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Ketoconazole

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242. Second-line hormonal therapy for men with chemotherapy-na&iuml

of ≥50% from baseline (v placebo). The drug is also well tolerated. Alternative treatment options include immunotherapy (sipuleucel-T) (Kantoff et al., 2010), chemotherapy (docetaxel and prednisone) (Basch et al., 2014), and radium-223. If none of these therapies can be obtained or tolerated by the patient, other antiandrogens, prednisone, and ketoconazole/hydrocortisone may be offered because they provide modest clinical benefits in this population, but no survival benefits have been established (...) acetate plus prednisone Enzalutamide Immunotherapy (sipuleucel-T) Chemotherapy (docetaxel and prednisone) Radium-223 Other antiandrogens Prednisone Ketoconazole/hydrocortisone Palliative care Frequency of prostate-specific antigen (PSA) monitoring Radiographic imaging Bone scan Computed tomography of the abdomen and pelvis Magnetic resonance imaging of the abdomen and pelvis Imaging with fluorine-18 (18F)-labeled positron emission tomography ( 18 FPET) (not recommended routinely) Overall survival (OS

2017 National Guideline Clearinghouse (partial archive)

244. Second-Line Hormonal Therapy for Men with Chemotherapy-Naïve Castration-Resistant Prostate Cancer PCO

of a first skeletal-related event, complete or partial soft tissue response, time to PSA progression, time to deterioration in quality of life, and decline in PSA of ≥ 50% from baseline ( v placebo). The drug is also well tolerated. Alternative treatment options include immunotherapy (sipuleucel-T), chemotherapy (docetaxel and prednisone), and radium-223. If none of these therapies can be obtained or tolerated by the patient, other antiandrogens, prednisone, and ketoconazole/hydrocortisone may be offered (...) symptomatic patients. No significant differences in survival outcomes were reported between treatment groups. However, Small et al found that patients randomly assigned to AAWD and ketoconazole (AAWD/K) experienced higher rates of PSA decline ≥ 50% (27% v 11%; P < .001) and objective response (20% v 2%; P = .02) compared with those who underwent AAWD alone. Of patients randomly assigned to AAWD who later had ketoconazole, the total PSA response rate was similar to those who received immediate AAWD/K

2017 American Society of Clinical Oncology Guidelines

245. BSR guideline on the management of gout

(eGFR) <10 ml/min/1.73 m 2 and doses should be reduced in patients with eGFR 10–50 ml/min/1.73 m 2 and in the elderly [ ]. Colchicine should also only be used with caution and at low doses in patients taking drugs that are potent inhibitors of cytochrome P450 3A4 (e.g. cimetidine, clarithromycin, erythromycin, fluoxetine, ketoconazole, protease inhibitors, tolbutamide) or p-glycoprotein (e.g. clarithromycin, ciclosporin, erythromycin) [ ]. Caution is also required when using colchicine in patients

2017 British Society for Rheumatology

246. Ifunny Channel Inhibitors: An Emerging Option for Heart Failure

by cytochrome CYP3A4 enzyme; therefore, its use may pose a risk to patients when CYP3A4 inducers and/or inhibitors are administered concomitantly. 1,10 Strong CYP3A4 inhibitors are contraindicated with the use of ivabradine (e.g., ketoconazole increases ivabradine’s plasma concentration by 7-fold). Also, non-dihydropyridine calcium channel blockers verapamil and diltiazem should not be used with ivabradine as they increase ivabradine concentrations through moderate CYP3A4 inhibition and can enhance

2017 CADTH - Issues in Emerging Health Technologies

247. CRACKCast E076 – Pneumonia

Blastomyces dermatitidis – blastomycosis Coccidioides immitis – coccidiodomycosis Treatment: This is a super important differential to think of in the patient with “non-resolving” pneumonia Get help from ID and Respirology (need a bronchcoscopy) Managed with: Amphotericin B, Azoles (itraconazole, ketoconazole, fluconazole, etc) Pneumocystis pneumonia (PCP) Occurs in immunocompro- mised hosts, principally people with immune deficiency syndrome (AIDS) or malignancy. Pneumocystis jiroveci (previously known

