Itraconazole GPO

Itraconazole GPO Special Precautions

itraconazole

Manufacturer:

GPO

Distributor:

GPO
Full Prescribing Info
Special Precautions
Concerns related to adverse effects: Hearing loss: Transient or permanent hearing loss has been reported. Quinidine (a contraindicated drug) was used concurrently in several of these cases. Hearing loss usually resolves after discontinuation, but may persist in some patients.
Heart failure: Negative inotropic effects have been observed following intravenous administration. Discontinue or reassess use if signs or symptoms of heart failure (HF) occur during treatment. HF has been reported, particularly in patients receiving a total daily oral dose of 400 mg. Use with caution in patients with risk factors for HF (COPD, renal failure, edematous disorders, ischemic or valvular disease).
Hepatotoxicity: Rare cases of serious hepatotoxicity (including liver failure and death) have been reported (including some cases occurring within the first week of therapy); hepatotoxicity was reported in some patients without pre-existing liver disease or risk factors. Use with caution in patients with pre-existing hepatic impairment; monitor liver function closely and dosage adjustment may be warranted. Not recommended for use in patients with active liver disease, elevated liver enzymes, or prior hepatotoxic reactions to other drugs unless the expected benefit exceeds the risk of hepatotoxicity.
Neuropathy: Discontinue if signs or symptoms of neuropathy occurs during treatment.
Disease-related concerns: Cystic fibrosis: Large differences in itraconazole pharmacokinetic parameters have been observed in cystic fibrosis patients receiving the solution; if a patient with cystic fibrosis does not respond to therapy, alternate therapies should be considered.
Onychomycosis: Not recommended for treatment of onychomycosis in patients with ventricular dysfunction or a history of HF.
Renal impairment: Use with caution in patients with renal impairment.
Concurrent drug therapy issues: Calcium channel blockers (CCBs): May cause additive negative inotropic effects when used concurrently with itraconazole. Itraconazole may also inhibit the metabolism of CCBs. Therefore, use caution with concurrent use of itraconazole and CCBs due to an increased risk of heart failure. Concurrent use of itraconazole and nisoldipine is contraindicated.
High potential for interactions: Serious cardiovascular (CV) adverse events including, QT prolongation, ventricular tachycardia, torsade de pointes, cardiac arrest and/or sudden death have been observed due to increased cisapride, pimozide, quinidine, dofetilide or levomethadyl concentrations induced by itraconazole; concurrent use contraindicated. Additionally, the following drugs metabolized by the CYP 3A4 isoenzyme system are also contraindicated: Ergot derivatives, lovastatin, midazolam (oral), simvastatin, and triazolam.
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