Latest & greatest articles for Ketoconazole

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Top results for Ketoconazole

1. The safety and efficacy of ketoconazole combined with calmodulin inhibitor in solid organ transplantation: a systematic review and meta-analysis

The safety and efficacy of ketoconazole combined with calmodulin inhibitor in solid organ transplantation: a systematic review and meta-analysis Print | PDF PROSPERO This information has been provided by the named contact for this review. CRD has accepted this information in good faith and registered the review in PROSPERO. The registrant confirms that the information supplied for this submission is accurate and complete. CRD bears no responsibility or liability for the content

2019 PROSPERO

2. Ketoconazole and endogenous Cushing's syndrome: effective but tricky to use

Ketoconazole and endogenous Cushing's syndrome: effective but tricky to use Prescrire IN ENGLISH - Spotlight ''Ketoconazole and endogenous Cushing's syndrome: effective but tricky to use'', 1 March 2016 {1} {1} {1} | | > > > Ketoconazole and endogenous Cushing's syndrome: effective but tricky to use Spotlight Every month, the subjects in Prescrire’s Spotlight. 100 most recent :  |   |   |   |   |   |   |   |   |  Spotlight (...) Ketoconazole and endogenous Cushing's syndrome: effective but tricky to use FEATURED REVIEW Endogenous Cushing's syndrome is a rare but serious disease. Ketoconazole was effective in over 50% of cases in non-comparative series in a total of 800 patients. However, ketoconazole is hepatotoxic and interacts with many other drugs. Full review (2 pages) available for download by subscribers. Summary Endogenous Cushing's syndrome is caused by chronic excessive secretion of cortisol, a glucocorticoid, which

2016 Prescrire

3. Ketoconazole HRA (ketoconazole), imidazole - Cushing?s syndrome

Ketoconazole HRA (ketoconazole), imidazole - Cushing?s syndrome KETOCONAZOLE SUMMARY CT14104

2015 Haute Autorite de sante

4. Ketoconazole HRA

Ketoconazole HRA 30 Churchill Place ? Canary Wharf ? London E14 5EU ? United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5520 Send a question via our website www.ema.europa.eu/contact 25 September 2014 EMA/CHMP/534845/2014 Committee for Medicinal Products for Human Use (CHMP) Assessment report Ketoconazole HRA International non-proprietary name: KETOCONAZOLE HRA Procedure No. EMEA/H/C/003906/0000 Note Assessment report as adopted by the CHMP (...) with all information of a commercially confidential nature deleted. Ketoconazole HRA Assessment report EMA/CHMP/534845/2014 Page 2/115 Table of contents 1. Background information on the procedure 5 1.1. Submission of the dossier 5 1.2. Manufacturers 5 1.3. Steps taken for the assessment of the product 6 2. Scientific discussion 6 2.1. Introduction 6 2.2. Quality aspects 10 2.3. Non-clinical aspects 14 2.4. Clinical aspects 22 2.5. Clinical efficacy 31 2.6. Clinical safety 61 2.7. Pharmacovigilance 79

2014 European Medicines Agency - EPARs

5. Oral ketoconazole: do not prescribe or use for fungal infections?risk of liver injury outweighs benefits

Oral ketoconazole: do not prescribe or use for fungal infections?risk of liver injury outweighs benefits Oral ketoconazole: do not prescribe or use for fungal infections—risk of liver injury outweighs benefits - GOV.UK GOV.UK uses cookies to make the site simpler. or Search Oral ketoconazole: do not prescribe or use for fungal infections—risk of liver injury outweighs benefits Published 11 December 2014 From: Therapeutic area: , Article date: August 2013 Doctors should no longer prescribe oral (...) ketoconazole for fungal infections, and should review patients’ treatment options because of a risk of liver injury. The European Medicines Agency’s Committee on Medicinal Products for Human Use (CHMP) concluded that although liver injury such as hepatitis is a known side effect of antifungal medicines, the incidence and the seriousness are higher with oral ketoconazole than with other antifungals. Reported cases of hepatotoxicity include hepatitis, cirrhosis, and liver failure with fatal outcomes

