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FLUCONAZOLE is a brand name for Fluconazole, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE..............................................................................3 CONTRAINDICATIONS ...................................................................................................3 WARNINGS AND…
Verbatim from this product's HC label. Tap a section to expand.
0 Most of the reported side effects were mild to moderate in severity. Less Common Clinical Trial Adverse Drug Reactions Occasional allergic reactions including pruritus and urticaria were reported. Post-Market Adverse Drug Reactions In marketing experience of single dose fluconazole, rare cases of anaphylactic reaction and angioedema have been reported.
g. open trials, marketing experience fluconazole) where a causal relationship is uncertain or in patients treated with multiple doses of fluconazole: Cardiovascular: QT prolongation, torsade de pointes (see WARNINGS AND PRECAUTIONS, QT Prolongation).
Central and Peripheral Nervous System: seizures. Dermatologic: alopecia, exfoliative skin disorders including Stevens-Johnson syndrome and toxic epidermal necrolysis (see WARNINGS AND PRECAUTIONS). FLUCONAZOLE Product Monograph Page 7 of 30 Gastrointestinal: vomiting.
Hematopoietic and Lymphatic: leukopenia including neutropenia and agranulocytosis, thrombocytopenia. Immunologic: face edema. Body as a Whole: face edema, urticaria Liver/Biliary: hepatic failure, hepatitis, hepatocellular necrosis, jaundice.
Metabolic/Nutritional: hypercholesterolemia, hypertriglyceridemia, hypokalemia. DRUG INTERACTIONS Overview Drug-Drug Interactions Clinically or potentially significant drug interactions between fluconazole and the following agents/classes have been observed.
BENZODIAZEPINES (SHORT ACTING) Following oral or intravenous administration of midazolam, fluconazole resulted in substantial increases in midazolam concentrations and psychomotor effects. This effect on midazolam appears to be more pronounced following oral administration of fluconazole than with fluconazole administered intravenously.
If concomitant benzodiazepine therapy, such as midazolam or triazolam, is necessary in patients being treated with fluconazole, consideration should be given to decreasing the benzodiazepine dosage. CIMETIDINE Absorption of orally administered fluconazole does not appear to be affected by gastric pH.
Fluconazole 100 mg was administered as a single oral dose alone and two hours after a single dose of cimetidine 400 mg to six healthy male volunteers. After the administration of cimetidine, there was a significant decrease in fluconazole AUC (area under the plasma concentration-time curve) and Cmax.
FLUCONAZOLE is indicated for single dose only. Some (not all) adverse experiences have been reported in patients following exposure to multiple doses of fluconazole. Clinically significant warnings and precautions for FLUCONAZOLE (fluconazole) are listed below.
General The convenience of the single oral dose fluconazole regimen for the treatment of vaginal yeast infections should be weighed against the acceptability of a higher incidence of drug related adverse events with oral fluconazole (26%) versus intravaginal agents (16%) in comparative clinical studies where no difference in efficacy was demonstrated (see ADVERSE REACTIONS).
Fluconazole administered in combination with ethinyl estradiol- and levonorgestrel-containing oral contraceptives produced an overall mean increase in ethinyl estradiol and levonorgestrel levels; however, in some patients there were decreases up to 47% and 33% of ethinyl estradiol and levonorgestrel levels, respectively (See DRUG INTERACTIONS).
The data presently available indicate that the decreases in some individual ethinyl estradiol and levonorgestrel AUC values with fluconazole treatment may be the result of random variation. While there is evidence that fluconazole can inhibit the metabolism of ethinyl estradiol and levonorgestrel, there is no evidence that fluconazole is a net inducer of ethinyl estradiol or levonorgestrel metabolism.
The clinical significance of these effects is presently unknown.
Cardiovascular QT Prolongation:
Some azoles, including fluconazole, have been associated with prolongation of the QT interval on the electrocardiogram. During post-marketing surveillance, there have been very rare cases of QT prolongation and torsade de pointes in patients taking fluconazole.
These reports included seriously ill patients with multiple confounding risk factors, such as structural heart disease, electrolyte abnormalities and concomitant medications that may have been contributory. Fluconazole should be administered with caution to patients with these potentially proarrhythmic conditions (see WARNINGS AND PRECAUTIONS, DRUG INTERACTIONS AND ADVERSE EFFECTS).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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4 to -31%) and Cmax decreased 19% ± 14% (range: -5 to -40%). However, the administration of cimetidine 600 mg to 900 mg intravenously over a 4-hour period (from 1 hour before to 3 hours after a single oral dose of fluconazole 200 mg) did not affect the bioavailability or pharmacokinetics of fluconazole in 24 healthy male volunteers.
