DIFLUCAN ORAL SUSP Rx
Generic Name and Formulations:
Fluconazole 10mg/mL, 40mg/mL; pwd for oral susp; orange flavor; contains sucrose.
Indications for DIFLUCAN ORAL SUSP:
Oropharyngeal, esophageal candidiasis. Candidiasis prophylaxis in bone marrow transplant. Cryptococcal meningitis. Candida urinary tract infection (UTI), peritonitis, systemic infections.
All doses are once daily. Oropharyngeal candidiasis: 200mg on Day 1, then 100mg/day for at least 2 weeks. Esophageal candidiasis: 200mg on Day 1, then 100mg/day for at least 3 weeks; treat for at least 2 weeks after symptoms resolve; max 400mg/day. Systemic infections: doses of up to 400mg/day have been used. Prophylaxis in bone marrow transplant: 400mg/day; if anticipated severe granulocytopenia: see full labeling. Cryptococcal meningitis: 400mg on Day 1, then 200mg/day (400mg/day may be used) for 10–12 weeks after negative CSF cultures; to suppress relapse in AIDS: 200mg/day. UTI, peritonitis: 50–200mg/day have been used. Renal impairment (CrCl ≤50mL/min): see full labeling.
All doses are once daily. Neonates: see full labeling. >2wks: Oropharyngeal candidiasis: 6mg/kg on Day 1, then 3mg/kg/day for at least 2 weeks. Esophageal candidiasis: 6mg/kg on Day 1, then 3mg/kg/day for at least 3 weeks; treat for at least 2 weeks after symptoms resolve; max 12mg/kg/day. Systemic infections: 6–12mg/kg/day have been used. Cryptococcal meningitis: 12mg/kg on Day 1, then 6mg/kg/day (12mg/kg/day may be used) for 10–12 weeks after negative CSF cultures; to suppress relapse in AIDS: 6mg/kg/day. Max for all: 600mg/day. Renal impairment (CrCl ≤50mL/min): see full labeling.
Concomitant terfenadine at multiple doses of fluconazole ≥400mg. Concomitant drugs known to prolong the QT interval and metabolized by CYP3A4 (eg, cisapride, astemizole, erythromycin, pimozide, quinidine).
Risk of serious hepatotoxicity; monitor liver function during therapy and for signs/symptoms of hepatic injury; discontinue if occurs. Proarrhythmic conditions. Monitor closely for skin rashes; discontinue if lesions progress. Renal or hepatic impairment. Susp: hereditary fructose, glucose/galactose malabsorption, sucrose-isomaltase deficiency: not recommended. Elderly. Use effective contraception during and for 1 week after last dose. Pregnancy (avoid); may cause rare congenital anomalies in infants exposed in-utero to high doses (400–800mg/day) during 1st trimester. Nursing mothers.
See Contraindications. Avoid concomitant voriconazole; if needed, monitor closely esp. when given within 24hrs after fluconazole. Caution with amiodarone (esp. with high-dose fluconazole), other drugs metabolized by CYP2C9 and CYP3A4 with a narrow therapeutic window. Potentiates warfarin, oral hypoglycemics, oral midazolam, triazolam, tofacitinib, alfentanil, amitriptyline, nortriptyline, saquinavir, tacrolimus, sirolimus, carbamazepine, methadone, NSAIDs, zidovudine; adjust dose as necessary. May increase levels of phenytoin, theophylline, halofantrine, rifabutin, vinca alkaloids, cyclosporine, fentanyl, calcium channel blockers, losartan; monitor. Concomitant celecoxib: reduce celecoxib dose by half. Increased risk of myopathy/rhabdomyolysis with concomitant HMG-CoA reductase inhibitors; closely monitor. May be potentiated by diuretics. May be antagonized by oral cimetidine, rifampin. Concomitant prednisone: monitor for adrenal cortex insufficiency when fluconazole stopped. CNS effects with Vitamin A. Oral contraceptives: see full labeling. Avoid other hepatotoxic drugs.
Nausea, headache, rash, vomiting, abdominal pain, diarrhea, dizziness; hepatotoxicity; rare: anaphylaxis, exfoliative dermatitis, QT prolongation, Torsade de pointes.
Tabs—30; Susp (35mL)—1; IV—contact supplier
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