Gluconate Complex Research Articles

The safety of sodium ferric gluconate complex in haemodialysis patients has been extensively evaluated

The safety of sodium ferric gluconate complex in haemodialysis patients has been extensively evaluated

Do we need to change our administration practice with regard to sodium ferric gluconate complex in glucose?

Do we need to change our administration practice with regard to sodium ferric gluconate complex in glucose?

Parenteral Iron Therapy in Treatment of Anemia in End-Stage Renal Disease Patients: A Comparative Study between Iron Saccharate and Gluconate

Background: Anemia in hemodialysis patients is a complex syndrome. The impetus of this study was to assess the safety and efficacy of iron saccharate complex (ISC) and sodium ferric gluconate complex (SFGC) in treating anemia in hemodialysis patients. Methods: Forty-eight adult anemic patients of both genders (33 males and 15 females) who had an adequate level of both hemodialysis and nutrition status and received neither EPO nor parenteral iron therapy during the preceding 6 months were randomized to 2 groups. The first group comprised 22 patients who were treated with parenteral ISC, 100 mg twice weekly for 2 months and once weekly thereafter. The second group included 26 patients who received SFGC, 62.5 mg twice weekly for 2 months and once weekly thereafter. The patients were followed up for 6 months. Results: This head-to-head study showed that iron stores were adequately repleted by the use of both drugs. Repletion of iron stores was associated with a significant rise in both hemoglobin and hematocrit in both groups at the end of the follow-up period in comparison to their initial values at the start of the study (p < 0.001). Both parenteral iron therapy preparations were tolerated without a statistical difference between both groups. Conclusion: This head-to-head study confirmed that both parenteral iron preparations are effective for adequate repletion of iron stores and constituted a step forward in the management of anemic hemodialysis patients without noticeable adverse effects related to the administration of both iron preparations.

Intravenous Iron Replacement with Sodium Ferric Gluconate Complex in Sucrose for Iron Deficiency Anemia in Adults

Background: When oral iron replacement therapy is ineffective, IV or IM iron dextran products have been used successfully in many patients. However, adverse events, including urticaria, anaphylaxis, and death, sometimes are associated with the use of these products. Objective: The aim of this study was to assess the efficacy and tolerability of sodium ferric gluconate complex (SFGC) in sucrose in the treatment of adults with iron deficiency anemia. Methods: This was a single-center, open-label, uncontrolled study. Consecutive adults in need of IV iron replacement who experienced severe reactions to generic IV iron dextran and who had previously failed to respond to oral iron products were treated with a single dose of IV SFGC (312, 375, or 500 mg) infused over 2 hours. A second dose of SFGC could be administered 6 to 8 weeks later, if needed. Results: Six patients (3 men, 3 women; mean [SD] age, 77.0 [10.4] years) were enrolled. All patients received a single-dose infusion of SFGC, and 2 patients received a second dose. No adverse events were observed at the lower doses (312 and 375 mg); however, both patients given the 500-mg dose reported transient nausea, and 1 had pruritus and the other had transient hypertension. Conclusion: The results of this study show that SFGC is a satisfactory alternative when IV iron replacement is needed by adults with iron deficiency anemia.

Chronic use of sodium ferric gluconate complex in hemodialysis patients: Safety of higher-dose (≥250 mg) administration

Background: Almost all hemodialysis (HD) patients require intravenous iron therapy to correct their anemia and maintain their iron stores. Sodium ferric gluconate complex (SFGC) is approved by the Food and Drug Administration (FDA) for treatment of iron deficiency anemia in HD patients at individual doses up to 125 mg over 10 minutes (12.5 mg/min) and has been shown to have a superior safety profile compared with iron-dextran. Higher individual doses of SFGC would permit more rapid repletion of iron stores and greater flexibility in maintenance iron therapy as well as simplify treatment of peritoneal dialysis patients and chronic kidney disease patients. Methods: The authors reviewed the safety and tolerability of higher-dose SFGC infusions (≥250 mg) in 144 HD patients who were previously tolerant to a single 125-mg dose of SFGC. These 144 patients received a total of 590 doses of ≥250 mg of SFGC; 571 doses were 250 mg SFGC, and most of these were infused over 1 hour, an infusion rate of 4.17 mg/min. The other 19 doses were 312.5 mg (n = 1), 375 mg (n = 14), and 500 mg (n = 4). Infusion rates varied from 1.22 mg/min to 25.0 mg/min. Results: Only one patient was considered intolerant to higher-dosing SFGC after having pruritus after a second 250-mg dose of SFGC. Three patients had nonserious events that did not preclude further dosing of SFGC. Conclusion: Administration of 250 mg SFGC over 1 hour is safe and well tolerated. Individual doses of 375 mg and 500 mg SFGC also were well tolerated, but further research and experience are needed to confirm the safety and tolerance of these doses. Am J Kidney Dis 41:651-657. © 2003 by the National Kidney Foundation, Inc.

