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Orthostatic Sodium Retention

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44. Empagliflozin / linagliptin (Glyxambi) - type 2 diabetes

cutaneous adverse reaction Summary of Clinical Efficacy SCS Summary of Clinical Safety SD Standard deviation SE Standard error SGLT SGOT Sodium-dependant glucose co-transporter Serum glutamic oxaloacetic transaminase SmPC Summary of Product Characteristics SMQ Standardised MedDRA query SOC T2DM System-organ class Type 2 diabetes mellitus TS Treated set UACR Urinary-albumin-to-creatinine ratio UGT Uridine 5'-diphospho-glucuronosyltransferases ULN Upper limit of normal USPI URTI UTI UV vPvB ZDF United (...) the Article 3(1) and point 3 of Annex of Regulation (EC) No 726/2004. The eligibility to the centralised procedure was agreed upon by the EMA/CHMP on 25 July 2013. The applicant applied for the following indication: Glyxambi is indicated in adults with type 2 diabetes mellitus to improve glycaemic control: • when diet and exercise, plus metformin and a sodium glucose co-transporter 2 (SGLT2) inhibitor do not provide adequate glycaemic control, • when diet and exercise, plus metformin and a dipeptidyl

2016 European Medicines Agency - EPARs

45. Jinarc - tolvaptan

- polycystic kidney disease; ERK - extracellular signal-regulated kinase; Na - sodium; NGAL - neutrophil gelatinase-associated lipocalin; NHK - normal human kidney; OPC-41061 - tolvaptan; P-ERK - phosphorylated extracellular signal-regulated kinase; SD - Sprague Dawley. sessment Report EMA/154879/2015 Page 20/124 In the PCK rat, an animal model of ARPKD, oral administration of tolvaptan resulted in a decrease in kidney levels of cAMP and a reduction in cyst volume and cyst fibrosis. Increases in urine (...) volume and water intake and decreased urinary osmolality also were evident and are consistent with the established pharmacological action of tolvaptan. Slight changes in BUN, creatinine, and sodium levels were observed in the treated rats, although the changes were not considered to be biologically meaningful. In the mouse models for ADPKD (Pkd2WS25/-, pcy and cpk) similar results are observed as with the PCK rat. Decreases in kidney weights, cyst volume, and fibrotic volume were observed in the pcy

2015 European Medicines Agency - EPARs

46. Farydak - panobinostat

tolerance of panobinostat after single intravenous, intra-arterial and perivenous injections were investigated in New Zealand White rabbits. The concentration of panobinostat solution injected Assessment report EMA/CHMP/496296/2015 Page 38/124 was 0.78 mg/mL freebase in vehicle. The control site received the control item, 7.206 mg DL lactic acid, 34.46 mg mannitol, 200 mg propylene glycol, sodium hydroxide q.s. to pH4 and water for injection q.s. with 5% dextrose in water. The outcome of the study (...) . An assessment (study 0517503) of the Ultraviolet/Visible (UV/Vis) absorption spectrum for panobinostat lactate salt indicated light absorption within the range of natural sunlight. The phototoxic potential of panobinostat was evaluated in the 3T3 NRU phototoxicity assay (study 0580320) performed with Balb/c 3T3 clone 31. The EC 50 values for panobinostat were 1.3 µg/mL (-UV) and 1.0 µg/mL (+UV). The resulting Photo Irritation Factor was 1.3 and the calculated Mean Photo Effect was 0.027. 2.3.5. Ecotoxicity

