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MYLAN-FLUCONAZOLE is a brand name for Fluconazole, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Treatment MYLAN-FLUCONAZOLE (fluconazole) is indicated for the treatment of: 1. Oropharyngeal and esophageal candidiasis. MYLAN-FLUCONAZOLE is also effective for the treatment of serious systemic candidal infections, including urinary tract infection, peritonitis, and pneumonia. 2. Cryptococcal meningitis. 3.…
Verbatim from this product's HC label. Tap a section to expand.
MYLAN-FLUCONAZOLE is only available in tablets of 50 mg and 100 mg. 1 Dosing Considerations Fluconazole is well absorbed and excreted predominantly unchanged in urine following oral administration in humans. The oral bioavailability is essentially complete (greater than 90%), and is independent of dose.
Peak plasma concentrations after oral administration are attained rapidly, usually within 2 hours of dosing. Since oral absorption is rapid and almost complete, the daily dose of fluconazole is the same for oral tablets and suspension, and intravenous administration.
The terminal plasma elimination half-life is approximately 30 hours (range 20-50 hours). The daily dose of MYLAN-FLUCONAZOLE and the route of administration should be based on the infecting organism, the patient’s condition and the response to therapy.
Treatment should be continued until clinical parameters and laboratory tests indicate that an active fungal infection has been cured or has subsided. An inadequate period of treatment may lead to recurrence of active infection. Patients with AIDS and cryptococcal meningitis or recurrent oropharyngeal candidiasis usually require maintenance therapy to prevent relapse.
IN THE DOSING INSTRUCTIONS BELOW, THE DAILY DOSE OF FLUCONAZOLE IS THE SAME FOR ORAL (TABLETS AND SUSPENSION) AND INTRAVENOUS ADMINISTRATION SINCE ORAL ABSORPTION IS RAPID AND ALMOST COMPLETE. 2 Recommended Dose and Dosage Adjustment RECOMMENDED DOSAGES IN ADULTS AND CHILDREN (also see 10 CLINICAL PHARMACOLOGY) TREATMENT Loading Dose Administration of a loading dose on the first day of treatment, consisting of twice the usual daily dose, results in plasma concentrations close to steady state by the second day.
Patients with acute infections should be given a loading dose equal to twice the daily dose, not to exceed a maximum single dose of 400 mg in adults or 12 mg/kg in children, on the first day of treatment. MYLAN-FLUCONAZOLE (Fluconazole Tablets) Page 6 of 50 Dosage Equivalency Scheme Pediatric Patients Adults 3 mg/kg 100 mg 6 mg/kg 200 mg 12 mg/kg* 400 mg * Some older children may have clearances similar to that of adults.
Absolute doses exceeding 600 mg/day are not recommended. Recommended Treatment Guidelines Indication Adults Children Oropharyngeal Candidiasis 100 mg once daily for at least 2 weeks to decrease the likelihood of relapse. 3 mg/kg once daily for at least 2 weeks to decrease the likelihood of relapse.
). Driving and Operating Machinery When driving vehicles or operating machines it should be taken into account that occasionally dizziness or seizures may occur. , ketoconazole). Reversible cases of adrenal insufficiency were reported in patients while receiving fluconazole or when fluconazole was discontinued (see
05/2023 9 DRUG INTERACTIONS 05/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ..........................................................................................................
2 TABLE OF CONTENTS ............................................................................................................................ 2 PART I: HEALTH PROFESSIONAL INFORMATION ...................................................................................
4 1 INDICATIONS..................................................................................................................................... 1 Pediatrics ............................................................................................................................................
2 Geriatrics............................................................................................................................................. 4 2 CONTRAINDICATIONS .......................................................................................................................
5 4 DOSAGE AND ADMINISTRATION ....................................................................................................... 1 Dosing Considerations ........................................................................................................................
2 Recommended Dose and Dosage Adjustment ................................................................................... 4 Missed Dose........................................................................................................................................
8 5 OVERDOSAGE ................................................................................................................................... 8 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .......................................................
MYLAN-FLUCONAZOLE (fluconazole) is contraindicated in patients who have shown hypersensitivity to fluconazole, to any of its excipients or to related azole compounds. For a complete listing (see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING).
Co-administration of 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 (see 9 DRUG INTERACTIONS).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Esophageal Candidiasis 100 mg to 200 mg once daily for a minimum of 3 weeks, and for at least 2 weeks following resolution of symptoms. 3 mg/kg to 6 mg/kg once daily for a minimum of 3 weeks, and for at least 2 weeks following resolution of symptoms.
