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Subcutaneous Fat Necrosis

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801. Gout and Pseudogout (Overview)

are as follows: Avoidance or restricted consumption of high-purine foods Avoidance of excess ingestion of alcoholic drinks, particularly beer Avoidance of sodas and other beverages or foods sweetened with high-fructose corn syrup Limited use of naturally sweet fruit juices, table sugar, and sweetened beverages and desserts, as well as table salt Maintenance of a high level of hydration with water (≥8 glasses of liquids daily) A low-cholesterol, low-fat diet, if such a diet is otherwise appropriate (...) chemotactic factors, and tumor necrosis factor (TNF)-α. [ , ] Neutrophil phagocytosis leads to another burst of inflammatory mediator production. Chatfield et al reported that the interaction of urate crystals with lysosomes results in the formation of web-like chromatin structures known as neutrophil extracellular traps (NETs) and subsequent cell death (NETosis), via a mechanism independent of nicotinamide adenine dinucleotide phosphate (NADPH) oxidase. The urate crystal–induced NETs are enriched

2014 eMedicine Emergency Medicine

802. Fournier Gangrene (Overview)

and superficial fascia Because Fournier gangrene is predominately an infectious process of the superficial and deep fascial planes, understanding the anatomic relationship of the skin and subcutaneous structures of the perineum and abdominal wall is important. The skin cephalad to the inguinal ligament is backed by Camper fascia, which is a layer of fat-containing tissue of varying thickness and the superficial vessels to the skin that run through it. Scarpa fascia forms another distinct layer deep to Camper (...) , an obliterative endarteritis develops, and the ensuing cutaneous and subcutaneous vascular necrosis leads to localized ischemia and further bacterial proliferation. Rates of fascial destruction as high as 2-3 cm/h have been described. Infection of superficial perineal fascia (Colles fascia) may spread to the penis and scrotum via Buck and Dartos fascia, or to the anterior abdominal wall via Scarpa fascia, or vice versa. Colles fascia is attached to the perineal body and urogenital diaphragm posteriorly

2014 eMedicine Emergency Medicine

803. Toxicity, Cocaine (Overview)

aspiration pneumonitis or after an intravenous injection of bacteria or toxic organic or inorganic materials Aneurysm or pseudoaneurysm: May be noted with mainlining (ie, directly injecting into a central artery or vein); this finding is an indication for further imaging studies In addition, radiography may be useful for evaluating cellulitis, an abscess, or a nonhealing wound in an intravenous drug user; it may reveal a foreign body or subcutaneous emphysema produced by gas-forming organisms (...) is fat soluble and freely crosses the blood-brain barrier. Cocaine appears to stimulate the CNS, with particular activity in the limbic system. There, it potentiates dopaminergic transmission in the ventral basal nuclei, producing the pleasurable behavioral effects that result in its widespread use. Cocaine enters the United States in the form of a hydrochloride salt, having undergone numerous steps in refinement from the original coca leaf. In its hydrochloride form, cocaine may be absorbed

2014 eMedicine Emergency Medicine

804. Pediatrics, Respiratory Distress Syndrome (Overview)

permeability, influx of protein rich edema fluid into the alveolar sacs, dysfunction of surfactant production, and defective ion transport leading to impaired fluid clearance from alveolar cells. These changes are the hallmark of ARDS pathophysiology and are accompanied by dysregulated inflammation from dysfunctional leukocytes and influx of pro-inflammatory cytokines like interleukins and tumor-necrosis factor. The role of neutrophils in this mechanism is controversial. Animal models have favored both (...) , if they are associated with shock and thrombocytopenia. [ ] Other more common etiologies include bronchiolitis, aspiration pneumonia, aspiration of gastric contents, major trauma, pulmonary contusion, burns, inhalational injury, massive transfusions or transfusion-related acute lung injury (TRALI). [ , , , , , ] Transfusion of all type of blood products including packed red blood cells, fresh frozen plasma and platelets has been associated with development of ARDS. [ , ] Other causes include acute pancreatitis, fat

2014 eMedicine Emergency Medicine

805. Necrotizing Fasciitis (Overview)

can range from skin and subcutaneous necrosis to muscle and fascial involvement, but classification is less important than the general principles. [ , , ] NSTI is pathophysiologically characterized by effects of bacterial toxins and enzymes (eg, hyaluronidase) that enable horizontal extension through the fascial planes, leading to intravascular thromboses and ischemic necrosis with disturbance of the host’s humoral and cellular immune response. [ ] The infection is usually polymicrobial. Typical (...) an aggressive infection of subcutaneous tissue and the superficial fascia. Histologically, the necrosis of the fascia can manifest with or without polymorphonuclear infiltrates or bacteria. Surgical findings include presence of foul-smelling “dishwater” pus and gray, friable necrotic fascia that does not resist blunt dissection. [ ] The infection primarily does not affect musculature, but the prolongations of the deep fascia reach the surroundings of the skeletal muscle; progression to intermuscular fascia