2015 European Medicines Agency - EPARs

47. Intuniv - guanfacine

The Predicted no effect concentrations PSD Particle size distribution PVC Polyvinyl chloride RH Relative Humidity RTT Relative retention time QT c Corrected QT Interval s.c. Subcutaneous SH Spontaneously hypertensive SmPC Summary of Product Characteristics t 1/2 Half-life TCL Thin-layer chromatography USP United States Pharmacopoeia WASTEWinhab Amount of wastewater per inhabitant per day WKY Wistar Kyoto Assessment report EMA/CHMP/534329/2015 Page 4/86 1. Background information on the procedure 1.1 (...) monohydrate, povidone, crospovidone type A, microcrystalline cellulose, silica colloidal anhydrous, sodium laurisulfate, polysorbate 80, fumaric acid, glycerol dibehenate, indigo carmine aluminium lake (E132) (3 and 4 mg tablets), iron oxide yellow (E172) (3 and 4 mg tablets). The product is available in PCTFE/PVC/alu blisters as described in section 6.5 of the SmPC. 2.2.2. Active substance General information The chemical name of guanfacine hydrochloride is N-(Diaminomethylidene)-2-(2,6-dichlorophenyl

2015 European Medicines Agency - EPARs

48. Aripiprazole Zentiva

/232319/2015 Page 7/36 RCT randomised controlled trial RH Relative Humidity RMS Reference Member State RP Restricted Part (or Closed Part) of a DMF RR relative risk RRT Relative retention time RSD Relative standard deviation SAE serious adverse event SF-12 short form health survey (short form of SFSF36) SLS sodium lauryl sulphate SmPC Summary of Product Characteristics SPC Summary of Product Characteristics TGA Thermo-Gravimetric Analysis US NF Unites States National Formulary USP United States (...) . Introduction The finished product is presented in the form of 5 mg, 10 mg, 15 mg or 30 mg tablets and 10 mg, 15 mg or 30 mg orodispersible tablets (ODT), containing aripiprazole as active substance. Other ingredients of the tablets are: lactose monohydrate, microcrystalline cellulose, crospovidone, hydroxypropyl cellulose, silica colloidal anhydrous, croscarmellose sodium and magnesium stearate. The orodispersable tablets contain, in addition, acesulfame potassium and mango flavour. The product

2015 European Medicines Agency - EPARs

49. Chronic kidney disease

or secondary to CKD itself). See the CKS topic on for more information. Palpable bilateral flank masses with possible hepatomegaly (suggests polycystic kidney disease with possible liver cysts). Palpable distended bladder (suggests obstructive uropathy). Peripheral oedema (may be due to renal sodium retention, hypoalbuminaemia, or co-morbid heart failure). See the CKS topic on for more information. Peripheral neuropathy (may present with paraesthesia, sleep disturbance, and restless legs syndrome (...) to possible acute kidney injury [AKI], obstructive uropathy causing urinary retention; or end-stage renal disease). Any potentially , including over-the-counter or herbal medicines. Any known for CKD or previous history of AKI. See the CKS topic on for more information. Any associated co-morbidities or of CKD. Any family history, such as autosomal dominant polycystic kidney disease. Any associated clinical features of anxiety or depression. See the CKS topics on and for more information. Examine for signs

2019 NICE Clinical Knowledge Summaries

50. LUTS in men

about: Storage symptoms, including urgency, daytime urinary frequency, nocturia, urinary incontinence, and feeling the need to urinate again just after passing urine. The man should also be asked about bedwetting, which can be a sign of chronic urinary retention. Voiding symptoms, including hesitancy, weak or intermittent urinary stream sometimes causing splitting or spraying, straining, incomplete emptying, and terminal dribbling. Post-micturition symptoms, including post-micturition dribble (...) care management of men with lower urinary tract symptoms (LUTS) that are not caused by infection, inflammation, neurological disease, drugs, or cancer. It covers the management of voiding symptoms, overactive bladder, nocturnal polyuria, stress urinary incontinence, urinary retention, and post-micturition dribbles. There are separate CKS topics on , , , , , and . The target audience for this CKS topic is healthcare professionals working within the NHS in the UK, and providing first contact