Incidence of side-effects associated with high-dose ferric gluconate in patients with severe chronic renal failure.

Ferric gluconate complex in sucrose (Ferrlecit) has been associated with less side-effects than iron dextran; however, the recommended dose of 62.5-125 mg per treatment is only suitable for haemodialysis (HD) patients. We retrospectively analysed the incidence of the side-effects associated with a high dose of Ferrlecit infusion (20 treatments in 13 patients; 10 treatments of 250 mg/3-4 h, and 10 treatments of 500 mg/5 h infusion). The patients were in the age range of 32-75 years old, seven with chronic renal failure (CRF), and six on dialysis treatment. One (10%) of the 10 treatments using a 250 mg dose was complicated with severe nausea/vomiting, diarrhoea and a burning sensation in the feet. Three (30%) of the 10 treatments using a 500 mg dose were complicated with: chills, severe nausea/vomiting, hypotension and syncope in one; severe nausea/vomiting, diarrhoea and hypotension in one; and an episode of vomiting in one patient. A single treatment with a 250 mg dose resulted in no significant change in haematological parameters. A single treatment with a 500 mg dose resulted in a significant increase in haemoglobin (Hgb) and haematocrit (Hct), but only a rising trend in serum iron,% transferrin saturation and ferritin pre versus 1-2 months postinfusion. In conclusion, Ferrlecit doses of 250 or 500 mg are complicated with significant untoward reactions in 10-30% of patients, in a dose-dependent fashion.

Sodium ferric gluconate complex in hemodialysis patients. II. Adverse reactions in iron dextran-sensitive and dextran-tolerant patients

Iron dextran administration is associated with a high incidence of adverse reactions including anaphylaxis and death. Although dextran, rather than iron, is believed to be the cause of these reactions, it is not known whether iron dextran-sensitive patients can be safely administered another form of parenteral iron, sodium ferric gluconate in sucrose (SFGC). In a 69 center, prospective, double-blind, controlled trial of safety and tolerability of SFGC, the rate of reactions to SFGC and placebo in 144 iron dextran-sensitive patients was compared with 2194 patients who were previously tolerant to iron dextran preparations. Serum tryptase levels, a marker of mast cell degranulation, also were measured. Among 143 iron dextran-sensitive patients exposed to SFGC, three (2.1%) were intolerant. All three had suspected allergic events to SFGC, including one patient with a serious reaction (0.7%). One dextran-sensitive patient (0.7%) had a suspected allergic reaction after placebo. In contrast, among 2194 iron dextran-tolerant patients, reactions to SFGC were significantly less common, with SFGC intolerance seen in seven patients (0.3%; P = 0.020), including five (0.2%) who had suspected allergic events (P = 0.010), but none who had serious events (0.0%; P = 0.061). Two iron dextran-tolerant patients (0.09%) had allergic-like reactions following placebo injections. Two of the three suspected allergic events in the iron dextran-sensitive group were confirmed as mast cell dependent by a 100% increase in serum tryptase, while there were no confirmed allergic events in the iron dextran-tolerant group. Long-term exposure to SFGC in iron dextran-sensitive patients resulted in intolerance in only one additional patient and no serious adverse events. Patients with a history of iron dextran sensitivity had approximately sevenfold higher rates of reaction to both placebo and SFGC compared to iron dextran tolerant patients. However, logistic regression analysis, performed to account for the higher reaction rate to placebo, suggests that this increased reactivity was not drug-specific nor immunologically mediated, but represented host idiosyncrasy. These results support the conclusions that reactions to SFGC can be attributed to pseudoallergy, and that SFGC is not a true allergen.

