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fluconazole (Rx)Brand and Other Names:Diflucan

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injected solution

  • 2mg/mL

oral suspension

  • 10mg/mL
  • 40mg/mL

tablets

  • 50mg
  • 100mg
  • 150mg
  • 200mg
more...

Oropharyngeal Candidiasis

200 mg PO on Day 1, THEN 100 mg qDay

Dosing considerations

  • Treatment should be continued for at least 2 weeks to decrease likelihood of relapse

Esophageal Candidiasis

200 mg PO on Day 1, THEN 100 mg qDay; doses up to 400 mg/day may be used based on patient’s response

Dosing considerations

  • Treat for a minimum of 3 weeks and for at least 2 weeks following resolution of symptoms

Cryptococcal Meningitis

400 mg PO on Day 1, THEN 200 mg PO qDay

Dosage of up to 400 mg qDay may be used based on patient’s response

Suppression of relapse in patients with AIDS: 200 mg PO qDay

Dosing considerations

  • Recommended duration of therapy is 10-12 weeks after cerebrospinal fluid becomes culture negative

Prophylaxis of Candidiasis with BMT

Prevention of candidiasis incidence in patients undergoing bone marrow transplant

400 mg PO qDay

Dosing considerations

  • Patients who are anticipated to have severe granulocytopenia should start prophylaxis several days before anticipated onset of neutropenia and continue for 7 days after neutrophil count rises >1000 cells per mm³

Vaginal Candidiasis

Uncomplicated: 150 mg PO as a single dose

Complicated: 150 mg PO q72hr for 3 doses

Recurrent: 150 mg PO qDay for 10-14 days followed by 150 mg once weekly for 6 months

Candida UTI/Peritonitis

50-200 mg PO qDay

Dosage Modifications

Hepatic impairment: Not studied

Renal impairment

  • Percent of recommended dose:
  • -CrCl >50 mL/min: 100% of dose
  • -CrCl ≤50 mL/min: 50% dose
  • -Regular dialysis: 100% dose after each dialysis; on nondialysis days, reduce dose according to creatinine clearance

Dosage Forms & Strengths

injected solution

  • 2mg/mL

oral suspension

  • 10mg/mL
  • 40mg/mL

tablets

  • 50mg
  • 100mg
  • 150mg
  • 200mg
more...

Oropharyngeal Candidiasis

6 mg/kg PO on Day 1, THEN 3 mg/kg qDay; not to exceed 600 mg/day 

Dosing considerations

  • Treatment should be administered for at least 2 weeks to decrease likelihood of relapse

Esophageal Candidiasis

Esophageal candidiasis: 6 mg/kg PO on Day 1, THEN 3 mg/kg qDay 

Doses up to 12 mg/kg/day may be used, based on patient’s response

Dosing considerations

  • Treat for a minimum of 3 weeks and for at least 2 weeks following resolution of symptoms

Systemic Candida Infections

6-12 mg/kg/day PO/IV; not to exceed 600 mg/day 

Cryptococcal Meningitis

12 mg/kg PO/IV on Day 1, THEN 6 mg/kg qDay 

Dose of 12 mg/kg once daily may be used, based on patient’s response

Suppression in children with AIDS: 6 mg/kg once daily

Dosing considerations

  • Recommended duration of therapy is 10-12 weeks after cerebrospinal fluid becomes culture negative

Premature Neonates

26-29 weeks' gestation:: 6-12 mg/kg IV/PO  

Maintenance: 3-6 mg/kg IV/PO qDay

Maintenance dose interval

  • 26-29 weeks' gestation: q72hr; administer q24hr after 2 weeks of life
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Interactions

Interaction Checker

fluconazole and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Headache (2-13%)

            1-10%

            Nausea (2-7%)

            Abdominal pain (2-6%)

            Diarrhea (2-3%)

            Rash (2%)

            Vomiting (2-5%)

            Frequency Not Defined

            QT prolongation

            Torsades de pointes

            Alopecia

            Anaphylactic reactions

            Angioedema

            Cholestasis

            Dizziness

            Dyspnea

            Hepatic failure

            Hepatitis

            Hypertriglyceridemia

            Hypokalemia

            Increased alkaline phosphatase

            Increased ALT/AST

            Jaundice

            Leukopenia

            Pallor

            Seizures

            Stevens-Johnson syndrome

            Taste perversion

            Thrombocytopenia

            Toxic epidermal necrolysis

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            Warnings

            Contraindications

            Hypersensitivity

            Pregnancy

            Concurrent QT-prolonging drugs that are metabolized via the enzyme CYP3A4 (cisapride, erythromycin, pimozide, and quinidine)

            Cautions

            Hypersensitivity to other azoles

            Use caution in proarrhythmic conditions and renal impairment

            Use extreme caution or avoid in congenital long-QT patients and patients with conditions that increase QT-prolongation risk

            Fluconazole inhibits CYP2C9, CYP2C19, and CYP3A4 isoenzymes; coadministration with drugs that are substrates if these isoenzymes may be contraindicated or warrant dosage modifications

            Capsules contain lactose and should not be given to patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption

            Powder for oral suspension contains sucrose and should not be used in patients with hereditary fructose, glucose/galactose malabsorption or sucrase-isomaltase deficiency

            Syrup contains glycerol; may cause headache, stomach upset, and diarrhea

            Hepatotoxicity reported with use; use with caution in patients with hepatic impairment

            Rare exfoliative skin disorders reported; monitor closely if rash develops and discontinue if it progresses

            When driving vehicles or operating machines, it should be taken into account that dizziness or seizures may occasionally occur

