Diflucan

Tinea capitis Fluconazole has been studied for the treatment of tinea capitis in children. It was shown to be no more effective than griseofulvin, and the overall clinical success rate was less than 20%. Therefore, Diflucan should not be used for the treatment of tinea capitis. Cryptococcosis Evidence for the efficacy of fluconazole in the treatment of other forms of cryptococcosis (e.g. pulmonary, cutaneous) is limited, precluding any dosing recommendation. Deep endemic mycoses Evidence for the efficacy of fluconazole in the treatment of other forms of endemic mycoses such as paracoccidioidomycosis, lymphocutaneous sporotrichosis, and histoplasmosis is limited, precluding any dosing recommendation. Renal system Diflucan should be administered with caution in patients with renal impairment (see also section 4.2). Adrenal insufficiency Ketoconazole is known to cause adrenal insufficiency, and this may also, although rarely observed, apply to fluconazole. Adrenal insufficiency related to concomitant therapy with prednisone is discussed in section 4.5 – Effects of fluconazole on other medicinal products. Hepatobiliary system Diflucan should be administered with caution in patients with hepatic dysfunction. Diflucan has been associated with rare cases of serious hepatic toxicity, including fatalities, primarily in patients with serious underlying medical conditions. No obvious relationship between fluconazole-associated hepatotoxicity and the total daily dose, duration of therapy, sex, or age of the patient has been observed. Fluconazole-associated hepatotoxicity has usually been reversible on discontinuation of therapy. Patients who develop abnormal liver function tests during Diflucan therapy should be carefully monitored for the development of more serious hepatic injury. The patient should be informed about the signs suggestive of serious hepatic effects (marked asthenia, anorexia, persistent nausea, vomiting, and jaundice). Fluconazole therapy should be discontinued immediately, and the patient should contact a physician. Cardiovascular system Some azoles, including fluconazole, have been associated with prolongation of the QT interval on the electrocardiogram. Fluconazole causes QT prolongation by inhibition of the rapid component of the potassium channel (Ikr). QT prolongation caused by other medicinal products (such as amiodarone) may be amplified through inhibition of cytochrome P450 (CYP) 3A4. During post-marketing surveillance, very rare cases of QT prolongation and torsades de pointes have occurred in patients taking fluconazole. These reports involved patients with multiple confounding risk factors, such as structural heart disease, electrolyte abnormalities, and concomitant medications that may have contributed. Patients with hypokalaemia and advanced cardiac failure are at increased risk of the development of life-threatening ventricular arrhythmia and torsades de pointes. Fluconazole should be administered with caution to patients with potentially proarrhythmic conditions. Concomitant administration with other medicinal products that prolong the QT interval and are metabolised via cytochrome P450 (CYP) 3A4 is contraindicated (see sections 4.3 and 4.5). Halofantrine Halofantrine is a CYP3A4 substrate and has been associated with QTc interval prolongation at recommended therapeutic doses. The concomitant administration of fluconazole and halofantrine is therefore not recommended (see section 4.5). Dermatological reactions Exfoliative skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have rarely been reported during treatment with fluconazole. Drug reaction with eosinophilia and systemic symptoms (DRESS) has been reported. Patients with AIDS are more prone to the development of severe cutaneous reactions to many medicinal products. If a rash, which may be attributable to fluconazole, develops in a patient being treated for a superficial fungal infection, further therapy with this agent should be discontinued. If patients with invasive or systemic fungal infections develop a rash, they should be monitored closely and fluconazole discontinued if bullous lesions or erythema multiforme develop. Hypersensitivity In rare cases, anaphylaxis has been reported (see section 4.3). Cytochrome P450 Fluconazole is a moderate inhibitor of CYP2C9 and CYP3A4. Fluconazole is also a strong inhibitor of CYP2C19. Patients treated with fluconazole who are concomitantly treated with medicinal products with a narrow therapeutic window metabolised through CYP2C9, CYP2C19, and CYP3A4 should be monitored (see section 4.5). Terfenadine Concomitant administration of Diflucan at doses up to 400 mg with terfenadine should be carefully monitored (see sections 4.3 and 4.5). Candidiasis Studies have demonstrated an increasing prevalence of infection with Candida species other than C. albicans. These are often inherently resistant (e.g. C. krusei and C. auris) or display reduced susceptibility (C. glabrata) to fluconazole. Such infections may require alternative antifungal therapy following treatment failure. Therefore, prescribers should take into account the prevalence of fluconazole resistance among various Candida species when prescribing (see section 5.1). Excipients Diflucan capsules contain lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product. This medicinal product contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially "sodium-free".