2014 eMedicine Emergency Medicine

806. Myocardial Infarction (Follow-up)

variability and narrow therapeutic window. Low molecular weight heparin (LMWH) Enoxaparin is given at a dose of 1 mg/kg subcutaneously (SC) every 12 hours. It should be continued for the duration of hospitalization or until PCI is performed. A dose reduction is required for patients with impaired kidney function. Enoxaparin results in a more predictable and efficient anticoagulation compared to unfractionated heparin, leading to reduction in recurrent MI events [ , ] ; however, there is possibly a higher (...) bleeding risk in patients undergoing PCI. [ ] These findings were demonstrated in the Efficacy and Safety of Subcutaneous Enoxaparin in Non–Q wave Coronary Events (ESSENCE) trial. [ , , ] Bivalirudin Bivalirudin is direct thrombin inhibitor that is given as 0.1 mg/kg loading dose, followed by 0.25 mg/kg per hour only in patients managed with an early invasive strategy. This regimen is continued until diagnostic angiography or PCI. [ ] In the Acute Catheterization and Urgent Intervention Triage Strategy

2014 eMedicine Emergency Medicine

807. Necrotizing Fasciitis (Follow-up)

can range from skin and subcutaneous necrosis to muscle and fascial involvement, but classification is less important than the general principles. [ , , ] NSTI is pathophysiologically characterized by effects of bacterial toxins and enzymes (eg, hyaluronidase) that enable horizontal extension through the fascial planes, leading to intravascular thromboses and ischemic necrosis with disturbance of the host’s humoral and cellular immune response. [ ] The infection is usually polymicrobial. Typical (...) an aggressive infection of subcutaneous tissue and the superficial fascia. Histologically, the necrosis of the fascia can manifest with or without polymorphonuclear infiltrates or bacteria. Surgical findings include presence of foul-smelling “dishwater” pus and gray, friable necrotic fascia that does not resist blunt dissection. [ ] The infection primarily does not affect musculature, but the prolongations of the deep fascia reach the surroundings of the skeletal muscle; progression to intermuscular fascia

2014 eMedicine Emergency Medicine

808. Assistive Devices to Improve Independence (Treatment)

-velocity, low-impact exercise in harmony with deep breathing and concentration. Tai chi promotes strength, flexibility, balance, and postural stability (even in patients with simultaneous disturbances of vision and proprioception). Tai chi also benefits the cardiovascular system by reducing the patient's blood pressure, decreasing fat composition, and fear of falling. In a study by Rand et al, on exercise and balance in adults older than 60 years without a neurological condition, tai chi interventions (...) formerly known as causalgia) and transient regional osteoporosis. It is also seen as a secondary disease due to a primary condition, such as immobilization, inflammation, tumor, or necrosis. Generalized osteoporosis includes involutional osteoporosis. This most common type of osteoporosis is divided into type I "high turnover" postmenopausal osteoporosis and type II "low turnover" age-associated (senile) osteoporosis. General osteoporosis can also be secondary to a disease process; in this case

2014 eMedicine.com

809. Nasal Reconstruction (Treatment)

skin graft and a subcutaneous transposition flap harvested from adjacent cheek fat. Using the graft to resurface the flap, the investigators stated, avoided the asymmetry and pincushioning that can occur in this area with local flaps. [ ] Burow Graft A Burow skin graft is a technique in which the most superior portion of the nasal wound is closed in a linear manner, and the dog-ear redundancy is donated to the nasal tip wound as a full-thickness skin graft (see the images below). Predictably (...) necrosis and nasal distortion can occur. Necrosis is particularly an unfortunate complication, because it introduces a larger surgical defect on the nose. Nonetheless, with proper experience, flap repairs of the nose offer significant advantages. Therefore, flaps constitute a large percentage of nasal reconstructive procedures performed by some surgeons. Although a full discussion of the various flaps relevant in nasal reconstruction is beyond the scope of this article, a few general comments

