Renacidin

• It is used to treat kidney and bladder stones.
• It is used to prevent clogs in bladder catheters and tubes.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of high magnesium levels like change in thinking clearly and with logic, feeling sluggish, slow movements, shortness of breath, upset stomach, or very bad dizziness or passing out.
• Back pain, blood in the urine, or fever or chills.
• Pain in side.
• Cloudy or pink-red urine.
• Pain when passing urine.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Renacidin, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Renacidin. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Renacidin.

Review Date: October 4, 2017

The use of Renacidin Irrigation in the treatment of renal calculi is contraindicated in patients with urinary tract infections. Urea splitting bacteria reside within struvite and apatite stones which therefore serve as a source of infection. Dissolution therapy with Renacidin Irrigation in the presence of an infected urinary tract may lead to sepsis and death. Urine specimens should be obtained for culture prior to initiating chemolytic therapy of the renal pelvis. Appropriate antibiotic therapy should be instituted to treat any infection detected. A sterile urine must be present prior to initiating therapy. An infected stone can serve as a continual source for infection and, therefore, antibiotic therapy should be continued throughout the course of dissolution therapy.
Renacidin Irrigation is contraindicated in the presence of demonstrable urinary tract extravasation.

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.

The most common adverse reaction in selected case series is transient flank pain which occurs in most patients. Additional common reactions include urothelial ulceration and/or edema (13%) or fever (20% but up to 40% in some case series). Other adverse reactions which occur in 1-10% of cases include: urinary tract infection, back pain, dysuria, transient hematuria, nausea, hypermagnesemia, hyperphosphatemia, elevated serum creatinine, candidiasis, and bladder irritability. Adverse reactions which occur in less than 1 % of patients include: septicemia, ileus, vomiting and thrombophlebitis. Death from sepsis has been reported.

See Warnings

NOT FOR I.V. USE
FOR UROLOGICAL IRRIGATION ONLY
USE WITH VENTED SET

Read accompanying package insert for complete instructions on use. Store at room temperature (59°-86°F) (15°-30°C). Use only if seal is intact, solution is clear, and vacuum is detectable. Additives may be incompatible with Renacidin Irrigation. If additives are introduced into this irrigation system, aseptic techniques should be used and the solution should be thoroughly mixed. A solution of Renacidin Irrigation containing an additive drug should not be stored.

Each 100 mL contains:
Active ingredients: Citric acid, anhydrous, USP 6.602 gm. Glucono delta-lactone, USP 0.198 gm. Magnesium carbonate, USP 3.376 gm. Inert ingredient: Benzoic acid, USP 0.023 gm. Solution pH: 3.85 (3.5-4.2)

Product Code: RN500.
Made in U.S.A.
U.S. Patent
SINGLE DOSE STERILE, NON-PYROGENIC

Bottle Label

Bottle Label