2017 CandiEM

248. CRACKCast E126 – Diabetes Mellitus and Disorders of Glucose Homeostasis

-1.5 mg/kg/day OR Posaconazole 400 mg BID Mucocutaneous Candidiasis Ketoconazole 200 mg PO daily; may need several weeks of therapy Non-clostridial Gas Gangrene (including Fournier’s) Clindamycin 600 mg q6h + third-generation cephlasporin + Vancomycin 15 mg/kg q12h NOTE: Occult osteomyelitis should be considered in all cases of neuropathic ulceration [9] How does hypoglycemia classically present? The Brain needs glucose. The CNS cannot synthesize glucose, store more than a few minutes’ supply

2017 CandiEM

249. CRACKCast E120 – Dermatologic presentations

by genus Malassezia. Superficial hypopigmented or hyperpigmented patches occur mainly on the chest and trunk but may extend to the head and limbs. Tinea versicolor may be treated with topical antifungal agents, such as 2.5% selenium sulfide shampoo, imidazole creams, and ketoconazole cream or foam. Systemic therapy may be indicated, such as oral ketoconazole. Tinea Unguium (onychomycosis) Tinea unguium may be caused by dermatophytes, candida, or other fungal species. Paronychia or untreated tinea pedis

2017 CandiEM

250. Abiraterone for treating metastatic hormone-relapsed prostate cancer before chemotherapy is indicated

treatment) and ketoconazole (which has not been proven to extend life); the committee concluded it was not necessary to control for the effects of docetaxel and ketoconazole in analyses. The committee agreed that treatment switching and subsequent treatments that are not available in the NHS Abiraterone for treating metastatic hormone-relapsed prostate cancer before chemotherapy is indicated (TA387) © NICE 2019. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms

2016 National Institute for Health and Clinical Excellence - Technology Appraisals

251. Psoriasis

of apremilast, which may result in a loss of efficacy of apremilast. 16 Therefore, the use of strong CYP3A4 enzyme inducers (Table 4) with apremilast is not recommended. There was no clinically meaningful drug-drug interaction with ketoconazole, methotrexate and oral contraceptives. 16 Table 4: List of most important drugs with potential interactions Drugs with strong cytochrome P450 3A4 (CYP3A4) enzyme inducing effect Rifampicin Phenobarbital Carbamazepine 7Phenytoin St. John’s Wort Overdose/ measures

2017 European Dermatology Forum

252. Tinea Cruris Skin Infection - Guidelines for Prescribing Topical Antifungals

has not been studied in children <12, so should not be recommended. Ketoconazole 2% Cream Ketoconazole is fungicidal to tinea dermatophytes by interfering with fungal sterol biosynthesis. Dosage: Apply to clean, dry affected area and surrounding area (approximately 2cm beyond visible edge of lesions) ONCE daily. Duration of treatment: 2 - 4 weeks. Systemic absorption is minimal to undetectable. Treatment should meet, but not exceed recommended duration as safety for longer periods has not been (...) established. Pregnancy: Adverse effects are noted in animal studies with oral ketoconazole. Systemic absorption is very low suggesting that ketoconazole is unlikely to have adverse effects but there is no data to confirm safety. The official recommendation is to avoid during pregnancy. Clotrimazole and miconazole are the agents of choice in pregnancy . Lactation: Has been detected in breast milk at very low concentrations, but since it requires acidic conditions for absorption from the GI tract

2017 medSask

253. Tinea Corporis Infection - Guidelines for Prescribing Topical Antifungals

: Topical terbinafine has not been studied in children <12, so should not be recommended Ketoconazole 2% Cream Ketoconazole is fungicidal to tinea dermatophytes through interference with fungal sterol biosynthesis Dosage: Children and Adults: Apply to clean, dry affected area and surrounding area (approximately 2cm beyond visible edge of lesions) ONCE or TWICE daily; duration of treatment 3 - 4 weeks Systemic absorption is minimal to undetectable. Treatment should meet but not exceed recommended (...) duration as safety for longer periods has not been established Pregnancy: Adverse effects are noted in animal studies with oral ketoconazole. Systemic absorption is very low suggesting that ketoconazole is unlikely to have adverse effects but there is no data to confirm safety. Clotrimazole and miconazole are the agents of choice in pregnancy but application to large areas should be avoided Lactation: Has been detected in breast milk at very low concentrations, but since it requires acidic conditions

