Concise Prescribing Info
Acute or recurrent vag candidiasis. Mucosal candidiasis, including oropharyngeal, oesophageal, noninvasive bronchopulmonary infection, candiduria, mucocutaneous & chronic oral atrophic Candida infection. Tinea pedis, tinea cruris, tinea corporis, tinea versicolor & dermal candidiasis. Systemic candidiasis eg, candidaemia, disseminated candidiasis & invasive candidal infection of the peritoneum, endocardium & urinary & pulmonary tracts. Cryptococcosis, including pulmonary & cutaneous infections & cryptococcal meningitis. In AIDS patients, as maintenance therapy to prevent relapse of cryptococcal disease. Prevention of fungal infection in immunocompromised patients at risk as a result of neutropenia following cytotoxic chemotherapy or radiotherapy.
Dosage/Direction for Use
Adult Vag candidiasis 150 mg as a single oral dose. Oropharyngeal candidiasis 50 mg once daily for 7-14 days; treat longer in severely immunocompromised patients. Atrophic oral candidiasis 50 mg once daily for 14 days. Oesophagitis, non-invasive bronchopulmonary infection, mucocutaneous candidiasis & candiduria 50 mg once daily for 14-30 days, may be increased to 100 mg for difficult mucosal candidal infections. Tinea pedis, tinea cruris, tinea corporis, tinea versicolor & dermal Candida infection 50 mg once daily for 2-4 wk. Tinea pedis may require treatment for up to 6 wk. Candidaemia, disseminated candidiasis & invasive candidal infections Initially 400 mg on the 1st day followed by 200 mg once daily. If required, may be increased to 400 mg once daily. Cryptococcal meningitis & other cryptococcal infections Initially 400 mg on the 1st day followed by 200-400 mg once daily, usually 6-8 wk. Prevention of relapse of cryptococcal meningitis in AIDS patient 100-200 mg once daily. Prevention of fungal infection in immunocompromised patient at risk due to neutropenia consequent upon cytotoxic chemotherapy or radiotherapy 50-400 mg once daily. High risk patient eg, bone marrow transplants 400 mg once daily. Dosage should be initiated several days before the anticipated onset of neutropenia & should be continued for 7 days after neutrophil count >1,000 cells/mm3. Childn >4 wk Mucosal candidiasis 3 mg/kg once daily. A loading dose of 6 mg/kg may be given on the 1st day to rapidly achieve steady state. Systemic candidiasis & cryptococcal infections 6-12 mg/kg once daily depending upon severity of infection. Prevention of fungal infection in immunocompromised patient at risk as a consequence of induced neutropenia 3-12 mg/kg depending upon extent & duration of neutropenia.
May be taken with or without food.
Hypersensitivity to fluconazole or related azole antifungals. Co-administration w/ terfenadine & cisapride.
Special Precautions
Serious & severe underlying disease (eg, AIDS, cancer), significant rise in liver enzymes. Discontinue if rash develops during superficial fungal infection therapy. Patients w/ pro-arrhythmia conditions. Do not  use in women of childbearing potential & pregnancy (1st trimester). Not recommended during lactation.
Adverse Reactions
Hepatobiliary disorders, abdominal discomfort, flatulence, nausea & diarrhoea.
Drug Interactions
Increased the prothrombin time of warfarin. Prolonged serum t½ of oral sulphonylureas. Increased plasma conc w/ hydrochlorothiazide. Increased levels of phenytoin. Decreased AUC & t½ w/ rifampicin. Increased in AUC of levonorgestrel & ethinyl estradiol; zidovudine. Increased conc of cyclosporin. Decreased plasma clearance of theophylline. Elevated plasma levels of rifabutin. Risk of cardiac arrhythmia w/ terfenadine. Increased conc & psychomotor effects of short acting benzodiazepines (eg, midazolam). Cardiac events including Torsades de pointes w/ cisapride. Increased serum levels of tacrolimus & nephrotoxicity. May increase serum levels of astemizole & other drugs metabolized by CYP450 system.
MIMS Class
ATC Classification
J02AC01 - fluconazole ; Belongs to the class of triazole derivatives. Used in the systemic treatment of mycotic infections.
Additional Information
Exemptions granted for limited sale and supply without prescription (with effect from 1 Jan 2013) for 150 mg cap only:
As an oral preparation containing 150 mg
Indications: Vaginal Candidiasis
Maximum daily dose: 150 mg
Maximum supply: 1 tablet
Minimum age: 16 years. Not recommended in adults older than 60 years of age
Medoflucon cap 150 mg
Medoflucon cap 50 mg
1 × 7's
Exclusive offer for doctors
Register for a MIMS account and receive free medical publications worth $139 a year.
Sign up for free
Already a member? Sign in