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Orthostatic Sodium Retention

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82. KDOQI US Commentary on the 2012 KDIGO Clinical Practice Guideline for the Evaluation and Management of CKD Full Text available with Trip Pro

posture (orthostatic proteinuria) x 71 Vehaskari, V.M. Orthostatic proteinuria. Arch Dis Child . 1982 ; 57 : 729–730 | | | , x 72 Leung, A.K. and Wong, A.H. Proteinuria in children. Am Fam Physician . 2010 ; 82 : 645–651 | Other conditions increasing vascular permeability (e.g., septicemia) Intraindividual variability Intrinsic biological variability 73 x 73 Howey, J.E., Browning, M.C., and Fraser, C.G. Selecting the optimum specimen for assessing slight albuminuria, and a strategy for clinical

2012 National Kidney Foundation

85. Vasovagal Syncope

syncopal episodes Increasingly recurrent syncopal episodes without warning or prodrome in high risk occupation Airplane pilot Truck driver VII. Approach Step 1: Assess Hemodynamic response to standing No Hemodynamic Response See Step 2 below decreases: Criteria Systolic decreases more than 20 mmHg Systolic <90 mmHg within 3 minutes Management See for management Increased salt intake Consider (water and salt retention) in refractory cases Consider ( ) in refractory cases increase: Postural Orthostatic (...) (POTS) Criteria increases more than 30 beats per minute >120 beats per minute Management (water and salt retention) ( ) s VIII. Approach Step 2: Tilt Test not done (Empiric Therapy) No See Consider Tilt Test Consider (water and salt retention) Consider ( ) First line Second line Disopyramide ( ) ( ) 20 mg orally daily Third line Dual Chamber IX. Approach Step 3: Obtain Tilt Test Tilt Test Criteria No concurrent medications Tilt for 45 minutes at 60 to 70 degrees Gradual fall in : Dysautonomic (water

2018 FP Notebook

86. Administration of medicinal products by non - medical personnel as part of Clinical Nuclear Medicine Procedures

flushing bradycardia, palpitations, tachycardia, orthostatic hypotension. mental clouding, confusion (with large doses), hallucinations, headache, vertigo, mood changes including dysphoria and euphoria. dry mouth, biliary spasm. blurred or double vision or other changes in vision, miosis. pruritus, urticaria, rash, sweating. Contact dermatitis has been reported and pain and irritation may occur on injection. difficulty with micturition, ureteric spasm, urinary retention, antidiuretic effect. Tolerance (...) Laxatives Gallium imaging Lugols iodine Iodine-labelled RPx Lysine/Arginine Peptide Receptor Radionuclide Therapy Methylphenidate F-18 Fallypride Morphine * Hepato-cholescintigraphy Omeprazole * Meckels Diverticulum Potasium iodide Iodine-labelled RPx Potasium iodate Iodine-labelled RPx Ranitidine * Meckels Diverticulum Regadenason* Myocardial perfusion imaging Sincalide* Hepato-cholescintigraphy Sodium Perchlorate Iodine-labelled RPx Thyrotropin Alpha Thyroid imaging and therapy Where adverse reactions

2013 British Nuclear Medicine Society

87. Sleep Disorders (PDQ®): Health Professional Version

vitamins, corticosteroids, neuroleptics for nausea and vomiting, and sympathomimetics for the treatment of dyspnea—as well as other treatment factors can negatively impact sleep patterns. Side effects of treatment that may affect the sleep-wake cycle include the following:[ ];[ ][ ] Pain. Anxiety. Night sweats/hot flashes (refer to the PDQ summary on for more information). GI disturbances (e.g., incontinence, diarrhea, constipation, or nausea). GU disturbances (e.g., incontinence, retention, or GU (...) irritation). Respiratory disturbances. Fatigue. Sustained use of the following can cause insomnia: Sedatives and hypnotics (e.g., glutethimide, benzodiazepines, pentobarbital, chloral hydrate, secobarbital sodium, and amobarbital sodium). Anticonvulsants (e.g., phenytoin). Corticosteroids. Oral contraceptives. Monoamine oxidase inhibitors. Methyldopa. Propranolol. Atenolol. Alcohol. Thyroid preparations. In addition, withdrawal from the following substances may cause insomnia: Central nervous system

