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Skin Discoloration

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181. Topiloric/Uriadec (topiroxostat)

). Allopurinol, which, as with topiroxostat, is an XOR inhibitor classified as a uric acid production inhibitor, has been reported to cause serious skin disorders such as toxic epidermal necrolysis and oculomucocutaneous syndrome as clinically significant adverse drug reactions. Moreover, the skin disorders may become serious when accompanied by abnormal 5 renal function. Administration to patients with renal impairment requires adequate caution and appropriate measures (e.g. dose reduction (...) , an XOR related enzyme, and on non-XOR enzymes 1 of purine and pyrimidine metabolism were studied. The results showed that topiroxostat (100 ?mol/L) inhibited the enzymes tested by only 2000 mg/kg in mice, dogs, and monkeys and >750 mg/kg in rats after oral administration; and 300 mg/kg in mice and 500 to 600 mg/kg in rats after intraperitoneal administration. Toxicity findings included white discoloration of the kidney in rats after oral administration. Bloody stools and loose stools were observed

2013 Pharmaceuticals and Medical Devices Agency, Japan

183. Vyndaqel (tafamidis meglumine)

disorder; night blindness; corneal deposits; corneal leukoma; corneal lesion; corneal degeneration; and dry skin. 13 ) Events in the MedDRA SMQ “hyperglycaemia/new onset diabetes mellitus”, HLGT “diabetic complications”, and HLTs “hyperglycaemic conditions NEC”, “diabetes mellitus (incl subtypes)”, and “carbohydrate tolerance analyses (incl diabetes)” (excluding “decreased” PTs under the HLT “carbohydrate tolerance analyses (incl diabetes)”). 16 3.(ii) Summary of pharmacokinetic studies 3.(ii (...) /animal) (vehicle, 7.5% VE TPGS) to male and female albino rats, radioactivity levels peaked within 2 hours post-dose in the majority of tissues and then declined gradually, but radioactivity was still present at 168 hours post-dose. The organ/plasma ratio was >1 at 0.5 hours post-dose for the liver and stomach and at ?1 hour post-dose for the harderian glands (at all time points after 6 hours post-dose), liver (at all timepoints), and perirenal fat and skin (at 168 hours post-dose). The blood/plasma

2013 Pharmaceuticals and Medical Devices Agency, Japan

184. Hypereosinophilic vasculitis: A case report. Full Text available with Trip Pro

. This is a condition that involves a vascular injury due to either a primary eosinophilic vasculitis or an underlying connective tissue disease and it predisposes patients to a prothrombotic state.A 39-year-old patient presented with left hand digital ischemia, preceded by Raynaud phenomenon, and vasculitic rash. For 3 months, he was having digital ischemia affecting the left 2nd and 3rd digits in the form of pallor and gangrenous discoloration with a preceding history of a pinpoint pruritic rash affecting his (...) of the left ulnar artery distally and the radial artery branches in the left hand and subsequently was diagnosed with hypereosinophilic vasculitis.He was started on oral prednisone of 1 mg/kg daily orally tapering done as well as azathioprine for maintenance.Two weeks postdischarge, the patient was seen in the outpatient department where his ischemic symptoms improved, and his skin rash healed. Noticed improvement in his splinter hemorrhages was also detected. He continued to do well on 2 years follow-up

2019 Medicine

185. Predictive fiberoptic endoscopic findings of upper airway in children with allergic rhinitis. (Abstract)

Predictive fiberoptic endoscopic findings of upper airway in children with allergic rhinitis. To determine predictive fiberoptic findings of upper airway in children with allergic rhinitis.129 children had fiberoptic evaluation of nasal cavity, pharynx and larynx. They were divided into allergic rhinitis group and normal group based on skin prick test results. All video recordings were randomly reviewed by three independent national board-certified otolaryngologists who were blinded (...) to the clinical details and outcomes of the participants' allergy testing. Each physician assessed and documented 10-item questionnaire. Intra-rater, inter-rater reliability and correlation between items and allergic status was calculated.Intra-rater reliability was moderate to perfect for all physicians on all items (kappa = 0.578-0.962). Inferior turbinate hypertrophy (κ = 0.714, p = 0.02), middle turbinate hypertrophy (κ = 0.728, p = 0.01), discoloration of inferior turbinate (κ = 0.685, p = 0.01), adenoid

