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    University of Maryland Medical Center Fluconazole (Diflucan®)

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    University of Maryland Medical Center Fluconazole (Diflucan®)

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    damondouglas
    2K views6 pages

    Original Title

    Fluconazole

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    2K views6 pages

    University of Maryland Medical Center Fluconazole (Diflucan®)

    Uploaded by

    damondouglas

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as DOC, PDF, TXT or read online from Scribd
    Download as doc, pdf, or txt
    of 6

    University of Maryland Medical Center

    Fluconazole (Diflucan®)
    Guidelines for Use

    BACKGROUND

    • These recommendations are to be utilized for the appropriate treatment of


    Candida infections with fluconazole. Please contact Infectious Diseases via
    BUGS or pharmacy for assistance.
    • Spectrum of activity:
    ✔Fluconazole will treat the following Candida species: C. albicans, C.
    parapsilosis, C. tropicalis and C. lusitaniei.
    ✔The following Candida species are resistant to fluconazole; C. krusei and
    C. glabrata (some C. glabrata may be treatable at higher doses but should
    be discussed with ID).
    • Colonization of non-sterile sites (ie sputum, urine in drainage catheters and
    wounds) with Candida is common and does not warrant therapy. The best
    treatment of Candida colonization is removing foreign bodies such as urinary
    catheters and reducing or stopping broad-spectrum antibiotics where
    appropriate.
    • Fluconazole has excellent oral bioavailability and should be given orally in all
    patients who are taking other oral medications or naso-gastric feedings.
    • Fluconazole dosing needs adjustment for severe liver and/or renal
    dysfunction.

    INDICATIONS

    Non-Transplant Patients

    • Blood Stream Infection (BSI)


    a. Remove intravascular devices including dialysis catheters.
    b. If endocarditis- CT surgery and ID consults and continue therapy.
    c. Endovascular grafts – continue therapy and monitor blood cultures.
    d. Narrow spectrum or stop antibiotics if possible
    e. Convert parenteral to enteral nutrition where possible

    • Urinary Tract Infections.


    *Note: Fluconazole therapy has NOT been shown to have either clinical or long-
    term microbiological benefit in treating Candida UTI.
    a. Needs urinalysis as proof
    b. Remove foley as primary therapy
    c. Do not treat colonization
    d. Remove urinary stents or drainage devices where possible
    e. If systemic infection suspected (i.e. large number white cells in UA and
    febrile) treat as per BSI.

    • Sputum
    a. No treatment indications
    b. Reduce broad spectrum antibiotics
    c. Encourage enteral feeding

    • Esophagitis
    a. Only in HIV and other immunocompromised patients.
    b. Refer to dosage section for treatment regimen
    • Wound
    a. No therapy required
    b. Reduce broad spectrum antibiotics
    c. Use enteral feeding where possible

    • CNS
    a. Remove intraventricular catheter
    b. Use BSI dosing

    • PD catheter Infection
    a. Remove PD catheter
    b. Refer to dosage section for treatment regimen

    Transplant Patients (Solid Organs)

    Fluconazole should be used with caution due to possible interactions with immune
    suppressive agents. Please contact Infectious Diseases and transplant pharmacist
    prior to using fluconazole. Exception is for liver transplant patients, which can be
    found in the prophylaxis guidelines.

    Cryptococcal Meningitis

    a. Induction with amphotericin B for 2 weeks.


    b b. Continue with Fluconazole for 2 months.
    c. Maintenance therapy in HIV patients with CD4 T cell ≤ 200.

    Note: Please refer to appendix I for empiric indications in SICU

    DOSAGE AND ADMINISTRATION

    Adult Dosage

    *Note: same dose for both PO and IV


    • Blood Stream Infection (BSI)
    ✑ ✔Fluconazole load – 800 mg X 1, then 400 mg once a day for 14 days.

    • Esophagitis
    ✔New patients only require Fluconazole 200 mg/day
    ✔In HIV patient with repeated infection, will need BSI dosing

    • PD catheter Infection
    ✔Fluconazole 400mg/day

    • Cryptococcal Meningitis
    ✔Induction: Amphotericin B. 0.7-1 mg/kg/day for 2 weeks, then Fluconazole
    400mg/day x 2 months
    ✔Maintenance treatment: Fluconazole 200mg/day (for HIV patients with CD4 T
    cell ≤ 200)

    • Allogenic bone marrow transplant


    ✔Fluconazole 400mg/ day (prophylaxis dose)

    Pediatric Dosage

    *Note: same dose for both PO and IV

    ***Consult Pediatric Infectious Disease Service for Treatment of Disseminated


    Fungal Infections***

    Premature Neonates:

    ≤ 29 weeks gestation:
    Postnatal age 0-14 days: 5-6 mg/kg/ dose Q72H
    Postnatal age >14 days: 5-6 mg/kg/dose Q48H
    30-36 weeks gestation:
    Postnatal age 0-14 days: 6mg/kg/dose Q48H

