Fodisis Special Precautions

Fluconazole should be administered with caution to patients with liver dysfunction.
Fluconazole has been associated with rare cases of serious hepatic toxicity including fatalities, primarily in patients with serious underlying medical condition. In cases of Fluconazole associated hepatotoxicity, no obvious relationship to total daily dose, duration of therapy, sex or age of patient has been observed. Fluconazole hepatotoxicity has usually been reversible on discontinuation of therapy.
Patients who develop abnormal liver function tests during Fluconazole therapy should be monitored for the development of more serious hepatic injury. Fluconazole should be discontinued if clinical signs or symptoms consistent with liver disease develop that may be attributable to Fluconazole.
Patients have rarely developed exfoliative cutaneous reactions, such as Stevens-Johnson Syndrome and toxic epidermal necrolysis, during treatment with Fluconazole. AIDS patients are more prone to the development of severe cutaneous reactions to many drugs. If a rash, which is considered attributable to Fluconazole, develops in a patient treated for for a superficial fungal infection, further therapy with this agent should be discontinued.
If patients with invasive/systemic fungal infections develop rashes, they should be monitored closely and Fluconazole discontinued if bullous lesions or erythema multiforme develop.
The co-administration of Fluconazole at doses lower than 400 mg per day with Terfenadine should be carefully monitored (see Interactions).
In rare cases, as with other azoles, anaphylaxis has been reported.
Some azoles, including Fluconazole, have been associated with prolongation of the QT interval on the electrocardiogram. QT prolongation and torsade de pointes can occur in patients taking Fluconazole, these reports included seriously ill patients with multiple confounding risk factors, such as structural heart disease, electrolyte abnormalities and concomitant medications that may have been contributory.
Fluconazole should be administered with caution to patients with these potentially proarrhythmic conditions.
Fluconazole should be administered with caution to patients with renal dysfunction (see also Dosage & Administration).
Fluconazole is a potent CYP2C9 and CYP2C19 inhibitor and a moderate CYP3A4 inhibitor. Fluconazole treated patients who are concomitantly treated with drugs with a narrow therapeutic window metabolised through CYP2C9, CYP2C19 and CYP3A4 should be monitored (see Interactions).
Effects on Ability to Drive and Use Machines: The therapy is unlikely to impair a patient ability to drive or use machinery.
When driving vehicles or operating machines it should be taken into account that occasionally dizziness or seizures may occur.