Renacidin

WARNINGS

Renacidin (citric acid, glucono-delta-lactone and magnesium carbonate irrigation) 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 had been reported with Renacidin (citric acid, glucono-delta-lactone and magnesium carbonate irrigation) 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 (citric acid, glucono-delta-lactone and magnesium carbonate irrigation) Irrigation followed by medical therapy with intravenous calcium gluconate, fluids and diuresis in severe cases.

PRECAUTIONS

Care must be taken during chemolysis of renal calculi with Renacidin (citric acid, glucono-delta-lactone and magnesium carbonate irrigation) Irrigation to maintain the patency of the irrigating catheter. Calculus fragments and debris may obstruct the outflow catheter. Continued irrigation under those circumstances leads to increased intrapelvic pressure with a danger of tissue damage or absorption of the irrigating solution. Catheter outflow blockage may be prevented by flushing the catheter with saline and repositioning of the catheter. Frequent monitoring of the system should be performed by a nurse, an aide or any person with sufficient skills to be able to detect any problems with the patency of the catheter. At the first sign of obstruction, irrigation should be discontinued and the system disconnected.

Intrapelvic pressures must be maintained at or below 25cm of water. The preferred method of pressure control is the insertion of an open V connection pop-off valve into the infusion line allowing immediate decompression if pressure exceeds 25 cm of water. An alternative method has been proposed to direct or stop the flow of the irrigating solution to prevent increased intrapelvic pressure: placement of a pinch clamp on the inflow line which can be used by the patient or nurse to stop the irrigation at the first sign of flank pain. However, extreme caution must be taken when relying on cooperation of the patient. Patients may not be sufficiently alert to detect signs and symptoms of out-flow obstruction. This is especially true in elderly patients or patients who have been sedated or who have severe neurological dysfunction with varying degrees of sensory loss and/or motor paralysis.

Patients with indwelling urethral or cystostomy catheters frequently have vesicoureteral reflux. Cystogram prior to initiation of Renacidin (citric acid, glucono-delta-lactone and magnesium carbonate irrigation) Irrigation is essential for such patients. If reflux is demonstrated, all precautions recommended for renal pelvis irrigation must be taken.

Throughout the course of therapy, patients should be monitored to assure safety. Serum creatinine, phosphate and magnesium should be obtained every several days. Urine specimens should be collected for culture and antibacterial sensitivity every three days or less and at the first sign of fever. The irrigation should be stopped if any culture exhibits growth and appropriate antibacterial therapy should be initiated. The irrigation may be started again after a course of antibacterial therapy upon demonstration of a sterile urine. Struvite calculi frequently contain bacteria within the stone and antibacterial therapy should therefore be continued throughout the course of dissolution therapy. Hypermagnesemia or an elevated serum creatinine level are indications to halt the irrigation until they return to pre-irrigation levels. Evidence of severe urothelial edema on X-ray is also an indication for temporarily halting the irrigation until the complication resolves.

Concurrent use of magnesium containing medications may contribute to production of hypermagnesemia and is not recommended.

Carcinogenesis, mutagenesis, impairment of fertility:

Long term studies to evaluate carcinogenic potential of Renacidin (citric acid, glucono-delta-lactone and magnesium carbonate irrigation) Irrigation in animals have not been conducted. Mutagenicity studies have not been conducted.

Pregnancy Category C.: Animal reproduction studies have not been conducted with Renacidin (citric acid, glucono-delta-lactone and magnesium carbonate irrigation) Irrigation. It is also not known whether Renacidin (citric acid, glucono-delta-lactone and magnesium carbonate irrigation) Irrigation can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Renacidin (citric acid, glucono-delta-lactone and magnesium carbonate irrigation) Irrigation should be given to a pregnant woman only if clearly needed.

Nursing Mothers: Magnesium is known to be excreted into human milk. It is not known whether Renacidin (citric acid, glucono-delta-lactone and magnesium carbonate irrigation) Irrigation is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Renacidin (citric acid, glucono-delta-lactone and magnesium carbonate irrigation) Irrigation is administered to a nursing woman.

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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