Canditral Special Precautions

Hepatic Effects: ITRACONAZOLE 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 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 ITRACONAZOLE use or reinstitution of treatment with ITRACONAZOLE is strongly discouraged unless there is a serious or life-threatening situation where the expected benefit exceeds the risk. (See Information for Patients under Patient Counselling Information and Adverse Reactions.)
Cardiac Dysrhythmias: Life-threatening cardiac dysrhythmias and/or sudden death have occurred in patients using drugs such as cisapride, pimozide, methadone, or quinidine concomitantly with ITRACONAZOLE and/or other CYP3A4 inhibitors. Concomitant administration of these drugs with ITRACONAZOLE is contraindicated. (See Warnings, and Contraindications.)
Cardiac Disease: ITRACONAZOLE Capsules should not be administered for the treatment of onychomycosis in patients with evidence of ventricular dysfunction such as congestive heart failure (CHF) or a history of CHF. ITRACONAZOLE Capsules should not be used for other indications 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 ITRACONAZOLE 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 ITRACONAZOLE Capsules, discontinue administration.
Itraconazole has been shown to have a negative inotropic effect. When itraconazole was administered intravenously to anesthetized dogs, a dose-related negative inotropic effect was documented. In a healthy volunteer study of itraconazole 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.
ITRACONAZOLE has been associated with reports of congestive heart failure. In postmarketing experience, heart failure was more frequently reported in patients receiving a total daily dose of 400 mg although there were also cases reported among those receiving lower total daily doses.
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 ITRACONAZOLE and felodipine or nisoldipine is contraindicated.
Cases of CHF, peripheral edema, and pulmonary edema have been reported in the postmarketing period among patients being treated for onychomycosis and/or systemic fungal infections. (See Pharmacology: Pharmacokinetics: Special Populations under Actions, and Contraindications.)
Interaction potential: ITRACONAZOLE has a potential for clinically important drug interactions. Co-administration of specific drugs with itraconazole may result in changes in efficacy of itraconazole and/or the co-administered drug, life-threatening effects and/or sudden death.
Interchangeability: ITRACONAZOLE Capsules and ITRACONAZOLE Oral Solution should not be used interchangeably. This is because drug exposure is greater with the Oral Solution than with the Capsules when the same dose of drug is given. In addition, the topical effects of mucosal exposure may be different between the two formulations. Only the Oral Solution has been demonstrated effective for oral and/or esophageal candidiasis.
General: ITRACONAZOLE Capsules should be administered after a full meal. (See Pharmacology: Pharmacokinetics under Actions.)
Under fasted conditions, itraconazole absorption was decreased in the presence of decreased gastric acidity. The absorption of itraconazole may be decreased with the concomitant administration of antacids or gastric acid secretion suppressors. Studies conducted under fasted conditions demonstrated that administration with 8 ounces of a non-diet cola beverage resulted in increased absorption of itraconazole in AIDS patients with relative or absolute achlorhydria.
This increase relative to the effects of a full meal is unknown. (See Pharmacology: Pharmacokinetics under Actions.)
Hepatotoxicity: Rare cases of serious hepatotoxicity have been observed with ITRACONAZOLE treatment, including some cases within the first week. It is recommended that liver function monitoring be considered in all patients receiving ITRACONAZOLE. Treatment should be stopped immediately and liver function testing should be conducted in patients who develop signs and symptoms suggestive of liver dysfunction.
Neuropathy: If neuropathy occurs that may be attributable to ITRACONAZOLE Capsules, the treatment should be discontinued.
Hearing Loss: Transient or permanent hearing loss has been reported in patients receiving treatment with itraconazole. Several of these reports included concurrent administration of quinidine which is contraindicated (see Drug Interactions under Warnings and Contraindications). The hearing loss usually resolves when treatment is stopped, but can persist in some patients.