RENACIDIN- citric acid, gluconolactone and magnesium carbonate solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL), GLUCONOLACTONE (UNII: WQ29KQ9POT) (GLUCONOLACTONE - UNII:WQ29KQ9POT), MAGNESIUM CARBONATE (UNII: 0E53J927NA) (CARBONATE ION - UNII:7UJQ5OPE7D)

Available from:

United-Guardian, Inc.

Administration route:

IRRIGATION

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Renacidin is indicated for dissolution of bladder calculi of the struvite or apatite variety by local intermittent irrigation through a urethral catheter or cystostomy tube as an alternative or adjunct to surgical procedures. Renacidin is also indicated for use as an intermittent irrigating solution to prevent encrustations of indwelling urethral catheters and cystostomy tubes. Renacidin is contraindicated in the presence of demonstrable urinary tract extravasation.

Product summary:

Renacidin is available as a sterile, non-pyrogenic irrigation solution in 30 mL single-use, low density, polyethylene containers, supplied in boxes of 30 containers each. Exposure of Renacidin to heat or cold should be minimized. Renacidin should be stored at room temperature, 59° to 86°F (15° to 30°C). Avoid excessive heat or cold (keep from freezing). Brief exposure to temperatures of up to 40°C or temperatures down to 5°C does not adversely affect the product. NDC: 0327-0012-30 PRODUCT CODE: RN030 Revised: December, 2018 Manufactured for GUARDIAN LABORATORIES A DIVISION OF UNITED-GUARDIAN, INC. Hauppauge, N.Y. 11788

Authorization status:

New Drug Application

Summary of Product characteristics

RENACIDIN- CITRIC ACID, GLUCONOLACTONE AND MAGNESIUM CARBONATE
SOLUTION
UNITED-GUARDIAN, INC.
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RENACIDIN (CITRIC ACID, GLUCONO DELTA-LACTONE, AND MAGNESIUM
CARBONATE) IRRIGATION SOLUTION
DESCRIPTION
Renacidin (Citric Acid, Glucono delta-lactone, and Magnesium
Carbonate) is a sterile, non-pyrogenic
irrigation solution for use within the lower urinary tract in the
dissolution of bladder calculi of the
struvite or apatite variety, and prevention of encrustations of
urethral catheters and cystostomy tubes.
Each 30 mL of Renacidin contains:
Active ingredients:
Citric Acid (anhydrous), USP 1980.6 mg
C H O
Glucono delta-lactone, USP 59.4 mg
C H O
Magnesium Carbonate, USP 980.4 mg
(MgCO ) · Mg(OH) · 5H O
CITRIC ACID
GLUCONO DELTA-LACTONE
MAGNESIUM CARBONATE
(MgCO ) · Mg(OH) · 5H O
Inert ingredients:
®
®
6
8
7
6
10
6
3 4
2
2
3 4
2
2
Benzoic Acid, USP 6.9 mg
Solution pH: 3.85 (3.5-4.2)
CLINICAL PHARMACOLOGY
Renacidin's action on susceptible apatite calculi results from an
exchange of magnesium from the
irrigating solution for calcium contained in the stone matrix. The
magnesium salts thereby formed are
soluble in the gluconocitrate irrigating solution resulting in the
dissolution of the calculus. Struvite
calculi are composed mainly of magnesium ammonium phosphates which are
solubilized by Renacidin
due to its acidic pH. Renacidin is not effective for dissolution of
calcium oxalate, uric acid or cysteine
stones.
INDICATIONS AND USAGE
Renacidin is indicated for dissolution of bladder calculi of the
struvite or apatite variety by local
intermittent irrigation through a urethral catheter or cystostomy tube
as an alternative or adjunct to
surgical procedures.
Renacidin is also indicated for use as an intermittent irrigating
solution to prevent encrustations of
indwelling urethral catheters and cystostomy tubes.
CONTRAINDICATIONS
Renacidin is contraindicated in the presence of demonstrable urinary
tract extravasation.
WARNINGS
Renacidin use should be stopped immediately if the patient develops
fever, urinary tra