Safety and efficacy of sodium ferric gluconate complex in patients with chronic kidney disease

Background: We hypothesized that intravenous iron will improve hemoglobin (Hgb) concentrations in anemic patients with chronic kidney disease (CKD), and the response would be greater if the underlying erythropoietin deficiency also was treated. Methods: Charts of 58 CKD veterans (glomerular filtration rate < 80 mL/min) administered at least 125 mg of sodium ferric gluconate complex in sucrose (SFGC) during a period of 1 year for the primary outcome of an increase in Hgb level by at least 0.5 g/dL were reviewed. Results: Mean Hgb level at baseline was 10.5 ± 1.4 (SD) g/dL (105 ± 14 g/L) in the 30 patients administered recombinant human erythropoietin (rHuEPO) plus SFGC and 10.1 ± 1.3 g/dL (101 ± 13 g/L) in the 28 patients administered SFGC alone (P = not significant). The primary event occurred in 83% of the rHuEPO-plus-SFGC group at 31 days compared with 60% at 62 days in the group administered SFGC alone (P = 0.037, Cox F test). In patients administered SFGC alone, mean maximal Hgb level was 11.4 ± 0.9 g/dL (114 ± 9 g/L) in contrast to 12.4 ± 1.7 g/dL (124 ± 17 g/L) in the combination group, which remained significantly different even after adjustment for biologically important covariates (P = 0.01, analysis of covariance). Of the 240 doses of SFGC administered for which infusion records were available, 237 doses were well tolerated; three hypotensive episodes occurred in 2 patients, which did not result in discontinuation of the drug in either case. Conclusion: Correction of anemia with parenteral iron alone suggests a high prevalence of iron deficiency in patients with CKD. Treatment of concomitant iron deficiency with SFGC was well tolerated in patients with CKD and appears to optimize management of anemia. Am J Kidney Dis 40:924-931. © 2002 by the National Kidney Foundation, Inc.

The Catalysis of the Ruff Oxidative Degradation of Aldonic Acids by Copper(II)-Containing Solids

The catalysis of the Ruff oxidative degradation of calcium D-gluconate to D-arabinose by aqueous diluted hydrogen peroxide was investigated using copper(II)-containing solids: zeolites and resins. Among zeolites, copper(II)-exchanged Y faujasite has given good results, similar to homogeneous copper catalysts. Only minute amounts of soluble copper were detected at the end of the reaction and the recovered solid was recycled twice without diminution of efficiency. However, it was not true heterogeneous catalysis because the chelating gluconate anion leached copper right from the beginning of the reaction. So, the catalysis occurred in solution but the metal precipitated again at the end of the reaction, when all the gluconate was consumed. Copper (II) iminodiacetic resin, in which the metal cation is more strongly bound than in the gluconate complex, was not active. This demonstrates that copper(II) must be in solution in order to be active.

Sodium ferric gluconate complex in hemodialysis patients: Adverse reactions compared to placebo and iron dextran

Parenteral iron is often required by hemodialysis patients to maintain adequate iron stores. Until recently, the only available form of intravenous iron was iron dextran, which is associated with significant adverse reactions, including anaphylaxis and death. Sodium ferric gluconate complex (SFGC) was recently approved for use in the U.S. under FDA's priority drug review. This Phase IV study was designed to evaluate the safety of a single dose of intravenous SFGC as compared to placebo and a historical iron dextran control. This multicenter, crossover, randomized, double blind, placebo-controlled prospective comparative study was performed in hemodialysis patients requiring at least 125 mg of elemental iron. The historical control was obtained from a meta-analysis of four publications examining outcomes in patients exposed to iron dextran. SFGC naïve patients were administered SFGC without a test dose, undiluted, at a rate of 125 mg over 10 minutes, and compared to placebo comprising bacteriostatic saline. A total of 2534 patients were enrolled. The incidence of drug intolerance (an adverse event precluding re-exposure) was significantly less [0.44%, confidence interval (CI) 0.21 to 0.71%] after SFGC as compared to the iron dextran control (2.47%, CI 1.87 to 3.07%, P < 0.0001), but higher than after placebo (0.1%, P = 0.02). There was no difference found between SFGC and placebo in serious adverse events. A single life-threatening event occurred after SFGC (0.04%, CI 0.00 to 0.22%), which was significantly less than following iron dextran (0.61%, CI 0.36 to 0.86%), P = 0.0001. SFGC is well tolerated when given by intravenous push without a test dose. SFGC has a significantly lower incidence of drug intolerance and life-threatening events as compared to previous studies using iron dextran. The routine use of iron dextran in hemodialysis patients should be discontinued.

Influence of sodium sulphite on corrosion inhibition by the sodium gluconate –Zn2+ system

The inhibition efficiency of sodium gluconate (SG) in controlling corrosion of carbon steel immersed in the environment containing 60 ppm Cl– has been evaluated in the presence and absence of Zn2+ by weight loss method. SG and Zn2+ show a synergistic effect. The protective film has been analysed by FTIR and fluorescence spectra. The protective film consists of Fe2+‐gluconate complex and Zn(OH)2. The film is found to be UV‐fluorescent. The IE of the SG‐Zn2+ system increases in the presence of Na2SO4; but decreases in the presence of Na2SO3 and also in the presence of N‐cetyl‐N,N,N‐trimethyl ammonium bromide. This study reveals that the transporting phenomenon plays a larger role than the scavenging of dissolved oxygen.