2019 International Journal of Pediatric Otorhinolaryngology

186. Role of Full Text available with Trip Pro

Role of Ayurveda has a rich and comprehensive concept of life and health. Callosity is a French word meaning a local thickened or hardened part of the skin. It is a plaque of hyperkeratosis caused by repeated friction or pressure. It is assumed that frictional forces induce hyperkeratosis leading to thickening of stratum corneum of the skin over certain areas prone to mechanical stresses. Kadara, as described by the Samhitas, can be closely related to lesions of the skin caused (...) . It was observed that eventually in 7 days the area of the lesion turned soft with reddish black discoloration. Softening of the lesion and its discoloration might be due to penetration of the volatile oil and active principles of Pippali into the affected area while doing the Agni Karma procedure. It was further observed that the area of lesion eventually dried and peeled off along with the Kadara tissue within about 15 days.Hence, Pippali was able to provide satisfactory results in case of superficial

2019 Ayu Controlled trial quality: uncertain

187. Clinical evaluation of Full Text available with Trip Pro

Clinical evaluation of In Ayurveda, majority of skin diseases have been mentioned under the umbrella of Kushtha and in other words, it can be listed as "Ayurvedic dermatology." Among them, Vicharchika (eczema) included under Kshudra Kushtha, has been mentioned as curable disease, but due to relapsing nature of the disease and hazardous side effects of the modern drugs, it is difficult to manage. Ayurveda classics described a number of formulations to combat Kushtha (skin diseases) which offers (...) , burning sensation, eruption, discoloration, pain and edema of cases of Vicharchika.Treatment with Trivritta (Operculina turpethum Linn.) along with local application of paste of Aragvadha Patra Lepa is effective in reducing the symptoms of Vicharchika Kushtha (eczema).

2019 Ayu Controlled trial quality: uncertain

188. An Integrated Safety Summary of Omadacycline, a Novel Aminomethylcycline Antibiotic. Full Text available with Trip Pro

An Integrated Safety Summary of Omadacycline, a Novel Aminomethylcycline Antibiotic. Omadacycline is a semisynthetic tetracycline antibiotic. Phase III clinical trial results have shown that omadacycline has an acceptable safety profile in the treatment of acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia. Similar to most tetracyclines, transient nausea and vomiting and low-magnitude increases in liver aminotransferases were the most frequent (...) treatment-emergent adverse events in phase III studies but were not treatment limiting. Package insert warnings and precautions for omadacycline include tooth discoloration; enamel hypoplasia; inhibition of bone growth following use in late pregnancy, infancy, or childhood up to 8 years of age; an imbalance in mortality (2%, compared with 1% in moxifloxacin-treated patients) was observed in the phase III study in patients with community-acquired bacterial pneumonia. Omadacycline has no effect on the QT

2019 Clinical Infectious Diseases

189. <i>In vitro</i> and <i>in vivo</i> activities of the riminophenazine TBI-166 against <i>Mycobacterium tuberculosis</i>. Full Text available with Trip Pro

In vitro and in vivo activities of the riminophenazine TBI-166 against Mycobacterium tuberculosis. The riminophenazine agent clofazimine (CFZ) is repurposed as an important component of the new short-course multidrug-resistant tuberculosis regimen and significantly shortens first-line regimen for drug-susceptible tuberculosis in mice. However, CFZ use is hampered by its unwelcome skin discoloration in patients. A new riminophenazine analog TBI-166 was selected (...) as a potential next-generation antituberculosis riminophenazine following an extensive medicinal chemistry effort. Here, we evaluated the activity of TBI-166 against Mycobacterium tuberculosis and its potential to accumulate and discolor skin. In vitro activity of TBI-166 against both drug-sensitive and drug-resistant M. tuberculosis is more potent than that of CFZ. Spontaneous mutants resistant to TBI-166 were found at a frequency of 2.3x10-7 in wild strains of M. tuberculosis TBI-166 demonstrates at least

2019 Antimicrobial Agents and Chemotherapy

190. Congenital Erythropoietic Porphyria with Erythrodontia: A Case Report. (Abstract)

Congenital Erythropoietic Porphyria with Erythrodontia: A Case Report. The causes for intrinsic tooth discoloration can be separated into two categories as systemic and local. Systemic causes are either genetic or drug-induced effects. The development of dentition can also be affected by a number of systemic factors and metabolic diseases such as porphyria. Congenital erythropoietic porphyria (CEP), also known as Gunther's disease, is a metabolic disease caused by a transformation in the gene (...) that codifies uroporphyrinogen-3 synthesis, leading to porphyrin aggregation in urine, skin, bone, and dentin.A 21-month-old girl with erythrodontia was referred to Paediatric Dentistry Department in September 2017. A physical examination revealed blisters on her face, nose, hands, and feet. Laboratory findings showed highly elevated urine total uroporphyrin and total coproporphyrin I and III levels. Next-generation sequencing multigene panel testing for porphyria demonstrated a homozygous c.10C>T (p.L4F

2019 International Journal of Paediatric Dentistry

191. The fate of delayed revascularization for neglected vascular injury of incompletely amputated digits and hands. (Abstract)

