Citric acid, glucono-delta-lactone, and magnesium carbonate are used together to form an acidic irrigation solution for dissolving apatite or struvite calculi. This combination is not effective for the dissolution of calcium oxalate, uric acid, or cysteine stones. Citric acid; glucono-delta-lactone; magnesium carbonate is FDA approved as a local irrigation solution to dissolve bladder calculi and to prevent encrustation of indwelling catheters or cystostomy tubes. Citric acid; glucono-delta-lactone; magnesium carbonate (Renacidin) irrigation solution was approved for use by the FDA in October 1990.
General Administration Information
For storage information, see the specific product information within the How Supplied section.
Route-Specific Administration
Other Administration Route(s)
Preparation of the Irrigation Solution:
-For local irrigation within the lower urinary tract. Not for injection.
-Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit.
-Remove the plastic tab connected to the conical tip of the Renacidin container by twisting the plastic tab.
-Connect the conical tip of the Renacidin container to the end of the urethral catheter of cystostomy tube.
-For administration, see instructions for individual indications and usage.
Bladder Intravesical Irrigation via Urinary Catheter or Cystostomy Tube for Dissolution of Bladder Calculi:
-Instill 30 mL of the irrigation solution through a urinary catheter or cystostomy tube into the
bladder. Clamp the 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.
Local Irrigation into a Urethral Catheter or Cystostomy Tube for Encrustation Prevention:
-Instill 30 mL of the irrigation solution through a urinary catheter or cystostomy tube. Clamp the catheter or cystostomy tube for 10 minutes. Remove the clamp.
-Repeat the instillation procedure 3 times a day.
The most common adverse reactions associated with the use of citric acid; glucono-delta-lactone; magnesium carbonate bladder irrigation (Renacidin) are bladder discomfort (e.g., bladder irritability, 3%) and chemical cystitis (3%). A transient burning sensation in the bladder has occurred in less than 1% of patients receiving Renacidin. The irrigation should be stopped if an elevated serum creatinine develops; do not restart the irrigation until creatinine concentrations have returned to pre-irrigation levels.
The development of fever, urinary tract infection or signs and symptoms consistent with urinary tract infection (such as dysuria), or persistent flank pain requires immediately discontinuation of citric acid; glucono-delta-lactone; magnesium carbonate irrigation. A urine specimen for culture should be obtained and appropriate antibacterial therapy should be initiated. A sterile urine must be present before the irrigation is restarted. Struvite calculi frequently contain bacteria within the stone and antibacterial therapy should therefore be continued throughout the course of dissolution therapy.
Patients should be monitored throughout therapy with citric acid; glucono-delta-lactone; magnesium carbonate bladder irrigation (Renacidin). The bladder irrigation solution is sterile and non-pyrogenic when unopened. However, any bladder treatment involves the potential for infection. Treatment should be stopped immediately for fever, urinary tract infection (UTI), signs and symptoms consistent with urinary tract infection, or persistent flank pain. In all patients, a urine specimen for culture and sensitivity should be obtained approximately every three days, and at the first sign of infection including fever. Stop the irrigation if any culture exhibits growth and initiate appropriate antibacterial therapy. Therapy with Renacidin may be re-initiated after a course of antibacterial therapy upon demonstration of sterile urine. Struvite calculi frequently contain bacteria within the stone and antibacterial treatment should therefore be continued throughout a course of dissolution therapy. Renacidin is not indicated for continuous irrigation of the upper urinary tract due to the possibility of sepsis and other serious adverse reactions. The contents of individual Renacidin bladder irrigation containers should not be combined for use as a continuous irrigation of the urinary tract because of complications that may occur from inadequate aseptic technique, such as sepsis or injury to persons handling the product.
Citric acid; glucono-delta-lactone; magnesium carbonate irrigation is contraindicated in the presence of demonstrable urinary tract extravasation.
Serum creatinine, phosphate, and magnesium levels should be obtained every several days during citric acid; glucono-delta-lactone; magnesium carbonate (Renacidin) bladder irrigation therapy. The irrigation should be stopped if elevated serum creatinine (e.g., renal impairment or renal failure) develops. Patients with vesicoureteral reflux are susceptible to hypermagnesemia, and concurrent use of Renacidin with medications containing magnesium may contribute to hypermagnesemia. Patients with indwelling urethral catheter or cystostomy tube may have undiagnosed vesicoureteral reflux. Appropriate evaluation prior to treatment initiation is recommended. If reflux is present, the potential benefits of therapy should outweigh the risks, and all recommended safety monitoring precautions should be strictly implemented. Renacidin is not indicated for continuous irrigation of the upper urinary tract due to the possibility of hypermagnesemia, sepsis, and other serious adverse reactions.
