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DIFLUCAN (fluconazole) is indicated for the treatment of:
- Vaginal candidiasis (vaginal yeast infections due to Candida).
- Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, DIFLUCAN was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia.
- Cryptococcal meningitis. Before prescribing DIFLUCAN (fluconazole) for AIDS patients with cryptococcal meningitis, please see Clinical Studies section. Studies comparing DIFLUCAN to amphotericin B in non-HIV infected patients have not been conducted.
Specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly.
DOSAGE AND ADMINISTRATION
Dosage and Administration in Adults
Vaginal candidiasis: The recommended dosage of DIFLUCAN for vaginal candidiasis is 150 mg as a single oral dose.
SINCE ORAL ABSORPTION IS RAPID AND ALMOST COMPLETE, THE DAILY DOSE OF DIFLUCAN (FLUCONAZOLE) IS THE SAME FOR ORAL (TABLETS AND SUSPENSION) AND INTRAVENOUS ADMINISTRATION. In general, a loading dose of twice the daily dose is recommended on the first day of therapy to result in plasma concentrations close to steady-state by the second day of therapy.
The daily dose of DIFLUCAN for the treatment of infections other than vaginal candidiasis should be based on the infecting organism and the patient's response to therapy. Treatment should be continued until clinical parameters or laboratory tests indicate that active fungal infection has subsided. An inadequate period of treatment may lead to recurrence of active infection. Patients with AIDS and cryptococcal meningitis or recurrent oropharyngeal candidiasis usually require maintenance therapy to prevent relapse.
Oropharyngeal candidiasis: The recommended dosage of DIFLUCAN for oropharyngeal candidiasis is 200 mg on the first day, followed by 100 mg once daily. Clinical evidence of oropharyngeal candidiasis generally resolves within several days, but treatment should be continued for at least 2 weeks to decrease the likelihood of relapse.
Esophageal candidiasis: The recommended dosage of DIFLUCAN for esophageal candidiasis is 200 mg on the first day, followed by 100 mg once daily. Doses up to 400 mg/day may be used, based on medical judgment of the patient's response to therapy. Patients with esophageal candidiasis should be treated for a minimum of three weeks and for at least two weeks following resolution of symptoms.
Systemic Candida infections: For systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia, optimal therapeutic dosage and duration of therapy have not been established. In open, noncomparative studies of small numbers of patients, doses of up to 400 mg daily have been used.
Urinary tract infections and peritonitis: For the treatment of Candida urinary tract infections and peritonitis, daily doses of 50-200 mg have been used in open, noncomparative studies of small numbers of patients.
Cryptococcal meningitis: The recommended dosage for treatment of acute cryptococcal meningitis is 400 mg on the first day, followed by 200 mg once daily. A dosage of 400 mg once daily may be used, based on medical judgment of the patient's response to therapy. The recommended duration of treatment for initial therapy of cryptococcal meningitis is 10-12 weeks after the cerebrospinal fluid becomes culture negative. The recommended dosage of DIFLUCAN for suppression of relapse of cryptococcal meningitis in patients with AIDS is 200 mg once daily.
Prophylaxis in patients undergoing bone marrow transplantation: The recommended DIFLUCAN daily dosage for the prevention of candidiasis in patients undergoing bone marrow transplantation is 400 mg, once daily. Patients who are anticipated to have severe granulocytopenia (less than 500 neutrophils per cu mm) should start DIFLUCAN prophylaxis several days before the anticipated onset of neutropenia, and continue for 7 days after the neutrophil count rises above 1000 cells per cu mm.
Dosage and Administration in Children
The following dose equivalency scheme should generally provide equivalent exposure in pediatric and adult patients:
|3 mg/kg||100 mg|
|6 mg/kg||200 mg|
|12* mg/kg||400 mg|
|* Some older children may have clearances similar to that of adults. Absolute doses exceeding 600 mg/day are not recommended.|
Experience with DIFLUCAN in neonates is limited to pharmacokinetic studies in premature newborns. (See CLINICAL PHARMACOLOGY.) Based on the prolonged half-life seen in premature newborns (gestational age 26 to 29 weeks), these children, in the first two weeks of life, should receive the same dosage (mg/kg) as in older children, but administered every 72 hours. After the first two weeks, these children should be dosed once daily. No information regarding DIFLUCAN pharmacokinetics in full-term newborns is available.
