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Fractional Excretion of Bicarbonate

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42. Bowel preparation before colonoscopy

, bicarbonate, sodium chloride, potassium chloride PEG, sodium bicarbonate, sodium chloride, potassium chloride PEG-3350, sodium sulfate, sodium chloride, ascorbic acid PEG-3350 Purgative volume/amount; recommended minimum additional fluid (per prescribing information for FDA-approved products) 4 L; none 4 L; none 2 L; 1 L clear liquid 238 g PEG-3350 in 2 L SD; regimens vary FDA approval Yes Yes Yes No Average wholesale price, US$ 24.56 26.89 (NuLYTELY) 27.98 (Trilyte) 81.17 10.08 Dosing regimensy Split (...) , and there are limited data evaluating its effectiveness as a stand-alone colonoscopy preparation. One study that compared magnesium citrate with an aqueous sodium phosphate preparation found the magne- sium citrate preparation to be superior. 91 Magnesium is excreted via the kidneys, and this preparation should be avoided in patients with known kidney disease or the elderly.Magnesiumtoxicitycanresultinbradycardia,hypo- tension, nausea, and drowsiness. Serious adverse events including death have been reported. 92,93

2015 American Society for Gastrointestinal Endoscopy

44. Enhanced Recovery After Surgery (ERAS) for gastrointestinal surgery, part 2: consensus statement for anaesthesia practice Full Text available with Trip Pro

. Therefore, one of the highest priorities of the anaesthesiologist is to try to ensure a patient does not become hypoxic to avoid interruption of cellular metabolism. Oxygen is widely available in anaesthesia and has traditionally been added to increase the inspired fraction of oxygen above 21% to overcome hypoxia under anaesthesia caused by physiological changes such as pulmonary shunt. Although increasing the FiO 2 is necessary to overcome hypoxia there has been increasing recognition that hyperoxia (...) concentrations (60%; 80%; 100%) of oxygen for 5 min prior to the induction of anaesthesia. Computed tomography showed an increase in atelectasis in the 100% inspired oxygen group although patients took longer to desaturate. The use of 80% oxygen in a subgroup of the PROXI study and in a recent meta‐analysis also did not demonstrate any increased risk of pulmonary complications. , Summary and recommendations The inspired fractional concentration of oxygen should be titrated to produce normal arterial oxygen

2015 ERAS Society

46. Guidelines for the treatment of malaria. Third edition

with falciparum malaria, although drug exposure was similar in pregnant and non-pregnant women with vivax malaria. 5 | Treatment of uncomplicated P.falciparum malaria in special risk groups 515.1.4 | LACTATING WOMEN The amounts of antimalarial drugs that enter breast milk and are consumed by breastfeeding infants are relatively small. Tetracycline is contraindicated in breastfeeding mothers because of its potential effect on infants’ bones and teeth. Pending further information on excretion in breast milk (...) . Drugs for preventing malaria in pregnant women in endemic areas: any drug regimen versus placebo/no treatment. Cochrane Database Systemat Rev 2014; 10:CD000169. doi: 10.1002/14651858.CD000169.pub3. Primaquine is contraindicated in pregnant women, infants 8 mEq/L or, if not available, a plasma bicarbonate level of 10 000/µL • Renal impairment: Plasma or serum creatinine > 265 µmol/L (3 mg/dL) or blood urea > 20 mmol/L • Jaundice: Plasma or serum bilirubin > 50 µmol/L (3 mg/dL) with a parasite count

2015 World Health Organisation Guidelines

48. Mechanisms for Falling Urine pH With Age in Stone Formers. (Abstract)

Mechanisms for Falling Urine pH With Age in Stone Formers. One of the main functions of the kidney is to excrete an acid load derived from both dietary and endogenous sources, thus maintaining body fluid pH. Urine pH is of particular interest in stone formers, as it determines the presence of either calcium phosphate or uric acid in stones. Others have noted in epidemiologic studies a rise in incidence of low pH-dependent uric acid stones with age, coinciding with a decrease in the incidence (...) determinants of urine pH such as urinary buffers, estimates of glomerular filtration, and dietary acid load, but these accounted for a small fraction of the pH fall. GI Anion absorption was the strongest predictor of urine pH in all age groups as we have previously reported in middle-aged normal men and women. However, we found that despite a decreasing urine pH, GI Anion absorption increases monotonically with age. In fact, after adjustment for GI Anion absorption urine pH declines more markedly

2019 American Journal of Physiology. Renal physiology

49. Orphacol - cholic acid

phosphatase AST asparagine aminotransferase ATC anatomical therapeutic chemical ATP adenosine triphosphate ATU Autorisation Temporaire d’Utilisation Nominative BA bile acid BSEP bile salt export pump CA cholic acid CDCA chenodeoxycholic acid DCA deoxycholic acid DNA deoxyribonucleic acid EU European Union F Female FAB-MS fast atom bombardment mass spectrometry FDA U.S. Food and Drug Administration FTR fractional turnover rate FXR a farnesoid X receptor alpha GC-MS gas chromatography-mass spectrometry GCP (...) to be 168 ± 21 and 106 ± 12 µmol/kg body weight for mice and rats, respectively. This is equivalent to 68.5 ± 8.6 and 43.2 ± 4.9 mg/kg for mice and rats respectively (Hulzebos et al. 2001). These are considered by the Applicant to be an underestimate and have proposed the pool sizes to be 150 mg/kg for rats and 69 mg/kg for mice. The Fractional Turnover Rate (FTR) values were 0.44 ± 0.03 and 0.88 ± 0.10 for mice and rats and the corresponding synthesis rates were 29.8 ± 6.5 mg/kg and 38 ± 0.4 mg/kg