            Candida krusei is inherently resistant

            Convenience and efficacy of single dose oral tablet of fluconazole regimen for the treatment of vaginal yeast infections should be weighed against acceptability of higher incidence of drug related adverse events with fluconazole (26%) versus intravaginal agents (16%)

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            Pregnancy & Lactation

            Pregnancy

            Single maternal PO dose of 150 mg for vaginal candidiasis

            • Results of a Danish study concludes there is a possible increased risk of miscarriage; women who are pregnant or actively trying to get pregnant should ask their physician about alternative treatments
            • Spontaneous abortion between 7 and 22 weeks' gestation occurred significantly more often in women exposed to oral fluconazole than unexposed pregnancies (4.43% vs. 4.25%; hazard ratio, 1.48); fluconazole was also compared with intravaginal azole antifungals to account for confounding by candidiasis, again, the oral drug was associated with significantly increased risk for spontaneous abortion - JAMA. 2016;315(1):58-67
            • CDC guidelines recommend only using topical antifungal products to treat pregnant women with vulvovaginal yeast infections, including for longer periods than usual if these infections persist or recur

            All other indications

            • A few published case reports describe a rare pattern of distinct congenital anomalies in infants exposed in-utero to high dose maternal fluconazole (400-800 mg/day) during most or all of the first trimester
            • Reported anomalies are similar to those seen in animal studies and consist of brachycephaly, abnormal facies, abnormal calvarial development, cleft palate, femoral bowing, thin ribs and long bones, arthrogryposis, and congenital heart disease

            Lactation

            Enters breast milk; use caution (AAP Committee states "compatible with nursing")  

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

            more...
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            Pharmacology

            Mechanism of Action

            Highly selective inhibitor of fungal cytochrome P-450-dependent enzyme lanosterol 14-alpha-demethylase

            Subsequent loss of normal sterols correlates with accumulation of 14 alpha-methyl sterols in fungi and may be responsible for the fungistatic activity of fluconazole

            Absorption

            Bioavailability: >90% (oral)

            Peak plasma time: 1-2 hr (PO)

            Distribution

            Vd: 0.6 L/kg; widely distributed throughout body, with good penetration into CSF, eye, peritoneal fluid, sputum, urine and skin

            CSF to blood level ratio: 50-90% (normal meninges); >70-80% (inflamed meninges)

            Relative diffusion blood into CSF: Adequate with or without inflammation (exceeds MICs)

            Protein bound: 11-12%

            Metabolism

            Liver, partially

            Enzymes inhibited: Hepatic CYP2C9 (potent); CYP3A4 (moderate)

            Elimination

            Half-life: 30 hr (range: 20-50 hrs); 46 hr (elderly)

            Excretion: Urine 80% (unchanged drug), 11% (metabolites)

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            Administration

            IV Incompatibilities

            Additive: TMP-SMX

            Y-site: Amphotericin B, amphotericin B cholesteryl sulfate, ampicillin, calcium gluconate, cefotaxime, ceftazidime(?), ceftriaxone, cefuroxime, chloramphenicol, clindamycin, co-trimoxazole, diazepam, digoxin, erythromycin lactobionate, furosemide, haloperidol, hydroxyzine, imipenem/cilastatin, pentamidine, piperacillin, ticarcillin, TMP-SMX

            IV Compatibilities

            Solution: D5W, LR

            Additive: Acyclovir, amikacin, amphotericin B, cefazolin, ceftazidime, ciprofloxacin, clindamycin, gentamicin, heparin, meropenem, metronidazole, morphine, piperacillin, potassium chloride, ranitidine with ondansetron, theophylline

            Y-site: Acyclovir, aldesleukin, allopurinol, amifostine, amikacin, aminophylline, amiodarone, ampicillin-sulbactam, aztreonam, benztropine, bivalirudin, cefazolin, cefepime, cefotetan, cefoxitin, cefpirome, chlorpromazine, cimetidine, cisatracurium, dexamethasone sodium phosphate, dexmedetomidine, diltiazem, diphenhydramine, dobutamine, docetaxel, dopamine, doxorubicin liposomal, droperidol, etoposide PO4, famotidine, fenoldopam, filgrastim, fludarabine, foscarnet, ganciclovir, gatifloxacin, gemcitabine, gentamicin, granisetron, heparin, hetastarch, hydrocortisone, immune globulin, leucovorin, linezolid, lorazepam, melphalan, meperidine, meropenem, metoclopramide, metronidazole, midazolam, morphine, nafcillin, nitroglycerin, ondansetron, oxacillin, paclitaxel, pancuronium, penicillin G, phenytoin, piperacillin-tazobactam, prochlorperazine, promethazine, propofol, quinupristin-dalfopristin, ranitidine, remifentanil, sargramostim, tacrolimus, teniposide, theophylline, thiotepa, ticarcillin-clavulanate, tobramycin, vancomycin, vecuronium, vinorelbine, zidovudine

            IV Preparation

            Standard diluent: 200 mg/100 mL NS (premixed); 200 mg/200 mL NS (premixed)

            Do not use if cloudy or precipitated

            IV Administration

            IV infusion over approximately 1-2 hr

            Maximum infusion rate: 200 mg/hr

            To prevent air embolism, do not connect in series with other infusions

            Storage

            Tablets: Store below 86° F (30° C)

            Dry powder: Store below 86° F (30° C); reconstituted suspension should be stored between 86° F (30° C) and 41° F (5° C), and unused portion should be discarded after 2 weeks; protect from freezing

            Injection (glass bottles): Store between 86° F (30° C) and 41° F (5° C); protect from freezing

            Injection (Viaflex Plus plastic containers): Store between 77° F (25° C) and 41° F (5° C); protect from freezing

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            Images

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            Formulary

            FormularyPatient Discounts

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

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            • View the formulary and any restrictions for each plan.
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            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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