Drug Information for SPORANOX (ITRACONAZOLE) ORAL SOLUTION (Ortho Biotech Products, L.P.): WARNINGS

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  • SPORANOX® (itraconazole) Oral Solution and SPORANOX® Capsules should not be used interchangeably. Only SPORANOX® Oral Solution has been demonstrated effective for oral and/or esophageal candidiasis. SPORANOX® Oral Solution contains the excipient hydroxypropyl-β-cyclodextrin which produced pancreatic adenocarcinomas in a rat carcinogenicity study. These findings were not observed in a similar mouse carcinogenicity study. The clinical relevance of these findings is unknown. (See Carcinogenesis, Mutagenesis, and Impairment of Fertility.)

  • Hepatic Effects:

  • SPORANOX®has been associated with rare cases of serious hepatotoxicity, including liver failure and death. Some of these cases had neither pre-existing liver disease nor a serious underlying medical condition and some of these cases developed within the first week of treatment. If clinical signs or symptoms develop that are consistent with liver disease, treatment should be discontinued and liver function testing performed. Continued SPORANOX®use or reinstitution of treatment with SPORANOX®is strongly discouraged unless there is a serious or life-threatening situation where the expected benefit exceeds the risk. (See PRECAUTIONS: Information for Patients and ADVERSE REACTIONS.)

  • Cardiac Dysrhythmias:

  • Life-threatening cardiac dysrhythmias and/or sudden death have occurred in patients using cisapride, pimozide, levacetylmethadol (levomethadyl), or quinidine concomitantly with SPORANOX® and/or other CYP3A4 inhibitors. Concomitant administration of these drugs with SPORANOX® is contraindicated. (See BOX WARNING, CONTRAINDICATIONS, and PRECAUTIONS: Drug Interactions.)

  • Cardiac Disease:

  • SPORANOX® Oral Solution should not be used in patients with evidence of ventricular dysfunction unless the benefit clearly outweighs the risk. For patients with risk factors for congestive heart failure, physicians should carefully review the risks and benefits of SPORANOX® therapy. These risk factors include cardiac disease such as ischemic and valvular disease; significant pulmonary disease such as chronic obstructive pulmonary disease; and renal failure and other edematous disorders. Such patients should be informed of the signs and symptoms of CHF, should be treated with caution, and should be monitored for signs and symptoms of CHF during treatment. If signs or symptoms of CHF appear during administration of SPORANOX® Oral Solution, monitor carefully and consider other treatment alternatives which may include discontinuation of SPORANOX® Oral Solution administration.

    When itraconazole was administered intravenously to anesthetized dogs, a dose-related negative inotropic effect was documented. In a healthy volunteer study of SPORANOX® Injection (intravenous infusion), transient, asymptomatic decreases in left ventricular ejection fraction were observed using gated SPECT imaging; these resolved before the next infusion, 12 hours later.

    SPORANOX® has been associated with reports of congestive heart failure. In post-marketing experience, heart failure was more frequently reported in patients receiving a total daily dose of 400 mg than among those receiving lower total daily doses. This suggests that the risk of heart failure might increase with the total daily dose of itraconazole.

    Calcium channel blockers can have negative inotropic effects which may be additive to those of itraconazole. In addition, itraconazole can inhibit the metabolism of calcium channel blockers. Therefore, caution should be used when co-administering itraconazole and calcium channel blockers due to an increased risk of CHF. Concomitant administration of SPORANOX® and nisoldipine is contraindicated.

    Cases of CHF, peripheral edema, and pulmonary edema have been reported in the post-marketing period among patients being treated for onychomycosis and/or systemic fungal infections. (See CLINICAL PHARMACOLOGY: Special Populations, PRECAUTIONS: Drug Interactions, and ADVERSE REACTIONS: Post-marketing Experience for more information.)

  • Cystic Fibrosis:

  • If a patient with cystic fibrosis does not respond to SPORANOX® Oral Solution, consideration should be given to switching to alternative therapy (see CLINICAL PHARMACOLOGY/Special Populations).

  • Treatment of Severely Neutropenic Patients:

  • SPORANOX® Oral Solution as treatment for oropharyngeal and/or esophageal candidiasis was not investigated in severely neutropenic patients. Due to its pharmacokinetic properties, SPORANOX® Oral Solution is not recommended for initiation of treatment in patients at immediate risk of systemic candidiasis.

    In febrile neutropenic subjects in whom the likelihood of systemic candidiasis is considered high, therapy should be initiated with Sporanox Intravenous formulation.

  • Drug Information Provided by National Library of Medicine (NLM).
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