Systemic Candidiasis (Candidemia and Disseminated Candidal Infections) 200 mg to 400 mg once daily for a minimum of 4 weeks, and for at least 2 weeks following resolution of symptoms. 6 mg/kg to 12 mg/kg per day have been used in an open, non- comparative study of a small number of patients.
Cryptococcal Meningitis 200 mg to 400 mg once daily. The duration of therapy for cryptococcal meningitis is unknown, it is recommended that the initial therapy should last a minimum of 10 weeks. 6 mg/kg to 12 mg/kg once daily. The recommended duration for initial therapy is 10-12 weeks after the cerebrospinal fluid becomes culture-negative.
Prevention of Recurrence of Cryptococcal Meningitis in Patients with AIDS 200 mg once daily. 6 mg/kg once daily. PREMATURE NEONATES Experience with fluconazole in neonates is limited to pharmacokinetic studies in premature newborns (see 10 CLINICAL PHARMACOLOGY).
Based upon the prolonged half-life seen in premature newborns (gestation age 26 to 29 weeks), these children, in the first two weeks of life, should receive the same dosage (mg/kg) as in older children, but administered every 72 hours.
After the first 2 weeks, these children should be dosed once daily. NEONATES No information regarding fluconazole pharmacokinetics in full-term newborns is available. PROPHYLAXIS IN ADULT PATIENTS MYLAN-FLUCONAZOLE (Fluconazole Tablets) Page 7 of 50 The recommended MYLAN-FLUCONAZOLE daily dosage for the prevention of candidiasis in adult patients undergoing bone marrow transplantation is 400 mg once daily.
Patients who are anticipated to have severe granulocytopenia (less than 500 neutrophils/mm3) should start MYLAN-FLUCONAZOLE prophylaxis several days before the anticipated onset of neutropenia and continue for 7 days after the neutrophil count rises above 1000 cells/mm3.
DOSAGE IN PATIENTS WITH IMPAIRED RENAL FUNCTION Adults Fluconazole is cleared primarily by renal excretion as unchanged drug. In patients with impaired renal function, an initial loading dose of 50 mg to 400 mg should be given (for children, see below).
34 (no dialysis) 25 Hemodialysis Hemodialysis 100 after each hemodialysis Patients on hemodialysis should receive 100% of the recommended dose after each hemodialysis; on non-dialysis days, patients should receive a reduced dose according to their creatinine clearance.
When serum creatinine is the only measure of renal function available, the following formula (based on sex, weight, and age of the patient) should be used to estimate the creatinine clearance. 85 x above value Children Although the pharmacokinetics of fluconazole have not been studied in children with renal insufficiency, dosage reduction in children with renal insufficiency […]
8 7 WARNINGS AND PRECAUTIONS ........................................................................................................ 1 Special Populations ...........................................................................................................................
1 Pregnant Women........................................................................................................................... 2 Breast-feeding ...............................................................................................................................
3 Pediatrics ....................................................................................................................................... 11 8 ADVERSE REACTIONS ......................................................................................................................
1 Adverse Reaction Overview .............................................................................................................. 2 Clinical Trial Adverse Reactions ........................................................................................................
1 Clinical Trial Adverse Reactions – Pediatrics ................................................................................. 3 Less Common Clinical Trial Adverse Reactions .................................................................................
4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data ..... 5 Post-Market Adverse Reactions .......................................................................................................
15 9 DRUG INTERACTIONS ...................................................................................................................... 2 Drug Interactions Overview ..............................................................................................................
4 Drug-Drug Interactions ..................................................................................................................... 5 Drug-Food Interactions .....................................................................................................................
6 Drug-Herb Interactions ..................................................................................................................... 7 Drug-Laboratory Test Interactions ...................................................................................................
27 10 CLINICAL PHARMACOLOGY ........................................................................................................... 1 Mechanism of Action ......................................................................................................................
2 Pharmacodynamics......................................................................................................................... 3 Pharmacokinetics ...........................................................................................................................
28 11 STORAGE, STABILITY AND DISPOSAL ............................................................................................. 32 PART II: SCIENTIFIC INFORMATION ....................................................................................................
33 13 PHARMACEUTICAL INFORMATION ................................................................................................ 33 14 CLINICAL TRIALS ............................................................................................................................
1 Trial Design and Study Demographics ............................................................................................ 2 Study Results […]