Fodisis

Fluconazole

Cryptococcosis, including cryptococcal meningitis & infections of other sites (eg, pulmonary, cutaneous). Normal hosts & patients w/ AIDS, organ transplants or other causes of immunosuppression; compromised immune function. Maintenance therapy to prevent relapse of cryptococcal disease in patients w/ AIDS. Systemic candidiasis eg, candidemia, disseminated candidiasis & other forms of invasive candidal infection. Peritoneum, endocardium & pulmonary infections & UTI. Malignancy, in ICU, receiving cytotoxic or immunosuppressive therapy, or w/ other factors predisposing to candidal infection. Mucosal candidiasis including oropharyngeal, esophageal, non-invasive broncho-pulmonary infections, candiduria, mucocutaneous & chronic oral atrophic candidiasis (denture sore mouth). Prevention of relapse of oropharyngeal candidiasis in patients w/ AIDS. Genital candidiasis, acute or recurrent vag candidiasis, Candidal balanitis. Prevention of fungal infections in patients w/ malignancy who are predisposed to such infections as a result of cytotoxic chemotherapy or RT. Dermatomycosis eg, tinea pedis, corporis, cruris, versicolor, & dermal candida infections.

Adult Cryptococcal meningitis & infections at other sites 400 mg on the 1st day followed by 200-400 mg once daily. Duration of treatment: 6-8 wk for cryptococcal meningitis. Prevention of cryptococcal meningitis relapse in patients w/ AIDS 200 mg daily, may be administered indefinitely. Candidemia, disseminated candidiasis & other invasive candidal infections 400 mg on the 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. Treatment can be continued for longer periods in patients w/ severely compromised immune function if necessary. Atrophic oral candidiasis associated w/ dentures 50 mg once daily for 14 days, administered concurrently w/ local antiseptic measures w/ denture. Other candidal infections of mucosa except genital candidiasis 50-100 mg daily given for 14-30 days. Prevention of oropharyngeal candidiasis relapse in patients w/ AIDS 150 mg once wkly. Candida balanitis 150 mg as a single dose. Prevention of candidiasis 50-400 mg once daily. Patients at high risk of systemic infection 400 mg once daily. Administration should start several days before the anticipated onset of neutropenia, & continue for 7 days after the neutrophil count rises >1,000 cell/mm³. Patients at risk of severe recurrent infections 100 mg once daily. Dermal infections including tinea pedis, corporis, cruris & candida infections 150 mg once wkly or 50 mg once daily. Duration of treatment: Normally 2-4 wk. Tinea pedis May require treatment for up to 6 wk. Tinea versicolor 50 mg once daily for 2-4 wk. Max duration: 6 wk. Vag candidiasis 150 mg as a single dose. Childn ≥1 yr w/ normal renal function Superficial candidal infections 1-2 mg/kg daily. Systemic candidal/cryptococcal infections 3-6 mg/kg daily. Serious or life-threatening infections Doses up to 12 mg/kg daily. Max adult daily dose: 400 mg. Patients w/ impaired renal function who will receive multiple doses Initially 50-400 mg daily; CrCl ≥50 mL/min 100% of the recommended dose; CrCl ≤50 mL/min (no dialysis) 50% of the recommended dose; Patients on regular dialysis 100% of the recommended dose after each dialysis.

May be taken with or without food.

Hypersensitivity to fluconazole, or to related azole compd. Co-administration of terfenadine in patients receiving fluconazole at multiple doses of ≥400 mg daily; other drugs known to prolong the QT interval & which are metabolised via the enzyme CYP3A4 eg, cisapride, astemizole, erythromycin, pimozide & quinidine.

