FLUCONAZOLE-WGR

What it is

FLUCONAZOLE-WGR is a fluconazole capsule available in 50 mg, 100 mg, and 200 mg strengths. Fluconazole is a white to off-white crystalline powder which is sparingly soluble in water and saline.

Approved indications

— Treatment of cryptococcal meningitis in patients who are unable to tolerate amphotericin B. — Maintenance therapy to prevent relapse of cryptococcal meningitis in patients with acquired immune deficiency syndrome (AIDS). — Treatment of oropharyngeal and oesophageal candidiasis in AIDS and other immunosuppressed patients. — Secondary prophylaxis of oropharyngeal candidiasis in patients with human immunodeficiency virus (HIV) infection. — Serious and life-threatening Candida infections in patients who are unable to tolerate amphotericin B. — Vaginal candidiasis, when topical therapy has failed. — Treatment of extensive tinea corporis, extensive tinea cruris and extensive tinea pedis infections in immunocompetent patients in whom topical therapy is not a practical treatment option.

Dosing overview

FLUCONAZOLE-WGR capsules are administered orally and the daily dose should be based on the infecting organism and the patient's response to therapy.

Key safety warnings

Anaphylaxis has been reported in rare instances. Patients have rarely developed exfoliative cutaneous reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, during treatment with fluconazole. Drug reaction with eosinophilia and systemic symptoms (DRESS) has been reported. If a rash attributable to fluconazole develops in a patient treated for a superficial fungal infection, fluconazole should be discontinued. Fluconazole has been associated with prolongation of the QT interval on the electrocardiogram via inhibition of Rectifier Potassium Channel current. During post-marketing surveillance, there have been very rare cases of QT prolongation and torsade de pointes in patients taking fluconazole, including seriously ill patients with multiple confounding risk factors such as structural heart disease, electrolyte abnormalities and concomitant medications. Patients with hypokalaemia and advanced cardiac failure are at increased risk for life-threatening ventricular arrhythmias and torsades de pointes, and fluconazole should be administered with caution to these patients. Fluconazole has been associated with rare cases of serious hepatic toxicity, including fatalities, primarily in patients with serious underlying medical conditions. Patients who develop abnormal liver function tests during fluconazole therapy should be monitored for more severe hepatic injury, and fluconazole should be discontinued if clinical signs and symptoms consistent with liver disease develop.

Contraindications

FLUCONAZOLE-WGR is contraindicated in patients with known sensitivity to fluconazole, related azole compounds or any of its excipients. Coadministration of terfenadine is contraindicated in patients receiving fluconazole at multiple doses of 400 mg per day or higher. Coadministration of other drugs known to prolong the QT interval and which are metabolised via CYP3A4 such as cisapride, astemizole, erythromycin, pimozide and quinidine is contraindicated in patients receiving fluconazole.

Regulatory history

FLUCONAZOLE-WGR was first registered on the ARTG on 12 August 2024, with three variant strengths: 50 mg, 100 mg, and 200 mg capsules in blister packs.