citric acid, gluconolactone and magnesium carbonate

FDA Drug Profile — Renacidin

Drug Details

Generic Name
citric acid, gluconolactone and magnesium carbonate
Brand Names
Renacidin
Application Number
NDA019481
Sponsor
United-Guardian, Inc.
NDC Codes
1
Dosage Forms
SOLUTION
Routes
IRRIGATION
Active Ingredients
ANHYDROUS CITRIC ACID, GLUCONOLACTONE, MAGNESIUM CARBONATE

Indications and 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.

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.