citric acid/glucono-delta-lactone/magnesium carbonate (Rx)

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Brand and Other Names:Renacidin

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

citric acid/glucono-delta-lactone/magnesium carbonate

renal irrigation solution

  • (1980.6mg/59.4mg/980.4mg)/30mL single-use plastic bottle
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Renal Calculi

Indicated for local irrigation for 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

Also indicated 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

Instilled via nephrostomy tube to permit calculus lavage; use second catheter for drainage if calculi obstruct ureter

Infuse NS at 60 mL/hr and increase until elevated pressure, pain, or maximum flow rate of 120 mL/hr reached

Start flow of infusion at maximum rate achieved with NS

Bladder Calculi

Indicated or 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

30 mL instilled through a urinary catheter into the bladder and the catheter is clamped for 30-60 minutes, release clamp and drain bladder

Repeat 4-6 times daily

Urinary Catheter Incrustation

Indicated for intermittent irrigation to prevent or minimize incrustations of indwelling urinary tract catheters

Instill 30 mL of the solution through the catheter and then clamp catheter for 10 minutes, after which the clamp is removed to allow drainage of the bladder

Repeat 3 times daily

Safety and efficacy not established

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Adverse Effects

>10%

Flank pain, transient (>50%)

Fever (20-40%)

Urothelial ulceration with or without edema (13%)

Frequency Not Defined

Urinary tract infection

Back pain

Dysuria

Transient hematuria

Nausea

Hypermagnesemia

Hyperphosphatemia

Elevated serum creatinine

Candidiasis

Bladder irritability

Septicemia

Ileus

Vomiting

Thrombophlebitis

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Warnings

Contraindications

Hypersensitivity

Urinary tract infections (urea-splitting bacteria reside within struvite and apatite stones); dissolution therapy in the presence of an infected urinary tract may lead to sepsis and death

Treatment (dissolution) of calcium oxalate, uric acid, cysteine calculi

Cautions

Obtain urine specimen and culture prior to initiating chemolytic therapy and treat with appropriate antibiotic therapy if infection evident

Demonstrable urinary tract extravasation

An infected stone can serve as a continual source for infection and, therefore, antibiotic therapy should be continued throughout the course of dissolution therapy

Discontinue immediately if the patient develops fever, urinary tract infection, signs and symptoms consistent with urinary tract infection, or persistent flank pain.

Discontinue if hypermagnesemia or elevated serum creatinine develops

Sterile urine must be present prior to initiating therapy

Concurrent use of magnesium containing medications may contribute to production of hypermagnesemia

Maintain patency of the irrigating catheter; calculus fragments and debris may obstruct the outflow catheter

Intrapelvic pressures must be maintained at or below 25cm of water

Patients with indwelling urethral or cystostomy catheters frequently have vesicoureteral reflux; cystogram prior to initiation irrigation is essential for such patients; if reflux demonstrated, all precautions recommended for renal pelvis irrigation must be taken

Monitor serum creatinine, phosphate, and magnesium every several days

Urine specimens should be collected for culture and antibacterial sensitivity q3Days or less and at the first sign of fever

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Pregnancy & Lactation

Pregnancy Category: C; generally avoided in pregnancy

Lactation: Magnesium is known to be excreted in human milk; unknown whether Renacidin components distributed in breast milk, caution advised

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

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Pharmacology

Mechanism of Action

Action on susceptible apatite calculi results from an exchange of magnesium from the irrigating solution for calcium contained in the stone matrix; resulting magnesium salts formed are soluble in the glucono-citrate irrigating solution, thereby resulting in the calculus dissolution

Struvite calculi are composed mainly of magnesium ammonium phosphates which are solubilized by Renacidin Irrigation due to its acidic pH (ie, 3.85)

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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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