Medication Guide App

Citric Acid, Glucono-delta-lactone, and Magnesium (Mucosal-Local)


VA CLASSIFICATION
Primary: GU900

Commonly used brand name(s): Renacidin Irrigation.

Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).



Category:


Antiurolithic (apatite calculi; struvite calculi)—Citric Acid, Glucono-delta-lactone, and Magnesium;

Indications

General considerations
Citric acid, glucono-delta-lactone and magnesium carbonate solution will dissolve apatite calculi (calcium carbonate-phosphate compound) and struvite calculi (magnesium ammonium phosphates) but not calculi formed of calcium oxalate, uric acid, or cysteine{01}.

Because many complications are associated with infusion of citric acid, glucono-delta-lactone, and magnesium carbonate solution into the renal pelvis, this treatment should be reserved for patients who are not candidates for surgical removal of calculi. Hospitalization is prolonged for days to weeks when chemolytic therapy is used in lieu of, or following, surgery{01}.


Accepted

Bladder calculi, apatite (treatment) or
Bladder calculi, struvite (treatment)—Citric acid, glucono-delta-lactone, and magnesium carbonate combination is indicated for dissolution of bladder calculi as an alternative or adjunct to surgical procedures{01}.

Catheter, urinary tract, patency maintenance—Citric acid, glucono-delta-lactone, and magnesium carbonate combination is used as an intermittent irrigation to prevent or minimize incrustations of indwelling urinary tract catheters{01}.

Renal calculi, apatite (treatment) or
Renal calculi, struvite (treatment)—Citric acid, glucono-delta-lactone, and magnesium carbonate combination is indicated for the dissolution of renal calculi composed of apatite or struvite in patients who are not candidates for surgical removal of the calculi{01}. 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{01}.


Pharmacology/Pharmacokinetics

Physicochemical characteristics:


pH
    3.85 (3.5 to 4.2){01}

Mechanism of action/Effect:

Magnesium in the irrigation solution exchanges for calcium in the apatite stone matrix, making the calculus soluble in the gluconocitrate irrigating solution and resulting in dissolution of the calculus. Struvite calculi are solubilized by the irrigation solution due to its acidic pH{01}.


Precautions to Consider

Carcinogenicity/Tumorigenicity/Mutagenicity

Long term studies to evaluate carcinogenicity of citric acid, glucono-delta-lactone, and magnesium carbonate solution have not been conducted{01}. Mutagenicity studies have not been done{01}.

Pregnancy/Reproduction

Pregnancy—
Studies have not been done in humans. Studies have not been done in animals{01}.

FDA Pregnancy Category C{01}

Breast-feeding

Magnesium is known to be distributed into human milk. It is not known whether citric acid, glucono-delta-lactone, and magnesium carbonate solution is distributed into human milk{01}. However, problems in humans have not been documented.

Pediatrics

Appropriate studies on the relationship of age to the effects of citric acid, glucono-delta-lactone, and magnesium carbonate solution have not been performed in the pediatric population.


Geriatrics


No information is available on the relationship of age to the effects of citric acid, glucono-delta-lactone, and magnesium carbonate irrigation solution in geriatric patients.

Drug interactions and/or related problems
The following drug interactions and/or related problems have been selected on the basis of their potential clinical significance (possible mechanism in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):

Magnesium-containing medications    (May increase the likelihood of hypermagnesemia{01})



Laboratory value alterations
The following have been selected on the basis of their potential clinical significance (possible effect in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):

With physiology/laboratory test values
Creatinine, serum
Magnesium, serum
Phosphate, serum    (may become elevated{01})


Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Except under special circumstances, this medication should not be used when the following medical problem exists:
» Urinary tract infection    (May lead to sepsis{01})


» Urinary tract extravasation
Risk-benefit should be considered when the following medical problem exists
» Impaired renal function    (May increase likelihood of hypermagnesemia{01})



Patient monitoring
The following may be especially important in patient monitoring (other tests may be warranted in some patients, depending on condition; » = major clinical significance):

» Creatinine, serum
» Magnesium, serum
Phosphate, serum    (Measurements should be obtained every several days{01}. Elevated serum magnesium and elevated creatinine are indications for halting irrigation until the parameters return to pre-irrigation levels{01}. )


Deep tendon reflexes    (Indicator of magnesium toxicity{01})


» Urine culture    (Every three days or less and at first sign of fever{01})




Side/Adverse Effects

Note: Severe hypermagnesemia has been reported with citric acid, glucono-delta-lactone, magnesium carbonate solution irrigation. Early signs and symptoms of hypermagnesemia include nausea, lethargy, confusion, and hypotension. Severe hypermagnesemia may result in hyporeflexia, dyspnea, apnea, coma, and cardiac arrest{01}.
Hyperphosphatemia and elevated serum creatinine also can occur with citric acid, glucono-delta-lactone, magnesium carbonate solution irrigation{01}. Side effects of hyperphosphatemia include muscle cramps; numbness, tingling, pain, or weakness in hands or feet; and shortness of breath or troubled breathing.