2019 NICE Clinical Knowledge Summaries

51. Therapies Targeting the Nervous System for Chronic Pelvic Pain Relief

to urinary frequency/retention and diarrhoea/constipation, and endocrine dysfunction, particularly alterations in the activity of the hypothalamic–pituitary–adrenal axis, potentially resulting in increased rates of infections and autoimmune conditions. Women with CPP frequently present to gynaecologists, of whom the majority will focus their assessment and treatments on the pelvis. This paper will therefore review the available treatments for CPP that target the nervous system rather than the pelvis (...) sodium and calcium channels and interactions with the ?-aminobutyric acid (GABA) system. 14 Given that women with CPP frequently report feeling that their doctors thought their pain was psychological, these points can be useful in counselling women prior to commencing an antidepressant or anticonvulsant medication. In general, both classes of drugs are well tolerated with relatively minor adverse effects (drowsiness and nausea most commonly), although specific adverse effects vary between drugs

2015 Royal College of Obstetricians and Gynaecologists

52. Acute pain management: scientific evidence (3rd Edition)

is not superior over others but some opioids are better in some patients (U) (Level II).SUMMARY xxii Acute Pain Management: Scientific Evidence 14. The incidence of clinically meaningful adverse effects of opioids is dose-related (U) (Level II). 15. High doses of methadone can lead to prolonged QT interval (N) (Level II). 16. Haloperidol is effective in the prevention of postoperative nausea and vomiting ( N) (Level II). 17. Opioid antagonists are effective treatments for opioid-induced urinary retention ( N

2015 National Health and Medical Research Council

53. 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

2018 PDQ - NCI's Comprehensive Cancer Database

55. Blackouts

of simple lifestyle changes that can lessen symptoms of orthostatic hypotension, including: First sitting when going from a supine to a standing position. Eating frequent, small meals to lessen postprandial blood pressure falls. Liberalising dietary salt intake (unless they have been diagnosed with hypertension). Drinking strong tea or coffee. Drinking at least 2 litres of water a day. Avoiding alcohol. Tilting the head of the bed up during the night, by inserting blocks 15 to 22 cm high under (...) Blackouts Blackouts - NICE CKS Share Blackouts: Summary A blackout is a transient, spontaneous loss of consciousness followed by complete recovery. Causes of blackouts include: Neurally-mediated reflex syncope — this term encompasses vasovagal syncope (fainting), carotid sinus syndrome, and situational syncope. Orthostatic hypotension. Cardiac abnormalities. Epilepsy. Blackouts are common. In the UK, 1 in 2 people will experience a blackout at some point in their life, with the most common

2018 NICE Clinical Knowledge Summaries

56. Drugs That May Cause or Exacerbate Heart Failure Full Text available with Trip Pro

Level of Evidence for HF Induction or Precipitation Possible Mechanism(s) Onset Comments Causes Direct Myocardial Toxicity Exacerbates Underlying Myocardial Dysfunction Analgesics COX, nonselective inhibitors (NSAIDs) x Major B Prostaglandin inhibition leading to sodium and water retention, increased systemic vascular resistance, and blunted response to diuretics Immediate COX, selective inhibitors (COX-2 inhibitors) x Major B Anesthesia medications Inhalation or volatile anesthetics Desflurane x (...) affect platelet aggregation, maintenance of the gastric mucosal barrier, and renal function. NSAIDs have the potential to trigger HF through sodium and water retention, increased systemic vascular resistance, and blunted response to diuretics. Observational studies suggest an association between traditional NSAIDs use and HF precipitation and exacerbation. In an evaluation of 7277 long-term NSAID users over 72 months, the Rotterdam study results found a trend to an increased risk for incident HF

