The most common side effects of DIFLUCAN are:Allergic reactions to DIFLUCAN are rare, but they can be very serious if not treated right away by a doctor. Fluconazole treatment did not cause a decrease in the ethinyl estradiol AUC of any individual subject in this study compared to placebo dosing. If patients with invasive/systemic fungal infections develop rashes, they should be monitored closely and fluconazole discontinued if bullous lesions or erythema multiforme develop.In rare cases anaphylaxis has been reported (see section 4.3).Fluconazole is a potent CYP2C9 and CYP2C19 inhibitor and a moderate CYP3A4 inhibitor. Do not store above 30°C.Topaz type III glass bottle with polyethylene cap and polyethylene seal for 35 ml of suspension. During post-marketing surveillance, there have been very rare cases of QT prolongation and torsade de pointes in patients taking fluconazole. This medicine has been prescribed for you only.Tell your doctor and pharmacist about all of your drugs prescription or OTC, natural products, vitamins and health problems. The CIn a second study, twenty-five normal females received daily doses of both 200 mg fluconazole tablets or placebo for two, ten-day periods. The mean ± SD increase in AUC was 20% ± 32% (range: –27 to 104%). In cases of fluconazole-associated hepatotoxicity, no obvious relationship to total daily dose, duration of therapy, sex or age of the patient has been observed.
The individual AUC values of norethindrone decreased very slightly (<5%) in 3 of the 21 subjects after fluconazole treatment.A second randomized, double-dummy, placebo-controlled, cross over study in three phases was performed to determine the effect of route of administration of fluconazole on the interaction between fluconazole and midazolam. The relationship between fluconazole and these incidents is unclear.Studies in animals have shown reproductive toxicity (see section 5.3).Fluconazole at standard doses and short-term treatment should not be used in pregnancy unless clearly necessary. The effects on parturition in rats are consistent with the species specific estrogen-lowering property produced by high doses of fluconazole. The proportions of patients discontinuing therapy due to clinical adverse events were similar in the two groups (1.5%).The following treatment-related clinical adverse events occurred at an incidence of 1% or greater in 4048 patients receiving fluconazole for 7 or more days in clinical trials: nausea 3.7%, headache 1.9%, skin rash 1.8%, vomiting 1.7%, abdominal pain 1.7%, and diarrhea 1.5%.In two comparative trials evaluating the efficacy of fluconazole for the suppression of relapse of cryptococcal meningitis, a statistically significant increase was observed in median AST (SGOT) levels from a baseline value of 30 IU/L to 41 IU/L in one trial and 34 IU/L to 66 IU/L in the other.
(See In 13 normal male volunteers, there was significant increase in tolbutamide (500 mg single dose) AUC and Cmax following the administration of fluconazole. Generally the symptoms start to go away after 24 hours. Dilution is not appropriate. In patients (including paediatric population) with impaired renal functions who will receive multiple doses of fluconazole, the normal recommended dose (according to indication) should be given on day 1, followed by a daily dose based in the following table:A maximum dosage of 400mg daily should not be exceeded in children.As with similar infections in adults, the duration of treatment is based on the clinical and mycological response. of 6.72 µg/mL (range: 4.12 to 8.08 µg/mL) and after single oral doses of 50 to 400 mg, fluconazole plasma concentrations and area under the plasma concentration-time curve (AUC) are dose proportional. You should know that unnecessary use of antibiotics may increase the risk of developing antibiotic-resistant infections.Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand.
Fluconazole causes QT prolongation via the inhibition of Rectifier Potassium Channel current (Ikr). Reversible cases of adrenal insufficiency have been reported in patients receiving fluconazole.Fluconazole for Oral Suspension contains sucrose and should not be used in patients with hereditary fructose, glucose/galactose malabsorption, and sucrase-isomaltase deficiency.When driving vehicles or operating machines, it should be taken into account that occasionally dizziness or seizures may occur.The convenience and efficacy of the single dose oral tablet of 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 fluconazole (26%) versus intravaginal agents (16%) in U.S. comparative clinical studies (See Although not specifically studied, fluconazole has the potential to increase the systemic exposure of other non-steroidal anti-inflammatory drugs (NSAIDs) that are metabolized by CYP2C9 (e.g., naproxen, lornoxicam, meloxicam, diclofenac).