Zuellig Pharma


Concise Prescribing Info
Cryptococcal meningitis & infections at other sites (eg, pulmonary, cutaneous). Maintenance therapy to prevent cryptococcal disease relapse in AIDS patients. Candidemia, disseminated candidiasis & other invasive candidal infections. Mucosal candidiasis eg, oropharyngeal, esophageal, non-invasive bronchopulmonary infections, candiduria, mucocutaneous & chronic oral atrophic candidiasis. Prevention of oropharyngeal candidiasis relapse in AIDS patients. Acute or recurrent vag candidiasis; prophylaxis to reduce vag candidiasis recurrence. Candida balanitis. Prevention of fungal infections in malignant patients. Dermatomycosis eg, tinea pedis, corporis, cruris & versicolor & dermal candida infections.
Dosage/Direction for Use
Adult Cryptococcal meningitis & cryptococcal infections at other sites 400 mg on 1st day followed by 200-400 mg once daily; cryptococcal meningitis for 6-8 wk. Prevention of cryptococcal meningitis relapse in AIDS patient 200 mg daily after full course of primary therapy. Candidemia, disseminated candidiasis & other invasive candidal infections 400 mg on 1st day followed by 200 mg daily, may be increased to 400 mg daily. Oropharyngeal candidiasis 50-100 mg once daily for 7-14 days. Atrophic oral candidiasis associated w/ dentures 50 mg once daily for 14 days concurrently w/ local antiseptic measures to dentures. Other mucosal candida infections except genital candidiasis 50-100 mg daily for 14-30 days. Prevention of oropharyngeal candidiasis relapse in AIDS patient 150 mg once wkly after full course of primary therapy. Vag candidiasis & candida balanitis 150 mg single oral dose. Reduce recurrence of vag candidiasis 150 mg once mthly for 4-12 mth. Prevention of candidiasis 50-400 mg once daily. Patient at high risk of systemic infection 400 mg once daily. Dermal infections eg, tinea pedis, corporis, cruris & candida infections 150 mg once wkly or 50 mg once daily for 2-4 wk; tinea pedis for up to 6 wk. Tinea versicolor 300 mg once wkly for 2 wk or 50 mg once daily for 2-4 wk. Childn Mucosal candidiasis Loading dose: 6 mg/kg on 1st day followed by 3 mg/kg daily. Systemic candidiasis & cryptococcal infections 6-12 mg/kg daily. Suppression of cryptococcal meningitis relapse in childn w/ AIDS 6 mg/kg once daily. Prevention of fungal infections in immunocompromised patient considered at risk as consequence of neutropenia following cytotoxic chemo- or radiotherapy 3-12 mg/kg daily. Neonate Dose of older childn administered every 72 hr for neonate up to 2 wk & every 48 hr in neonate 3-4 wk. Renal impairment Loading dose: Initially 50-400 mg.
May be taken with or without food.
Hypersensitivity to fluconazole or related azole compd. Co-administration of terfenadine in patients receiving fluconazole at multiple doses of ≥400 mg daily; drugs prolonging QT interval, cisapride, astemizole, erythromycin, pimozide, quinidine.
Special Precautions
Discontinue use if rash develops in patients treated for superficial fungal infection or w/ invasive/systemic fungal infection. Patients w/ potentially proarrhythmic conditions. Monitor closely & discontinue use if bullous lesions or erythema multiforme develops. Concomitant use w/ terfenadine; narrow therapeutic window drugs metabolized by CYP2C9, CYP2C19 & CYP3A4. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May affect ability to drive & use machines. Monitor for development of more serious hepatic injury. Hepatic & renal dysfunction. Avoid use during pregnancy. Not recommended during lactation.
Adverse Reactions
Headache; abdominal pain, diarrhea, nausea, vomiting; increased alanine & aspartate aminotransferase & blood alkaline phosphatase; rash.
Drug Interactions
Increased cisapride & terfenadine plasma levels. Decreased astemizole clearance. Inhibition of pimozide, quinidine, carbamazepine, losartan metabolism. Increased risk of cardiotoxicity w/ erythromycin. Increased plasma conc by hydrochlorothiazide. Decreased AUC & shorter t½ w/ rifampicin. Increased plasma conc of other CYP2C9, CYP2C19 & CYP3A4 metabolized compd; halofantrine, sirolimus, tacrolimus. Reduced clearance, distribution vol & t½ of alfentanil. Increased amitriptyline & nortriptyline effects. Increased prothrombin time w/ warfarin. Increased conc & psychomotor effects in midazolam. Increased AUC of triazolam, celecoxib, cyclosporine, saquinavir, voriconazole, zidovudine. Increased systemic exposure of Ca-channel blockers, tofacitinib. Increased serum bilirubin & creatinine w/ cyclophosphamide. Delayed fentanyl elimination. Increased risk of myopathy & rhabdomyolysis w/ HMG-CoA reductase inhibitors. Enhanced serum conc of methadone. Potentially increased systemic exposure of NSAIDs metabolized by CYP2C9 eg, naproxen, lornoxicam, meloxicam, diclofenac. Inhibits hepatic metabolism of phenytoin. Increased metabolism of prednisone. Increased serum levels of rifabutin, vinca alkaloids eg, vincristine & vinblastine. Prolonged serum t½ of oral sulfonylureas eg, chlorpropamide, glibenclamide, glipizide, tolbutamide. Decreased mean plasma clearance rate of theophylline.
MIMS Class
ATC Classification
J02AC01 - fluconazole ; Belongs to the class of triazole derivatives. Used in the systemic treatment of mycotic infections.
Diflucan cap 100 mg
Diflucan cap 150 mg
Diflucan cap 50 mg
Diflucan inj (vial) 2 mg/mL
100 mL x 1's;50 mL x 1's
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