2016 American Heart Association

57. Vokanamet - canagliflozin / metformin

RH Relative Humidity RLG Radioluminography RRT Relative retention time RSD Relative standard deviation RTG/RT G renal threshold for glucose RTT(s) renal tubular tumor(s) S9 exogenous mammalian metabolic activation system SAP statistical analysis plan SBP systolic blood pressure SCE Summary of Clinical Efficacy SD standard deviation SE standard error Sec Section SEM standard error of the mean SGLT1 sodium-glucose co-transporter-1 SGLT2 sodium-glucose co-transporter -2 SMIT1 sodium/myo-inositol co (...) hSGLT2 human SGLT2 hSGLT4 human sodium glucose co-transporter-4 hSGLT6 human sodium glucose co-transporter-6 hSMIT1 human sodium/myo-inositol co-transporter-1 IAS Integrated Analysis of Safety IC50 inhibiting concentration at 50% ICH International Conference on Harmonisation IPC In-process control IR Infrared ISE Integrated Summary of Efficacy ISS Integrated Summary of Safety J&JPRD Johnson & Johnson Pharmaceutical Research & Development, LLC JNJ- 28431754 Canagliflozin JRD Janssen Research

2014 European Medicines Agency - EPARs

58. Latuda - lurasidone

effects, or non-compliance, hence the need for additional treatments that are effective and well tolerated. Latuda Assessment report (EMA/113836/2014) Rev05.13 Page 9/147 2.2. Quality aspects 2.2.1. Introduction The finished product is presented as film-coated tablets available in three strengths designated as, 18.5 mg, 37 mg and 74 mg, corresponding to 18.6 mg, 37.2 mg and 74 g mg of lurasidone base. Other ingredients are mannitol, pregelatinised starch, croscarmellose sodium, hypromellose, magnesium (...) . It is not considered to constitute an isomer/mixture of isomers, complex, derivative, salt of any active substance already approved in the European Union. The INN of the substance is lurasidone, the entity which should be considered the new active substance and which is used in the finished product as its hydrochloride salt. The Applicant’s justification was accepted and lurasidone is considered a new active substance in itself. It was noted, that there are some structural similarities between lurasidone

2014 European Medicines Agency - EPARs

59. Hypertensive Urgency: Considerations for Management

crystal meth or ecstasy), anabolic steroids, caffeine, cocaine, phencyclidine. Energy drinks containing taurine, guarana root, yerba mate, glucuronolactone, etc. o Lifestyle 1 - High salt diet, excessive alcohol use. o Comorbid Conditions 2 - Thyroid storm, trauma, renovascular disease, acute ischemic stroke or adrenal dysfunction ? Some population groups are more likely to experience hypertensive urgency 10 : Elderly; African Americans; Men > Women HOW SHOULD HYPERTENSIVE URGENCY BE MANAGED? 1-11 (...) for cerebral autoregulation & blood flow ? Favorable effect on regional myocardial perfusion - Reduces pre- and afterload - No fluid retention - OK in chronic management of HF & scleroderma - Can use sl, but unlikely any therapeutic advantage CI: bilateral renal artery stenosis; immune-mediated diseases; pregnancy AE: cough, rash, dizzy, fatigue; angioedema, ?K+, dysgeusia DI: diuretic K + sparing ?K + , gold injection nitritoid reaction, lithium ? Li + level, NSAID ?BP effect & K + / BACTRIM

2014 RxFiles

60. Male Sexual Dysfunction

conditions may result in orthostatic hypotension.MALE SEXUAL DYSFUNCTION - UPDATE MARCH 2015 17 • Sildenafil labelling advises that 50 or 100 mg sildenafil should be used with caution in patients taking an a-blocker (especially doxazosin). Hypotension is more likely to occur within 4 h following treatment with an a-blocker. A starting dose of 25 mg is recommended [99]. • Concomitant tr eatment with var denafil should only be initiated if the patient has been stabilised on his a-blocker therapy. Co (...) - limited after prolonged use. It can be alleviated with the addition of sodium bicarbonate or local anaesthesia [143, 144, 146]. Cavernosal fibrosis (from a small hematoma) usually clears within a few months after temporary discontinuation of the injection program. However, tunical fibrosis suggests early onset of Peyronie’s disease and may indicate stopping intracavernosal injections indefinitely. Systemic side-effects are uncommon. The most common is mild hypotension, especially when using higher

2015 European Association of Urology

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