Product History

In the mid-1950s, Renacidin was developed by Dr. Alfred Globus, the founder and CEO of United-Guardian, Inc. It was evaluated and tested in collaboration with a well-known urologist in the Cincinnati, OH area, William P. Mullvaney, M.D.

By the late 1950s, Renacidin was being sold as a powder that had to be reconstituted to a 10% solution and then sterilized prior to use. This was the only form of the product available until 1991. In response to a Federal Register notice published by the FDA in the mid-1980s, a New Drug Application (NDA) for Renacidin was submitted by United-Guardian, Inc. to the United States Food and Drug Administration (FDA) that provided for the product to be manufactured and marketed as a ready-made sterile 10% solution. The NDA was approved in 1990, and sale of the product began in January 1991. The product was called “Renacidin Irrigation” and supplied in 500 mL glass bottles to enable patients to use the product for the newly approved use of the product for the dissolution of certain types of kidney stones. In 1995, the powder form of Renacidin was discontinued due to declining sales, as most patients had switched to the more convenient solution form of the product.

In 2011 and again in 2012-13, production issues experienced by the contract manufacturer of the product caused Renacidin Irrigation to be unavailable for extended time periods. In 2012, the contract manufacturer advised that they expected to close the facility that produced Renacidin Irrigation within 2-3 years. United-Guardian, Inc. then began investigating the feasibility of developing a single-dose 30 mL unit for catheter and bladder irrigation only, as kidney use of the product had decreased significantly due to newer techniques used to crush and remove those stones. In August 2014, a supplement to our NDA for Renacidin was submitted for the new 30 mL single-dose container; and marketing approval was received in December 2015. The use of the product for dissolving kidney stones is no longer an indicated use for the product, since it requires a large volume of liquid and the smaller 30 mL bottles are no longer practical to use for that purpose. Individual 30 mL Renacidin containers should not be combined for continuous irrigation of the urinary tract due to the potential for complications that may arise from inadequate aseptic technique or inadequate terminal sterilization. Serious adverse reactions, including sepsis and hypermagnesemia, have been reported, as well as potential injury to product handlers (e.g., irritation to exposed, unprotected areas of the skin). Renacidin is not indicated for continuous irrigation of the upper urinary tract.

Sales of Renacidin Irrigation in the 500 mL bottle continued until March 31, 2016, and sales of the new 30 mL sterile, single-dose container began on April 1, 2016.

The single-dose unit is sold in boxes containing thirty 30 mL units, NDC 00327-0012-30, and is available from the same drug wholesalers that were distributing the 500 mL bottle throughout the United States. These wholesalers distribute the product to retail drug stores (including drug chains), hospitals, long-term care facilities, and to the Department of Veterans Affairs and other federal agencies.

IMPORTANT SAFETY INFORMATION

Who should not take RENACIDIN?

• You should check with your doctor before taking Renacidin to make sure there is no urinary tract extravasation (leakage).
• Renacidin Irrigation should be used with caution in patients taking medications containing magnesium.
• It is 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. Animal reproduction studies have not been conducted with Renacidin.

Warnings about the use of RENACIDIN:

• Renacidin use should be stopped immediately if you develop fever, signs and symptoms consistent with urinary tract infection, persistent pain or discomfort in the upper abdomen, back, or sides, or if blood tests show elevated serum creatinine levels.
• 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 or inadequate terminal sterilization. Complications may include sepsis (a life-threatening response to infection that can lead to tissue damage, organ failure, and death), or hypermagnesemia (excess magnesium in the blood). In addition, there could be potential injury to product handlers (e.g., irritation to exposed, unprotected areas of the skin).
• DO NOT use Renacidin for continuous irrigation of the upper urinary tract (kidneys). Serious adverse reactions (including sepsis and hypermagnesemia (see above) have been reported to occur when Renacidin was used for continuous irrigation of the upper urinary tract.

Before using RENACIDIN:

Before using RENACIDIN tell your doctor about all your medical conditions, including if you are pregnant or plan to get pregnant, or if you are breastfeeding or plan to breastfeed. Tell your doctor about all the prescription and over-the-counter medicines you are taking. In addition:

• Before starting RENACIDIN, patients with an indwelling urethral catheter or a cystostomy tube should confirm that they don’t have undiagnosed vesicoureteral reflux (a condition in which urine flows backward from the bladder into the ureters and/or kidneys). If reflux is found, you should discuss the situation with your physician to determine whether the potential benefits of the use of RENACIDIN outweigh the risks. If it is decided to begin using RENACIDIN then all recommended safety monitoring precautions for someone with vesicoureteral reflux should be strictly implemented.
• You should be aware that mutagenicity studies (studies to determine whether a product is capable of causing genetic mutation), animal reproduction studies, and long-term studies to evaluate the carcinogenic potential of Renacidin, have not been conducted.
• Nursing mothers should be aware that magnesium is known to be excreted (expelled by the body as waste) into human milk. It is not known whether Renacidin is excreted in human milk, but because many drugs are, caution should be exercised when Renacidin is administered to a woman who is nursing.

