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R. Kaplan - One of the best experts on this subject based on the ideXlab platform.
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Efficacy of bowel preparation with the use of a prepackaged, low fibre diet with a low sodium, magnesium citrate cathartic vs. a clear liquid diet with a standard sodium phosphate cathartic.
Alimentary Pharmacology & Therapeutics, 2005Co-Authors: Mark H. Delegge, R. KaplanAbstract:Summary Background : A colon free of faecal residue is required for accurate diagnostic colonoscopy. Patient tolerance of his/her colonoscopy cathartic regimen affects patient compliance and willingness to undergo repeated examinations. Aim : To determine whether a meal could be consumed during standard bowel preparation. Methods : This was a randomized, endoscopists’ blinded comparison of the tolerability and efficacy of a prepackaged, low-residue diet (NutraPrep) combined with the LoSo Prep bowel cleansing system, which contains magnesium citrate, bisocodyl tablets and a bisocodyl suppository (NP-LS regimen), compared with a clear liquid diet and a double-dose sodium phosphate (Fleet Phospho-Soda) regimen (2F regimen). Outcome measures included efficacy of bowel preparation, patient preparation tolerability, side-effects and patient safety. Results : A total of 506 patients completed the study, 222 randomized to 2F and 284 to NP-LS. The NP-LS regimen resulted in significantly better colon cleansing in terms of the proportion with good or excellent results (P = 0.025) and in significantly better patient tolerance and willingness to repeat the cathartic preparation (P
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efficacy of bowel preparation with the use of a prepackaged low fibre diet with a low sodium magnesium citrate cathartic vs a clear liquid diet with a standard sodium phosphate cathartic
Alimentary Pharmacology & Therapeutics, 2005Co-Authors: Mark H. Delegge, R. KaplanAbstract:Summary Background : A colon free of faecal residue is required for accurate diagnostic colonoscopy. Patient tolerance of his/her colonoscopy cathartic regimen affects patient compliance and willingness to undergo repeated examinations. Aim : To determine whether a meal could be consumed during standard bowel preparation. Methods : This was a randomized, endoscopists’ blinded comparison of the tolerability and efficacy of a prepackaged, low-residue diet (NutraPrep) combined with the LoSo Prep bowel cleansing system, which contains magnesium citrate, bisocodyl tablets and a bisocodyl suppository (NP-LS regimen), compared with a clear liquid diet and a double-dose sodium phosphate (Fleet Phospho-Soda) regimen (2F regimen). Outcome measures included efficacy of bowel preparation, patient preparation tolerability, side-effects and patient safety. Results : A total of 506 patients completed the study, 222 randomized to 2F and 284 to NP-LS. The NP-LS regimen resulted in significantly better colon cleansing in terms of the proportion with good or excellent results (P = 0.025) and in significantly better patient tolerance and willingness to repeat the cathartic preparation (P < 0.01). Conclusion : The NP-LS regimen proved superior to the 2F regimen.
Eli D. Ehrenpreis - One of the best experts on this subject based on the ideXlab platform.
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Renal risks of sodium phosphate tablets for colonoscopy preparation: a review of adverse drug reactions reported to the US Food and Drug Administration.
Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland, 2011Co-Authors: Eli D. Ehrenpreis, Deepak Parakkal, Rumi SemerAbstract:Aim Sodium-phosphate-containing colonoscopy preparations cause renal failure by the development of calcium phosphate nephropathy. Although Fleet’s Phospho-Soda has been removed from the US market, sodium phosphate tablets sold as OsmoPrep and Visicol remain available. Our aim was to analyse renal risks of the sodium phosphate tablets. Method We conducted a retrospective study using the US Food and Drug Administration Adverse Event Reporting System, a voluntary reporting system available for public access. Renal adverse events were identified using search terms including renal impairment, increased blood urea nitrogen, increased creatinine, renal failure, acute renal failure, chronic renal failure, acute phosphate nephropathy, nephrocalcinosis, renal tubular necrosis, haemodialysis, nephropathy toxic, dialysis, peritoneal dialysis, renal injury, renal tubular disorder, decreased glomerular filtration rate and decreased creatinine clearance. Patient age, gender and body weight were compared with data for the general population in the National Health and Nutrition Examination Survey (NHANES). Results In total 2 097 223 files were extracted from the US Food and Drug Administration website for 2004–2008 and the first 9 months of 2009. Of these, 178 patients on tablet preparations (71% women) were identified, with increasing numbers of renal adverse drug reactions reported from tablet preparations each year. The mean weight for women with renal complications from tablet preparations was 68.57 ± 1.78 kg, significantly lower than the national average weight of 74 ± 0.5 kg for the same age group (P = 0.003) in NHANES. Conclusion Renal adverse drug reactions from sodium phosphate tablets are more common in women with a mean body weight lower than the national average weight.
