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Life-Threatening Drug-Induced Rashes

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121. CYP2B6 Genetics and Drug Interactions in Healthy Volunteers

and inducer of CYP2B6 (and other drug disposition proteins). Bupropion 4-hydroxylation is an alternative in vivo probe of CYP2B6 activity and will be studied here in addition to the metabolism and pharmacokinetics of efavirenz. Condition or disease Intervention/treatment Phase Healthy Drug: Efavirenz Drug: Bupropion Drug: Rosuvastatin Drug: Montelukast Phase 4 Detailed Description: Schedule of assessment PHASE 1 (CONTROL PHASE) Phase 1 (day 1 to day 4): baseline (control) activities of CYP2B6, CYP2C8 (...) their blood draw. Since efavirenz has a long half-life (~76 hours after single dose and ~50 at steady state), a total of 17 days of efavirenz treatment is required to achieve steady-state plasma concentrations of efavirenz and steady-state autoinduction of metabolism. Subjects will be instructed to take efavirenz at bed-time to minimize efavirenz-induced central nervous side effects. Minor rescheduling (±3 days) of the subject's fixed inpatient/outpatient visits will be allowed including adjusting

2015 Clinical Trials

122. Comparison of Biomatrix and Orsiro Drug Eluting Stent

of bleeding diathesis, known coagulopathy (including heparin- induced thrombocytopenia), abnormal hemogram (Hb<10g/dL or PLT count <100,000/μL) or will refuse blood transfusions Patients with severe LV systolic dysfunction (LVEF<25%) or cardiogenic shock Gastrointestinal or genitourinary bleeding within the prior 2 months, or major surgery within 2 months. Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's (...) Comparison of Biomatrix and Orsiro Drug Eluting Stent Comparison of Biomatrix and Orsiro Drug Eluting Stent - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. Comparison of Biomatrix and Orsiro Drug Eluting

2014 Clinical Trials

123. Progress in Psoriasis Therapy via Novel Drug Delivery Systems (PubMed)

appears on the skin. These conditions may negatively affect the patient's quality of life and lead to psychosocial stress. Psoriasis can be categorized as mild, moderate and severe conditions. Mild psoriasis leads to the formation of rashes, and when it becomes moderate, the skin turns into scaly. In severe conditions, red patches may be present on skin surface and becomes itchy. Topical therapy continues to be one of the pillars for psoriasis management. Drug molecules with target effect on the skin (...) Progress in Psoriasis Therapy via Novel Drug Delivery Systems Psoriasis is a lifelong condition which is caused by the negative signals produced by immune system, which leads to hyper proliferation and other inflammatory reactions on the skin. In this case, keratinocytes which are the outermost layer of skin possess shortened life cycle and results in the alteration of desquamation process where the cytokines will come out through lesions of affected patients and as a result, scaling marks

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2014 Dermatology Reports

124. Rash in Infants and Young Children

by infection (viral, fungal, or bacterial), contact with irritants, atopy, drug hypersensitivity, other allergic reactions, inflammatory conditions, or vasculitides (see Table: ). Examples of Rashes in Children The photo shows lesions of molluscum contagiosum. Lesions are typically 1 to 5 mm, solitary or grouped, firm, painless papules. They are pearly to pink in color, dome shaped, and may be umbilicated. This photo shows lesions on the face of a child infected with HIV. The lesions are extensive (...) Often viral respiratory prodrome Clinical evaluation Hypersensitivity reactions (eczema) Chronic or recurrent red, scaly patches, often in flexor creases Sometimes family history Clinical evaluation Intensely itchy erythema, sometimes with vesicles No systemic manifestations Clinical evaluation Diffuse maculopapular rash History of current or recent (within 1 wk) drug use Clinical evaluation Prodrome of fever, malaise, cough, sore throat, and conjunctivitis Painful mucosal ulcers, almost always

