KETOCONAZOLE SUMMARY
KETOCONAZOLE CREAM
Ketoconazole Cream 2%, for topical administration only, contains the broad-spectrum synthetic antifungal agent, ketoconazole 2%, formulated in an aqueous cream vehicle consisting of propylene glycol, stearyl and cetyl alcohols, sorbitan monostearate, polysorbate 60, isopropyl myristate, sodium sulfite anhydrous, polysorbate 80 and purified water.
Ketoconazole Cream 2% is indicated for the topical treatment of tinea corporis, tinea cruris and tinea pedis caused by Trichophyton rubrum, T. mentagrophytes and Epidermophyton floccosum; in the treatment of tinea (pityriasis) versicolor caused by Malassezia furfur (Pityrosporum orbiculare); in the treatment of cutaneous candidiasis caused by Candida spp. and in the treatment of seborrheic dermatitis.
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NEWS HIGHLIGHTS
Published Studies Related to Ketoconazole (Ketoconazole Topical)
Effects of ketoconazole and carbamazepine on lapatinib pharmacokinetics in healthy subjects. [2009.04]
AIMS: To characterize the impact of potent CYP3A4 inhibition and induction on lapatinib pharmacokinetics... CONCLUSIONS: Systemic exposure to lapatinib was significantly altered by potent inhibition and induction of CYP3A4. Dose adjustments may be required when lapatinib is administered with orally administered drugs that potently alter the activity of this enzyme.
Effect of different durations of ketoconazole dosing on the single-dose pharmacokinetics of midazolam: shortening the paradigm. [2009.04]
Given the prominent role of cytochrome P450 3A (CYP3A) in the metabolism of drugs, it is critical to determine whether new chemical entities will be affected by the inhibition of this enzyme system and result in clinically relevant drug interactions...
An open, randomized, prospective, comparative study of topical pimecrolimus 1% cream and topical ketoconazole 2% cream in the treatment of seborrheic dermatitis. [2009]
BACKGROUND: Seborrheic dermatitis (SD) is a chronic inflammatory disorder that mainly affects the seborrheic region. While ketoconazole is often used, pimecrolimus has been used successfully in SD. OBJECTIVE: To compare the efficacy and tolerability of pimecrolimus in comparison with ketoconazole in the treatment of SD... CONCLUSION: Our study showed that pimecrolimus had a comparable efficacy profile with that of ketoconazole, but side effects appeared more frequently in the pimecrolimus group than in the ketoconazole group.
Presystemic elimination of budesonide in man when administered locally at different levels in the gut, with and without local inhibition by ketoconazole. [2008.11.15]
The CYP3A4 substrate budesonide was used to investigate gut wall first-pass metabolism in jejunum, ileum and colon of eight healthy men. Three milligram budesonide in solution was installed at each location by intubation, with or without immediate prior local administration of 16mg ketoconazole...
Comparative efficacy and tolerability of Ketomousse (ketoconazole foam 1%) and ketoconazole cream 2% in the treatment of pityriasis versicolor: results of a prospective, multicentre, randomised study. [2008.11]
Ketomousse (K), a new thermophobic formulation (ketoconazole 1%), has proven its efficacy in the treatment of dandruff, caused by the same agent as pityriasis versicolor (PV). The objective of this study was to compare the efficacy and tolerability of K thermophobic foam vs...
Clinical Trials Related to Ketoconazole (Ketoconazole Topical)
A Study to Assess the Safety and Interaction Between Casopitant and Ketoconazole When Taken By Healthy Adults [Completed]
Ixabepilone and Ketoconazole in Treating Patients With Advanced Solid Tumors [Active, not recruiting]
RATIONALE: Drugs used in chemotherapy, such as ixabepilone and ketoconazole, work in
different ways to stop tumor cells from dividing so they stop growing or die. Giving
ixabepilone with ketoconazole may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of giving
ixabepilone together with ketoconazole and to see how well they work in treating patients
with advanced solid tumors.
Study Of Healthy Subjects To Assess The Effect Of Ketoconazole And The Way The Body Will React To Casopitant [GW679769] [Completed]
This is a two period study of healthy adult subjects to characterize the effect of the dosing
of ketoconazole on the the way the body reacts to a dose of GW679769, and to assess the
safety profile of oral casopitant with and without ketoconazole. This study will consist of a
screening period, two treatment periods and a post-treatment follow-up visit.
Study to Determine the Impact of Multiple Doses of Ketoconazole on Single-Dose Pharmacokinetics of HCV-796 [Active, not recruiting]
Calcitriol, Ketoconazole, and Dexamethasone in Treating Patients With Metastatic or Unresectable Solid Tumors [Completed]
RATIONALE: Calcitriol may cause solid tumor cells to look more like normal cells, and to grow
and spread more slowly. Ketoconazole and dexamethasone may help calcitriol work better by
making tumor cells more sensitive to the drug. Giving calcitriol together with ketoconazole
and dexamethasone may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of calcitriol when
given together with ketoconazole and dexamethasone in treating patients with metastatic or
unresectable solid tumors.
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