2014 eMedicine.com

810. Alogliptin and alogliptin/pioglitazone

evaluation and mitigation strategies RI Renal insufficiency SAE Severe adverse event SBP Systolic blood pressure SC Subcutaneous SCE Summary of clinical efficacy SCS Summary of clinical safety SD Standard deviation SMQ Standardized MedDRA query SOC Systems organ class Study 402 CV study SYR-322_402 SU Sulfonylurea SY Subject-years T1/2 Half-life T2DM Type 2 diabetes mellitus Tg Triglycerides TID Three times daily Tmax Time to peak plasma concentration TZD Thiazolidinedione ULN Upper limit of normal US (...) 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

811. Mirabegron (Myrbetriq)

that was dependent on meal composition (low-fat versus high-fat). Coadministration of a 50 mg tablet with a high-fat meal reduced mirabegron C max and AUC inf by 45% and 17%, respectively. A low-fat meal decreased mirabegron C max and AUC inf by 75% and 51%, respectively. After oral administration of mirabegron in healthy volunteers, mean peak plasma concentrations were reached between 3 and 4.3 hours. Mirabegron is a substrate for the efflux transporter P-gp and the influx organic cation transporters

2012 FDA - Drug Approval Package

812. Signifor - pasireotide

, hypertrichosis, ulceration and necrosis of the skin and underlying tissue at the injection site in mice at the LOAEL of 0.2 mg/kg/day. In rats, subcutaneous redding at the injection site, inflammation scab, alopecia, fibrosis, edema, necrosis, minimal to moderate mineralization and regeneration of skeletal muscle myofibers and regeneration of the panniculus muscle at the injection site and underlying tissues was observed at the LOAEL of 0.008 mg/kg/day. In monkey studies, swelling, redness, edema (...) form: Solution for injection Strengths: 0.3 mg, 0.6 mg, 0.9 mg Route of administration: Subcutaneous use Packaging: Ampoules (glass) Package sizes: 6 ampoules, 18 ampoules, 30 ampoules, 60 ampoules Page 2/90 Table of contents 1. Background information on the procedure 6 1.1. Submission of the dossier 6 1.2. Manufacturers 7 1.3. Steps taken for the assessment of the product 7 2. Scientific discussion 8 2.1. Introduction 8 2.2. Quality aspects 10 2.2.1. Introduction 10 2.2.2. Active Substance 10

2012 European Medicines Agency - EPARs

813. Revestive - teduglutide

-HPLC Reverse Phase High Performance Liquid Chromatography SBS Short Bowel Syndrome s.c. subcutaneous SDS-PAGE Sodium Dodecyl Sulfphate Polyacryl Amide Gel Electrphoresis SEC Size Exclusion Chromatography SGLT Sodium-dependent GLucose coTransporters SGS Société Générale de Surveillance SmPC Summary of Product Characteristics SOCs System Organ Classes SOP Standard Operating Procedure sWfI sterile Water For Injection t 1/2 Half Life TAMC Total Aerobic Microbial Count TAMV Time Averaged Maximal (...) for subcutaneous injection in strength of 5 mg. This is reconstituted with 0.5 ml of sterilised water for injection, i.e. after reconstitution a nominal 10 mg/ml solution is obtained. The reconstituted product containing a nominal 10 mg/ml Teduglutide solution is administrated subcutaneously with a recommended daily dose of 0.05 mg/kg body weight. Type of application and aspects on development This application is composed of administrative information, complete quality data, non-clinical and clinical data

2012 European Medicines Agency - EPARs

814. Forxiga - dapagliflozin

(comparators were metformin XR and glipizide) in drug-naïve subjects at an early stage of disease and subjects who require additional therapy after failure to reach adequate glycaemic control with their current regimen, including oral anti-diabetic agents or insulin at a later stage of the disease. The clinical development program also examined the persistent loss of calories in the urine due to glucosuria and the resulting potential for weight loss with a reduction in total body fat. The clinical studies (...) , body weight was reduced in dapagliflozin-treated (ad libidum fed) animals. This weight loss was not only due to water loss but body fat mass was also reduced by dapagliflozin treatment. Furthermore, the Applicant conducted glucose clamp studies to measure insulin resistance and islet function in ZDF rats previously treated with dapagliflozin for 34 days. Dapagliflozin was absent during the clamp. Improvements in insulin sensitivity and beta cell function were observed in the dapagliflozin-treated

