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Ketoconazole

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261. Clomiphene and other antioestrogens for ovulation induction in polycystic ovarian syndrome. Full Text available with Trip Pro

medical adjunct versus clomiphene alone was limited by the number of trials reporting the comparison and poor reporting of clinical outcomes relevant to this systematic review and by the number of adjuncts reported (ketoconazole, bromocriptine, dexamethasone, combined oral contraceptive, human chorionic gonadotropin, hormone supplementation). The addition of dexamethasone or combined oral contraceptive suggested a possible benefit in pregnancy outcomes, but findings were very uncertain and further

2016 Cochrane

262. Systemic antifungal therapy for tinea capitis in children. (Abstract)

of fluconazole or six weeks of griseofulvin (41.4% versus 52.7%; RR 0.92, 95% CI 0.81 to 1.05; N = 615; moderate quality evidence). Current evidence for ketoconazole versus griseofulvin was limited. One study favoured griseofulvin (12 weeks) because ketoconazole (12 weeks) appeared less effective for complete cure (RR 0.76, 95% CI 0.62 to 0.94; low quality evidence). However, their effects appeared to be similar when the treatment lasted 26 weeks (RR 0.95, 95% CI 0.83 to 1.07; low quality evidence). Another (...) study indicated that complete cure was similar for ketoconazole (12 weeks) and griseofulvin (12 weeks) (RR 0.89, 95% CI 0.57 to 1.39; low quality evidence). For one trial, there was no significant difference for complete cure between fluconazole (for two to three weeks) and terbinafine (for two to three weeks) (82.0% versus 94.0%; RR 0.87, 95% CI 0.75 to 1.01; N = 100; low quality evidence). For complete cure, we did not find a significant difference between fluconazole (for two to three weeks

2016 Cochrane

263. Antifungal agents for preventing fungal infections in non-neutropenic critically ill patients. Full Text available with Trip Pro

identified. Eleven trials compared the use of fluconazole to placebo or no antifungal treatment. Three trials compared ketoconazole versus placebo. One trial compared anidulafungin with placebo. One trial compared caspofungin to placebo. Two trials compared micafungin to placebo. One trial compared amphotericin B to placebo. Two trials compared nystatin to placebo and one trial compared the effect of clotrimazole, ketoconazole, nystatin and no treatment. We found two new ongoing studies and four new

2016 Cochrane

264. Diagnosis and management of testosterone deficiency syndrome in men: clinical practice guideline

with opioids, glucocorticoids or ketoconazole  Chronic alcohol abuse or heroin use Liver disease  Hemochromatosis Osteoporosis End-stage renal disease COPD Obstructive sleep apnea  Infertility Frailty  Hyperprolactinemia Sellar region mass, disease, radiation or trauma Testicular cancer treatment No TDS Normal Figure 1: Algorithm for the diagnosis of testosterone deficiency syndrome (TDS). cBAT = calculated bioavailable testosterone, CBC = com - plete blood count, cFT = calculated free

2015 CPG Infobase

265. Dasabuvir / ombitasvir/paritaprevir/ritonavir (Addendum to Commissions A15-03 and A15-04)

, cisapride, clarithromycin, conivaptan, dronedarone, efavirenz, eletriptan, eplerenone, everolimus, fusidic acid, itraconazole, ketoconazole, lovastatin, midazolam (orally), nefazodone, phenobarbital, phenytoin, pimozide, rifampin, salmeterol, simvastatin, telithromycin, triazolam, voriconazole ? CYP2C8 inhibitors: gemfibrozil, trimethoprim ? Other prohibited drugs: bepridil, bosentan, buprenorphine, St. John’s Wort, methadone, mifepristone, modafinil, montelukast, ergot alkaloids, pioglitazone (...) , quinidine, cisapride, clarithromycin, conivaptan, dronedarone, efavirenz, eletriptan, eplerenone, everolimus, fusidic acid, itraconazole, ketoconazole, lovastatin, midazolam (orally), nefazodone, phenobarbital, phenytoin, pimozide, rifampin, salmeterol, sildenafil, simvastatin, telithromycin, triazolam, voriconazole ? CYP2C8 inhibitors: gemfibrozil, trimethoprim ? Other prohibited drugs: bepridil, bosentan, buprenorphine, domperidone, St. John’s Wort, methadone, mifepristone, modafinil, montelukast

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

268. Erectile dysfunction: avanafil

; priapism; visual, bleeding and hearing disorders; and concomitant use of alpha-blockers, antihypertensive drugs, alcohol, and other treatments for erectile dysfunction. Co-administration of avanafil with potent inhibitors of CYP3A4, such as ketoconazole, clarithromycin or ritonavir, is contraindicated. See the summary of product characteristics for avanafil for full details. Course and cost Course and cost Avanafil is available as 50 mg, 100 mg or 200 mg tablets. The recommended dose is 100 mg