2016 PDQ - NCI's Comprehensive Cancer Database

88. Plenadren - hydrocortisone

of a disease in the adrenal cortex, or secondary (central) due to an underlying hypothalamic-pituitary disorder. Primary AI is usually referred to as Addison’s disease. The onset of AI may vary from insidious to an acute life-threatening situation with severe salt and water deficit, which leads to shock and death within hours if not treated adequately. Frequently reported symptoms associated with AI are asthenia, weakness, lethargy, easy fatigability, nervousness, irritability, apathy, dizziness, headache (...) after intravenous, intramuscularly, sublingual and gastric administration. It was concluded that the varying Assessment report EMA/CHMP/424438/2011 Page 15/69 route of administrations of 14 C -hydrocortisone to rats caused different excretion rates of the radiolabelled metabolites, but the amounts excreted were independent of the route of administration (Hyde et al 1957). This indicates that the absorption is complete from all administrations sites. The transdermal penetration and skin retention

2011 European Medicines Agency - EPARs

89. Vyndaqel - tafamidis

proteins (amyloid) in the tissues. Typically, sensory neuropathy starts in the lower extremities and is followed by motor neuropathy within a few years. Autonomic neuropathy may occur as the first clinical symptom of the disease. The symptoms of autonomic dysfunction include orthostatic hypotension, constipation alternating with diarrhoea, attacks of nausea and vomiting, delayed gastric emptying, sexual impotence, anhidrosis and urinary retention or incontinence. The TTR protein normally circulates (...) (E420), titanium dioxide (E171), purified water Capsule contents: polyethylene glycol 400, sorbitan monooleate polysorbate 80 Printing ink: opacode Black, n-Butyl alcohol, propylene glycol The capsules are packed in polyvinyl chloride/aluminium blisters. 2.2.2. Active Substance Tafamidis meglumine which has the chemical name d-Glucitol, 1-deoxy-1-(methylamino)-,2-(3,5- dichlorophenyl)-6-benzoxazolecarboxylate is a is the micronized meglumine salt of Tafamidis. It is a white to pink solid which

2011 European Medicines Agency - EPARs

90. Ezogabine (Potiga)

Potiga / ezogabine 17 5.2 Review Strategy Studies 303 & 304 1. Determine the number of patients remaining in each study 2. Determine the additional patient exposure in each study 3. Examine Key safety measures, Death, SAE, and Withdrawal. 4. Examine the new datasets in each of these studies for events of special interest in this submission- (7.3.5) Draw conclusions if there is a change in signal: a. increased frequency or severity b. greater or lesser predictability, urinary : urinary retention (...) , Nephrolithiasis c. greater or lesser predictability, hallucinations / psychotic symptoms. 5. Re-examine the new dataset for additional items of interest for change in signal intensity: a. hypokalemia b. orthostatic hypotension c. syncope d. atrial fibrillation e. hepatic dysfunction f. blood dyscrasias Clinical Pharmacology Studies RTG114137, RTG113214, RTG113215. 1. Determine the number of patients remaining in each study 2. Determine patient exposure in each study 3. Examine Key safety measures, Death, SAE

2011 FDA - Drug Approval Package

91. Primary Care Corner with Geoffrey Modest MD: Syncope Guidelines

suggest 43% reduction in symptoms. (moderate recommendation, RCTs) Orthostatic training: e.g. repetitive tilt-table tests, or daily standing against a wall in the house for prolonged time periods (weak recommendation, RCTs) Fludrocortisone, esp if inadequate response to fluids and salt (weak recommendation, nonrandomized trials) Other approaches with weak recommendations include: b-blockers in those >42 years old (poor performance in younger patients), encouraging increased salt and fluid intake (...) more common than standard orthostatic hypotension after a couple minutes) In terms of vasovagal syncope, which is so common: if the patient has baseline lowish blood pressure which decreases on standing, I do recommend fluids and salt (with limited effect though), and there was a recent article not included in the guidelines above which did show benefit of fludrocortisone (see ), which I have used on several patients, sometimes with midodrine, to good effect.​ As noted, the guidelines do go through