2013 Merck Manual (19th Edition)

125. Adverse drug reactions

and severity of the reaction. This will determine whether urgent action is required or whether the person can be in primary care. For example, a cough due to an angiotensin-converting enzyme inhibitor can be troublesome but not life threatening, but an anaphylactic reaction is a medical emergency. The nature of the presenting condition may strongly suggest that it is an adverse drug reaction (ADR). For example, the following conditions are often ADRs: Acute dystonias Blood dyscrasias Skin reactions (...) [ ] and on what CKS considers to be good clinical practice. Managing a suspected reaction How should I manage a person with a suspected adverse drug reaction? Following an : Arrange emergency hospital admission if the adverse drug reaction (ADR) is serious or life threatening. Assess whether the ADR can be managed in primary care. Consider seeking specialist advice. If the ADR can be managed in primary care: Review and discuss treatment options with the person. These may include: Stopping the suspected drug

2012 NICE Clinical Knowledge Summaries

126. Antiepileptic Drugs: An overview

%. Approximately 75-85% of the drug is plasma protein bound, and it has a free fraction of 20-24% of the total plasma concentration. Cerebrospinal fluid (CSF) levels range from 17% to 31%. It is metabolized extensively in the liver and induces its own metabolism. The major metabolic pathway is epoxidation to CBZ 10,11-epoxide and hydrolysis to CBZ 10,11- trans -dihydrodiol. Because CBZ induces its own metabolism, causing an increase in clearance and a decrease in levels, the serum half-life decreases by 50 (...) not affect the metabolism of lipid-soluble drugs such as warfarin and oral contraceptives. Conversely, drugs that induce hepatic enzymes may reduce the half-life of LTG from 23 hours to 14-16 hours. LTG levels must be adjusted accordingly. LTG’s significant effect on seizures was demonstrated in 9 of 10 placebo-controlled trials in which LTG was administered as add-on therapy. LTG resulted in a 17-59% reduction in seizures, with most trials showing 25-30% median reduction in seizures. LTG is effective

2014 eMedicine.com

127. Antiepileptic Drugs: An overview

%. Approximately 75-85% of the drug is plasma protein bound, and it has a free fraction of 20-24% of the total plasma concentration. Cerebrospinal fluid (CSF) levels range from 17% to 31%. It is metabolized extensively in the liver and induces its own metabolism. The major metabolic pathway is epoxidation to CBZ 10,11-epoxide and hydrolysis to CBZ 10,11- trans -dihydrodiol. Because CBZ induces its own metabolism, causing an increase in clearance and a decrease in levels, the serum half-life decreases by 50 (...) not affect the metabolism of lipid-soluble drugs such as warfarin and oral contraceptives. Conversely, drugs that induce hepatic enzymes may reduce the half-life of LTG from 23 hours to 14-16 hours. LTG levels must be adjusted accordingly. LTG’s significant effect on seizures was demonstrated in 9 of 10 placebo-controlled trials in which LTG was administered as add-on therapy. LTG resulted in a 17-59% reduction in seizures, with most trials showing 25-30% median reduction in seizures. LTG is effective

2014 eMedicine.com

128. Antiepileptic Drugs: An overview

%. Approximately 75-85% of the drug is plasma protein bound, and it has a free fraction of 20-24% of the total plasma concentration. Cerebrospinal fluid (CSF) levels range from 17% to 31%. It is metabolized extensively in the liver and induces its own metabolism. The major metabolic pathway is epoxidation to CBZ 10,11-epoxide and hydrolysis to CBZ 10,11- trans -dihydrodiol. Because CBZ induces its own metabolism, causing an increase in clearance and a decrease in levels, the serum half-life decreases by 50 (...) not affect the metabolism of lipid-soluble drugs such as warfarin and oral contraceptives. Conversely, drugs that induce hepatic enzymes may reduce the half-life of LTG from 23 hours to 14-16 hours. LTG levels must be adjusted accordingly. LTG’s significant effect on seizures was demonstrated in 9 of 10 placebo-controlled trials in which LTG was administered as add-on therapy. LTG resulted in a 17-59% reduction in seizures, with most trials showing 25-30% median reduction in seizures. LTG is effective

