Fluconazol

Fluconazole

Goedgekeurde toepassingen

• Fluconazole tablets are 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, fluconazole tablets were also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia.
• Cryptococcal meningitis.

Vormen en sterktes

• Bottles of 30 NDC 65862-059-30 Bottles of 100 NDC 65862-059-01 Bottles of 500 NDC 65862-059-05 Fluconazole Tablets USP, 150 mg are pink mottled, biconvex, capsule shaped uncoated tablets with "C"...

Hoe het wordt ingenomen

• Dosage and Administration in Adults: Single Dose Vaginal candidiasis: The recommended dosage of fluconazole tablets for vaginal candidiasis is 150 mg as a single oral dose.
• Multiple Dose SINCE ORAL ABSORPTION IS RAPID AND ALMOST COMPLETE, THE DAILY DOSE OF FLUCONAZOLE IS THE SAME FOR ORAL 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 fluconazole tablets for the treatment of infections other than vaginal candidiasis should be based on the infecting organism and the patient's response to therapy.

Mag niet worden gebruikt bij

• Fluconazole tablets are contraindicated in patients who have shown hypersensitivity to fluconazole or to any of its excipients.
• There is no information regarding cross-hypersensitivity between fluconazole and other azole antifungal agents.
• Caution should be used in prescribing fluconazole tablets to patients with hypersensitivity to other azoles.
• Coadministration of other drugs known to prolong the QT interval and which are metabolized via the enzyme CYP3A4 such as erythromycin, pimozide, and quinidine are contraindicated in patients receiving fluconazole.

Interacties

• Drug Interaction Studies (See PRECAUTIONS, Drug Interactions) Oral contraceptives: Oral contraceptives were administered as a single dose both before and after the oral administration of fluconazole 50 mg once daily for 10 days in 10 healthy women.
• There was no significant difference in ethinyl estradiol or levonorgestrel AUC after the administration of 50 mg of fluconazole.
• The mean increase in ethinyl estradiol AUC was 6% (range: -47 to 108%) and levonorgestrel AUC increased 17% (range: -33 to 141%).
• In a second study, twenty-five normal females received daily doses of both 200 mg fluconazole tablets or placebo for two, ten-day periods.

Waarschuwingen en voorzorgen

• Hepatic injury: Fluconazole should be administered with caution to patients with liver dysfunction.
• Fluconazole has 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 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.

Vaak voorkomende bijwerkingen

• Fluconazole is generally well tolerated. In some patients, particularly those with serious underlying diseases such as AIDS and cancer, changes in renal and hematological function test results and hepatic abnormalities have been observed during treatment with fluconazole and comparative agents, but the clinical significance and relationship to treatment is uncertain.

Zwangerschap

Teratogenic Effects. Potential for Fetal Harm: Use in pregnancy should be avoided except in patients with severe or potentially life-threatening fungal infections in whom fluconazole may be used if the anticipated benefit outweighs the possible risk to the fetus. A few published case reports describe a pattern of distinct congenital anomalies in infants exposed in utero to high dose maternal fluconazole (400 to 800 mg/day) during most or all of the first trimester.

Werkingsmechanisme

Microbiology Mechanism of Action Fluconazole is a highly selective inhibitor of fungal cytochrome P450 dependent enzyme lanosterol 14-α-demethylase. This enzyme functions to convert lanosterol to ergosterol.

Handelsvergunninghouder:

Aurobindo Pharma Limited

Versie van de productinformatie:

14 november 2024

De secties hierboven zijn geciteerd uit de Engelstalige productinformatie, want dat is het document dat de goedkeuring draagt. Waar een Europese instantie dezelfde informatie in het Nederlands publiceert, staat de link bij de bronnen. Wij vertalen regelgevende teksten niet zelf: een vertaalfout in een contra-indicatie is gevaarlijker dan een regel in een vreemde taal.

Deze sectie geeft de goedgekeurde productinformatie weer. De formulering is ingedikt uit de samenvatting van de toezichthouder zelf, en het volledige document staat bij de bronnen.