2017 Evidence-Based Medicine blog

92. Gastrointestinal Complications (PDQ®): Health Professional Version

that mineral oil be avoided because it can cause lipid pneumonitis. It can interfere with postoperative healing of anorectal surgery. Avoid giving with docusate sodium. Docusate sodium causes increased systemic absorption of mineral oil. Use: Prophylactically to prevent straining in patients for whom straining would be dangerous. Drugs and dosages: - Mineral oil: 5 to 30 cc at bedtime. Fecal softeners Fecal softeners promote water retention in the fecal mass, thus softening the stool. Up to 3 days may pass (...) of molasses enema with magnesium citrate 8 oz by mouth. Consider bowel management consult. If patient is neutropenic or thrombocytopenic, arrange for bowel management consult. Start one of the following regimens if the patient has not had a stool in 3 days or on the first day that any patient starts taking drugs associated with constipation: - Stool softeners (e.g., docusate sodium, one to two capsules per day). For opioid-related constipation, stool softeners may be used in combination with a stimulant

2015 PDQ - NCI's Comprehensive Cancer Database

93. American Association of Clinical Endocrinologists Medical Guidelines for Clinical Practice for the Diagnosis and Treatment of Acromegaly

[EL 2]). Hypertension is detected in up to 40% of patients, presumably attributable to an increase in plasma volume along with an increase in sodium retention (55 [EL 3]). Suppressed plasma renin activity and aldosterone con- centrations in acromegaly are consistent with a primary increase in total body sodium (56 [EL 3]). Of interest, acromegaly may be associated with an increase in carotid artery intima-media thickness, although the prevalence of atherosclerosis may be similar

2011 American Association of Clinical Endocrinologists

95. Silodyx - silodosin

contribute to the symptoms and impairment of outflow. The obstructive component relates primarily to the increased size of the prostate, and the storage component relates to the tone of the smooth muscle in the prostatic capsule and stroma. The aim of therapy is to improve LUTS and quality of life (QOL) and to prevent complications, such as urinary retention or upper urinary tract dilatation. Initial management of men with LUTS can be categorised into 1) watchful waiting, 2) medical therapy, and 3 (...) on conditions, granted for products intended to treat benign prostatic hyperplasia has been issued by the EMEA. 2.2 Quality aspects Introduction Silodyx is presented in the form of hard capsules containing 4 mg and 8 mg of silodosin as active substance. The other ingredients are mannitol, pregelatinised starch, purified water, sodium lauril sulfate and magnesium stearate. Other ingredients of the capsule shell are gelatine, titanium dioxide and colourants. The hard capsules are marketed in polyvinylchloride

2010 European Medicines Agency - EPARs

96. Sycrest - asenapine

episodes associated with bipolar I disorder. In adults, the recommended dose can range from 5 mg to 10 mg twice daily. Sycrest (asenapine) is a fast dissolving tablet for sublingual administration containing asenapine in the form of maleate salt as active substance. The product contains 5mg or 10mg asenapine in gelatin and mannitol. Schizophrenia is a severe, disabling disorder that affects about 1% of the world’s population. According to DSM-IV-TR, the diagnosis of schizophrenia requires the presence (...) . Quality aspects 2.2.1. Introduction Sycrest contains asenapine in the form of maleate salt as active substance. The drug product formulation is a fast dissolving tablet for sublingual administration .The bioavailability after sublingual dosing is much higher (approximately 35%) than after oral dosing ( 5-HT2C (0.02)> a1 (0.077), D2 (0.1), H1 (0.11), a2 (0.13), >D3 (1.1), D1 (1.3)>5-HT1A (6.5). Following studies in rat striatum and cortex using the irreversible antagonist Nethoxycarbonyl- 2- ethoxy-1,2

