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, non-electrolyte solution formulated specifically for urological irrigation during transurethral surgical procedures, such as transurethral resection of the prostate (TURP). This solution contains glycine at a concentration of 1.5% (15 g/L), dissolved in water for injection, and is provided in a 3000 ml plastic bag for continuous irrigation use.

• Purpose: Glycine irrigation is used to distend the urinary tract, clear surgical sites of blood and tissue debris, and provide a clear visual field during urological procedures.
• Composition: Each 1000 mL contains 15 grams of glycine (aminoacetic acid), an amino acid that is not metabolized into ions, making it ideal for use where electrolyte-free solutions are necessary.
• Formulation: It is a non-electrolyte, hypotonic solution, which helps prevent electrical conduction through irrigation fluid, thus allowing its safe use with electrosurgical instruments.
• Packaging: Supplied in 3000 ml plastic bags that are intended for single-use only in medical facilities.

This solution is particularly useful in procedures involving electrosurgical resection because it reduces the risk of electrical conductivity and provides an optimal operative environment. It is not intended for intravenous use and should not be administered systemically.

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

1.5% Glycine Irrigation Solution U.S.P. is intended for use by qualified healthcare professionals in controlled surgical environments, specifically for urological irrigation. It is not suitable for parenteral or intravenous use. Proper usage technique ensures the safety and effectiveness of the procedure.

• Preparation: Check the solution for particulate matter or discoloration before use. Do not use if the solution is cloudy or the container is damaged.
• Connection: Connect the irrigation bag to the urological irrigation system using aseptic technique. Prime the tubing to remove air bubbles before insertion.
• Administration: The irrigation fluid should be allowed to flow into the bladder or surgical site via gravity or pressure-assisted systems, as required by the surgical procedure.
• Monitoring: Monitor fluid input and output during the procedure to avoid overdistension or absorption-related complications such as hyponatremia or fluid overload.
• Disposal: Any unused solution should be discarded after the procedure. Do not reuse or re-sterilize the container.

The volume and duration of irrigation depend on the specific procedure and the surgeon's preference. Close monitoring is essential to detect early signs of fluid absorption or systemic complications.

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

The therapeutic utility of 1.5% Glycine Irrigation Solution lies in its non-conductive, hypotonic nature and its inert physiological properties. It serves as a physical medium for irrigation without contributing to significant systemic changes when absorbed in limited quantities.

• Non-electrolytic Action: Glycine does not contain electrolytes, making it safe to use with monopolar electrosurgical instruments by preventing unintended current transmission.
• Osmotic Characteristics: Being a hypotonic solution, it can be absorbed into the circulation if bladder mucosa is disrupted, potentially causing fluid and electrolyte imbalance in excessive quantities.
• Physiological Role: Glycine, a naturally occurring amino acid, acts as an inhibitory neurotransmitter in the central nervous system. In irrigation use, its systemic effects are minimal unless large volumes are absorbed.
• Safety Profile: Small amounts absorbed systemically are metabolized in the liver or excreted via the kidneys. However, excessive absorption may lead to glycine toxicity or TURP syndrome, especially in prolonged procedures.

Ultimately, its primary mode of action is mechanical—cleansing, flushing, and distending the urinary tract—rather than biochemical. It provides clear visualization and a safe operative field during endoscopic urologic procedures.

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

Since 1.5% Glycine Irrigation Solution is used topically in the surgical setting and is not administered systemically, drug interactions are relatively rare. However, systemic absorption may occur, especially during prolonged procedures or if mucosal integrity is compromised. Potential interactions include:

• Diuretics: Concomitant use of diuretics, especially loop diuretics, may exacerbate fluid and electrolyte disturbances if irrigation fluid is absorbed systemically.
• Lithium: Glycine may interact with lithium therapy due to its impact on electrolyte balance. Fluid overload or dilutional hyponatremia can alter lithium levels.
• Antihypertensives: Hypotension resulting from fluid absorption and dilutional effects may potentiate the action of antihypertensive drugs.
• Nephrotoxic agents: If glycine is absorbed and renal excretion is impaired, the risk of toxicity may increase when used alongside nephrotoxic medications.

