Citric Acid, Gluconolactone and Magnesium Carbonate

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.

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

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.

Maintain Patency of the Urethral Catheter or Cystostomy Tube Care must be taken during therapy with Renacidin to maintain the patency of the urethral catheter or cystostomy tube. Calculus fragments and debris may obstruct the catheter. Catheter outflow blockage may be prevented by flushing the catheter with saline and repositioning of the catheter. Frequent monitoring of the system should be performed by a nurse, an aide or any person with sufficient skills to be able to detect any problems with the patency of the catheter. At the first sign of obstruction, Renacidin should be discontinued. Caution in Patients with Vesicoureteral Reflux Patients with an indwelling urethral catheter or a cystostomy tube may have undiagnosed vesicoureteral reflux. Appropriate evaluation prior to initiation of Renacidin is recommended. If reflux is demonstrated, the potential benefits of therapy should outweigh the risks, and all recommended safety monitoring precautions should be strictly implemented. Safety Monitoring While on Therapy with Renacidin Patients should be monitored throughout the course of therapy with Renacidin. Serum creatinine, phosphate and magnesium should be obtained every several days. Urine specimens should be collected for culture and antibacterial sensitivity approximately every three days and at the first sign of fever. Therapy with Renacidin should be stopped if any culture exhibits growth and appropriate antibacterial therapy should be initiated. Therapy with Renacidin may be started again after a course of antibacterial therapy upon demonstration of sterile urine. Struvite calculi frequently contain bacteria within the stone and antibacterial therapy should therefore be continued throughout the course of dissolution therapy. An elevated serum creatinine concentration is also an indication to stop therapy with Renacidin. Concomitant Use with Medications Containing Magnesium Concomitant use of Renacidin and medications containing magnesium may contribute to hypermagnesemia in susceptible individuals, such as patients with vesicoureteral reflux. Renacidin Irrigation should be used with caution in patients taking concomitant medications containing magnesium. Carcinogenesis, Mutagenesis, Impairment of Fertility Long term studies to evaluate carcinogenic potential of Renacidin in animals have not been conducted. Mutagenicity studies have not been conducted. 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. Nursing Mothers Magnesium is known to be excreted into human milk. It is not known whether Renacidin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Renacidin is administered to a nursing woman.

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.

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.

Magnesium is known to be excreted into human milk. It is not known whether Renacidin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Renacidin is administered to a nursing woman.