IMPORTANT NOTE. We strongly recommend that you consult your doctor for proper advice before using any medications, including vitamins, supplements, herbals and products for the skin.
Funzela
Fluconazole
Brand Name, Dosage Format and Strength
Funzela 50 mg Tablet
Therapeutic Category
Anti-infectives (Systemic)
Class
Aminoglycoside, Cephalosporin, Chloramphenicol, Lincosamide, Macrolide, Penicillin, Penicillin + Beta lactamase Inhibitor , Penicillinase-resistant isoxazolylpenicillin, Penicillin; Beta-lactam + Beta-lactamase Inhibitor, Quinolone, Sulfonamide + Folate Inhibitor, Tetracycline, Triazole Antibiotic, Immunostimulant, Neuraminidase Inhibitor
DOSAGE AND ADMINISTRATION
Recommended Dosing Regimen for Adults
|
Infection/Condition
|
Adult Dosage
|
|
Cryptococcal meningitis & cryptococccal infections
at other sites
|
400 mg on the 1st day, then 200 to 400 mg OD. Recommended duration of treatment for initial therapy of cryptococcal meningitis is usually 6 to 8 wks up to 10 to 12 wks after CSF becomes culture negative.
|
|
Oropharyngeal candidiasis
|
50 to 100 mg OD for 7 to 14 days
|
|
Denture-associated atrophic oral candidiasis
|
50 mg OD for 14 days
(together with local antiseptic measures to the denture)
|
|
Esophageal candidiasis
|
50 to 100 mg OD for 14 to 30 days.
Dose may be increased to 400 mg OD if necessary.
|
|
For other candida infections
of the mucosa
(except genital candidiasis)
|
50 to 100 mg OD for 14 to 30 days.
|
|
Systemic candida infections
|
400 mg on the 1st day, then 200 mg OD. Dose may be increased to 400 mg OD. Treatment should be continued for a minimum of 4 wks and for at least 2 wks after symptoms have resolved.
|
|
Vaginal candidiasis and candidal balanitis
|
150 mg single dose
|
|
Recurrent vulvovaginal candidiasis
|
150 mg on the 1st day, then 150 mg on the 4th day; maintenance regimen is 100 to 150 mg once a wk for 6 mos
|
|
Dermatologic infections including tinea pedis, corporis, and cruris; candida infections
|
150 mg once a wk or 50 mg OD for 2 to 6 wks
|
|
Tinea versicolor and tinea capitis
|
50 mg OD for 2 to 4 wks
|
|
Tinea unguium
(onychomycosis)
|
150 mg once a wk; treatment should be continued until regrowth of toenails or fingernails and usually ranges from 3 to 6 mos for fingernails and 6 to 12 mos for toenails, depending on the patient’s condition
|
|
Deep endemic mycoses
|
200 to 800 mg OD; treatment duration depends on the condition being treated but usually ranges from 11 to 24 mos for coccidioidomycosis, 2 to 17 mos for paracoccidioidomycosis, 1 to 16 mos for sporotrichosis and 3 to 17 mos for histoplasmosis
|
|
Suppression of relapse of cryptococcal meningitis & cryptococccal infections
at other sites in patients with AIDS (after the patient receives a full course of primary therapy)
|
100 to 200 mg OD for an indefinite period of time
|
|
Prevention of oropharyngeal candidiasis relapse in patients with AIDS (after the patient receives a full course of primary therapy)
|
100 to 200 mg once a wk; duration of treatment is usually 4 to 9 mos.
|
|
Prevention of fungal infections in patients with HIV
|
100 to 200 OD; duration of treatment will depend on the patient’s condition
|
|
Prevention of fungal infections in transplant patients, patients undergoing chemotherapy, immunotherapy or radiotherapy and other patients who are at high risk of systemic fungal infections
|
400 mg OD depending on the patient’s condition
|
Recommended Dosing Regimen for Children
Usual recommended dose: 3 to 12 mg/kg BW OD. Do not exceed 600 mg OD in children.
|
Infection
|
Pediatric Dosage
|
|
Oropharyngeal candidiasis
|
6 mg/kg BW on the 1st day, then 3 mg/kg BW OD for at least 2 wks to decrease likelihood of relapse.
|
|
Esophageal candidiasis
|
6 mg/kg BW on the 1st day, then 3 mg/kg BW OD. Doses may be increased to 12 mg/kg BW/day.
Minimum treatment duration is 3 wks and at least 2 wks after the symptoms resolve.
|
|
Systemic candida infections
|
6 to 12 mg/kg BW daily; duration of treatment will depend on the organism being treated and the patient’s condition
|
|
Cryptococcal meningitis & cryptococccal infections
at other sites
|
12 mg/kg BW on the 1st day, then 6 mg/kg BW OD. Dose may be increased to 12 mg/kg BW/day. Recommended duration of treatment for initial therapy of cryptococcal meningitis is 10 to 12 wks after CSF becomes culture negative.
|
|
Suppression of cryptococcal meningitis in patients with AIDS
|
6 mg/kg BW OD for 6 mos or longer
|
For children < 4 wks, the same fluconazole dose as above should be given. However, the dosage regimen is changed as follows:
|
Age Group
|
Recommended Dosing Regimen
|
|
Infants < 2 wks old
|
Fluconazole dose to be given once every 3 days
|
|
Infants 2 to 4 wks old
|
Fluconazole dose to be given every other day
|
The following dose equivalency scheme should generally provide equivalent exposure in pediatric and adult patients:
|
Pediatric Patients
|
Adult Patients
|
|
3 mg/kg BW
|
100 mg
|
|
6 mg/kg BW
|
200 mg
|
|
12 mg/kg* BW
|
400 mg
|
|
*Some older children may have clearances similar to those of adults. Absolute doses exceeding 600 mg/day are not recommended in children.
|
|
Dosage in Patients with Impaired Renal Function
No dosage adjustment is necessary for patients with renal impairment who are to receive a single dose of fluconazole. For patients who need multiple doses of fluconazole, an initial loading dose of 50 to 400 mg is required followed by a daily dose based on CLCR as shown in the following table:
|
Creatinine Clearance (mL/min)
|
Percentage of Recommended Dose
|
|
> 50
|
100%
|
|
11 – 50
|
50%
|
|
Patients undergoing regular dialysis
|
One recommended dose
after each dialysis
|
These are suggested dose adjustments based on fluconazole PK after administration of multiple doses in patients with renal impairment. Further dose adjustment may be needed depending on the patient’s clinical condition.
When serum creatinine is the only measure of renal function available, use the following formula (Cockcroft and Gault equation) to estimate the CLCR.
Men: CLCR (mL/min) = Weight (kg) x (140-age in years)
72 x serum creatinine (mg/dL)
Women: 0.85 x value calculated using the above formula
Directions for Administration of IV Preparation
Fluconazole IV injection has been used safely for up to 14 days. Fluconazole IV infusion should be administered at a rate not exceeding 200 mg/hr. Fluconazole may be infused through an existing line with one of the following parenteral solutions: Aminofusin, Dextrose 20%, Hartmann’s solution, Normal saline or 0.9% Sodium Chloride, Potassium chloride in dextrose, Ringer’s solution or Sodium bicarbonate 4.2%.
Although no specific incompatibilities have been noted, mixing with any other drug prior to infusion is not recommended.
Inspect parenteral drug products visually for particulate matter and discoloration prior to use. Do not use if particulates or discoloration are observed.