The fate of delayed revascularization for neglected vascular injury of incompletely amputated digits and hands. We report the fate of neglected vascular injury in cases of incomplete amputation of the digits and hand after delayed revascularization. Twelve patients underwent primary bone fixation, tendon or skin repair for hand injuries without vessel repair despite ischaemic findings. There was discoloration or necrosis of the fingertips during follow-up examination and the patients were

2019 Journal of Hand Surgery - European

194. HyQvia - human normal immunoglobulin

reconstitution assay in nude mice. The effects of rHuPH20 were reversed within 24 h after injection. These data established that the dermal barrier is reconstituted within 24 h of administration of rHuPH20 in nude mice skin. rHuPH20 does not alter vascular permeability when injected intradermally compared to 100 ng Vascular Endothelial Growth Factor (VEGF) positive control, as determined by Miles Assay (dye extravasation assay). The increase in drug dispersion facilitated by rHuPH20 permeation enhancer

2013 European Medicines Agency - EPARs

195. Grastofil - filgrastim

and no signs of pain were noted after treatment with either test article during the observation period of 96 hours. Paravenous administration of Neukine caused several slight red discolorations in 1 animal. After p.v. administration Assessment report EMA/CHMP/303037/2013 Page 18/89 of the reference Neupogen, 2 animals showed slight hematoma formation and several slight red discolorations were noted in 2 animals. Histopathological examination showed moderate (grade 3) haematoma at the paravenous (...) observations that single intramuscular and paravenous administration of 480 µg Neukine is well tolerated and comparable to 480 µg Neupogen. Six New Zealand White rabbits were used for evaluating the safety of Neukine by patch test technique on intact skin (non-GLP). The hairs were clipped from the back and flanks one day prior to the application. Two areas on the back, approximately 2-3 cm apart, were designated for the position of control and test product patches in each rabbit. 0.2% SDS was applied

2013 European Medicines Agency - EPARs

196. Erivedge - vismodegib

decrease in body weight gain observed during the dosing phase in males given 50 or 100 mg/kg/day was correlated with a decrease in food consumption. Clinical signs of malocclusion/missing incisors were observed at all dose levels with additional findings of red ocular discharge and red discoloration of the skin or haircoat. Additional test article -related effects in animals given 50 or 100 mg/kg/day included previously observed tremors as well as squinted or protruding eyes, alopecia, and rough (...) , in the light of the overall data submitted and the scientific discussion within the Committee, issued a positive opinion for granting a conditional Marketing Authorisation to Erivedge on 25 April 2013. 2. Scientific discussion 2.1. Introduction Basal Cell Cancer or Basal Cell Carcinoma (BCC) is a slow-growing, locally invasive, malignant epidermal skin tumour predominantly affecting Caucasians. Although it is the most common malignancy worldwide, it is very difficult to estimate the incidence

2013 European Medicines Agency - EPARs

197. Stivarga - regorafenib

haemoglobin HCC hepatocellular carcinoma HCT haematocrit HFSR Hand-foot skin reaction HPLC high performance liquid chromatography HR hazard ratio KRAS Kirsten rat sarcoma 2 viral oncogene homologue LDH lactate dehydrogenase LVEF left ventricular ejection fraction MCH mean corpuscular haemoglobin Assessment report EMA/CHMP/403683/2013 Page 5/91 MCHC mean corpuscular haemoglobin concentration mCRC metastatic colorectal cancer MCV mean corpuscular volume MRP multidrug resistance-associated protein MTD (...) : decreased glycogen, Kupffer cell activation (M) =2: ? FC, ? GGT (F), ? liver, epididymides weight (M), kidney discoloration, glomerulopathy, liver: cytoplasmatic basophilia (M), flattened follicular epithelium of thyroid gland, ? haematopoiesis in spleen =8: 2 mortalities, teeth changes (dentin, periodontal ligaments, degeneration), ? BW (F), ungroomed coat, ? ery, Hb, HCT, MCHC (F), ? MCV, MCH, ?? reticulocytes, thrombocytes (F), ? neutrophils, ? hQuick, alb, T4, ? Glu (M), ? chol, TG, BUN, TSH, ? crea

2013 European Medicines Agency - EPARs

198. Relvar Ellipta - fluticasone furoate / vilanterol

contained concentrations greater than that observed in blood. Highest concentrations of DRM at 15 minutes post dose were observed in the kidney, adrenals, choroid plexus and thyroid. The highest observed concentrations for some tissues, including the Harderian gland, brown and white fat, preputial gland, seminal vesicles and pancreas, did not occur until 6 hours after dosing. DRM was also distributed into melanin containing tissues such as the eye and pigmented skin. Distribution into the brain or CNS

2013 European Medicines Agency - EPARs

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