2013 MHRA Drug Safety Update

6. Xolegel (Ketoconazole) Gel

Xolegel (Ketoconazole) Gel Drug Approval Package: Xolegel (Ketoconazole) NDA #021946 Drug Approval Package U.S. Food & Drug Administration Search FDA Drug Approval Package - Xolegel (Ketoconazole) Gel Company: Barrier Therqapeutics, Inc. Application No.: 021946 Approval Date: 07/28/2006 (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) Date created: June 6, 2008 Note: Documents in PDF format require the . - - Links on this page: Note: If you need help accessing information in different file

2006 FDA - Drug Approval Package

7. Co-administration of cyclosporine and ketoconazole in idiopathic childhood nephrosis

Co-administration of cyclosporine and ketoconazole in idiopathic childhood nephrosis Co-administration of cyclosporine and ketoconazole in idiopathic childhood nephrosis Co-administration of cyclosporine and ketoconazole in idiopathic childhood nephrosis El-Husseini A, El-Basuony F, Mahmoud I, Donia A, Hassan N, Sayed-Ahmad N, Sobh M Record Status This is a critical abstract of an economic evaluation that meets the criteria for inclusion on NHS EED. Each abstract contains a brief summary (...) of the methods, the results and conclusions followed by a detailed critical assessment on the reliability of the study and the conclusions drawn. Health technology Ketoconazole (keto) was used as a co-treatment to reduce the use of cyclosporine (CsA) in children with nephrotic syndrome (NS). Keto was administered at a daily dose of 50 mg. Type of intervention Treatment. Economic study type Cost-effectiveness analysis. Study population The study population comprised children with NS who were being treated

2004 NHS Economic Evaluation Database.

8. Ketoconazole in bipolar patients with depressive symptoms: a case series and literature review

Ketoconazole in bipolar patients with depressive symptoms: a case series and literature review Ketoconazole in bipolar patients with depressive symptoms: a case series and literature review Ketoconazole in bipolar patients with depressive symptoms: a case series and literature review Brown E S, Bobadilla L, Rush A J Authors' objectives To review the literature on the use of cortisol-lowering strategies in mood disorders. Searching MEDLINE was searched from 1966 to March 2000, and PsycINFO from (...) included. Specific interventions included in the review Antiglucorticoids. Studies of antiglucorticoids were eligible for inclusion. The cortisol-lowering agents included aminoglutethimide (750 to 1,000 mg/day), metyrapone (200 to 2,000 mg/day) and ketoconazole (200 to 1,200 mg/day). Participants included in the review Depression. Studies of patients with primary or idiopathic depression were eligible for inclusion. People with major depressive disorder (MDD) included those with bipolar disorder

2001 DARE.

9. Ketoconazole Cream

Ketoconazole Cream Drug Approval Package: Ketoconazole NDA #75-581 Drug Approval Package U.S. Food & Drug Administration Search FDA Drug Approval Package - Ketoconazole Cream Company: TEVA Pharmaceuticals Application No.: 75-581 Approval Date: 4/25/2000 (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) Date created: December 06, 2001 Note: Documents in PDF format require the . - - Links on this page: Note: If you need help accessing information in different file formats, see . Language Assistance

2000 FDA - Drug Approval Package

10. Ketoconazole for early treatment of acute lung injury and acute respiratory distress syndrome: a randomized controlled trial. The ARDS Network. (PubMed)

Ketoconazole for early treatment of acute lung injury and acute respiratory distress syndrome: a randomized controlled trial. The ARDS Network. Three clinical studies have suggested that ketoconazole, a synthetic imidazole with anti-inflammatory activity, may prevent the development of acute respiratory distress syndrome (ARDS) in critically ill patients. However, the use of ketoconazole as treatment for acute lung injury (ALI) and ARDS has not been previously studied.To test the efficacy (...) of ketoconazole in reducing mortality and morbidity in patients with ALI or ARDS.Randomized, double-blind, placebo-controlled trial conducted from March 1996 to January 1997.Twenty-four hospitals associated with 10 network centers in the United States, constituting the ARDS Network.A total of 234 patients with ALI or ARDS.Patients were randomly assigned to receive ketoconazole, 400 mg/d (n = 117), or placebo (n = 117), initiated within 36 hours of fulfilling study entry criteria and given enterally for up