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Increased serum phosphate levels and calcium fluxes are seen in smaller individuals after a single dose of sodium phosphate colon cleansing solution: a pharmacokinetic analysis
Alimentary pharmacology & therapeutics, 2009Co-Authors: Eli D. EhrenpreisAbstract:Summary Background Sodium phosphate containing colonoscopy preparations may cause electrolyte disturbances and calcium-phosphate nephropathy. Decreased body weight is an unexplored risk factor for complications with sodium phosphate ingestion. Aim To perform a pharmacokinetic analysis of a single dose of Fleet Phospho-Soda in smaller and larger individuals. Methods Seven subjects weighing 100 kg (Group II) consumed 45 mL Fleet Phospho-Soda. Serum electrolytes were measured. Hydration was closely maintained by monitoring weight, fluid intake and total body water. Results Marked increases in serum phosphate were seen in Group I compared to Group II. For example, mean serum phosphate at 120 min was 7.8 ± 0.5 mg/dL in Group I and 5.1 ± 0.8 mg/dL in Group II (P
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Serum electrolyte abnormalities secondary to Fleet's Phospho-Soda colonoscopy prep. A review of three cases.
Surgical endoscopy, 1996Co-Authors: Eli D. Ehrenpreis, J. J. Nogueras, V. A. Botoman, G. F. Bonner, D. Zaitman, K. M. SecrestAbstract:The authors report three cases of adverse reactions to commonly used lavage solutions generally believed harmless.
Mark H. Delegge - One of the best experts on this subject based on the ideXlab platform.
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Efficacy of bowel preparation with the use of a prepackaged, low fibre diet with a low sodium, magnesium citrate cathartic vs. a clear liquid diet with a standard sodium phosphate cathartic.
Alimentary Pharmacology & Therapeutics, 2005Co-Authors: Mark H. Delegge, R. KaplanAbstract:Summary Background : A colon free of faecal residue is required for accurate diagnostic colonoscopy. Patient tolerance of his/her colonoscopy cathartic regimen affects patient compliance and willingness to undergo repeated examinations. Aim : To determine whether a meal could be consumed during standard bowel preparation. Methods : This was a randomized, endoscopists’ blinded comparison of the tolerability and efficacy of a prepackaged, low-residue diet (NutraPrep) combined with the LoSo Prep bowel cleansing system, which contains magnesium citrate, bisocodyl tablets and a bisocodyl suppository (NP-LS regimen), compared with a clear liquid diet and a double-dose sodium phosphate (Fleet Phospho-Soda) regimen (2F regimen). Outcome measures included efficacy of bowel preparation, patient preparation tolerability, side-effects and patient safety. Results : A total of 506 patients completed the study, 222 randomized to 2F and 284 to NP-LS. The NP-LS regimen resulted in significantly better colon cleansing in terms of the proportion with good or excellent results (P = 0.025) and in significantly better patient tolerance and willingness to repeat the cathartic preparation (P
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efficacy of bowel preparation with the use of a prepackaged low fibre diet with a low sodium magnesium citrate cathartic vs a clear liquid diet with a standard sodium phosphate cathartic
Alimentary Pharmacology & Therapeutics, 2005Co-Authors: Mark H. Delegge, R. KaplanAbstract:Summary Background : A colon free of faecal residue is required for accurate diagnostic colonoscopy. Patient tolerance of his/her colonoscopy cathartic regimen affects patient compliance and willingness to undergo repeated examinations. Aim : To determine whether a meal could be consumed during standard bowel preparation. Methods : This was a randomized, endoscopists’ blinded comparison of the tolerability and efficacy of a prepackaged, low-residue diet (NutraPrep) combined with the LoSo Prep bowel cleansing system, which contains magnesium citrate, bisocodyl tablets and a bisocodyl suppository (NP-LS regimen), compared with a clear liquid diet and a double-dose sodium phosphate (Fleet Phospho-Soda) regimen (2F regimen). Outcome measures included efficacy of bowel preparation, patient preparation tolerability, side-effects and patient safety. Results : A total of 506 patients completed the study, 222 randomized to 2F and 284 to NP-LS. The NP-LS regimen resulted in significantly better colon cleansing in terms of the proportion with good or excellent results (P = 0.025) and in significantly better patient tolerance and willingness to repeat the cathartic preparation (P < 0.01). Conclusion : The NP-LS regimen proved superior to the 2F regimen.
