DIFLUCAN Tablet / Oral suspension (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

Roerig

Λέξεις κλειδιά

0049-3410 0049-3420 0049-3430 0049-3440 0049-3450 0049-3500

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1. Description

DIFLUCAN (fluconazole), the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration, as a powder for oral suspension. Fluconazole is designated ...

2. Clinical Pharmacology

Pharmacokinetics and Metabolism The pharmacokinetic properties of fluconazole are similar following administration by the intravenous or oral routes. In normal volunteers, the bioavailability of orally ...

3. Indications and Usage

DIFLUCAN (fluconazole) is indicated for the treatment of: Vaginal candidiasis (vaginal yeast infections due to <em>Candida</em>). Oropharyngeal and esophageal candidiasis. In open noncomparative studies ...

4. Contraindications

DIFLUCAN (fluconazole) is contraindicated in patients who have shown hypersensitivity to fluconazole or to any of its excipients. There is no information regarding cross-hypersensitivity between fluconazole ...

5. Warnings

<u>Hepatic injury:</u> DIFLUCAN should be administered with caution to patients with liver dysfunction. DIFLUCAN has been associated with rare cases of serious hepatic toxicity, including fatalities primarily ...

6.1. General

General Some azoles, including fluconazole, have been associated with prolongation of the QT interval on the electrocardiogram. Fluconazole causes QT prolongation via the inhibition of Rectifier Potassium ...

6.4. Drug Interactions

(See CONTRAINDICATIONS). Fluconazole is a moderate CYP2C9 and CYP3A4 inhibitor. Fluconazole is also a strong inhibitor of CYP2C19. Patients treated with DIFLUCAN, who are also concomitantly treated with ...

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

Fluconazole showed no evidence of carcinogenic potential in mice and rats treated orally for 24 months at doses of 2.5 mg/kg/day, 5 mg/kg/day, or 10 mg/kg/day (approximately 2 to 7 times the recommended ...

6.7. Pregnancy

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 ...

6.9. Nursing Mothers

Fluconazole was present in low levels in breast milk following administration of a single 150 mg dose, based on data from a study in 10 breastfeeding women who temporarily or permanently discontinued breastfeeding ...

6.10. Pediatric Use

An open-label, randomized, controlled trial has shown DIFLUCAN to be effective in the treatment of oropharyngeal candidiasis in children 6 months to 13 years of age (See CLINICAL STUDIES). The use of DIFLUCAN ...

6.11. Geriatric Use

In non-AIDS patients, side effects possibly related to fluconazole treatment were reported in fewer patients aged 65 and older (9%, n =339) than for younger patients (14%, n=2240). However, there was no ...

7. Adverse Reactions

DIFLUCAN 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 ...

9. Overdosage

There have been reports of overdose with fluconazole accompanied by hallucination and paranoid behavior. In the event of overdose, symptomatic treatment (with supportive measures and gastric lavage if ...

10. Dosage and Administration

Dosage and Administration in Adults Single Dose Vaginal candidiasis The recommended dosage of DIFLUCAN for vaginal candidiasis is 150 mg as a single oral dose. Multiple Dose SINCE ORAL ABSORPTION IS RAPID ...

11. How Supplied

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 ...

13. Clinical Studies

Cryptococcal meningitis In a multicenter study comparing DIFLUCAN (200 mg/day) to amphotericin B (0.3 mg/kg/day) for treatment of cryptococcal meningitis in patients with AIDS, a multivariate analysis ...

12. Storage and Handling

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 ...