The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
Incidence more frequent
    
Fever{01}
    
urothelial ulceration/edema{01} (blood in urine ; frequent urge to urinate; painful urination )
{01}
Incidence less frequent
    
Bladder irritability{01} (blood in urine; frequent urge to urinate; painful urination, severe or continuing)
    
candidiasis{01}
    
dysuria{01} (difficult urination)
    
urinary tract infection{01} (bladder pain; bloody or cloudy urine; difficult, burning, or painful urination; frequent urge to urinate; lower back or side pain )

Incidence rare
    
Ileus{01} ( abdominal pain; severe constipation ; severe vomiting)
    
septicemia{01} (rapid breathing; chills; fever; abdominal pain; nausea; diarrhea)
    
thrombophlebitis{01} ( bluish color changes in skin color; pain or tenderness; swelling of foot or leg)
{01}


Those indicating need for medical attention only if they continue or are bothersome
Incidence more frequent
    
{01}
    
Flank pain, transient{01}

Incidence less frequent
    
Back pain{01}
    
hematuria, transient{01} (blood in urine )
    
nausea

Incidence rare
    
Vomiting{01}





Overdose
For specific information on the agents used in the management of hypermagnesemia due to the use of citric acid, glucono-delta-lactone, magnesium carbonate irrigation solution, see:   • Calcium Supplements (Systemic) monograph.

For more information on the management of overdose or unintentional ingestion, contact a poison control center (see Poison Control Center Listing).

Clinical effects of overdose
The following effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:
    
Hypermagnesemia (Cardiac arrest ; chest pain; confusion; hyporeflexia; lightheadedness; nausea; shortness of breath or labored breathing; tiredness and weakness)
{01}

Treatment of overdose


To decrease absorption:
Discontinue irrigation with citric acid, glucono-delta-lactone, magnesium carbonate solution{01}



Specific treatment:
Administer calcium gluconate intravenously{01}.

See Calcium Supplements (Systemic) for specific dosing guidelines for use of this product.



Monitoring:
Serum magnesium{01}



Supportive care:
Administer fluids and diuretics in severe cases{01}.



General Dosing Information

For topical dosing forms:
Because of the high frequency of complications associated with irrigation of the renal pelvis, this procedure should be reserved for patients who are not candidates for surgical removal of calculi. In addition, chemolytic therapy prolongs hospital stay by days or weeks{01}.

Care must be taken to maintain patency of the irrigation catheter{01}.

Calculus fragments may obstruct the outflow catheter. Continued irrigation under these circumstances leads to increased intrapelvic pressure with risk of tissue damage or absorption of the irrigating solution. Catheter outflow blockage can be prevented by flushing the catheter with saline and repositioning the catheter. At the first sign of obstruction, irrigation should be discontinued and the system disconnected{01}.

Intrapelvic pressure must be maintained at or below 25 centimeters (cm) of water. The preferred method of pressure control is the insertion of an open Y connection pop-off valve into the infusion line, allowing immediate decompression if pressure exceeds 25 cm of water. An alternative method is to direct or stop the flow of the irrigating solution to prevent increased pelvic pressure. This can be accomplished by placing a pinch clamp on the inflow line, which a nurse or the patient can use to stop the irrigation at the first sign of flank pain. However, caution must be taken when relying on cooperation of the patient. Patients may not be sufficiently alert to detect signs and symptoms of outflow obstruction{01}

Patients with indwelling urethral or cystostomy catheters frequently have vesicoureteral reflux. A cystogram prior to initiation of irrigation with citric acid, glucono-delta-lactone, and magnesium carbonate solution is essential in such patients. If reflux is demonstrated, all precautions recommended for renal pelvis irritation must be taken{01}.

For postoperative patients, irrigation should not be started before the fourth or fifth postoperative day{01}.


Topical Dosage Forms

CITRIC ACID, GLUCONO-DELTA-LACTONE, AND MAGNESIUM CARBONATE SOLUTION

Usual Adult Dose
Bladder calculi
Topical, 30 mL instilled through a urinary catheter into the bladder and retained 30 to 60 minutes, 4 to 6 times per day{01}.

Renal calculi
Rate of flow, through a nephrostomy tube, equal to that tolerated in a test with sterile saline (between 60 mL/hr and 120 mL/hr), continuing until stones are no longer evident in nephrostomograms{01}; if stones fail to diminish in size after several days of adequate irrigation, the procedure should be discontinued{01}.

Urinary tract catheter incrustation
Topical, 30 mL instilled through the indwelling catheter and retained for 10 minutes, 3 times per day{01}.


Usual Pediatric Dose
Dosage has not been established.

Usual Geriatric Dose
See Usual adult dose.

Strength(s) usually available
U.S.—


Citric acid 6.602 grams per 100 mL, glucono-delta-lactone 0.198 gram per 100 mL, and magnesium carbonate 3.177 grams per 100 mL (Rx) [Renacidin Irrigation (sterile, non-pyrogenic solution ) (benzoic acid USP)]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F). Protect from freezing and excessive heat.{01}


Caution:
Product should be inspected visually for particulate matter and discoloration prior to administration{01}.



Developed: 06/19/2000



References
  1. Product Information: Renacidin® Irrigation, citric acid, glucono-delta-lactone and magnesium carbonate solution. Guardian Laboratories, Hauppauge, NY (PI revised 10/1996) reviewed 5/2000.
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