Greg L. Plosker - One of the best experts on this subject based on the ideXlab platform.
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Oral Sodium Phosphate Solution
Drugs, 2004Co-Authors: Monique P. Curran, Greg L. PloskerAbstract:Oral sodium phosphate solution (Fleet® Phospho-Soda®, Casen-Fleet® FosfoSoda®) is a low-volume, hyperosmotic agent used as part of a colorectal-cleansing preparation for surgery, x-ray or endoscopic examination. The efficacy and tolerability of oral sodium phosphate solution was generally similar to, or significantly better than, that of polyethylene glycol (PEG) or other colorectal cleansing regimens in patients preparing for colonoscopy, colorectal surgery or other colorectal-related procedures. Generally, oral sodium phosphate solution was significantly more acceptable to patients than PEG or other regimens. The use of this solution should be considered in most patients (with the exception of those with contraindications) requiring colorectal cleansing. Pharmacological Properties After the first and second 45mL dose of oral sodium phosphate solution, the mean time to onset of bowel activity was 1.7 and 0.7 hours and the mean duration of activity was 4.6 and 2.9 hours. Bowel activity ceased within 4 hours of administration of the second dose in 83% of patients. Elevations in serum Phosphorus and falls in serum total and ionised calcium from baseline occurred during the 24 hours after administration of oral sodium phosphate solution in seven healthy volunteers. These changes were not associated with significant changes in clinical assessments. The decrease in serum potassium levels after administration of oral sodium phosphate solution was negatively correlated with baseline intracellular potassium levels. Therapeutic Use A regimen that administered the first dose of sodium phosphate on the previous evening and a second dose on the morning of the procedure (10–12 hours apart) was significantly more effective than PEG-based regimens for colorectal cleansing in preparation for colonoscopy, sigmoidoscopy or colorectal surgery. A regimen that administered both doses of oral sodium phosphate on the day prior to the procedure offered no colorectal cleansing advantage over PEG-based regimens and was significantly less effective than an oral sodium phosphate solution regimen that administered one dose on the previous evening and a second dose on the morning of the procedure. Oral sodium phosphate solution was generally as effective as other colorectal cleansing solutions (including magnesium citrate-containing regimens with sodium picosulfate). The direct costs of a diagnostic colonic examination with oral sodium phosphate solution were less than those with PEG ($US465 vs $US503 per patient; 1995 values), according to data from a US study. Oral sodium phosphate solution was significantly more effective than a commercially available tablet formulation as a colorectal cleanser prior to colonoscopy (data from one study only). Tolerability Oral sodium phosphate solution administered as two 45mL doses (generally 10–12 hours apart) was well tolerated in well designed trials in which adults with major comorbid conditions were excluded. Sodium phosphate-associated adverse events were mostly gastrointestinal (including abdominal pain/cramping, abdominal fullness and/or bloating, anal or perianal irritation or soreness, nausea, vomiting or hunger pains), although dizziness, weakness/fatigue, thirst, chest pain, chills, headache and sleep loss were also reported. Faecal incontinence was commonly reported in the elderly. Three doses (administered 10 minutes apart) of 15mL of oral sodium phosphate solution, each diluted in 250mL of clear fluid was associated with less vomiting than one 45mL dose of the solution diluted in 250mL of clear fluid (data from one study). In patients without major comorbid conditions, oral sodium phosphate has been associated with transient and clinically inconsequential changes in intravascular volume and electrolyte disturbances. Serious electrolyte disturbances have been associated with oral sodium phosphate administration in patients in whom sodium phosphate is contraindicated or should be use with caution (the elderly and those with bowel obstructions, small intestinal disorders, poor gut motility, renal insufficiency, cardiovascular disease or taking concomitant medication) or in patients ingesting more than the recommended dosage. Changes in the colonic mucosa have been reported in patients treated with oral sodium phosphate solution; however, the exact role of this agent in the appearance of these changes has not been fully clarified. The tolerability profile of oral sodium phosphate solution was similar to, or significantly better than, that of PEG or other colorectal cleansing regimens. Oral sodium phosphate solution was generally significantly more acceptable than PEG or other colorectal cleansing regimens. Oral sodium phosphate solution had similar tolerability, but was considered to be more acceptable than commercially available oral sodium phosphate tablets prior to colonoscopy (data from one study).