2000 JAMA

11. Ketoconazole Tablets

Ketoconazole Tablets Drug Approval Package: Ketoconazole NDA #74-971 FDA Application U.S. Food & Drug Administration Search FDA FDA Application - Ketoconazole Tabelts Company: Novopharm NC, Inc. Agent for: Novopharm Limited Application No.: 74-971 Approval Date: 6/15/1999 (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) Date created: November 20, 2001 Note: Documents in PDF format require the . - - Links on this page: Note: If you need help accessing information in different file formats, see . Language

1999 FDA - Drug Approval Package

12. Cost-containment strategies in transplantation: the utility of cyclosporine-ketoconazole combination therapy

Cost-containment strategies in transplantation: the utility of cyclosporine-ketoconazole combination therapy Cost-containment strategies in transplantation: the utility of cyclosporine-ketoconazole combination therapy Cost-containment strategies in transplantation: the utility of cyclosporine-ketoconazole combination therapy Odocha O, Kelly B, Trimble S, Murigande C, Toussaint R M, Callender C O Record Status This is a critical abstract of an economic evaluation that meets the criteria (...) for inclusion on NHS EED. Each abstract contains a brief summary of the methods, the results and conclusions followed by a detailed critical assessment on the reliability of the study and the conclusions drawn. Health technology Cyclosporine-ketoconazole (CyA-KCZ) combination therapy in kidney and liver transplantation. Type of intervention Secondary prevention and treatment. Economic study type Cost-effectiveness analysis. Study population Patients with kidney and liver transplants. Setting Hospital

1996 NHS Economic Evaluation Database.

13. Ketoconazole to reduce the need for cyclosporine after cardiac transplantation. (PubMed)

Ketoconazole to reduce the need for cyclosporine after cardiac transplantation. Because ketoconazole can markedly reduce the need for cyclosporine and because it also has antimicrobial properties, it may offer benefits in the treatment of patients after cardiac transplantation.We randomly assigned 43 patients at the time of cardiac transplantation to receive ketoconazole (200 mg per day) (23 patients) or no ketoconazole (20 patients). The main end points were the dose of cyclosporine required (...) and the incidence of cardiac rejection and infection.Ketoconazole reduced the dose of cyclosporine needed to maintain target levels by 62 percent at one week and by 80 percent at one year. The cost savings per patient (in U.S. dollars, inclusive of the cost of ketoconazole) was about $5,200 in the first year and about $3,920 in each subsequent year. The mean (+/- SD) rate of rejection in the first month was lower in the ketoconazole group than in the controls (4.2 +/- 0.8 vs 5.7 +/- 1.0 episodes per 100 patient

1995 NEJM

14. Increased gastric pH and the bioavailability of fluconazole and ketoconazole. (PubMed)

Increased gastric pH and the bioavailability of fluconazole and ketoconazole. 2012358 1991 05 07 2013 11 21 0003-4819 114 9 1991 May 01 Annals of internal medicine Ann. Intern. Med. Increased gastric pH and the bioavailability of fluconazole and ketoconazole. 755-7 Blum R A RA Millard Fillmore Hospital, Buffalo, New York. D'Andrea D T DT Florentino B M BM Wilton J H JH Hilligoss D M DM Gardner M J MJ Henry E B EB Goldstein H H Schentag J J JJ eng Clinical Trial Journal Article Randomized (...) Controlled Trial Research Support, Non-U.S. Gov't United States Ann Intern Med 0372351 0003-4819 80061L1WGD Cimetidine 8VZV102JFY Fluconazole R9400W927I Ketoconazole AIM IM Adult Biological Availability Cimetidine pharmacology Drug Interactions Fluconazole pharmacokinetics Gastric Acidity Determination Humans Ketoconazole pharmacokinetics Male Random Allocation Statistics as Topic 1991 5 1 1991 5 1 0 1 1991 5 1 0 0 ppublish 2012358