2013 European Medicines Agency - EPARs

50. Study of Sodium Bicarbonate in Kidney Transplant Recipients

Description Go to Brief Summary: The purpose of this study is to compare the effect of sodium bicarbonate versus no sodium bicarbonate treatment on urinary ammonia levels and urinary transforming growth factor-beta1 (TGF-beta1) excretion in renal transplant patients with low-to-normal serum bicarbonate levels (20 - 28 mmol/L). Condition or disease Intervention/treatment Phase Kidney Transplantation Drug: Sodium bicarbonate Early Phase 1 Detailed Description: Renal allograft survival ten years after (...) to be an important predictor of chronic allograft nephropathy, and alkalinizing agents may have an effect on TFG-beta1 excretion. Retrospective analysis of participants in the African American Study of Kidney Disease and Hypertension showed the lowest risk of CKD progression was among those having baseline serum bicarbonate levels in the range of 28-30 mmol/L. Recent studies in people with pre-transplant CKD have suggested that increasing low serum bicarbonate levels (< 22 mmol/L) with alkalinizing agents

2010 Clinical Trials

51. Forxiga - dapagliflozin

as the undesirable side effects of currently available therapies. About the product Dapagliflozin (BMS-512148) is a potent, competitive, reversible, highly selective and orally active inhibitor of the human sodium-glucose co-transporter 2 (SGLT2), the major transporter responsible for the renal glucose reabsorption. It improves glycaemic control in patients with T2DM by reducing renal glucose reabsorption leading to urinary glucose excretion (glucuresis). Dapagliflozin’s mechanism of action is different from (...) leads to the excretion of glucose in the urine, and only in diabetic animal models lower blood glucose in a manner independent of insulin secretion or insulin action, without hypoglycaemia. Primary pharmacodynamic in vitro The Applicant demonstrated dapagliflozin’s activity towards human, rat and mouse SGLT2 in vitro (artificial overexpression of the respective transporters in Chinese hamster ovary (CHO) cells) and thereby also verified the suitability of the rodent models used for further studies

2012 European Medicines Agency - EPARs

52. Kalydeco - ivacaftor

in bicarbonate–chloride exchange. A deficiency in bicarbonate secretion leads to poor solubility and aggregation of luminal mucins (O’Suvillan et al. 2009). CFTR mutations can be classified according to the mechanisms by which they disrupt CFTR function. Stop codon mutations (class I) result in a truncated nonfunctional CFTR, class II mutations consist of aberrantly folded CFTR protein that is degraded by the cell quality control system, while class III mutations lead to defective regulation of the CFTR (...) or any of the 5 potassium channel targets in the receptor binding panel at rat > human > dog. Using S9 fractions and microsomes, marked species difference had been observed in the conversion rate between primates and rodents metabolic conversions rates. Indeed the relative concentration of M1 to ivacaftor is much higher in humans than was seen in animal studies. Human cytochrome P450 (CYP) 3A4 and CYP3A5 are the predominant isozymes involved in the metabolism of ivacaftor and human metabolism

2012 European Medicines Agency - EPARs

53. Alogliptin and alogliptin/pioglitazone

with a high-fat meal, alogliptin may be administered with or without food. It is well distributed into tissues and negligibly bound Reference ID: 3247308 (b) (4)Clinical Review Valerie S.W. Pratt, M.D. NDAs 22-271 and 22-426 Nesina (alogliptin) and (alogliptin/pioglitazone FDC) 24 to plasma proteins (20%). Alogliptin does not undergo extensive metabolism and 60- 71% of the dose is excreted as unchanged drug in the urine. Following oral administration of pioglitazone hydrochloride, peak concentrations

2012 FDA - Drug Approval Package

54. Mirabegron (Myrbetriq)

, indicating no absorption-rate limitation in the PK of the OCAS tablet. The effective half-life is estimated to be about 19 hours (based on population PK analysis). Mirabegron is cleared by multiple mechanisms (renal and possibly biliary excretion of unchanged drug, and metabolism) and drug-metabolizing enzymes, with no single predominating clearance pathway. Mirabegron is metabolized via multiple pathways involving dealkylation, oxidation, (direct) glucuronidation, and amide hydrolysis. Urinary excretion (...) and formulation, indicating no absorption-rate limitation in the PK of the OCAS tablet. The effective half-life is estimated to be about 19 hours (based on population PK analysis). Mirabegron is cleared by multiple mechanisms (renal and possibly biliary excretion of unchanged drug, and metabolism) and drug- metabolizing enzymes, with no single predominating clearance pathway. Mirabegron is metabolized via multiple pathways involving dealkylation, oxidation, (direct) glucuronidation, and amide hydrolysis

