pharmacopeia

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Biological Macromolecular Activity.

Indications

Sourced from openFDA
  • 1.5% Glycine Irrigation, USP is indicated for use as irrigating fluid during transurethral prostatic resection and other transurethral surgical procedures.

Contraindications

Sourced from openFDA
  • NOT FOR INJECTION BY USUAL PARENTERAL ROUTES. Do not use in patients with anuria.contraindicated

Dosage & administration

Sourced from openFDA

1.5% Glycine Irrigation, USP 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. Drug Interactions Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution container permits. See PRECAUTIONS.

Warnings & precautions

Sourced from openFDA

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. Do not heat container over 66°C (150°F).

Adverse reactions

Sourced from openFDA

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.

Use in specific populations

Sourced from openFDA

Pregnancy: Teratogenic Effects. 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.

Overdosage

Sourced from openFDA

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

Approval history

Sourced from openFDA
  • Feb 6, 1978NDANDA016784B Braun
  • Feb 22, 1980NDANDA018315Otsuka Icu Medcl
  • May 30, 1980NDANDA017865Baxter Hlthcare
  • Jul 20, 1984NDANDA019018B Braun
  • Aug 23, 1984NDANDA018931Baxter Hlthcare
  • Sep 6, 1985NDANDA019398Otsuka Icu Medcl
  • Oct 17, 1986NDANDA019492Otsuka Icu Medcl
  • Dec 19, 1991NDANDA020041Otsuka Icu Medcl

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
1,019 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Nausea727.1%
  2. 2Parenteral Nutrition Associated Liver Disease504.9%
  3. 3Vomiting494.8%
  4. 4Pneumonia464.5%
  5. 5Pyrexia454.4%
  6. 6Diarrhoea434.2%
  7. 7Drug Ineffective403.9%
  8. 8Dyspnoea403.9%
  9. 9Condition Aggravated393.8%
  10. 10Chills383.7%
  11. 11Rash383.7%
  12. 12Death373.6%
  13. 13Fatigue373.6%
  14. 14Asthenia363.5%
  15. 15Off Label Use353.4%

Literature

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Recent PubMed references pinned to Glycine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 240 ClinicalTrials.gov registrations naming Glycine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Glycine work?
Mechanism-of-action class: Biological Macromolecular Activity.
What is Glycine used for?
According to FDA labeling, Glycine carries indications including: 1.5% Glycine Irrigation, USP is indicated for use as irrigating fluid during transurethral prostatic resection and other transurethral surgical procedures.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Glycine?
Glycine is classified as Other irrigating solutions, Biological Macromolecular Activity, Glycine Activity Alteration, Metabolic Activity Alteration.
What are the brand names for Glycine?
Glycine is marketed under brand names including Aminosyn 10%, Sulfite-Free, Aminosyn 3.5 % M, Sulfite Free, Aminosyn 8.5 % with Electrolytes, Sulfite-Free, Aminosyn 8.5%, Sulfite-Free, Aminosyn II 10 %, Aminosyn II 15%, Aminosyn II 8.5 % with Electrolytes, Sulfite-Free, Aminosyn II 8.5 %, Sulfite-Free.
What are the contraindications for Glycine?
Glycine labeling lists contraindications including: NOT FOR INJECTION BY USUAL PARENTERAL ROUTES. Do not use in patients with anuria.. Always consult the full prescribing information and a clinician.
Note. Data for glycine is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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