Corrosion behaviour of carbon steel in the presence of N‐cetyl‐N,N,N‐trimethylammonium bromide, Zn2+ and calcium gluconate

The inhibition efficiency of N‐cetyl‐N,N,N‐trimethylammonium bromide (CTAB), a cationic surfactant, in controlling the corrosion of carbon steel in an aqueous solution containing 60ppm Cl–, in the absence and presence of Zn2+ and also calcium gluconate (CG), had been evaluated by the weight‐loss method. Weight‐loss studies revealed that the behaviour of CTAB changed when its concentration is ≥ 150ppm. Organisation of assembly of CTAB molecules is expected to take place at this critical concentration. The protective film has been analysed using FTIR spectra. In the presence of CTAB, the protective film consists of Fe2+‐CTAB complex. In the presence of CTAB and Zn2+, the protective film consists of Fe2+‐CTAB complex and Zn(OH)2. In the presence of CTAB and calcium gluconate, the protective film consists of Fe2+‐CTAB complex, Fe2+‐gluconate complex and Ca(OH)2.

Questions and Answers from the F.I.X./More on UFH after LMWH/Carboprost (Hemabate) in Hemorrhagic Cystitis/Stability of Ferrlecit (Sodium Ferric Gluconate Complex)/Pamidronate (Aredia) IV Weekly/Pantoprazole (Protonix) Continuous Infusion/Heparin Dosing in Cardiology Patients

The Formulary Information Exchange (The F.I.X.) is an online drug information service available to subscribers to The Formulary Monograph Service at http://theformulary.com , or you may log on through drugfacts.com. In this column, we present samples of recent dialog on The F.I.X. If you would like more information on The Formulary Monograph Service or The F.I.X., please call 800-322-4349.

Safety in repeat exposure to sodium ferric gluconate complex (SFGC) in 1413 patients given by slow IV push: Beckie Michael, Andrea Shaer, Steven Fishbane and Jur Strobos. Thomas Jefferson University, Philadelphia, PA, Medical University of South Carolina, Charleston, SC, Winthrop University Hospital, Mineola, NY, R& D Labs, Los Angeles, CA

Safety in repeat exposure to sodium ferric gluconate complex (SFGC) in 1413 patients given by slow IV push: Beckie Michael, Andrea Shaer, Steven Fishbane and Jur Strobos. Thomas Jefferson University, Philadelphia, PA, Medical University of South Carolina, Charleston, SC, Winthrop University Hospital, Mineola, NY, R& D Labs, Los Angeles, CA

Sodium Ferric Gluconate Complex in Sucrose Injection

Each month, subscribers to The Formulary® Monograph Service receive five to six researched monographs on drugs that are newly released or are in late Phase III trials. The monographs are targeted to your Pharmacy and Therapeutics Committee. Subscribers also receive monthly one-page summary monographs on the agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation (DUE) is also provided each month. The monographs are published in printed form and on diskettes that allow customization. Subscribers to the The Formulary Monograph Service also receive access to a pharmacy bulletin board called The Formulary Information Exchange (The F.I.X). All topics pertinent to clinical pharmacy are discussed on The F.I.X. Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. If you would like information about The Formulary Monograph Service or The F.I.X., call The Formulary at 800-322-4349. The August 1999 Formulary monographs are on rofecoxib/celecoxib, rosiglitazone, rivastigmine, doxercalciferol, oseltamivir. The DUE is on rosiglitazone.

Celecoxib

Each month, subscribers to The Formulary® Monograph Service receive five to six researched monographs on drugs that are newly released or are in late Phase III trials. The monographs are targeted to your Pharmacy and Therapeutics Committee. Subscribers also receive monthly one-page summary monographs on the agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation (DUE) is also provided each month. The monographs are published in printed form and on diskettes that allow customization. Subscribers to the The Formulary Monograph Service also receive access to a pharmacy bulletin board called The Formulary Information Exchange (The F.I.X). All topics pertinent to clinical pharmacy are discussed on The F.I.X. Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. If you would like information about The Formulary Monograph Service or The F.I.X., call The Formulary at 800-322-4349. The May 1999 Formulary monographs are on pantoprazole, denileukin diftitox, nesiritide, sirolimus, and sodium ferric gluconate complex in sucrose. The DUE is on sodium ferric gluconate complex in sucrose.

