Fulcover Special Precautions

There is no information regarding cross hypersensitivity between Itraconazole and other azole antifungal agents. Caution should be used in prescribing Itraconazole to patients with hypersensitivity to other azoles.
In a healthy volunteer study with intravenous Itraconazole, a transient asymptomatic decrease of the left ventricular ejection fraction was observed.
Itraconazole has been shown to have a negative inotropic effect and has been associated with reports of congestive heart failure. Itraconazole should not be used in patients with congestive heart failure or with a history of congestive heart failure unless the benefit clearly outweighs the risk.
Caution should be exercised when co-administering Itraconazole and calcium channel blockers.
Itraconazole has a potential for clinically important drug interactions. (See Interactions.)
Decreased gastric acidity: Absorption of Itraconazole is impaired when gastric acidity is decreased. In patients also receiving acid neutralising medicines (e.g. aluminium hydroxide) these should be administered at least 2 hours after the intake of Itraconazole Capsules. In patients with achlorhydria such as certain AIDS patients and patients on acid secretion suppressors (e.g. H₂-antagonists proton-pump inhibitors) it is advisable to administer Itraconazole Capsules with a cola beverage.
Hepatic impairment: Itraconazole is predominantly metabolised in the liver. A slight decrease in oral bioavailability in cirrhotic patients has been observed, although this was not of statistical significance. The terminal half-life was however significantly increased. The dose should be adapted if necessary.
Renal Impairment: The oral bioavailability of Itraconazole may be lower in patients with renal insufficiency. Dose adaptation may be considered.