Renacidin 6.602 g/100mL
citric acid, gluconolactone and magnesium carbonate · SOLUTION · United-Guardian, Inc.
Renacidin is a solution containing citric acid, gluconolactone and magnesium carbonate at 6.602 g/100mL, taken irrigation. Manufactured by United-Guardian, Inc..
Key Facts
- Brand Name
- Renacidin
- Generic Name
- citric acid, gluconolactone and magnesium carbonate
- NDC Code (Product)
0327-0012- Manufacturer
- United-Guardian, Inc.
- Strength
- 6.602 g/100mL
- Dosage Form
- SOLUTION
- Route
- IRRIGATION
- Marketing Status
- Application #
- NDA019481
- Drug Class
- Calculi Dissolution Agent [EPC]; Anti-coagulant [EPC]
- Marketing Start
- 02/01/2016
Recall History
Nora Apothecary and Alternative Therapies, Inc.
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Oregon Compounding Centers, Inc. dba Creative Compounds
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Health Innovations Pharmacy, Inc
Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Natures Pharmacy & Compounding Center
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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 & Administration
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)…
Warnings
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.
Contraindications
CONTRAINDICATIONS Renacidin is contraindicated in the presence of demonstrable urinary tract extravasation.
Adverse Reactions
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.
Frequently Asked Questions
What is Renacidin used for?
Renacidin contains citric acid, gluconolactone and magnesium carbonate. It is a solution taken irrigation. Consult your doctor for specific uses.
Is Renacidin a controlled substance?
Renacidin is not classified as a controlled substance by the DEA.
What is the generic name for Renacidin?
The generic name for Renacidin is citric acid, gluconolactone and magnesium carbonate. There are no other listed brand versions of citric acid, gluconolactone and magnesium carbonate.
What is the NDC code for Renacidin 6.602 g/100mL?
The NDC (National Drug Code) for Renacidin 6.602 g/100mL is 0327-0012, listed by United-Guardian, Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)