2012 FDA - Drug Approval Package

57. Insulin Treatment in Diabetic Older People With Heart Failure.

. natriuretic peptide plasma concentration, HbA1c and urinary albumin excretion will be measured Echocardiographic evaluation will be done at baseline, 1 and 12 mo after randomization. Central randomization in a 1:1 ratio will be performed by a web-based system. Masking: Single (Outcomes Assessor) Masking Description: Insulin-HF is a randomized, open-label, controlled, multicenter (PROBE design, prospective Randomized Open Trial with Blinded Evaluation of Outcomes), and central adjudication of adverse (...) of a natriuretic peptide [ Time Frame: baseline, 1, 6, 12 months. ] BNP or NT-proBNP concentrations will be measured as ng/L of plasma. Changes in urinary albumin excretion [ Time Frame: baseline, 1, 6, 12 months. ] Urinary albumin concentration will be expressed as the urinary albumin-to-creatinine ratio (UACR), measured in milligrams per grams of creatinine, with a limit of detection of 1.5 mg/g. Change in New York Heart Association (NYHA) class [ Time Frame: baseline, 1, 6, 12 months. ] Any change in NYHA

2018 Clinical Trials

58. A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD8233 in Healthy Male Subjects With Increased Elevated LDL-C Levels.

at the last sampling interval (Ae[0-last]) [ Time Frame: Treatment Days 1 to 3 (Pre-dose, 0-6, 6-12, 12-24, 24-36 and 36-48 hours post-dose) ] To characterize Ae(0-last) of AZD8233 following SC administration of SAD. Urine PK analysis: Fraction of analyte excreted unchanged in urine from t1 to t2 (fe[t1-t2]) [ Time Frame: Treatment Days 1 to 3 (Pre-dose, 0-6, 6-12, 12-24, 24-36 and 36-48 hours post-dose) ] To characterize fe(t1-t2) of AZD8233 following SC administration of SAD. Urine PK analysis (...) : Cumulative fraction of dose excreted unchanged into the urine from time zero to the last measured time-point for an analyte (fe[0-last]) [ Time Frame: Treatment Days 1 to 3 (Pre-dose, 0-6, 6-12, 12-24, 24-36 and 36-48 hours post-dose) ] To characterize fe(0-last) of AZD8233 following SC administration of SAD; estimated by dividing Ae(0-last) by dose. Urine PK analysis: Percentage of dose excreted unchanged into the urine from time zero to the last measured time-point for an analyte (%fe[0-last]) [ Time

2018 Clinical Trials

59. A Combined SAD and MAD Study to Investigate the Safety, Tolerability and Pharmacokinetic Profile of IFB-088

biochemestry parameters and identify potential adverse events/reactions. Sodium, potassium, chloride, calcium, total bilirubin, alanine aminotransferase (ASAT), aspartate aminotransferase (ALAT), gamma-glutamyl transferase (GGT), alkaline phosphatases, total protein, albumin, urea, uric acid, bicarbonate, creatine phosphokinase (CPK), creatinine, glycaemia, lactate dehydrogenase (LDH), total cholesterol, HDL and LDL cholesterol, triglycerides will be monitored. Timepoints expected are: SAD phase: Screening (...) hours, 8-16 hours,16-32 hours SAD phase - cohort 2 to 6 (two intakes for daily administration): Day 1 at predose, 0-4, 4-8, 8-12, 12-24, 24-32 hours MAD phase (two intakes for daily administration): Day 1 and Day 14: predose, 0-4, 4-12, 12-24 hours; Day 6: predose, 0-4 and 4-12 hours; Day 15: 24-36, 36-48 hours after Day 14 Pharmacokinetic: Total amount excreted in urine (Ae) [ Time Frame: Starting 1 hour prior to dosing on Day 1 and until 48 hours after last dosing (Day 16) ] Urine samples

2018 Clinical Trials

60. Management of Heart Failure  (3rd Edition)

diagnosis. To satisfy the definition of HF, symptoms, signs and/or objective evidence of cardiac dysfunction must be present. (see Fig 1, pg 9) • HF may occur in the presence of reduced left ventricular (LV) function, the left ventricular ejection fraction (LVEF) = 40% (HFrEF) or with normal LV function, the LVEF = 50% (HFpEF). If the LVEF is 41% - 49% it is called HFpEF, borderline. • It may be classified as Acute HF or chronic HF depending on the acuteness of the clinical presentation (...) ejection fraction (LVEF) is normal, the symptoms being due to diastolic dysfunction ie heart failure with preserved ejection fraction (HFpEF).Often patients with a reduced LVEF have features of diastolic dysfunction as well. (Table III,pg 16)16 3.1 HFrEF In HFrEF, cardiac output is reduced due to depressed myocardial contractility. This initiates a complex pathophysiological process which includes haemodynamic alterations and structural changes within the myocardium and vasculature. Activation

2014 Ministry of Health, Malaysia

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