2010 European Medicines Agency - EPARs

97. Urorec - silodosin

of life (QOL) and to prevent complications, such as urinary retention or upper urinary tract dilatation. Initial management of men with LUTS can be categorised into 1) watchful waiting, 2) medical therapy, and 3) surgical treatment. Medical therapy may consist of the use of 5 a-reductase inhibitors (finasteride, dutasteride) or a- adrenoreceptor antagonists (terazosin, doxazosin, tamsulosin, prazosin, alfuzosin). The active substance of Urorec is silodosin. Silodosin is an a1-adrenoreceptor antagonist (...) starch, purified water, sodium lauril sulfate and magnesium stearate. Other ingredients of the capsule shell are gelatine, titanium dioxide and colourants. The hard capsules are marketed in polyvinylchloride (PVC)/polyvinylidenchloride (PVDC)/aluminium foil blisters, packed in carton packs. Active Substance The drug substance is silodosin its chemical name is (-)-1-(3-hydroxypropyl)-5-[(2R)-2-({2-[2-(2,2,2- trifluoroethoxy)phenoxy]ethyl}amino)propyl]-2,3-dihydro-1H-indole-7-carboxamide according

2010 European Medicines Agency - EPARs

98. Ceftaroline fosamil for injection (Teflaro)

Table 89. PCS Postbaseline Vital Sign Values in Pooled Phase 3 Trials 195 Table 90. PCS Changes in Systolic and Diastolic BP Meeting Orthostatic Criteria 196 Table 91. IRT Analysis of Point Estimate and 90% CI of QTcIB Changes in Thorough QT Study 198 Table 92. Incidence of TEAEs representing Potential Renal Impairment 199 Table 93. Incidence of Treatment-Emergent Adverse Events Indicating Potential Renal Impairment for Phase 3 Trials 200 Table 94. PCS Postbaseline Renal Chemistry Values for Pooled (...) of Water for Injection, USP and the entire constituted solution should be diluted within 2 minutes in = 250 mL of 0.9% Sodium Chloride Injection, USP (normal saline), 0.45% Sodium Chloride Injection, USP, 5% Dextrose Injection, USP, 2.5% Dextrose Injection USP, or Lactated Ringer’s Injection, USP before infusion. Compatibility evaluation includes evaluation of appearance, turbidity, stability, and examination for particulate matter. The resulting solution should be administered over 1 hour

2010 FDA - Drug Approval Package

99. SGLT2 Inhibition in Diabetes and Heart Failure

(within the past month), which may induce volume and sodium retention; Chronic Kidney Disease (GFR<45 ml/kg*min); Uncontrolled thyroid dysfunction (TSH<0.4>4.5 mcIU/ml); Pregnancy or of child-bearing potential; Active or recent (within 2 weeks) genital/urinal infection; Concomitant conditions or treatment which would affect completion or interpretation of the study including physical inability to walk or run on a treadmill such as decompensated HF (edema, NYHA class IV), significant ischemic heart (...) Details Study Description Go to Brief Summary: To determine the effects of SGLT2 inhibition with empagliflozin on cardio-respiratory fitness in patients with systolic heart failure. Condition or disease Intervention/treatment Diabetes Mellitus, Type 2 Heart Failure, Systolic Other: Assessment of cardiorespiratory fitness Detailed Description: The investigators hypothesize that Sodium-GLucose coTransporters (SGLT)-2 inhibition will improve cardio-respiratory fitness (CRF) in patients with systolic

2016 Clinical Trials

100. Sleep Disorders

include the following:[ ];[ ][ ] Pain. Anxiety. Night sweats/hot flashes (refer to the PDQ summary on for more information). GI disturbances (e.g., incontinence, diarrhea, constipation, or nausea). GU disturbances (e.g., incontinence, retention, or GU irritation). Respiratory disturbances. Fatigue. Sustained use of the following can cause insomnia: Sedatives and hypnotics (e.g., glutethimide, benzodiazepines, pentobarbital, chloral hydrate, secobarbital sodium, and amobarbital sodium). Anticonvulsants (...) . [ ][ ] Second-generation antidepressant trazodone (Desyrel) 25–100 mg Risk of orthostatic hypotension and falls. [ ] mirtazapine (Remeron) 7.5–45 mg If depression not a concern, 7.5–15 mg best for sleep, hot flashes, increased appetite, and less morning sedation. Risk of falls. [ ][ ] Antipsychotic quetiapine (Seroquel) 25–100 mg Risk of weight gain, metabolic syndrome, abnormal/involuntary movements; possible cardiovascular effects (e.g., prolonged QT interval). Generally not a preferred agent due to side

2012 PDQ - NCI's Comprehensive Cancer Database

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