aminoacetic acid 1.5% in plastic container
Aminoacetic Acid 1.5% in Plastic Container (Glycine) is a medication used to treat Nutritional and Metabolic Diseases, Peptic Ulcer.
Glycine · by Baxter Hlthcare
Key facts
- Active ingredient
- Glycine
- Form
- Solution
- Strength
- Glycine 1.5GM/100ML
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Baxter Hlthcare
- FDA application
- NDA017865
What is Aminoacetic Acid 1.5% in Plastic Container?
From the FDA label:1.5% Glycine Irrigation, USP is a sterile, nonpyrogenic, nonhemolytic, nonelectrolytic or very weakly ionized solution in single dose UROMATIC containers for use as a urologic irrigating solution. Each liter contains 15 g Glycine, USP (NH 2 CH 2 COOH) in water for injection. pH 6.0 (4.5 to 6.5). Osmolarity 200 mOsmol/L (calc.). Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. No antimicrobial agent has been added. The UROMATIC plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 plastic). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million; however, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.
How to use
The volume of solution needed will vary with the nature and duration of the urologic procedure. If desired, warm in overwrap to near body temperature in a water bath or oven heated to not more than 45°C. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
Side effects
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 adverse reactions occur, discontinue the irrigation and re-evaluate the clinical status of the patient. Post-Marketing Experience Following off-label use of 1.5% Glycine Irrigation, USP for hysteroscopic procedures in women, life-threatening adverse events related to fluid overload have been reported.
Warnings
Important safety information
Not for injection. 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 1.5% Glycine Irrigation, USP must be regarded as a systemic drug. Absorption of large amounts of fluids containing glycine may significantly alter cardiopulmonary and renal dynamics. Careful cardiovascular monitoring should be maintained due to the possibility of fluid overload. Should fluid overload occur, intensive fluid and electrolyte management is necessary. Monitoring of fluid and electrolyte levels beyond the acute phase may be considered due to the possibility of delayed fluid absorption. (See ADVERSE REACTIONS, Post-Marketing Experience). The contents of an opened container should be used promptly to minimize the possibility of bacterial growth or pyrogen formation. Discard the unused portion of irrigating solution since no antimicrobial agent has been added.
Who should not take Aminoacetic Acid 1.5% in Plastic Container
Anuria.
Overdose — what happens if you take too much
In the event of overhydration or solute overload, re-evaluate the patient and institute appropriate corrective measures. See WARNINGS, PRECAUTIONS and ADVERSE REACTIONS.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
May treat (source: NIH RxClass)
Dosage forms
Solution
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
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Frequently asked questions
- What does Aminoacetic Acid 1.5% in Plastic Container treat?
- Aminoacetic Acid 1.5% in Plastic Container (Glycine) may be used to treat nutritional and metabolic diseases, peptic ulcer, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- Is there a coupon or discount for Aminoacetic Acid 1.5% in Plastic Container?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Aminoacetic Acid 1.5% in Plastic Container. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Aminoacetic Acid 1.5% in Plastic Container?
- Aminoacetic Acid 1.5% in Plastic Container is marketed by Baxter Hlthcare. You can see Baxter Hlthcare's full profile, rating, and other products on pharmaranks.
- Is Aminoacetic Acid 1.5% in Plastic Container a brand-name or generic drug?
- Aminoacetic Acid 1.5% in Plastic Container is a brand-name product with the active ingredient Glycine.
- Is Aminoacetic Acid 1.5% in Plastic Container available over the counter?
- No. Aminoacetic Acid 1.5% in Plastic Container is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Aminoacetic Acid 1.5% in Plastic Container come in?
- Aminoacetic Acid 1.5% in Plastic Container is currently marketed as solution, per the FDA's National Drug Code Directory.
- Is Aminoacetic Acid 1.5% in Plastic Container FDA-registered?
- Aminoacetic Acid 1.5% in Plastic Container is on record with the U.S. FDA under application number NDA017865. You can verify this on its official FDA label.
- Is Aminoacetic Acid 1.5% in Plastic Container safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Aminoacetic Acid 1.5% in Plastic Container. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Aminoacetic Acid 1.5% in Plastic Container?
- Aminoacetic Acid 1.5% in Plastic Container's side effects are taken directly from its FDA label. From the label: 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,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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