2014 eMedicine.com

129. Drug Eruptions (Diagnosis)

after drug withdrawal and any reaction with readministration Physical examination should address clinical features that may indicate a severe, potentially life-threatening drug reaction, including the following: Mucous membrane erosions Blisters Nikolsky sign Confluent erythema Angioedema and tongue swelling Palpable purpura Skin necrosis Lymphadenopathy High fever, dyspnea, or hypotension It is important to appreciate the morphology and physical features of drug eruptions, as follows: Acneiform (...) clearing may be 1-2 weeks or longer. Severe and potentially life-threatening eruptions occur in approximately 1 in 1000 hospital patients. Mortality rates for erythema multiforme (EM) major are significantly higher. Stevens-Johnson syndrome (SJS) has a mortality rate of less than 5%, whereas the rate for TEN approaches 20-30%; most patients die from sepsis. Patients with exanthematous eruptions should be counseled to expect mild desquamation as the rash resolves. Patients with hypersensitivity syndrome

2014 eMedicine.com

130. Antiepileptic Drugs: An overview

%. Approximately 75-85% of the drug is plasma protein bound, and it has a free fraction of 20-24% of the total plasma concentration. Cerebrospinal fluid (CSF) levels range from 17% to 31%. It is metabolized extensively in the liver and induces its own metabolism. The major metabolic pathway is epoxidation to CBZ 10,11-epoxide and hydrolysis to CBZ 10,11- trans -dihydrodiol. Because CBZ induces its own metabolism, causing an increase in clearance and a decrease in levels, the serum half-life decreases by 50 (...) not affect the metabolism of lipid-soluble drugs such as warfarin and oral contraceptives. Conversely, drugs that induce hepatic enzymes may reduce the half-life of LTG from 23 hours to 14-16 hours. LTG levels must be adjusted accordingly. LTG’s significant effect on seizures was demonstrated in 9 of 10 placebo-controlled trials in which LTG was administered as add-on therapy. LTG resulted in a 17-59% reduction in seizures, with most trials showing 25-30% median reduction in seizures. LTG is effective

2014 eMedicine.com

131. Drug Eruptions (Overview)

after drug withdrawal and any reaction with readministration Physical examination should address clinical features that may indicate a severe, potentially life-threatening drug reaction, including the following: Mucous membrane erosions Blisters Nikolsky sign Confluent erythema Angioedema and tongue swelling Palpable purpura Skin necrosis Lymphadenopathy High fever, dyspnea, or hypotension It is important to appreciate the morphology and physical features of drug eruptions, as follows: Acneiform (...) clearing may be 1-2 weeks or longer. Severe and potentially life-threatening eruptions occur in approximately 1 in 1000 hospital patients. Mortality rates for erythema multiforme (EM) major are significantly higher. Stevens-Johnson syndrome (SJS) has a mortality rate of less than 5%, whereas the rate for TEN approaches 20-30%; most patients die from sepsis. Patients with exanthematous eruptions should be counseled to expect mild desquamation as the rash resolves. Patients with hypersensitivity syndrome

2014 eMedicine.com

132. Drug Eruptions (Treatment)

life threatening. Timely recognition of the syndrome and immediate discontinuation of the anticonvulsant or other offending drug are crucial. Patients may require liver transplantation if the drug is not stopped in time. Treatment with systemic corticosteroids has been advocated. References Monteagudo B, Cabanillas M, Iriarte P, Ramírez-Santos A, León-Muinos E, González-Vilas D, et al. Clindamycin-induced Maculopapular Exanthema with Preferential Involvement of Striae Distensae: A Koebner (...) be promptly discontinued. Knowledge of the common eruption inducing–medications may help in identifying the offending drug. Patients can possibly continue to be treated through morbilliform eruptions (ie, continue medication even in patients with a rash). The eruption often resolves, especially if the individual is being treated with antihistamines. Most authorities believe that exanthematous drug eruptions are not a precursor to severe reactions, such as TEN. Nevertheless, all patients with severe