2012 European Medicines Agency - EPARs

816. Rasitrio - aliskiren / amlodipine / hydrochlorothiazide

for general toxicity in rats and marmosets. Premature deaths were encountered at doses = 200 mg/kg/day in oral (gavage) repeated dose toxicity study in rats. As aliskiren is a local irritant and can cause necrosis of the respiratory epithelium, the deaths were attributed to aspiration of the dosing solution into the respiratory tract rather than systemic toxic effects. In marmosets, two incidences of urinary stasis in decedent animals were attributed to hypotension and poor renal perfusion. Other changes (...) treated with amlodipine at 10 mg/kg/day and SPA100 at 300/10 mg/kg/day. Aliskiren/hydrochlorothiazide Preclinical safety studies conducted with SPH100 included 2- and 13-week oral (gavage) repeated dose toxicity studies in rats. In the 2-week rat study, the dose of 300/25 mg/kg/day (aliskiren and hydrochlorothiazide) resulted in morbidity and an early group sacrifice. Increased plasma urea and creatinine concentrations and basophilic tubules, hyaline casts and tubular necrosis in the kidney were

2011 European Medicines Agency - EPARs

817. Xeplion - paliperidone

. In the 3 month minipig study, in which the formulation intended for marketing (F013) has been tested a dose-related local reaction was found at the injection site after repeated dosing of approximately 5 and 20 mg eq./kg/month. Deposit of test article formulation was observed in the subcutaneous tissue and/or fat, and/or the injection site muscle. Histologically a dose-related (fibro) histiocytic inflammatory reaction, often with granuloma formation especially in the high-dose group, was found . Since (...) to slight muscular necrosis and concomitant regeneration were noted. These changes decreased over time. Regeneration was also detected in the vehicle group. In dogs, most notable findings were anaphylactic reactions and more pronounced injection site reactions. Signs of CNS toxicity (e.g sedation, tremors, abnormal behaviour) were observed in all animal species. Repeat dose toxicity Studies were performed in rats (up to 6 months and 160 mg eq./kg), dogs (up to 12 months and 80/40 mg eq./kg) and minipigs

2011 European Medicines Agency - EPARs

818. Brilique (ticagrelor)

performed on possible drug-drug interactions of ticagrelor with aspirin. However, this was investigated in the clinical trials and no interactions on plasma protein binding or on metabolism were observed. Ingestion of a high-fat meal resulted in a 21% increase in ticagrelor AUC and 22% decrease in the active metabolite Cmax, indicating a possible interaction with P-gp and/or CYP3A4/5. The Applicant concluded that these changes are considered of minimal clinical significance. The in vivo pharmacokinetic (...) in the liver. In the 24-month rat carcinogenicity study, focal necrosis in the liver was seen in males at all dose groups, albeit at low incidence and without a dose response. No liver effects were seen in marmosets and signals of liver toxicity in clinical trials are questionable, therefore this effect is likely a rodent specific response to increased liver load. Nevertheless, from these results, it cannot be completely ruled out that ticagrelor treatment induces liver toxicity, and liver toxicity

2011 European Medicines Agency - EPARs

819. Necrotising fasciitis of the thigh (PubMed)

Necrotising fasciitis of the thigh Necrotising fasciitis (NF) is an extremely virulent form of infectious fasciitis. It affects skin, subcutaneous fat and superficial and deep muscular fascia by rapidly progressive necrosis. Expeditious diagnosis and radical debridement is necessary to prevent the onset of sepsis, multisystem organ failure and possible death. Perforated rectal cancer resulting in NF can spread to the perineum and genitals known as Fournier gangrene. This case describes

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2013 BMJ case reports

820. Differential dose effect of fish oil on inflammation and adipose tissue gene expression in chronic kidney disease patients. (PubMed)

. Serum adiponectin, leptin, C-reactive protein, and tumor necrosis factor-α were not modified in either group. Interleukin-6 levels tended to decrease with 1.8 g of ω-3 PUFA. Additionally, a subset of inflammation-related genes (CD68 and MMP9) was reduced in subcutaneous adipose tissue in this group. Adiponectin, leptin, and adipoR2 gene expression were upregulated with 3.6 g of ω-3 PUFA.A moderate dose of FO alters the gene expression profile of adipose tissue to a more antiinflammatory status (...) patients with stage IV/V CKD were randomly allocated to receive 1.8 g or 3.6 g/d of ω-3 PUFA for 10 wk. Metabolic parameters, adipose tissue function, and gene expression were evaluated at baseline and 10 wk.Body weight, fat mass, energy intake, fasting glucose, and insulin were unchanged. The daily intake of 3.6 g of ω-3 PUFA resulted in decreased serum triacylglycerol and increased high-density lipoprotein cholesterol, whereas low-density lipoprotein cholesterol increased with 1.8 g of ω-3 PUFA

2013 Nutrition (Burbank, Los Angeles County, Calif.)

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