How We Recognize and Treat Them
Indications and Usage
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.
Important Safety Information for ONMEL
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.
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.
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.
Anaphylaxis and hypersensitivity have been reported with use of itraconazole. ONMEL is contraindicated for patients who have shown hypersensitivity to itraconazole products.
Warnings and Precautions
Cases of CHF, peripheral edema, and pulmonary edema have been reported with itraconazole administration among patients being treated for onychomycosis and/or systemic fungal infections.
Itraconazole has been associated with rare cases of serious hepatotoxicity, including liver failure and death. If clinical signs or symptoms develop that are consistent with hepatotoxicity, treatment should be discontinued immediately and liver function testing performed. Other warnings and precautions include cardiac dysrhythmias, cardiac disease, hepatic effects, calcium channel blockers, neuropathy, and hearing loss.
The most common adverse reactions observed in the treatment phase of the onychomycosis clinical trial (>1%) were upper respiratory tract infections, increased hepatic enzymes, hypoacusis, headache, abdominal pain, diarrhea, nausea, fatigue, arrhythmia, cough, sore throat, and back pain.
In the ONMEL group, the most commonly reported adverse events that lead to discontinuation were increased hepatic enzyme (6 subjects, 1.0%) and dizziness (3 subjects, 0.5%). No other adverse reaction leading to discontinuation occurred in more than one subject.
The following adverse reactions have been identified during post-approval use of itraconazole (all formulations). Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Adverse reactions reported post-approval that appear in other sections of the prescribing information (eg, warnings and precautions) are not listed here: leukopenia, neutropenia, thrombocytopenia, serum sickness, angioneurotic edema, hypertriglyceridemia, hypokalemia, paresthesia, hypoesthesia, visual disturbances, including vision blurred and diplopia, tinnitus, vomiting, dyspepsia, constipation, dysgeusia, toxic epidermal necrolysis, Stevens-Johnson syndrome, exfoliative dermatitis, leukocytoclastic vasculitis, erythema multiforme, alopecia, photosensitivity, rash, urticaria, pruritus, myalgia, arthralgia, urinary incontinence, pollakiuria, menstrual disorders, and erectile dysfunction.
Concomitant administration of ONMEL Tablets with certain drugs metabolized by cytochrome P450 3A4 isoenzyme system (CYP3A4) or transported by
P-glycoprotein may result in increased plasma concentrations of those drugs, leading to potentially serious and/or life-threatening adverse events.
Drug Interactions with the following drugs or classes of drugs may occur: Antiarrhythmics, Anticonvulsants, Anti-HIV Agents, Antimycobacterials, Antineoplastics, Antipsychotics, Benzodiazepines, Calcium Channel Blockers, Gastric Acid Suppressors/Neutralizers, Gastrointestinal Motility Agents, HMG CoA-Reductase, Macrolide Antibiotics, Oral Hypoglycemic Agents, Polyenes, Opiate Analgesics. Not all drug interactions are included here. See Full Prescribing Information for complete listing.
Use in Specific Populations
Itraconazole is excreted in human milk; the expected benefits of ONMEL therapy for the mother should be weighed against the potential risk from exposure of itraconazole to the infant.
The safety and effectiveness of ONMEL in pediatric patients have not been established. No pharmacokinetic data on ONMEL are available in children.
In clinical trials with NAFTIN® Cream 2%, the most common adverse
reaction (?1%) was pruritus.
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