Precautions to take while using RENACIDIN:

• Make sure that the flow through the urethral catheter or cystostomy tube remains unobstructed by flushing the catheter with saline and repositioning of the catheter. The flow should be monitored frequently by a nurse or other person with sufficient skills to be able to detect any problems with the flow through the catheter. At the first sign of catheter obstruction, Renacidin should be discontinued.
• You should be monitored throughout the course of therapy with Renacidin. Blood tests to determine the levels of serum creatinine, phosphate and magnesium should be performed every several days. Use of RENACIDIN should be discontinued if there is elevated serum creatinine concentration.
• Urine specimens should be collected for culture and antibacterial sensitivity approximately every three days and at the first sign of fever. Therapy with Renacidin should be stopped if any culture exhibits growth and appropriate antibacterial therapy should be initiated. Therapy with Renacidin may be started again after a course of antibacterial therapy upon demonstration of sterile urine.
• Renacidin Irrigation should be used with caution in patients taking medications containing magnesium, since it may contribute to elevated levels of magnesium in the blood of certain patients, such as those with vesicoureteral reflux (see above).

How is RENACIDIN supplied?

Renacidin is available as a sterile solution in 30 mL single-use plastic bottles. It is sold in boxes of 30 bottles each. It does not require refrigeration, and should be stored at room temperature; 59° to 86°F (15° to 30°C).

How do I use RENACIDIN?

RENACIDIN should be used exactly as directed by your doctor. Prior to using RENACIDIN, the solution should be inspected visually for particulate matter and discoloration. If either is observed, the product should not be used, and you should notify your doctor.

To use RENACIDIN, remove the plastic tab connected to the conical tip of the Renacidin container by twisting the plastic tab (please see detailed instructions in the product insert), and then connect the conical tip of the Renacidin container to the end of the urethral catheter or cystostomy tube. Squeeze the Renacidin container to expel the entire contents into the urethral catheter or cystostomy tube.

• Specific instructions for using RENACIDIN for the dissolution of calcifications in the bladder:
  1. Instill one 30 mL container of Renacidin into the bladder through the urethral catheter or cystostomy tube.
  2. Clamp the urethral catheter or cystostomy tube for 30 to 60 minutes.
  3. Release the clamp and drain the bladder.
  4. Repeat the procedure 4 to 6 times a day or as directed by your doctor. Monitor for dissolution of the calcifications.
• Specific instructions for the prevention of calcifications or encrustations in urethral catheters and cystostomy tubes:
  1. Instill one 30 mL container of Renacidin into the urethral catheter or cystostomy tube.
  2. Clamp the urethral catheter or cystostomy tube for 10 minutes.
  3. Remove the clamp and drain the bladder.
  4. Repeat the procedure 3 times a day or as directed by your doctor.

What are the possible side effects of RENACIDIN?

Renacidin may cause serious side effects, including:

• Fever
• urinary tract infections
• elevated serum creatinine levels in the blood
• discomfort in your upper abdomen, back, or sides

The most common side effects of RENACIDIN are “bladder irritability” (a condition where the muscles in the bladder contract involuntarily, resulting in a sudden, urgent, uncontrollable need to urinate) and chemical cystitis (an inflammation of the bladder caused by a reaction in the body to certain chemical substances, including certain hygiene products), which occur in approximately 3% of patients. In addition, less than 1% of patients receiving RENACIDIN will experience a transient (temporary or intermittent) burning sensation in the bladder following the introduction of Renacidin.

If you experience any of these side effects, you should stop using RENACIDIN immediately and notify your doctor right away. You are encouraged to report any negative side effects to the manufacturer, United-Guardian, Inc., at 631-273-0900, and to the FDA at 1-800-FDA-1088, or the FDA web site at ww.fda.gov/medwatch.

Need more information?

This is only a summary of important information regarding RENACIDIN. Ask your healthcare provider for complete product information.