Renacidin
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Questions & Answers
Side Effects & Adverse Reactions
Renacidin Irrigation 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 hypermagnesemia or elevated serum creatinine develops.
Severe hypermagnesemia has been reported with Renacidin Irrigation. Caution should be employed when irrigating the renal pelvis of patients with impaired renal function. Patients should be observed for early signs and symptoms of hypermagnesemia including nausea, lethargy, confusion and hypotension. Severe hypermagnesemia may result in hyporeflexia, dyspnea, apnea, coma, cardiac arrest and subsequent death. Serum magnesium levels should be monitored and deep tendon reflexes should be evaluated. Treatment of hypermagnesemia should include discontinuation of Renacidin Irrigation followed by medical therapy with intravenous calcium gluconate, fluids and diuresis in severe cases.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
Renacidin 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 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 Irrigation is also indicated for use as an intermittent irritating solution to prevent or minimize encrustations of indwelling urinary tract catheters.
Since many complications are experienced by patients receiving infusions of Renacidin 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 Irrigation is not indicated for dissolution of calcium oxalate, uric acid or cysteine calculi.
History
There is currently no drug history available for this drug.
Other Information
Renacidin® (Citric Acid, Glucono delta-lactone, and Magnesium Carbonate) Irrigation is a sterile, non-pyrogenic irrigation for use within the urinary tract in the prevention and dissolution of calculi.
Each 100 mL of Renacidin Irrigation contains:
Active ingredients:
Citric Acid (anhydrous), USP 6.602 grams
C6H8O7 Glucono delta-lactone, USP 0.198 grams
C6H10O6 Magnesium Carbonate, USP 3.376 grams
(MgCO3)4 · Mg(OH)2 · 5H2O
Citric Acid
Glucono delta-lactone
Magnesium Carbonate
(MgCO3)4 · Mg(OH)2 · 5H2O
Inert ingredients:
Benzoic Acid, USP 0.023 grams
Solution pH: 3.85 (3.5-4.2)
Sources
Renacidin Manufacturers
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United-guardian, Inc.
![Renacidin (Citric Acid, Gluconolactone And Magnesium Carbonate) Solution [United-guardian, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Renacidin | United-guardian, Inc.
Renacidin Irrigation (sterile, non-pyrogenic) in water for local irrigation within the urinary tract.
The action of Renacidin 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 H20) 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 occur, irrigation is then started with Renacidin 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 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 reflux, all precautions required for irrigation of the renal pelvis must be observed.
Indwelling Urinary Tract Catheter Encrustation: Periodic instillation of Renacidin Irrigation is indicated to minimize or prevent encrustation 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.
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