Oropharyngeal candidiasis: The recommended dosage of DIFLUCAN for oropharyngeal candidiasis in children is 6 mg/kg on the first day, followed by 3 mg/kg once daily. Treatment should be administered for at least 2 weeks to decrease the likelihood of relapse.
Esophageal candidiasis: For the treatment of esophageal candidiasis, the recommended dosage of DIFLUCAN in children is 6 mg/kg on the first day, followed by 3 mg/kg once daily. Doses up to 12 mg/kg/day may be used, based on medical judgment of the patient's response to therapy. Patients with esophageal candidiasis should be treated for a minimum of three weeks and for at least 2 weeks following the resolution of symptoms.
Systemic Candida infections: For the treatment of candidemia and disseminated Candida infections, daily doses of 6-12 mg/kg/day have been used in an open, noncomparative study of a small number of children.
Cryptococcal meningitis: For the treatment of acute cryptococcal meningitis, the recommended dosage is 12 mg/kg on the first day, followed by 6 mg/kg once daily. A dosage of 12 mg/kg once daily may be used, based on medical judgment of the patient's response to therapy. The recommended duration of treatment for initial therapy of cryptococcal meningitis is 10-12 weeks after the cerebrospinal fluid becomes culture negative. For suppression of relapse of cryptococcal meningitis in children with AIDS, the recommended dose of DIFLUCAN is 6 mg/kg once daily.
Dosage In Patients With Impaired Renal Function
Fluconazole is cleared primarily by renal excretion as unchanged drug. There is no need to adjust single dose therapy for vaginal candidiasis because of impaired renal function. In patients with impaired renal function who will receive multiple doses of DIFLUCAN, an initial loading dose of 50 to 400 mg should be given. After the loading dose, the daily dose (according to indication) should be based on the following table:
|Creatinine Clearance (mL/min)||Percent of Recommended Dose|
|≤ 50 (no dialysis)||50%|
|Regular dialysis||100% after each dialysis|
These are suggested dose adjustments based on pharmacokinetics following administration of multiple doses. Further adjustment may be needed depending upon clinical condition.
When serum creatinine is the only measure of renal function available, the following formula (based on sex, weight, and age of the patient) should be used to estimate the creatinine clearance in adults:
|Males:||(weight in kg) x (140 – age)|
|(72) x serum creatinine (mg/100 mL)|
|Females||(0.85) x (above value)|
Although the pharmacokinetics of fluconazole has not been studied in children with renal insufficiency, dosage reduction in children with renal insufficiency should parallel that recommended for adults. The following formula may be used to estimate creatinine clearance in children:
|K x linear length or height (cm)|
|serum creatinine (mg/100 mL)|
|(Where K=0.55 for children older than 1 year and 0.45 for infants.)|
DIFLUCAN may be administered either orally or by intravenous infusion. DIFLUCAN can be taken with or without food. DIFLUCAN injection has been used safely for up to fourteen days of intravenous therapy. The intravenous infusion of DIFLUCAN should be administered at a maximum rate of approximately 200 mg/hour, given as a continuous infusion.
DIFLUCAN injections in glass and Viaflex® Plus plastic containers are intended only for intravenous administration using sterile equipment.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
Do not use if the solution is cloudy or precipitated or if the seal is not intact.
Directions for Mixing the Oral Suspension
Prepare a suspension at time of dispensing as follows: tap bottle until all the powder flows freely. To reconstitute, add 24 mL of distilled water or Purified Water (USP) to fluconazole bottle and shake vigorously to suspend powder. Each bottle will deliver 35 mL of suspension. The concentrations of the reconstituted suspensions are as follows:
|Fluconazole Content per Bottle||Concentration of Reconstituted Suspension|
|350 mg||10 mg/mL|
|1400 mg||40 mg/mL|
Note: Shake oral suspension well before using. Store reconstituted suspension between 86°F (30°C) and 41°F (5°C) and discard unused portion after 2 weeks. Protect from freezing.
Directions for IV Use of DIFLUCAN in Viaflex® Plus Plastic Containers
Do not remove unit from overwrap until ready for use. The overwrap is a moisture barrier. The inner bag maintains the sterility of the product.
CAUTION: Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is completed.
