Medoflucon

Medoflucon

fluconazole

Manufacturer:

Medochemie

Distributor:

Medochemie
Concise Prescribing Info
Contents
Fluconazole
Indications/Uses
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.
Administration
May be taken with or without food.
Contraindications
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
Antifungals
ATC Classification
J02AC01 - fluconazole ; Belongs to the class of triazole and tetrazole 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
Presentation/Packing
Form
Medoflucon cap 150 mg
Packing/Price
1's
Form
Medoflucon cap 50 mg
Packing/Price
1 × 7's
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