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Drug Name:


Generic Name and Formulations:
Fluconazole 10mg/mL, 40mg/mL; pwd for oral susp; orange flavor; contains sucrose.

Pfizer Inc.

Therapeutic Use:

Indications for DIFLUCAN ORAL SUSP:

Oropharyngeal, esophageal, systemic candidiasis. Bone marrow transplant prophylaxis. Cryptococcal meningitis. Candida urinary tract infection (UTI), peritonitis.


Individualize. 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 candidiasis: doses of up to 400mg/day have been used. Prophylaxis of candidiasis in bone marrow transplantation: 400mg/day; if anticipated severe granulocytopenia: see full labeling. Cryptococcal meningitis: 400mg on Day 1, then 200–400mg/day for 10–12 weeks after spinal fluid negative; to suppress relapse in AIDS: 200mg/day. UTI, peritonitis: 50–200mg/day have been used. Renal impairment (CrCl ≤50mL/min): see full labeling.


Individualize. All doses are once daily. Neonates: see full labeling. Over 2 weeks of age: 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 candidiasis: 6–12mg/kg/day have been used. Cryptococcal meningitis: 12mg/kg on Day 1, then 6mg/kg/day for 10–12 weeks after negative CSF cultures; max 12mg/kg/day; 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).


Proarrhythmic conditions. Renal or hepatic impairment. Monitor liver function during therapy and for signs/symptoms of hepatic injury; discontinue if develop. Monitor closely for skin rashes; discontinue if lesions progress. Susp: hereditary fructose, glucose/galactose malabsorption, sucrose-isomaltase deficiency: not recommended. Elderly. Pregnancy (Cat.D); may cause rare congenital anomalies in infants exposed in-utero to high doses (400–800mg/day) during 1st trimester. Nursing mothers.


See Contraindications. Risk of cardiotoxicity with erythromycin; avoid. Avoid concomitant voriconazole; if needed, monitor closely esp. when given within 24hrs after fluconazole. Caution with other drugs metabolized by CYP2C9 and CYP3A4 with a narrow therapeutic window. Potentiates warfarin, oral hypoglycemics, oral midazolam, tofacitinib, alfentanil, amitriptyline, nortriptyline, calcium channel blockers, losartan, saquinavir; adjust dose as necessary. May increase serum levels of phenytoin, theophylline, halofantrine, rifabutin, tacrolimus, sirolimus, vinca alkaloids, triazolam, methadone, NSAIDs, cyclosporine, zidovudine, sulfonylureas, carbamazepine. Concomitant celecoxib: reduce celecoxib dose by half. Thiazides increase fluconazole levels. Monitor levels and/or effects of cyclosporine, phenytoin, sulfonylureas, rifabutin, tacrolimus, theophylline, warfarin, prednisone. Increased risk of myopathy/rhabdomyolysis with concomitant HMG-CoA reductase inhibitors; closely monitor. Cimetidine (oral), rifampin may decrease fluconazole levels. Oral contraceptives: see full labeling. Avoid other hepatotoxic drugs.

See Also:



Pharmacological Class:

Azole antifungal.

Adverse Reactions:

Nausea, headache, rash, vomiting, abdominal pain, diarrhea, dizziness, seizures; hepatotoxicity; rare: exfoliative dermatitis, QT prolongation, Torsade de pointes.

How Supplied:

Tabs—30; Susp (35mL)—1; IV (200mg, 400mg)—6

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