    Neonates > 14 days, Infants and Children: Dose Frequency is Q24H

    Oropharyngeal Candidiasis
    6 mg/kg/day on day #1, 3 mg/kg/day for 14 days
    Esophageal Candidiasis
    6 mg/kg/day on day #1, 3-6 mg/kg/day for 21 days (For serious or
    recurrent infection, may increase dose to 12mg/kg/day)
    Systemic Candidiasis
    Loading dose: 12mg/kg/day, then 6 mg/kg/day for 28 days
    Cryptococcal Meningitis
    Acute
    12 mg/kg/day on day #1, 6-12 mg/kg/day for 10-12 wk after CSF culture
    becomes negative
    Relapse
    6 mg/kg/day

    Dosage Adjustment in Renal Impairment

    GFR 50-80 ml/min ➔ usual dose


    GFR 10-50 ml/min ➔ 50% of usual dose
    GFR <10 ml/min ➔ 25-50 mg/day
    Hemo ➔ Dose after dialysis
    CAPD ➔ 50% of the usual dose
    CAVH ➔ 50% of the usual dose

    ADVERSE EFFECTS

    GI - Bloating, nausea, vomiting, pain, anorexia, weight loss (dose related)


    CNS - headache
    Dermatologic - Rash
    Misc - Reversible alopecia (dose related)
    Laboratory - Transaminase elevation to > 8x normal (1%)
    Prolonged prothrombin time with warfarin
    Hypokalemia (<1%)

    PREGNANCY CATEGORY

    Pregnancy category C

    MONITORING

    Periodic liver function tests (AST, ALT, alkaline phosphatase), renal function (Scr,
    BUN) & potassium.
    DRUG INTERACTIONS

    Mechanism: inhibit cytochrome P-450

    Alprazolam Increased sedation


    Atovaquone Increased atovaquone levels
    Benzodiazepines Increased benzodiazepines levels
    Caffeine Possible caffeine toxicity
    Cisapride* Ventricular arrhythmias
    Clarithromycin Increased clarithromycin levels
    Contraceptive Decreased contraceptive effect
    Coumadin Increased prothrombin time
    Cyclosporine Increased Cyclosporine nephrotoxicity
    Midazolam Increased sedation
    Nortriptyline increased sedation, cardiac arrhythmias
    Phenytoin Increased phenytoin levels
    Rifabutin* Increased rifabutin levels with possible uveitis
    Rifampin Reduced fluconazole absorption
    Saquinavir Increased saquinavir levels
    Seldane* Ventricular arrhythmias
    Sulfonylureas Increased levels with hypoglycemia
    Tacrolimus Increased nephrotoxicity
    Theophylline Increased levels of theophylline
    Triazolam Increased sedation
    Zidovudine Increased levels of zidovudine
    * Concurrent use should be avoided

    STORAGE

    Oral Form: Store below 30 degree Celsius


    Parenteral Form: Store glass bottle between 30 degree and 5 degree Celsius

    AVAILABILITY

    Injection: 2 mg/ml (100 ml, 200 ml)


    Tablet: 50 mg, 100 mg, 150 mg, 200 mg
    Powder for Oral Suspension: 10 mg/ml (35 ml), 40 mg/ml (35 ml)

    The IV Formulation require approval from Infectious Disease Service


    Two prophylactic indications that are EXEMPT from ID approval include
    Post-operative liver transplant patients and allogenic bone marrow transplant
    patients
    Revised April, 2002
    Appendix I. Fluconazole Guidelines for Empiric Use in SICU.

    Class 1: Demonstrated reduction in Candidal colonization with resultant decrease in


    candidemia.
    NOTE: Studies have not shown any survival benefit from empiric fluconazole usage,
    only a reduction in candidemia.
    Class 2: Case reports demonstrating benefit, but needs further study to reach Class 1.
    Empiric fluconazole should only be implemented after evaluating the following risk
    factors that can be reduced:
    1) Reduce or stop broad-spectrum antibiotics
    2) Remove intravascualar and urinary devices where possible
    3) Early use of GI tract where possible and less parenteral nutrition
    4) drainage of intra-abdominal collections
    Class 1 Indication Risk Factors
    A Liver or Pancreatic > 2 Risk re-transplantation
    Transplantation factors Cr > 2.0
    Cholangio-jejunostomy
    > 40 units blood loss
    Positive culture for Candida < 72 hours of Transplant

    B Must have
    these
    High Risk SICU 2 risk Febrile
    patient factors: > 72 hours in ICU

    With one 2 or more abdominal surgeries


    of persistent entero-cutaneous fistula
    > 2 sites of Candidal colonization
    Prolonged treatment with broad spectrum antibiotics
    Hyperalimentation
    Hemodialysis
    Corticosteroid and/or Immunosuppressive therapy
    Undrained intra-abdominal collection

    Class 2
    Necrotizing
    Pancreatitis Must meet criteria in Class1 B
    Cirrhosis with Transplant listed with positive culture-near surgery
    ascites And must meet one of the criteria in Class 1B
    Initial GI > 72 hours in ICU
    Perforation and must meet one of the criteria in Class 1B
    References:
    1) Pelz RK et al. Double-blinded Placebo Controlled Trial of Fluconazole to Prevent
    Candidal Infections in Critically Ill Surgical Patients. Ann of Surg. 2001;233:542-8.
    2) Rex JH, Sobel, JD. Prohylactic Antifungal Therapy in the ICU. CID 2001;32:1191-
    1200.

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