After being sidelined for the past year and a half due to manufacturing issues, Renacidin Irrigation is available once again. The solution, which consists of citric acid, glucono-delta-lactone, and magnesium carbonate, is indicated for the dissolution of renal and vesical calculi of the apatite or struvite variety. There is no alternative product for this indication.
FDA information shows that as of June 30, 2012, Renacidin Irrigation manufacturer United-Guardian, Inc. did not expect the product to be available again until November 2013 due to production problems as noted in United-Guardian earnings statements issued in August 2012 and forward.
United-Guardian President Ken Globus announced that, as expected, the company is now able to provide Renacidin Irrigation again. In addition, United-Guardian is developing a more convenient single-dose unit of the product that should obtain FDA approval sometime in 2014.
Renacidin Irrigation is indicated for use by local irrigation in the dissolution of kidney stones composed of apatite or struvite in patients who are not candidates for surgical removal of the calculi. It can also be used as an adjunctive therapy to dissolve residual apatite or struvite calculi and fragments after surgery or to partially dissolve kidney stones prior to surgical removal. In addition, the product can dissolve apatite or struvite stones in the bladder by means of local intermittent irrigation through a urethral catheter or cystostomy catheter as an alternative or adjunct to surgical procedures.
Renacidin Irrigation also is indicated for use as an intermittent irrigating solution to prevent or minimize incrustations of indwelling urinary tract catheters.