Although interactions are minimal due to the route of administration, clinical vigilance is warranted, especially in patients with underlying renal, cardiac, or electrolyte disorders. Always inform the surgical and anesthesia teams of the patient's current medication profile.

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

Being an irrigation solution, 1.5% Glycine is not dosed in the conventional pharmacologic sense. The amount used depends entirely on the surgical procedure and the clinical need for bladder irrigation or surgical site visibility.

• Typical Volume: Volumes of 3000 ml or more may be used during a single procedure, especially during TURP or other endoscopic urological surgeries.
• Administration Rate: Administer via gravity or controlled pressure systems, as per the requirements of the surgical procedure.
• Monitoring: Continuous monitoring of irrigation fluid input and output is essential to avoid fluid retention, especially in prolonged surgeries.
• Systemic Absorption: There is no "maximum dose," but clinicians must be aware of the potential for systemic absorption, particularly in surgeries where the mucosal barrier is breached.

Since this solution is not intended for systemic administration, the term "dosage" relates to the procedural requirements and the surgeon’s discretion. It must be used with proper aseptic technique and should not be reused once opened.

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

Although 1.5% Glycine Irrigation Solution is used externally within the body cavities, side effects may arise due to systemic absorption, particularly during long surgeries. Awareness of possible adverse effects is essential.

• TURP Syndrome: Absorption of large volumes may lead to dilutional hyponatremia, confusion, nausea, bradycardia, or seizures—a condition known as transurethral resection syndrome.
• Fluid Overload: Systemic absorption may result in pulmonary edema, hypertension, or congestive heart failure in susceptible individuals.
• Electrolyte Imbalance: The hypotonic nature of glycine may dilute serum sodium and potassium, affecting nerve and muscle function.
• Visual Disturbances: Transient visual impairment or blindness has been reported, possibly due to glycine’s neuroactive properties.
• Allergic Reactions: Although rare, hypersensitivity reactions may include rash, itching, or anaphylaxis.

Most side effects are preventable with careful fluid management and intraoperative monitoring. Any unusual symptoms post-surgery should be promptly evaluated for signs of fluid or electrolyte imbalance.

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

While generally safe when used as directed, certain situations and patient conditions warrant caution or complete avoidance of 1.5% Glycine Irrigation Solution. Contraindications include:

• Parenteral Administration: This solution is not suitable for intravenous use due to its hypotonic, non-electrolytic nature and potential for hemolysis.
• Known Hypersensitivity: Patients with a known allergy to glycine should not receive this product.
• Congestive Heart Failure or Renal Impairment: These patients are at increased risk of fluid overload and should be monitored extremely closely if irrigation is necessary.
• Severe Electrolyte Imbalance: Conditions such as hyponatremia may be exacerbated by the absorption of hypotonic fluids.
• Neurological Disorders: Due to the neuroactive nature of glycine, caution should be exercised in patients with seizure disorders or elevated intracranial pressure.

Proper preoperative assessment, fluid monitoring, and understanding of contraindications are critical in preventing serious complications associated with glycine irrigation.

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

Proper storage ensures the sterility, stability, and efficacy of 1.5% Glycine Irrigation Solution. Follow these guidelines for safe handling and storage:

• Temperature: Store at controlled room temperature between 15°C and 30°C (59°F to 86°F). Avoid freezing or excessive heat.
• Protection from Light: Although the solution is generally stable, it should be kept away from direct sunlight and UV exposure to maintain quality.
• Container Integrity: Use only if the solution is clear and the container is intact. Do not use if the plastic bag is damaged or leaking.
• Shelf Life: Refer to the product label for expiration date. Do not use past the indicated date.
• Post-Opening Use: Discard any unused portion after single use. Do not re-sterilize or reuse the bag.

Adhering to proper storage conditions preserves the sterility and effectiveness of the irrigation solution, ensuring safe usage during surgical procedures.