Care must be taken to maintain the patency of the urethral catheter or cystostomy tube during citric acid; glucono-delta-lactone; magnesium carbonate (Renacdin) therapy because calculus fragments and debris may obstruct the outflow catheter. Renacidin should be discontinued at the first sign of urinary tract obstruction. Flushing the catheter with saline and repositioning the catheter may help prevent catheter outflow obstruction. The system should be frequently monitored by a nurse, an aide, or any person with sufficient skills to detect any problems with urethral catheter patency.
Citric acid; glucono-delta-lactone; magnesium carbonate solution is classified as FDA pregnancy risk category C. According to the manufacturer, it is not known if the components can cause fetal harm when administered to a pregnant woman. Administration to a woman who is pregnant should only be considered if clearly needed.
Magnesium is known to be excreted in breast milk, but excretion of citric acid; glucono-delta-lactone; magnesium carbonate (Renacidin) bladder irrigation into breast milk is unknown, and it is not certain if local bladder instillation in the mother results in any detectable levels of the product components reaching the systemic maternal circulation that could then be passed into human milk. Caution should be exercised when this product is administered to a nursing woman. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.
For the dissolution of bladder calculi via urologic irrigation and as an intermittent irrigation solution to prevent encrustations of indwelling catheters and cystostomy tubes:
-for intermittent irrigation to prevent encrustations of indwelling urethral catheters or cystostomy tubes:
Catheter or cystostomy tube irrigation dosage:
Adults: Instill 30 mL of the irrigation solution into the urethral catheter or cystostomy tube and clamp the catheter or cystostomy tube for 10 minutes. Then, remove the clamp and drain the bladder. Repeat this process 3 times per day. NOTE: Do not initiate treatment until appropriate studies to evaluate possible vesicoureteral reflux have been completed. If reflux is present, the potential benefits of therapy should outweigh the risks, and all recommended safety monitoring precautions should be strictly implemented.
-for dissolution of bladder calculi of the apatite or struvite variety by local intermittent irrigation, through a urethral catheter or cystostomy tube, as an alternative or adjunct to surgical procedures:
Bladder irrigation dosage:
Adults: Instill 30 mL of the irrigation solution through a urethral catheter or cystostomy tube into the bladder. Clamp the catheter or cystostomy tube for 30 to 60 minutes, then release the clamp and drain the bladder. Repeat the instillation procedure 4 to 6 times a day. Monitor for dissolution of calculi. Renacidin is not effective for dissolution of calcium oxalate, uric acid, or cysteine calculi. Chemolysis of bladder calculi may be used as an adjunct to surgical procedures or as an alternative to cystoscopic or surgical removal of the stones in patients who refuse surgery or cystoscopic removal, or in whom these procedures constitute an unwarranted risk. NOTE: Do not initiate the bladder instillation procedure until appropriate studies to evaluate possible vesicoureteral reflux have been completed. If reflux is present, the potential benefits of therapy should outweigh the risks, and all recommended safety monitoring precautions should be strictly implemented.
Maximum Dosage Limits:
-Adults
30 mL per treatment as an irrigation solution.
-Geriatric
30 mL per treatment as an irrigation solution.
-Adolescents
Safety and efficacy have not been established.
-Children
Safety and efficacy have not been established.
-Infants
Safety and efficacy have not been established.
-Neonates
Safety and efficacy have not been established.
Patients with Hepatic Impairment Dosing
Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are required.
Patients with Renal Impairment Dosing
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are required.
*non-FDA-approved indication
There are no drug interactions associated with Citric Acid; Glucono-Delta-Lactone; Magnesium Carbonate products.
Citric acid; glucono-delta-lactone; magnesium carbonate is used as an irrigation solution to dissolve apatite or struvite calculi. On susceptible apatite calculi, there is an exchange of magnesium from the irrigating solution for insoluble calcium contained in the stone matrix. The magnesium salts thereby formed are soluble in the gluconocitrate irrigating solution, resulting in dissolution of the calculus. Struvite calculi are composed mainly of magnesium ammonium phosphates, which are solubilized by the irrigation due to the solutions' acidic pH. Citric acid; glucono-delta-lactone; magnesium carbonate irrigation is not effective for dissolution of calcium oxalate, uric acid, or cysteine stones.
Citric acid; glucono-delta-lactone; magnesium carbonate is administered by urological irrigation. Pharmacokinetic information is limited.