Rare cases of anaphylaxis w/ other azoles. Serious hepatic toxicity including fatalities, primarily in patients w/ serious underlying medical condition. Monitor for more serious hepatic injury in patients who develop abnormal LFTs during therapy. Discontinue if clinical signs or symptoms consistent w/ liver disease develop; rash develops in patient treated for a superficial fungal infection. Exfoliative cutaneous reactions eg, SJS & TEN during treatment. Development of severe cutaneous reactions in AIDS patients. Monitor closely for rashes & discontinue if bullous lesions or erythema multiforme develops in patients w/ invasive/systemic fungal infections. Carefully monitor co-administration of fluconazole (doses <400 mg/day) w/ terfenadine. QT prolongation & Torsades de Pointes; including seriously ill patients w/ multiple confounding risk factors eg, structural heart disease, electrolyte abnormalities & concomitant medications that may have been contributory. Potentially proarrhythmic conditions. Monitor patients who are concomitantly treated w/ drugs w/ a narrow therapeutic window metabolised through CYP2C9, CYP2C19 & CYP3A4. May impair ability to drive or use machinery due to occasional dizziness or seizures. Liver & renal dysfunction. Avoid use in pregnancy except in patients w/ severe or potentially life-threatening fungal infections. Not recommended in nursing mothers. Not recommended in childn <16 yr.

Headache; abdominal pain, diarrhea, flatulence, nausea; hepatic toxicity including rare cases of fatalities, elevated alkaline phosphatase, bilirubin, SGOT & SGPT; rash. Leukopenia (eg, neutropenia, agranulocytosis), thrombocytopenia; anaphylaxis (eg, angioedema, face edema, pruritus, urticaria); hypercholesterolemia, hypertriglyceridemia, hypokalemia; dizziness, seizures, paraesthesia, taste perversion, tremor; QT prolongation, Torsades de Pointes; dyspepsia, vomiting, dry mouth; hepatic failure, hepatitis, hepatocellular necrosis, jaundice; alopecia, exfoliative skin disorders (eg, SJS & TEN).

Increased the prothrombin time; bleeding events (eg, bruising, epistaxis, GI bleeding, hematuria, & melena) w/ warfarin. Substantial increases in midazolam conc & psychomotor effects. Concomitant use w/ benzodiazepine therapy, cisapride, cyclosporin, terfenadine, amphotericin B, voriconazole. Increased plasma conc w/ hydrochlorothiazide. Increased phenytoin levels to a clinical significant degree. Increased rifabutin serum levels & uveitis. Decreased AUC & shorter t_½. Prolonged serum t_½ of oral sulfonylureas (eg, chlorpropamide, glibenclamide, glipizide & tolbutamide); possible hypoglycemic episode in diabetic patients. Increased tacrolimus serum levels & nephrotoxicity. Increased astemizole, pimozide & quinidine plasma conc can lead to QT prolongation & occurrences of Torsades de Pointes. Increased risk for theophylline toxicity. Reduction in clearance & distribution vol, prolongation of t_½ of alfentanil. Increased amitriptyline & nortriptyline effect. Increased triazolam AUC (single dose) & t_½. Inhibited metabolism & increased serum of carbamazepine. Increased systemic exposure of Ca channel antagonist (eg, nifedipine, isradipine, amlodipine, verapamil, & felodipine). Increased C_max & AUC w/ celecoxib. Increased serum bilirubin & creatinine w/ cyclophosphamide. Delayed elimination & elevated conc of fentanyl may lead to resp depression. Increased plasma conc of halofantrine, sirolimus. Increased risk of myopathy & rhabdomyolysis w/ HMG-CoA reductase inhibitors metabolised through CYP3A4 (eg, atorvastatin & simvastatin), or through CYP2C9 (eg, fluvastatin). Inhibits the metabolism of losartan to its active metabolite (E-31 74). May enhance the serum conc of methadone. Potential increased systemic exposure of other NSAIDs that are metabolized by CYP2C9 (eg, naproxen, lornoxicam, meloxicam, diclofenac). Liver-transplanted patient treated w/ prednisone developed acute adrenal cortex insufficiency; increased metabolism of prednisone. Increased AUC & decreased clearance of saquinavir. Increased exposure of tofacitinib. May increase the plasma levels of the vinca alkaloids (eg, vincristine & vinblastine) & lead to neurotoxicity. CNS related undesirable effects eg, pseudo tumour cerebri in patient receiving combination therapy w/ all-trans-retinoid acid (an acid form of vit A). Increased C_max & AUC of zidovudine. Potential increased risk of cardiotoxicity (eg, prolonged QT interval, Torsades de Pointes) & consequently sudden heart death w/ erythromycin.

Antifungals

J02AC01 - fluconazole ; Belongs to the class of triazole and tetrazole derivatives. Used in the systemic treatment of mycotic infections.

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