pharmacopeia

Gluconolactone

Calculi Dissolution AgentIrrigationUS-FDASourced from openFDA
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Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Irrigation.

Indications

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  • Renacidin is indicated for dissolution of bladder calculi of the struvite or apatite variety by local intermittent irrigation through a urethral catheter or cystostomy tube as an alternative or adjunct to surgical procedures. Renacidin is also indicated for use as an intermittent irrigating solution to prevent encrustations of indwelling urethral catheters and cystostomy tubes.

Contraindications

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  • Renacidin is contraindicated in the presence of demonstrable urinary tract extravasation.contraindicated

Dosage & administration

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Renacidin for local irrigation within the lower urinary tract is available in single-use 30 mL containers. Prepare and Administer the Dose: Step 1: Inspect Renacidin visually for particulate matter and discoloration prior to administration. If particulate matter or discoloration are observed, do not administer. Step 2: Remove the plastic tab connected to the conical tip of the Renacidin container by twisting the plastic tab. See Figure 1. Figure 1 Step 3: Connect the conical tip of the Renacidin container to the end of the urethral catheter or cystostomy tube. See Figure 2. Figure 2 Step 4: Squeeze the Renacidin container to expel the entire contents into the urethral catheter or cystostomy tube. See Figure 3. Figure 3 For Dissolution of Bladder Calculi: Instill 30 mL (one container) of Renacidin into the bladder via a urethral catheter or cystostomy tube. Clamp the urethral catheter or cystostomy tube for 30 to 60 minutes. Release the clamp and drain the bladder. Repeat the instillation procedure 4 to 6 times a day. Monitor for dissolution of calculi. For Prevention of Encrustations in Urethral Catheters and Cystostomy Tubes: Instill 30 mL (one container) of Renacidin into the urethral catheter or cystostomy tube. Clamp the urethral catheter or cystostomy tube for 10 minutes. Remove the clamp and drain the bladder. Repeat the instillation procedure 3 times a day. Figure 1 Figure 2 Figure 3

Warnings & precautions

Sourced from openFDA

Renacidin use should be stopped immediately if the patient develops fever, urinary tract infection, signs and symptoms consistent with urinary tract infection, or persistent flank pain. Irrigation should be stopped if elevated serum creatinine develops. The contents of individual Renacidin containers should not be combined for use as continuous irrigation of the urinary tract because of complications that may arise from inadequate aseptic technique. Terminal sterilization processes that are not adequate may result in sepsis and/or injury to product handlers (e.g., irritation to exposed, unprotected areas of the skin). Serious adverse reactions, including sepsis and hypermagnesemia, have been reported to occur when Renacidin was used for continuous irrigation of the upper urinary tract. Renacidin is not indicated for continuous irrigation of the upper urinary tract.

Adverse reactions

Sourced from openFDA

The most common adverse reactions with use of Renacidin for dissolution of bladder calculi or prevention of encrustations of indwelling urethral catheters are “bladder irritability” and chemical cystitis, both reported to occur in approximately 3% of patients. A transient burning sensation in the bladder following Renacidin has been reported to occur in less than 1% of patients receiving Renacidin.

Use in specific populations

Sourced from openFDA

Pregnancy Category C Animal reproduction studies have not been conducted with Renacidin. It is also not known whether Renacidin can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Renacidin should be given to a pregnant woman only if clearly needed.

Approval history

Sourced from openFDA
  • Oct 2, 1990NDANDA019481United Guardian

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.
17 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. 1Cardio-respiratory Arrest212%
  2. 2Device Failure212%
  3. 3Fall212%
  4. 4Haematuria212%
  5. 5Nephrolithiasis212%
  6. 6Septic Shock212%
  7. 7Urinary Tract Infection212%
  8. 8Acute Respiratory Distress Syndrome15.9%
  9. 9Apnoea15.9%
  10. 10Aspiration15.9%
  11. 11Asthenia15.9%
  12. 12Balance Disorder15.9%
  13. 13Bladder Perforation15.9%
  14. 14Blood Magnesium Increased15.9%
  15. 15Blood Sodium Decreased15.9%

Clinical trials

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The 3 most recently updated of 3 ClinicalTrials.gov registrations naming Gluconolactone as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Gluconolactone work?
Mechanism-of-action class: Irrigation.
What is Gluconolactone used for?
According to FDA labeling, Gluconolactone carries indications including: Renacidin is indicated for dissolution of bladder calculi of the struvite or apatite variety by local intermittent irrigation through a urethral catheter or cystostomy tube as an alternative or adjunct to surgical procedures. Renacidin is also indicated for use as an intermittent irrigating solution to prevent encrustations of indwelling urethral catheters and cystostomy tubes.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Gluconolactone?
Gluconolactone is classified as Calculi Dissolution Agent, Irrigation.
What are the brand names for Gluconolactone?
Gluconolactone is marketed under brand names including Renacidin.
What are the contraindications for Gluconolactone?
Gluconolactone labeling lists contraindications including: Renacidin is contraindicated in the presence of demonstrable urinary tract extravasation.. Always consult the full prescribing information and a clinician.
Note. Data for gluconolactone 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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