Tear overwrap down side at slit and remove solution container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. After removing overwrap, check for minute leaks by squeezing inner bag firmly. If leaks are found, discard solution as sterility may be impaired.
DO NOT ADD SUPPLEMENTARY MEDICATION.
Preparation for Administration:
- Suspend container from eyelet support.
- Remove plastic protector from outlet port at bottom of container.
- Attach administration set. Refer to complete directions accompanying set.
DIFLUCAN Tablets: Pink trapezoidal tablets containing 50, 100, or 200 mg of fluconazole are packaged in bottles or unit dose blisters. The 150 mg fluconazole tablets are pink and oval shaped, packaged in a single dose unit blister.
DIFLUCAN Tablets are supplied as follows:
DIFLUCAN 50 mg Tablets: Engraved with “DIFLUCAN” and “50” on the front and “ROERIG” on the back.
NDC 0049-3410-30 Bottles of 30
DIFLUCAN 100 mg Tablets: Engraved with “DIFLUCAN” and “100” on the front and “ROERIG” on the back.
NDC 0049-3420-30 Bottles of 30
NDC 0049-3420-41 Unit dose package of 100
DIFLUCAN 150 mg Tablets: Engraved with “DIFLUCAN” and “150” on the front and “ROERIG” on the back.
NDC 0049-3500-79 Unit dose package of 1
DIFLUCAN 200 mg Tablets: Engraved with “DIFLUCAN” and “200” on the front and “ROERIG” on the back.
NDC 0049-3430-30 Bottles of 30
NDC 0049-3430-41 Unit dose package of 100
Store tablets below 86°F (30°C).
DIFLUCAN for Oral Suspension: DIFLUCAN for Oral Suspension is supplied as an orange-flavored powder to provide 35 mL per bottle as follows:
NDC 0049-3440-19 Fluconazole 350 mg per bottle
NDC 0049-3450-19 Fluconazole 1400 mg per bottle
Storage: Store dry powder below 86°F (30°C). Store reconstituted suspension between 86°F (30°C) and 41°F (5°C) and discard unused portion after 2 weeks. Protect from freezing.
DIFLUCAN Injections: DIFLUCAN injections for intravenous infusion administration are formulated as sterile iso-osmotic solutions containing 2 mg/mL of fluconazole. They are supplied in glass bottles or in Viaflex® Plus plastic containers containing volumes of 100 mL or 200 mL, affording doses of 200 mg and 400 mg of fluconazole, respectively. DIFLUCAN injections in Viaflex® Plus plastic containers are available in both sodium chloride and dextrose diluents.
DIFLUCAN Injections in Glass Bottles:
NDC 0049-3371-26 Fluconazole in Sodium Chloride Diluent
200 mg/100 mL x 6
NDC 0049-3372-26 Fluconazole in Sodium Chloride Diluent 400 mg/200 mL x 6
Storage: Store between 86°F (30°C) and 41°F (5°C). Protect from freezing.
DIFLUCAN Injections in Viaflex® Plus Plastic Containers:
NDC 0049-3435-26 Fluconazole in Sodium Chloride Diluent
200 mg/100 mL x 6
NDC 0049-3436-26 Fluconazole in Sodium Chloride Diluent 400 mg/200 mL x 6
NDC 0049-3437-26 Fluconazole in Dextrose Diluent 200 mg/100 mL x 6
NDC 0049-3438-26 Fluconazole in Dextrose Diluent 400 mg/200 mL x 6
Storage: Store between 77°F (25°C) and 41°F (5°C). Brief exposure up to 104°F (40°C) does not adversely affect the product. Protect from freezing.
3. Pfaller, M. A., Messer, S. A., Boyken, L., Rice, C., Tendolkar, S., Hollis, R. J., and Diekema1, D. J. Use of Fluconazole as a Surrogate Marker To Predict Susceptibility and Resistance to Voriconazole Among 13,338 Clinical Isolates of Candida spp. Tested by Clinical and Laboratory Standard Institute-Recommended Broth Microdilution Methods. 2007. Journal of Clinical Microbiology. 45:70–75.
Distributed by: Roerig, Division of Pfizer Inc, NY, NY 10017. Revised September 2013
Last reviewed on RxList: 9/27/2013
This monograph has been modified to include the generic and brand name in many instances.
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