Fluconazole Stella Special Precautions

Deep endemic mycoses: The evidence for efficacy of fluconazole in the treatment of other forms of endemic mycoses such as paracoccidioidomycosis, lymphocutaneous sporotrichosis and histoplasmosis is limited, which prevents specific dosing recommendations.
Renal system: Fluconazole should be administered with caution to patients with renal dysfunction.
Adrenal insufficiency: Ketoconazole is known to cause adrenal insufficiency, and this could also, although rarely seen, be applicable to fluconazole.
Hepatobiliary system: Fluconazole should be administered with caution to patients with liver dysfunction.
Cardiovascular system: Some azoles, including fluconazole, have been associated with prolongation of the QT interval on the electrocardiogram. Fluconazole causes QT prolongation via the inhibition of Rectifier Potassium Channel current (I_kr).
Fluconazole should be administered with caution to patients with potentially proarrhythmic conditions.
Co-administration of other medicinal products known to prolong the QT interval and which are metabolised via the cytochrome P450 (CYP) 3A4 are contraindicated.
Halofantrine: Halofantrine has been shown to prolong QTc interval at the recommended therapeutic dose and is a substrate of CYP3A4. The concomitant use of fluconazole and halofantrine is therefore not recommended.
Dermatological reactions: 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 medicinal products. If a rash, which is considered attributable to fluconazole, develops in a patient treated for a superficial fungal infection, further therapy with this medicinal product should be discontinued.
Hypersensitivity: In rare cases, anaphylaxis has been reported.
Cytochrome P450: Fluconazole is a moderate CYP2C9 and CYP3A4 inhibitor. Fluconazole is also a strong inhibitor of CYP2C19. Fluconazole-treated patients, who are concomitantly treated with medicinal products with a narrow therapeutic window metabolised through CYP2C9, CYP2C19 and CYP3A4, should be monitored.
Terfenadine: The co-administration of fluconazole at doses lower than 400 mg per day with terfenadine should be carefully monitored.
Excipient: The product contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Effects on ability to drive and use machines: No studies have been performed on the effects of fluconazole on the ability to drive or use machines.
Patients should be warned about the potential for dizziness or seizures while taking fluconazole and should be advised not to drive or operate machines if any of these symptoms occur.