OZOLE

What it is

Ozole is fluconazole, a member of the bis-triazole class of antifungal agents. OZOLE (fluconazole) capsules are available in strengths of 50, 100 and 200 mg.

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 AIDS. — Treatment of oropharyngeal and oesophageal candidiasis in AIDS and other immunosuppressed patients. — Secondary prophylaxis of oropharyngeal candidiasis in patients with 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

Patients have rarely developed exfoliative cutaneous reactions, such as Stevens-Johnson Syndrome and toxic epidermal necrolysis, during treatment with fluconazole, and drug reaction with eosinophilia and systemic symptoms (DRESS) has been reported. Fluconazole should be discontinued if rash attributable to fluconazole develops in patients treated for superficial fungal infection, or if patients with invasive/systemic fungal infections develop bullous lesions or erythema multiforme. Some azoles, including fluconazole, have been associated with prolongation of the QT interval on the electrocardiogram, with fluconazole causing QT prolongation 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, with increased risk in patients with hypokalaemia and advanced cardiac failure. Cases of adrenal insufficiency have been reported in patients receiving fluconazole. 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 that may be attributable to fluconazole.

Contraindications

Ozole is contraindicated in patients with known sensitivity to fluconazole, related azole compounds, or any of its excipients. Concomitant administration with cisapride is contraindicated, as is co-administration of other drugs known to prolong the QT interval and which are metabolised via CYP3A4 such as astemizole, erythromycin, pimozide and quinidine. Co-administration of terfenadine is contraindicated in patients receiving fluconazole at multiple doses of 400 mg/day or higher. Fluconazole capsules should not be given to patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.

Regulatory history

Ozole fluconazole capsules in strengths of 50 mg, 100 mg, 200 mg and 150 mg were first listed on the ARTG on 6 October 2006.