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Ketoconazole

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281. Contraception - combined hormonal methods: Scenario: Combined oral contraceptive

the efficacy of progestogen-containing contraceptives. The manufacturers of Esmya® (ulipristal acetate 5 mg) advise avoiding concomitant use. Antihypertensives — the hypotensive effect may be antagonized. Monitor blood pressure, and adjust the dose of antihypertensive medication accordingly. Antidiabetic drugs — oestrogens and progestogens antagonize the hypoglycaemic effect. Monitor blood glucose. Antifungals (such as fluconazole, itraconazole, ketoconazole, voriconazole) — modest increase in plasma

2020 NICE Clinical Knowledge Summaries

282. Feedback on LH in Testosterone-Clamped Men Depends on the Mode of Testosterone Administration and Body Composition. Full Text available with Trip Pro

was a placebo-controlled, blinded, and prospectively randomized crossover study comprising 16 healthy men [age range 23 to 54 years and a body mass index (BMI) between 22.3 and 34.2 kg/m2]. Subjects received ketoconazole to block endogenous T secretion and received continuous or 90-minute pulses of IV T addback.The study was performed in a Clinical Translational Research Unit.Subjects underwent 14 hours of blood sampling at 10-minute intervals, with a bolus IV injection of 33 ng/kg gonadotropin-releasing

2019 Journal of the Endocrine Society Controlled trial quality: uncertain

283. Dabrafenib (new therapeutic indication) - Benefit assessment

investigational preparations ? antiretroviral therapy ? herbal agents (e.g. St. John’s Wort) ? strong inhibitors or inducers of CYP3A or CYP2C8 (e.g. carbamazepine, ketoconazole, clarithromycin) a: In case of dose reduction or treatment discontinuation of one substance, continued treatment with the other substance was possible. b: According to the SPC of dabrafenib, further dose reduction to 50 mg twice daily is possible in combination with trametinib [3]. It is not assumed that this deviation had a relevant

2016 Institute for Quality and Efficiency in Healthcare (IQWiG)

284. Trametinib - Benefit assessment (dossier assessment)

? antiretroviral therapy ? herbal agents (e.g. St. John’s Wort) ? strong inhibitors or inducers of CYP3A or CYP2C8 (e.g. carbamazepine, ketoconazole, clarithromycin) a: In case of dose reduction or treatment discontinuation of one substance, continued treatment with the other substance was possible. b: According to the SPC of dabrafenib, further dose reduction to 50 mg twice daily is possible in combination with trametinib [4]. It is not assumed that this deviation had a relevant influence on the study results

2016 Institute for Quality and Efficiency in Healthcare (IQWiG)

285. 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)

286. 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)

287. 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

288. 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

289. 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

290. 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)

295. 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

300. Treatment of Hepatitis C

, phenytoin), antibiotics (erythromycin, clar- ithromycin, telithromycin), antimycobacterials (rifampin, rifabu- tin, rifapentine), systemically administered antifungals (itraconazole, ketoconazole, posaconazole, ?uconazole, voricona- zole), systemically administered dexamethasone, cisapride, her- bal products (milk thistle, St John’s wort) and a number of antiretroviral drugs, including cobicistat-based regimens, efavir- enz,etravirine,nevirapine,ritonavir,andanyHIVproteaseinhibi- tor

2016 European Association for the Study of the Liver

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