine, increasing the risk of systemic toxicity.
• Electrolyte imbalances: Avoid use in patients with existing hyponatremia or water intoxication, as glycine absorption can worsen these conditions.
• Increased intracranial pressure: Hypotonic solutions can exacerbate cerebral edema if absorbed systemically, posing risks in patients with neurological conditions.
• Use as intravenous fluid: This product is contraindicated for intravenous administration and must not be used as a volume expander.

Careful patient assessment and selection are critical before using this irrigation solution. Always ensure procedures are performed in controlled, well-monitored environments.

Storage of 1.5% GLYCINE IRRIGATION SOLUTION U.S.P. _

Proper storage of 1.5% Glycine Irrigation Solution U.S.P. is essential to maintain sterility, efficacy, and safety. Follow manufacturer and institutional guidelines for storage and handling.

• Temperature: Store at controlled room temperature, ideally between 15°C and 30°C (59°F to 86°F). Avoid excessive heat.
• Light protection: Though not highly photosensitive, store away from direct sunlight and fluorescent lighting when possible.
• Freezing: Do not freeze. Freezing may compromise container integrity and solution stability.
• Container inspection: Prior to use, inspect the plastic bag for leaks, discoloration, or particulate matter. Do not use if the bag appears damaged or cloudy.
• Shelf life: Use the solution before the expiration date printed on the label. Do not re-sterilize or reuse partially used bags.
• Handling: Maintain aseptic technique during handling and connection to prevent contamination.

Strict adherence to proper storage conditions ensures that the glycine solution retains its sterility and effectiveness during surgical procedures. Discard any unused portions after opening.