WARNING
When used orally, ketoconazole has been associated with hepatic toxicity, including some fatalities. Patients receiving this drug should be informed by the physician of the risk and should be closely monitored. See WARNINGS and PRECAUTIONS sections.
Coadministration of terfenadine with ketoconazole tablets is contraindicated. Rare cases of serious cardiovascular adverse events, including death, ventricular tachycardia and tordades de pointes have been observed in patients taking ketoconazole tablets concomitantly with terfenadine, due to increased terfenadine concentrations induced by ketoconazole tablets. See CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS sections.
Pharmacokinetic data indicate that oral ketoconazole inhibits the metabolism of astemizole, resulting in elevated plasma levels of astemizole and its active metabolite desmethylastemizole which may prolong QT intervals. Coadministration of astemizole with ketoconazole tablets is therefore contraindicated. See CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS sections.
Coadministration of cisapride with ketoconazole is contraindicated. Serious cardiovascular adverse events including ventricular tachycardia, ventricular fibrillation and torsades de pointes have occurred in patients taking ketoconazole concomitantly with cisapride. See CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS sections.
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NIZORAL SUMMARY
NIZORAL® (KETOCONAZOLE) TABLETS
NIZORAL® (ketoconazole) is a synthetic broad-spectrum antifungal agent available in scored white tablets, each containing 200 mg ketoconazole base for oral administration.
NIZORAL® (ketoconazole) Tablets are indicated for the treatment of the following systemic fungal infections: candidiasis, chronic mucocutaneous candidiasis, oral thrush, candiduria, blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis. NIZORAL® Tablets should not be used for fungal meningitis because it penetrates poorly into the cerebral-spinal fluid.
NIZORAL® Tablets are also indicated for the treatment of patients with severe recalcitrant cutaneous dermatophyte infections who have not responded to topical therapy or oral griseofulvin, or who are unable to take griseofulvin.
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NEWS HIGHLIGHTS
Published Studies Related to Nizoral (Ketoconazole)
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 Nizoral (Ketoconazole)
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.
Long Term Study of Extina in Patients With Seborrheic Dermatitis [Recruiting]
Open-label, multicenter, single-group study to assess the long-term safety of twice daily
treatment with Extina (ketoconazole) Foam, 2% in subjects with seborrheic dermatitis.
Ketoconazole Foam 2% for the Treatment of Versicolor [Recruiting]
Objectives
1. To assess the efficacy of ketoconazole 2% foam for the treatment of tinea versicolor
2. To assess the safety of ketoconazole 2% foam for the treatment of tinea versicolor
based on the occurrence of adverse events.
3. To assess treatment satisfaction as rated by patients
Study Design:
This will be a mono-centered, single arm, open-label pilot study. Ten adult patients age 19
and older with a clinical diagnosis of tinea versicolor, as well as a positive KOH using
calcofluor, will be enrolled at the University of Alabama at Birmingham. There will be 4
scheduled visits (baseline, week 1, week 2, and week 4). A target area will be identified
and mycological and clinical assessments will be performed at this site as well as a global
assessment of each subject. Ketoconazole 2% foam will be applied to all affected areas for 2
weeks with a follow-up visit at week 4. Skin scraping using a disposable #15 blade for
calcofluor/KOH assessment and photographs of target lesions will be performed at baseline,
week 1, week 2, and week 4. Photographs will be taken at baseline and at week 4 (only if KOH
is positive). Body surface area estimation of disease will also be performed at each visit.
Evaluation of scale, hyperpigmentation/erythema, and hypopigmentation using a 4 point scale
(0 = none, 1 = mild, 2 = moderate, 3 = severe) of the target area will be performed at
baseline, week 1, week 2, and week 4. A global assessment will be conducted at each visit
using the same 4 point scale. Patient questionnaires will be administered at baseline and
week 2 to assess symptoms and satisfaction with study medication.
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Page last updated: 2009-10-20
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