2014 National Institute for Health and Clinical Excellence - Advice

269. Asthma: fluticasone furoate/vilanterol (Relvar Ellipta) combination inhaler

corticosteroid-related adverse reactions. The summaries of product characteristics also advise avoiding the use of concomitant strong CYP3A4 inhibitors such as ketoconazole. The summaries of product characteristics include special warnings and precautions for use of fluticasone furoate/vilanterol if there is deterioration of disease; possible systemic corticosteroid effects of fluticasone furoate/vilanterol use; and cardiovascular effects, including advice that fluticasone furoate/vilanterol should be used

2014 National Institute for Health and Clinical Excellence - Advice

270. Edoxaban: benefit assessment according to §35a Social Code Book V (dossier assessment)

discontinuation of the study medication in case of systemic administration of: ketoconazole, itraconazole, erythromycin, azithromycin or clarithromycin (topical use allowed) for = 3 weeks Administration of aspirin was limited to 3. For patients with a score = 3, there was no hint of an added benefit of edoxaban in comparison with warfarin. Hence an added benefit of edoxaban for the outcome “stroke (disabling)” is not proven for patients with a CHADS 2 score = 3. This deviates from the company’s assessment

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

271. Nivolumab (new therapeutic indication): benefit assessment according to §35a Social Code Book V (dossier assessment)

CYP3A4 inhibitors such as ketoconazole, itraconazole, clarithromycin nivolumab 3 mg/kg body weight every 2 weeks IV no dose escalation or reduction allowed docetaxel 75 mg/m² BSA every 3 weeks IV dose reduction in 2 steps a on occurrence of prespecified AEs b Postponement of the planned dose up to < 6 weeks allowed a: Reduction step 1: to 55 mg/m 2 BSA; reduction step 2: to 37.5 mg/m 2 BSA. b: The docetaxel dose could be reduced if the following treatment-induced AEs occurred: febrile neutropenia

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

278. Neofordex - dexamethasone. To treat adults with multiple myeloma

hydrolysed in serum and the metabolism of dexamethasone acetate is expected to be similar. In an in vitro study using mouse, rat, hamster, guinea pig, rabbit, dog and human liver microsome preparations, dexamethasone was shown to be extensively metabolised to 6-hydroxydexamethasone and side-chain cleaved metabolites to various extents. The inhibitory potency of ketoconazole (a CYP3A4 inhibitor) and glycyrrhetinic acid (a specific inhibitor of 11-dehydrogenase) on dexamethasone metabolism was investigated (...) . 6-Hydroxylation was variable (highest in the hamster), not always the major route of metabolism and its formation was sex-specific Assessment report EMA/CHMP/6613/2016 Page 19/61 in the rat. The inhibition of 6-hydroxylation by ketoconazole also varied. Cytosolic preparations produced similar profiles in different species with the formation of a metabolite (M5) which was inhibited by glycyrrhetinic acid and tentatively identified as 11-dehydro-side-chain cleaved dexamethasone (11DH-9aF

2016 European Medicines Agency - EPARs

279. Warfarin Therapy Management

• amoxicillin • cephalosporins (some) • isoniazid • fluoroquinolones 2 • macrolides 3 • metronidazole • sulfonamides • telithromycin • tetracyclines 4 Anticonvulsants • phenytoin (early on) • sodium valproate Antidepressants • duloxetine • venlafaxine • SSRI - fluoxetine - fluvoxamine - paroxetine - sertraline - citalopram Antifungals • fluconazole • itraconazole • ketoconazole • miconazole (oral, vaginal) • voriconazole Antihyperlipidemics • ezetimibe • fenofibrate • fluvastatin • gemfibrozil

2015 Clinical Practice Guidelines and Protocols in British Columbia

280. Addyi - Flibanserin

with a strong CYP3A4 inhibitor (ketoconazole) ? Concern with flibanserin being a P-gp inhibitor given the increase in digoxin level when co-administered with flibanserin The second CR letter requests that the Applicant conduct additional pharmacokinetic investigations to examine whether additional enzymes, such as CYP2C9 or CYP2C19, contribute to the metabolism of flibanserin. The letter also recommended a driving simulation study to assess the potential for impaired next-day driving. The applicant (...) female subjects 511.93 Evaluate effect of flibanserin on oral contraceptives (weak CYP3A4 inhibitors) R; O; 2-way crossover 100 mg flibanserin qd x 14 days + single dose 30 mcg EE/150 mcg LNG 24 healthy female subjects 511.96 Evaluate effect of renal impairment O; parallel group (matched pairs) 50 mg flibanserin, single dose 35 male and female subjects (healthy and renally impaired subjects) 511.111 Evaluate effect of ketoconazole (a strong CYP3A4 inhibitor) R; O; 2-way crossover 50 mg flibanserin

2015 FDA - Drug Approval Package

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