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oral sodium phosphate solution a review of its use as a colorectal cleanser
Drugs, 2004Co-Authors: Monique P. Curran, Greg L. PloskerAbstract:Abstract Oral sodium phosphate solution (Fleet® Phospho-Soda®, Casen-Fleet® FosfoSoda®) is a low-volume, hyperosmotic agent used as part of a colorectal-cleansing preparation for surgery, x-ray or endoscopic examination. The efficacy and tolerability of oral sodium phosphate solution was generally similar to, or significantly better than, that of polyethylene glycol (PEG) or other colorectal cleansing regimens in patients preparing for colonoscopy, colorectal surgery or other colorectal-related procedures. Generally, oral sodium phosphate solution was significantly more acceptable to patients than PEG or other regimens. The use of this solution should be considered in most patients (with the exception of those with contraindications) requiring colorectal cleansing.
Scs Chung - One of the best experts on this subject based on the ideXlab platform.
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Severe hyperphosphatemia and hypocalcemia following sodium phosphate bowel preparation: a forgotten menace.
Endoscopy, 2003Co-Authors: K. K., L. M. Mui, K. C. Chan, Scs ChungAbstract:A 74-year-old woman was scheduled forcolonoscopy due to positive fecal occultblood. On admission, her serum levels ofcreatinine, adjusted calcium, and phos-phate were 113mol/l, 2.24mmol/l, and1.17mmol/l, respectively. She received90ml of oral Fleet Phospho-Soda (C.B.Fleet Co. Inc., Lynchburg, Virginia, USA),from which she developed profuse diar-rhea. Six hours later, she complained offacial and limb numbness, and appeareddrowsy. Her serum phosphate level hadrisento7.29mmol/landhercalciumlevelhadfallento1.82mmol/l.Duringthenexthour, muscle cramps and tetany devel-oped over her lower limbs, trunk, andface, with a positive Chvosteks sign. In-travenous administration of 9.0mmol(40ml 10%) calcium gluconate was car-ried out over 6h, resulting in resolutionofhertetany,whilethenumbnesspersist-edoverthedistallimbs.Furtherinfusionstotaling 24.75mmol calcium gluconatewere required over the next 17h to re-store the calcium level to 2.32mmol/l(Figure1). Extensive investigations ex-cluded a secondary cause of the electro-lytedisturbance.Most complications of sodium phosphatebowelpreparationaretheresultofhyper-phosphatemia after rapid phosphate ab-sorption and subsequent binding to se-rum calcium, causing secondary hypocal-cemia [1]. Patients usually present 6–12h after ingestion, with abdominalpain, vomiting, dizziness, muscle cramp-ing,orseizures[2].Otherassociatedelec-trolyte disturbances include hypokal-emia, hypernatremia, and metabolicacidosis,withincreasedaniongap[3].Ex-cessive diarrhea can lead to significantpotassium and bicarbonate loss, con-tributing to hypokalemia and metabolicacidosis [2]. Hypernatremia is secondaryto intestinal absorption of sodium fromPhospho-Soda, dehydration, and colonicshiftingbetweensodiumandpotassium.Factors exacerbating hyperphosphatemiaare old age, impaired renal function withreduced phosphate clearance, dehydra-tion, bowel immotility, and repeateddosing.Symptomatichyperphosphatemiaand hypocalcemia are very uncommon inpatients with normal renal function [4].Theaimsoftreatmentaretoreducephos-phate absorption by oral phosphate bin-ders (calcium acetate or Alusorb), to in-crease phosphate clearance, and to cor-rect dehydration and electrolyte dis-turbances. Care must be taken when giv-ing calcium supplement, as renal cal-cium-phosphate precipitation may fur-therdeterioraterenalfunction[2].This unusual case is a dramatic reminderthat patients with normal renal functionmay rapidly develop symptomatic hypo-calcemia and hyperphosphatemia after asingledoseoforalPhospho-Soda.K.K.Ma,C.S.H.Ng,L.M.Mui,K.C.Chan,E. K. W. Ng, S. C. S. ChungDept.ofSurgery,ChineseUniversityofHongKong,PrinceofWalesHospital,ShaTin,NewTerritories,HongKongReferences