Renacidin

Renacidin is an FDA-registered drug product whose active ingredient is CITRIC ACID, GLUCONOLACTONE AND MAGNESIUM CARBONATE. It is labelled by United-Guardian, Inc. taken by irrigation and marketed as a human prescription drug product. Identifiers on file: NDC 0327-0012, application NDA019481, label effective 20191217. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing CITRIC ACID, GLUCONOLACTONE AND MAGNESIUM CARBONATE are most often described in connection with: usage renacidin, dissolution bladder, struvite apatite, variety local, intermittent irrigation, through urethral, catheter cystostomy, tube alternative. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

INDICATIONS AND USAGE 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.

DOSAGE AND ADMINISTRATION 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

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

WARNINGS 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 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.

4 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Renacidin used for?
INDICATIONS AND USAGE 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 …

Who makes Renacidin?
United-Guardian, Inc. is the labeler of record for Renacidin.

What form does Renacidin come in?
administered by irrigation. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Renacidin prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Has Renacidin been recalled?
4 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.