Sodium ferric gluconate complex in sucrose: safer intravenous iron therapy than iron dextrans.

Use of recombinant human erythropoietin in patients with end-stage renal disease has highlighted iron deficiency as the major cause of resistant anemia. The current mainstay of intravenous (i.v.) iron replacement therapy, iron dextran, has been shown in prior studies to have a risk of serious life-threatening anaphylaxis of just under 1 per 100 patients exposed. The current study assessed the safety profile of an alternative i.v. iron, sodium ferric gluconate complex in sucrose (Ferrlecit), as compared with iron dextrans. Sodium ferric gluconate complex in sucrose, a unique chemical preparation, has been in use since 1959, principally in Europe, at a rate of approximately 2.7 million i.v. doses per year (1992 to 1996) in Germany and Italy alone. For iron dextran, usage in the United States was comparable--principally renal hemodialysis--and estimated from market sources at 3.0 million doses per year (1995). From 1976 to 1996, there were 74 allergic adverse events reported for sodium ferric gluconate complex in sucrose to the World Health Organization (WHO), German Health Bureau, and the manufacturer (all combined). For the years 1992 to 1996, sodium ferric gluconate complex in sucrose had an allergy event reporting rate of 3.3 allergy episodes per million doses per year compared with a similar rate of 8.7 reported allergy events per million doses per year for iron dextran in the United States in 1995. Case fatalities for sodium ferric gluconate complex in sucrose and iron dextran within these reports were then compared. For sodium ferric gluconate complex in sucrose, there were no reports of deaths over the entire period (1976 to 1996). However, for iron dextrans, there were 31 fatalities among 196 allergy/anaphylaxis cases reported in the United States between 1976 and 1996, yielding a case-fatality rate of 15.8%. These data show that sodium ferric gluconate complex in sucrose, when compared with iron dextrans in comparably sized patient usage populations with similar total rates of reporting of allergic events, has a significantly lower reported mortality rate (P < 0.001). Thus, the data justify usage of sodium ferric gluconate complex in sucrose as the safer iron replacement therapeutic agent.

Corrosion Inhibition of Carbon Steel by Blends of Gluconate/Benzoate at Temperatures Up to 60°C

The inhibition of carbon steel in solutions of mixtures of calcium- and zinc-gluconate with sodium benzoate was investigated in the temperature range from 25° to 60°C, under atmospheric conditions in stagnant solutions prepared with the tap water. The efficiency and the mechanism of inhibition were estimated by potentiodynamic polarization measurements. The influence of the concentration and the ratio of gluconate/benzoate on the anodic reaction and an observed cathodic effect, indicating slowing down the oxygen reduction process, relevant to the concentration of zinc ions, have been demonstrated. The performed inhibition of carbon steel, as shown by polarization data, may be attributed to the adsorption of gluconate along with benzoate or/and to the formation of a low soluble iron gluconate complex on the metal surface. The inhibition is enhanced by the cathodic polarization mechanism resulting in the precipitation of a zinc hydroxide film, due to the local cathodic gradient of hydroxyl ions. Gluconates act also as sequestring agents preventing a deposition of calcium carbonate from hard waters. Results obtained by electrochemical measurements were confirmed by immersion tests, and could be of interest for the application in cooling water treatement systems, and for the injection water in oil and gas recovery. Investigated compounds are environmentally acceptable being non-toxic and non-polluting.

Technical noteCalcium gluconate as corrosion inhibitor for mild steel in low chloride media

AbstractThe efficiency of calcium gluconate in inhibiting the corrosion of mild steel in a neutral aqueous solution containing 60 ppm Cl−, a situation commonly encountered in cooling water systems, has been evaluated by the weight loss method. It was found that 200 ppm calcium gluconate resulted in 99% inhibition efficiency after 24 h but that this decreased to 60% after 7 days. The decrease in inhibition efficiency is attributed to the dissolution of the Fe2+–gluconate complex formed on the metal surface. The protective film formed on the metal surface consisted of an Fe2+–gluconate complex and Ca(OH)2.

Enhanced synergistic inhibition by calcium gluconate in low chloride media. Part II. Surface film characterisation

2-Carboxy ethyl phosphonic acid (2-CEPA) in presence of zinc ions synergistically inhibits mild steel corrosion in 60 ppm chloride solutions. Addition of calcium gluconate provides enhanced inhibition. Spectrochemical analyses of the solution and the surface inhibitor film reveal the presence of Zn (OH)2 and iron phosphono gluconate complex.