Renacidin

INDICATIONS

Renacidin (citric acid, glucono-delta-lactone and magnesium carbonate irrigation) Irrigation is indicated for use by local irrigation in the dissolution of renal calculi composed of apatite (a calcium carbonate- phosphate compound) or struvite (magnesium ammonium phosphates) in patients who are not candidates for surgical removal of the calculi.

It may also be used as adjunctive therapy to dissolve residual apatite or struvite calculi and fragments after surgery or to achieve partial dissolution of renal calculi to facilitate surgical removal.

Renacidin (citric acid, glucono-delta-lactone and magnesium carbonate irrigation) Irrigation is also indicated for dissolution of bladder calculi of the struvite or apatite variety by local intermittent irrigation through a urethral catheter or cystostomy catheter as an alternative or adjunct to surgical procedures.

Renacidin (citric acid, glucono-delta-lactone and magnesium carbonate irrigation) Irrigation is also indicated for use as an intermittent irrigating solution to prevent or minimize incrustations of indwelling urinary tract catheters.

Since many complications are experienced by patients receiving infusions of Renacidin (citric acid, glucono-delta-lactone and magnesium carbonate irrigation) Irrigation into the renal pelvis, considerable caution must be employed. Additionally, hospitalization is prolonged for days to weeks when chemolytic therapy is used in lieu of, or following surgery. For these reasons, use of this therapy should be reserved for selected patients.

Renacidin (citric acid, glucono-delta-lactone and magnesium carbonate irrigation) Irrigation is not indicated for dissolution of calcium oxalate, uric acid or cysteine calculi.

DOSAGE AND ADMINISTRATION

Renacidin (citric acid, glucono-delta-lactone and magnesium carbonate irrigation) Irrigation (sterile, non-pyrogenic) in water for local irrigation within the urinary tract.

The action of Renacidin (citric acid, glucono-delta-lactone and magnesium carbonate irrigation) Irrigation in the prevention and dissolution of calculi results from an ion exchange mechanism or solvent action. (See CLINICAL PHARMACOLOGY)

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit

Renal Calculi: See PRECAUTIONS. It is essential that patients be free from urinary tract infections prior to initiating chemolytic therapy. Urine specimens should be collected for culture and appropriate antibiotic therapy should be initiated for any bacteria identified. A nephrostomy tube is placed at surgery or percutaneously to permit lavage of the calculi. A single catheter may be sufficient if the calculus is not obstructing the ureter or ureteropelvic junction. In patients with an obstructed ureter, a retrograde catheter can be placed through the ureter to the renal pelvis via a cystoscope. This second catheter is used to irrigate the calculus while the percutaneous nephrostomy tube is used for drainage.

Plain radiographs and nephrostomograms are performed to assure proper placement of the catheter(s). Pressure measurements are made under fluoroscopy to assure that 2-3 mL/min can be infused without causing pain, pyelovenous or pyelotubular backflow or manometric evidence of elevated pressure within the collecting system.

For postoperative patients irrigation should not be started before the fourth or fifth postoperative day. Irrigation of the renal pelvis is begun with sterile saline only after a sterile urine has been demonstrated. The saline is infused at a rate of 60 mL/hr initially and the rate is increased until pain or an elevated pressure (25 cm 1120) appears, or until a maximum flow-rate of 120 mL/hr is achieved. The site of insertion should be inspected for leakage. If leakage occurs, the irrigation is discontinued temporarily to allow for complete healing around the nephrostomy tube.

If no leakage or flank pain occurs, irrigation is then started with Renacidin (citric acid, glucono-delta-lactone and magnesium carbonate irrigation) Irrigation with a flow rate equal to the maximum rate achieved with the saline solution. A clamp should be placed on the inflow tube and patients (see PRECAUTIONS) and nursing personnel should be instructed to stop the irrigating solution whenever pain develops. Nursing personnel who are responsible for performing the irrigation must be instructed concerning the location of the nephrostomy tube(s) and the direction of flow of the irrigating solution to insure against misconnection of the inflowing and egress tubes. Nephrostomograms should be performed periodically to assure proper placement of the catheter tip and to assess efficacy. If stones fail to change size after several days of adequate irrigation the procedure should be discontinued.

Upon demonstration of complete dissolution of the calculus the inflow tube is clamped and left in place for a few days to ensure that no obstruction exists, after which time the nephrostomy tube is removed.

Bladder Calculi- Chemolysis of bladder calculi is used 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. Following appropriate studies to evaluate possible vesicoureteral reflux, thirty mL of Renacidin (citric acid, glucono-delta-lactone and magnesium carbonate irrigation) Irrigation is instilled through a urinary catheter into the bladder and the catheter is clamped for 30-60 minutes. The clamp is then released and the bladder is drained. This is repeated 4-6 times a day. A continuous drip through a 3-way Foley catheter is an alternative means of dissolving bladder stones. In the presence of bladder spasm and associated high pressure reflex, all precautions required for irrigation of the renal pelvis must be observed.

Indwelling Urinary Tract Catheter Incrustation- Periodic instillation of Renacidin (citric acid, glucono-delta-lactone and magnesium carbonate irrigation) Irrigation is indicated to minimize or prevent incrustation of indwelling catheters which frequently results in plugging of the catheter and discomfort to the patient. This is accomplished by instilling 30 mL of the solution through the catheter and then clamping the catheter for 10 minutes, after which the clamp is removed to allow drainage of the bladder. This process is repeated 3 times a day.

HOW SUPPLIED

Renacidin (citric acid, glucono-delta-lactone and magnesium carbonate irrigation) Irrigation is available as a sterile, non-pyrogenic solution in 500 mL containers, packaged in cartons of six. Exposure of Renacidin (citric acid, glucono-delta-lactone and magnesium carbonate irrigation) Irrigation to heat or cold should be minimized. Renacidin (citric acid, glucono-delta-lactone and magnesium carbonate irrigation) Irrigation should be stored at controlled room temperature, 59-86°F (15°-30°C). Avoid excessive heat or cold (keep from freezing). Brief exposure to temperatures of up to 40°C or temperatures down to 5°C does not adversely affect the product.

NDC: 0327-0011-05
Product Code:RN500

Mfd. for GUARDIAN LABORATORIES a division of UNITED-GUARDIAN, Inc. Hauppauge, N.Y. 11788
Revised: October 1996, FDA rev date: 5/3/2007

Last reviewed on RxList: 6/6/2007
This monograph has been modified to include the generic and brand name in many instances.

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