DIZOLE

What it is

DIZOLE is a fluconazole capsule, which is a white to off-white crystalline powder that is sparingly soluble in water and saline. The medicine is available in three strengths: 50 mg, 100 mg, and 200 mg hard gelatin capsules.

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

Key safety warnings

Anaphylaxis has been reported in rare instances. Patients have rarely developed exfoliative cutaneous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis, as well as drug reaction with eosinophilia and systemic symptoms (DRESS), during treatment with fluconazole. If a rash attributable to fluconazole develops in a patient treated for a superficial fungal infection, fluconazole should be discontinued. Some azoles, including fluconazole, have been associated with prolongation of the QT interval on the electrocardiogram, caused by 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 should be administered with caution to patients with liver dysfunction, as it has been associated with rare cases of serious hepatic toxicity, including fatalities, primarily in patients with serious underlying medical conditions.

Contraindications

DIZOLE 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 the enzyme CYP3A4 such as cisapride, astemizole, erythromycin, pimozide and quinidine is contraindicated in patients receiving fluconazole.

PBS listing

DIZOLE is not currently listed on the PBS. In November 2016, the PBAC did not recommend PBS subsidy for vaginal candidiasis, noting that this indication is available over the counter and current PBS restrictions do not include this indication.

Regulatory history

DIZOLE 200 mg was first registered on the ARTG on 28 November 2006. DIZOLE 100 mg was registered on 5 June 2009, DIZOLE 50 mg on 27 July 2009, and DIZOLE ONE 150 mg (a new formulation) on 24 June 2009. The PBAC considered DIZOLE for vaginal candidiasis and other systemic fungal infections in November 2016 and did not recommend it for PBS subsidy.