1991 Annals of Internal Medicine

15. Comparison of fluconazole and ketoconazole for oropharyngeal candidiasis in AIDS. (PubMed)

Comparison of fluconazole and ketoconazole for oropharyngeal candidiasis in AIDS. In a randomised, double-blind study the efficacy and toxicity of oral fluconazole 50 mg daily and ketoconazole 200 mg daily were compared for the treatment of oropharyngeal candidiasis in patients with acquired immunodeficiency syndrome (AIDS) and AIDS-related complex (ARC). 20 episodes (18 patients) were treated with fluconazole and 20 episodes (19 patients) with ketoconazole. Pretreatment clinical features (...) and laboratory test results were similar in both groups. 17 episodes (85%) in the fluconazole group and 16 (80%) in the ketoconazole group could be evaluated. There was clinical cure at the end of therapy in all fluconazole-treated and 12 of 16 (75%) ketoconazole-treated episodes. Cultures were negative at the end of therapy in 87% of the fluconazole group and 69% of the ketoconazole group. 1 patients stopped taking fluconazole because of severe nausea. 1 of 18 fluconazole-treated and 4 of 19 ketoconazole

1989 Lancet

16. Recurrent vulvovaginal candidiasis. A prospective study of the efficacy of maintenance ketoconazole therapy. (PubMed)

Recurrent vulvovaginal candidiasis. A prospective study of the efficacy of maintenance ketoconazole therapy. In a prospective, placebo-controlled study, 74 women with recurrent vulvovaginal candidiasis were treated with oral ketoconazole (400 mg daily for two weeks) and were then randomly assigned to receive placebo (Group A), prophylactic ketoconazole, 400 mg daily for five days beginning with the onset of menses for six menstrual cycles (Group B), or low-dose ketoconazole, 100 mg daily (...) of the women in Group A remained asymptomatic and attack-free, in contrast to 42.9 percent of the women in Group B (P greater than 0.05) and 52.4 percent in Group C (P less than 0.05). It appears that maintenance prophylactic therapy with oral ketoconazole is effective in preventing recurrent episodes of vulvovaginal candidiasis, but that relapse is common after withdrawal of the drug. Because of the risk of hepatotoxicity, caution is essential in selecting patients for long-term ketoconazole therapy

1986 NEJM

17. Response of scalp psoriasis to oral ketoconazole. (PubMed)

Response of scalp psoriasis to oral ketoconazole. A randomised double-blind placebo-controlled study showed improvement of scalp psoriasis with oral ketoconazole, although the study had to be stopped before completion because of the possibility of drug toxicity. The common appearance of psoriasis in the scalp and certain other sites may be due to pityrosporal colonisation that also causes seborrhoeic dermatitis and dandruff.

1985 Lancet

18. Ketoconazole versus nystatin plus amphotericin B for fungal prophylaxis in severely immunocompromised patients. (PubMed)

Ketoconazole versus nystatin plus amphotericin B for fungal prophylaxis in severely immunocompromised patients. 72 patients severely immunocompromised by their underlying disease (marrow aplasia, acute leukaemia, or solid tumour) or by the treatment they were receiving, or both, were randomised to receive antifungal prophylaxis with either oral ketoconazole or conventional doses of oral amphotericin B and nystatin. All patients also had gut decontamination with non-absorbable antibiotics, skin (...) antisepsis, sterile food, and oral cotrimoxazole. Protection against fungal infection was significantly superior with ketaconazole. When patients who had received allogeneic bone-marrow transplant were studied separately, there was no significant difference between the two treatments, probably because there was a fall-off in ketoconazole absorption from the end of the third week after the transplant. However, ketoconazole greatly reduced the likelihood of fungal infection in non-transplant patients.

1982 Lancet