Citric Acid, Gluconolactone And Magnesium Carbonate

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.

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.

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.

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