2014 eMedicine.com

133. Drug Eruptions (Follow-up)

life threatening. Timely recognition of the syndrome and immediate discontinuation of the anticonvulsant or other offending drug are crucial. Patients may require liver transplantation if the drug is not stopped in time. Treatment with systemic corticosteroids has been advocated. References Monteagudo B, Cabanillas M, Iriarte P, Ramírez-Santos A, León-Muinos E, González-Vilas D, et al. Clindamycin-induced Maculopapular Exanthema with Preferential Involvement of Striae Distensae: A Koebner (...) be promptly discontinued. Knowledge of the common eruption inducing–medications may help in identifying the offending drug. Patients can possibly continue to be treated through morbilliform eruptions (ie, continue medication even in patients with a rash). The eruption often resolves, especially if the individual is being treated with antihistamines. Most authorities believe that exanthematous drug eruptions are not a precursor to severe reactions, such as TEN. Nevertheless, all patients with severe

2014 eMedicine.com

134. Does sunscreen prevent epidermal growth factor receptor (EGFR) inhibitor-induced rash? Results of a placebo-controlled trial from the North Central Cancer Treatment Group (N05C4). (PubMed)

Does sunscreen prevent epidermal growth factor receptor (EGFR) inhibitor-induced rash? Results of a placebo-controlled trial from the North Central Cancer Treatment Group (N05C4). Rash occurs in >50% of patients prescribed epidermal growth factor receptor (EGFR) inhibitors. This study was undertaken to determine whether sunscreen prevents or mitigates these rashes.This placebo-controlled, double-blinded trial enrolled rash-free patients starting an EGFR inhibitor. Patients were randomly (...) assigned to sunscreen with a sun protection factor of 60 applied twice a day for 28 days versus placebo. They were then monitored for rash and quality of life (Skindex-16) during the 4-week intervention and for an additional 4 weeks.Fifty-four patients received sunscreen, and 56 received placebo; the arms were balanced at baseline. During the 4-week intervention, physician-reported rash occurred in 38 (78%) and 39 (80%) sunscreen-treated and placebo-exposed patients, respectively (p = 1.00

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2010 The oncologist

135. Drug Drug Interaction of BI 201335 and Tenofovir

, cardiovascular, metabolic, musculoskeletal, immunologic, rheumatologic, hormonal, neurological system, clinically relevant electrolyte disorders or bleeding disorders that require current medical treatment. Diseases of the central nervous system or psychiatric disorders. History of photosensitivity or recurrent rash. History of orthostatic hypotension, fainting spells or blackouts. Chronic or clinically relevant acute infections. History of allergy/hypersensitivity (including drug allergy) which is deemed (...) relevant. Intake of drugs with a long half-life >24:00 hours within at least one month or less than ten half lives of the respective drug before enrollment in the study (with the exception of hormonal contraceptives). Use of any drugs which might influence the results of the trial up to 7 days prior to enrolment as nutraceuticals and herbal remedies that would interfere with either the absorption, distribution or metabolism of BI 201335 NA, or that prolong the QT/QTc interval. Use of any

2011 Clinical Trials

136. Auricular Acupressure for Chemotherapy-Induced Nausea and Vomiting in Female Breast Cancer Patients

acupressure Drug: Standard anti-emetic treatment (5-HT3 receptor antagonists and/or Dexamethasone) Not Applicable Detailed Description: Chemotherapy-induced nausea and vomiting (CINV) is one of the most common and distressing side-effects among cancer patients undergoing chemotherapy. Despite steady progresses in antiemetic prophylaxis and treatment during the past decades, approximately half of cancer patients receiving moderately to highly emetogenic chemotherapy still experience significant nausea (...) at the same acupoints as in the true auricular acupressure arm using Junci Medulla but no pressure will be applied. Other Name: Auricular tape with Junci Medulla Drug: Standard anti-emetic treatment (5-HT3 receptor antagonists and/or Dexamethasone) 5-HT3 receptor antagonists and/or Dexamethasone will be administered to manage chemotherapy-induced nausea and vomiting. Other Name: 5-HT3 receptor antagonists and/or Dexamethasone Standard Care Group Participants in this group will only receive standard anti

