WARNING: CONGESTIVE HEART FAILURE, CARDIAC EFFECTS, AND DRUG INTERACTIONS
Do not administer ONMEL for the treatment of onychomycosis in patients with evidence of ventricular dysfunction such as congestive heart failure (CHF) or a history of CHF. When itraconazole was administered intravenously to dogs and healthy human volunteers, negative inotropic effects were seen. If signs or symptoms of congestive heart failure occur during administration of ONMEL, discontinue administration. [See Contraindications (4), Warnings and Precautions (5), Drug Interactions (7), and Clinical Pharmacology]
Drug Interactions: Co-administration of cisapride, pimozide, quinidine, dofetilide, levacetylmethadol (levomethadyl), felodipine, oral midazolam, nisoldipine, triazolam, lovastatin, simvastatin, ergot alkaloids such as dihydroergotamine, ergometrine (ergonovine), ergotamine and methylergometrine (methylergonovine) or methadone with ONMEL is contraindicated. ONMEL, a potent cytochrome P450 3A4 isoenzyme system (CYP3A4) inhibitor, may increase plasma concentrations of drugs metabolized by this pathway. Serious cardiovascular events, including QT prolongation, torsades de pointes, ventricular tachycardia, cardiac arrest, and/or sudden death have occurred in patients using cisapride, pimozide, levacetylmethadol (levomethadyl), methadone or quinidine concomitantly with itraconazole and/or other CYP3A4 inhibitors. [See Contraindications (4), Warnings and Precautions (5), and Drug Interactions (7) ]
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ONMEL SUMMARY
ONMEL (itraconazole) is a synthetic triazole antifungal agent for oral use. Itraconazole is a 1:1:1:1 racemic mixture of four diastereomers (two enantiomeric pairs), each possessing three chiral centers.
ONMEL is indicated for the treatment of onychomycosis of the toenail due to Trichophyton rubrum or T. mentagrophytes in non-immunocompromised patients. Prior to initiating treatment, appropriate nail specimens for laboratory testing (KOH preparation, fungal culture, or nail biopsy) should be obtained to confirm the diagnosis of onychomycosis. [ See Contraindications (4), Warnings and Precautions (5), Drug Interactions (7), and Clinical Pharmacology
.]
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NEWS HIGHLIGHTS
Published Studies Related to Onmel (Itraconazole)
Itraconazole vs. trimethoprim-sulfamethoxazole: A comparative cohort study of 200
patients with paracoccidioidomycosis. [2014] Paracoccidioidomycosis (PCM) is a systemic mycosis endemic to Latin America. Brazil accounts for approximately 80% of cases, where it represents a major
public health issue due to its disabling impact and the number of premature
deaths it causes... Although the results of this study show that
itraconazole was the best treatment option for PCM patients, a double-blind,
randomized, controlled trial is necessary to confirm this conclusion.
Efficacy of itraconazole in the treatment of patients with chronic cough whose
sputa yield basidiomycetous fungi-fungus-associated chronic cough (FACC). [2009] a sputum culture yielded basidiomycetous (BM) fungi... CONCLUSIONS: Low-dose itraconazole was shown to be an effective antitussive in
A comparison of the efficacy between two itraconazole generic products and the
innovative itraconazole in the treatment of tinea pedis. [2005] CONCLUSION: The present study demonstrated that the efficacy of the original and
Effects of gemfibrozil, itraconazole, and their combination on the
pharmacokinetics of pioglitazone. [2005] these enzymes in the fate of pioglitazone in humans... CONCLUSIONS: Gemfibrozil elevates the plasma concentrations of pioglitazone,
A randomized, double-blind, placebo-controlled clinical trial of itraconazole in
the treatment of cutaneous leishmaniasis. [2005] treatment of CL caused by L. major... CONCLUSIONS: An 8-week course of oral itraconazole was not more effective than
Clinical Trials Related to Onmel (Itraconazole)
Itraconazole Tablets Vs. Itraconazole Capsules vs. Placebo in Onychomycosis of the Toenail. [Completed]
Onychomycosis is a common condition accounting for approximately half of all nail disorders.
It is most commonly caused by dermatophytes. Itraconazole has been approved for the
treatment of onychomycosis in the United States with an approved dosage regimen for the
treatment of onychomycosis of the toenail of once daily (QD) treatment with 200mg of
itraconazole (two 100 mg capsules) for 12 weeks. Barrier Therapeutics has developed a 200
mg tablet which could be used in a more convenient one-tablet-per-day dosing regimen. This
clinical trial will compare the efficacy and safety of this new tablet formulation with
itraconazole capsules and placebo.
A Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of Alisertib in Patients With Advanced Solid Tumors or Relapsed/Refractory Lymphoma [Recruiting]
This study will assess the effect of multi-dose administration of itraconazole on the
single-dose pharmacokinetics (PK) of alisertib.
Concentration of Itraconazole Solution in Nasal Secretions [Completed]
The primary objective of this study is to determine the concentration of itraconazole
irrigation in nasal mucous specimens via collection and High-performance liquid
chromatography (HPLC) assay.
Eight (8) patients with chronic rhinosinusitis (CRS) and two (2) healthy controls will be
enrolled in the initial evaluation. After an initial control nasal specimen, followed by
seven days of twice daily topical itraconazole irrigation, nasal specimens will be collected
at varying time intervals and the concentrations measured.
The primary endpoint is development of a reliable collection and assay technique with
concentration curves over time of topically administered itraconazole. A secondary endpoint
is to determine if the concentrations measured achieve a mean inhibitory concentration
(MIC90) to commonly cultured fungal species in the nose.
The Relationship of Defeverscence and Itraconazole Plasma Level Study in Immunocompromised Participants [Completed]
The purpose of this observational study is to investigate whether a sufficient concentration
of itraconazole can influence disappearance of a fever (defeverscence) when intravenous
(into the vein) itraconazole is administered for resolving unknown neutropenic fever of
participants who are given itraconazole oral solution as a prophylaxis under general
treatment conditions.
A Study of Empirical Antifungal Therapy With Itraconazole [Completed]
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Page last updated: 2014-11-30
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