RENACIDIN citric gluconolactone and magnesium carbonate solution

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL)

Tillgänglig från:

United-Guardian, Inc.

INN (International namn):

ANHYDROUS CITRIC ACID

Sammansättning:

ANHYDROUS CITRIC ACID 6.6 g in 100 mL

Receptbelagda typ:

PRESCRIPTION DRUG

Bemyndigande status:

New Drug Application

Produktens egenskaper

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
DESCRIPTION
Renacidin (Citric Acid, Glucono delta-lactone, and Magnesium
Carbonate) Irrigation is a sterile, non-
pyrogenic irrigation for use within the urinary tract in the
prevention and dissolution of calculi.
Each 100 mL of Renacidin Irrigation contains:
Active ingredients:
Citric Acid (anhydrous), USP 6.602 grams
C H O Glucono delta-lactone, USP 0.198 grams
C H O Magnesium Carbonate, USP 3.376 grams
(MgCO ) · Mg(OH) · 5H O
CITRIC ACID
GLUCONO DELTA-LACTONE
MAGNESIUM CARBONATE
(MgCO ) · Mg(OH) · 5H O
Inert ingredients:
Benzoic Acid, USP 0.023 grams
Solution pH: 3.85 (3.5-4.2)
®
®
6
8
7
6
10
6
3 4
2
2
3 4
2
2
CLINICAL PHARMACOLOGY
Renacidin Irrigation'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
Irrigation due to its acidic pH.
Renacidin Irrigation is not effective for dissolution of calcium
oxalate, uric acid or cysteine stones.
INDICATIONS AND USAGE
Renacidin Irrigation is indicated for use by local irrigation in the
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 of the calculi.
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.
Renacidin Irrigation is also indicated for dissolution of bladder
calculi of the struvite or apatite variety
by local intermittent irrigation through a urethral cath