2017 medSask

254. Tinea Pedis Infection - Guidelines for Prescribing Topical Antifungals

applied cream and spray treatment, the small amounts absorbed through the skin are unlikely to affect the infant. Pediatrics: Topical terbinafine has not been studied in children <12, so should not be recommended Ketoconazole 2% Cream Ketoconazole is fungicidal to tinea dermatophytes by interfering with fungal sterol biosynthesis. Dosage: Apply to clean, dry affected area and surrounding area (approximately 2cm beyond visible edge of lesions) ONCE daily. Duration of treatment 4 to 6 weeks. Systemic (...) absorption is minimal to undetectable. Treatment should meet, but not exceed recommended duration as safety for longer periods has not been established. Pregnancy: Adverse effects are noted in animal studies with oral ketoconazole. Systemic absorption is very low suggesting that ketoconazole is unlikely to have adverse effects but there is no data to confirm safety. The official recommendation is to avoid during pregnancy. Clotrimazole and miconazole are the agents of choice in pregnancy. Lactation: Has

2017 medSask

255. Diaper Dermatitis, Irritant and Candidal - Guidelines for Prescribing Topical Antifungals and Hydrocortisone

hydrocortisone 1% has recently been changed to OTC, it is still considered prescription if used under two years of age. Continue with barrier therapy. Apply topical hydrocortisone first, wait five minutes, then apply barrier product. Do not use hydrocortisone alone if candidal diaper dermatitis is suspected. Candidal Diaper Dermatitis A topical antifungal such as clotrimazole 1% cream, ketoconazole 2% cream, miconazole 2% cream, or nystatin cream. Apply cream twice daily, morning and evening, after diaper (...) , or other reliable drug monograph references. For comprehensive drug comparisons, see RxFiles charts ( ) . This information should be routinely consulted before prescribing. DIAPER DERMATITIS Hydrocortisone 1% TOPICAL CREAM (<2 years of age Ketoconazole 2% TOPICAL CREAM * Note: These are the prescription only products. The OTC products, clotrimazole, miconazole and nystatin can also be used, but will not be eligible for the minor ailment assessment fee. pseudoDIN: 00951091 Max of 4 claims per 365 days

2017 medSask

256. Management of Acute Atrial Fibrillation and Atrial Flutter in Non-Pregnant Hospitalized Adults

heart valves. Special Considerations: Recent Stroke/CVA In patients with recent ischemic stroke ( 60 kg: 1 mg IVPB over 10 minutes 80 or weight <60kg: 2.5mg BID Dose – Hepatic Impairment Moderate-severe: not recommended Child-Pugh B or C, or coagulopathy: not recommended Use caution Drug Interactions Ketoconazole or dronedarone & CrCl 30-50 ml/min: 75mg BID;P-gp inhibitor & CrCl 15-30 ml/min: not recommended; P-gp inducer: avoid Strong dual- inhibitors or inducers of P-gp and CYP3A4: avoid; Combined

2017 University of Michigan Health System

257. Edoxaban for preventing stroke and systemic embolism in people with non-valvular atrial fibrillation

of the following clinical factors: moderate or severe renal impairment (creatinine clearance 15–50 ml/min); body weight of 60 kg or less; concomitant use of the P-glycoprotein inhibitors ciclosporin, dronedarone, erythromycin or ketoconazole. 2.2 The summary of product characteristics includes the following adverse reactions for edoxaban: bleeding, anaemia, nausea, rash, hepatobiliary disorders (increased blood bilirubin and gamma-glutamyl transferase) and abnormal liver function test. For full details

2015 National Institute for Health and Clinical Excellence - Technology Appraisals

258. 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

259. 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)

260. 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)

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