COUMARIN-TYPE ANTICOAGULANTS In a clinical trial, there was a significant increase in prothrombin time response (area under the prothrombin time-time curve) following a single dose of warfarin (15 mg) administered to 13 FLUCONAZOLE Product Monograph Page 8 of 30 normal male volunteers following oral fluconazole 200 mg administered daily for 14 days as compared to the administration of warfarin alone.
There was a mean ± SD increase in the prothrombin time response (area under the prothrombin time-time curve) of 7% ± 4% (range: -2 to 13%). Mean is based on data from 12 subjects as one of 13 subjects experienced a 2-fold increase in his prothrombin time response.
During the post-marketing experience, as with some azole antifungals, bleeding events (bruising, epistaxis, gastrointestinal bleeding, hematuria, and melena) have been reported, in association with increases in prothrombin time in patients receiving fluconazole concurrently with warfarin.
Prothrombin time may be increased in patients receiving concomitant fluconazole and coumarin- type anticoagulants. CYCLOSPORINE Cyclosporine AUC and Cmax were determined before and after the administration of fluconazole 200 mg daily for 14 days in eight renal transplant patients who had been on cyclosporine therapy for at least 6 months and on a stable cyclosporine dose for at least 6 weeks.
There was a significant increase in cyclosporine AUC, Cmax, Cmin (24-hour concentration), and a significant reduction in apparent oral clearance following the administration of fluconazole. The mean ± SD increase in AUC was 92% ± 43% (range: 18 to 147%).
The Cmax increased 60% ± 48% range (range: -5 to 133%). The Cmin increased 157% ± 96% (range: 33 to 360%). The apparent oral clearance decreased 45% ± 15% (range: -15 to -60%). Fluconazole administered at 100 mg daily dose does not affect cyclosporine pharmacokinetic levels in patients with bone marrow transplants.
Fluconazole may significantly increase cyclosporine levels in renal transplant patients with or without renal impairment. DRUGS PROLONGING THE QTc INTERVAL The use of fluconazole in patients concurrently taking drugs metabolized by the Cytochrome P- 450 system may be associated with elevations in the serum levels of these drugs.
Astemizole*:
Definitive interaction studies with fluconazole have not been conducted. The use of fluconazole may be associated with elevations in serum levels of astemizole. Caution should be used when coadministering fluconazole with astemizole.
Patients should be carefully monitored.
Cisapride*:
There have been reports of cardiac events including […]
Dermatologic In very rare cases, during the treatment of systemic and vaginal infections, patients have developed exfoliative skin disorders (Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis) during treatment with fluconazole. Hepatic/Biliary/Pancreatic In the treatment of systemic infections, multiple doses of fluconazole have been associated with rare cases of serious hepatic toxicity, including fatalities primarily in patients with serious underlying medical conditions.
In cases of fluconazole-associated hepatotoxicity, no obvious FLUCONAZOLE Product Monograph Page 5 of 30 relationship to total daily dose, duration of therapy, sex or age of the patient has been observed. Fluconazole hepatotoxicity has usually, but not always, been reversible on discontinuation of therapy.
Hypersensitivity In rare cases, anaphylaxis and angioedema has been reported in patients using fluconazole.
Special Populations Pregnant Women:
Single-dose oral fluconazole 150 mg does not appear to increase the risk of congenital anomalies. There have been reports of multiple congenital abnormalities in infants whose mothers were treated with high dose (400-800 mg/day) fluconazole therapy for coccidioidomycosis (an unapproved indication).
Exposure to fluconazole began during the first trimester in all cases and continued for three months or longer. Fluconazole should not be used in pregnant women unless the potential benefit outweighs the potential risk to the fetus.
Women of child-bearing potential taking fluconazole for vaginal candidiasis should consider using adequate contraception. Fluconazole was administered orally to pregnant rabbits during organogenesis in two studies, at 5, 10 and 20 mg/kg and at 5, 25 and 75 mg/kg respectively.
4x the maximum recommended human dose); no adverse fetal effects were detected. In several studies in which pregnant rats were treated orally with fluconazole during organogenesis, maternal weight gain was impaired and placental weights were increased at the 25 mg/kg dose.
There were no fetal effects at 5 or 10 mg/kg; increases in fetal anatomical variants (supernumerary ribs, renal pelvis dilation) and delays in ossification were observed at 25 and 50 mg/kg and higher doses. At doses ranging from 80 mg/kg to 320 mg/kg (approximately 10-40x the maximum recommended human dose) embryolethality in rats was increased and fetal abnormalities included wavy ribs, cleft palate and abnormal cranio-facial ossification.
These effects are consistent with the inhibition of estrogen synthesis in rats and may be a result of known effects of lowered estrogen on pregnancy, organogenesis and parturition.
Nursing Women:
FLUCONAZOLE is secreted in human breast milk at concentrations similar to plasma, hence its use in nursing mothers is not recommended. Pediatrics FLUCONAZOLE should not be used by girls less than 12 years of age unless advised by a physician.
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