2015 Clinical Trials

137. Weekly cetuximab concurrent with IMRT aggravated radiation-induced oral mucositis in locally advanced nasopharyngeal carcinoma: Results of a randomized phase II study. (PubMed)

Weekly cetuximab concurrent with IMRT aggravated radiation-induced oral mucositis in locally advanced nasopharyngeal carcinoma: Results of a randomized phase II study. To evaluate the clinical efficacies and toxicities of induction chemotherapy followed by concomitant cisplatin-chemoradiotherapy (CRT) or cetuximab-radiotherapy (ERT) in locally advanced nasopharyngeal carcinoma (NPC).Previously untreated patients with stage III-IVb NPC were eligible. They were randomized to CRT arm: intensity (...) modulated radiation therapy (IMRT) with weekly cisplatin (30 mg/m(2)/w) or ERT arm: IMRT with weekly cetuximab (loading dose of 400 mg/m(2) followed by weekly doses of 250 mg/m(2)). Two cycles of induction chemotherapy (docetaxel 75 mg/m(2) d1 and cisplatin 80 mg/m(2) d1) were administered to both arms. Endpoints were survivals, toxicities and quality of life (QoL).Because of the unexpectedly high rates of grade 3/4 mucositis observed in the ERT arm, the study was closed ahead of schedule. A total of 44

2015 Oral oncology

138. A Study to Evaluate Use of Induced Skin Blisters in Adult Participants With Atopic Dermatitis, Allergic Asthma and Atopic Healthy Participants

with and Investigators Global Assessment (IGA) score of 2 to 4 at Screening Exclusion Criteria: Participant has taken any prohibited or restricted medications as noted below under Prestudy and Concomitant Therapy Participant has received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 6 weeks or 5 half-lives (whichever is longer) before the Screening visit * For participants with Asthma: Participant has a history of life-threatening asthma (...) A Study to Evaluate Use of Induced Skin Blisters in Adult Participants With Atopic Dermatitis, Allergic Asthma and Atopic Healthy Participants A Study to Evaluate Use of Induced Skin Blisters in Adult Participants With Atopic Dermatitis, Allergic Asthma and Atopic Healthy Participants - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save

2015 Clinical Trials

139. Randomized, open-label trial evaluating the preventive effect of tetracycline on afatinib induced-skin toxicities in non-small cell lung cancer patients. (PubMed)

Randomized, open-label trial evaluating the preventive effect of tetracycline on afatinib induced-skin toxicities in non-small cell lung cancer patients. Afatinib has shown long progression free survival and improvement in quality of life in advanced Non-Small Cell Lung Cancer (NSCLC) patients. Although afatinib causes acneiform rash, it can be manageable. Tetracyclines are usually used to treat it; nonetheless, there is no trial that evaluates their prophylactic efficacy on afatinib induced (...) . All patients were blindly monitored for skin toxicities by an expert dermatologist at the start of treatment with afatinib (day 0), weeks 2 and 4 of treatment. The protocol is registered on clinicaltrials.gov (NCT01880515).We included 90 patients, no differences were found in clinical and dermatological baseline characteristics. Rash incidence of any grade, and grade ≥2 was less frequent in the pre-emptive arm vs. the control arm (44.5 vs. 75.6%, RR 0.4 [95% CI 0.17-0.99], p=0.046 and 15.6 vs

2015 Lung Cancer

140. Low Level Laser Therapy for Radiation Induced Dermatitis in H & N Squamous Cell Carcinoma

, or larynx No prior radiotherapy to the head and neck region. No previous systemic chemotherapy or targeted therapy Must be aware of the neoplastic nature of his/her disease and willingly provide written, informed consent after being informed of the procedure to be followed, the nature of the therapy, alternatives, potential benefits, side-effects, risks and discomforts. Patients using standard therapies for cetuximab-induced acne-form rash will be included. Exclusion Criteria: Evidence of distant (...) Low Level Laser Therapy for Radiation Induced Dermatitis in H & N Squamous Cell Carcinoma Low Level Laser Therapy for Radiation Induced Dermatitis in H & N Squamous Cell Carcinoma - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more

2015 Clinical Trials

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