Fluconazole
Visa No.: 893110906924
Product: Pyme FUCAN
API: Fluconazole
Product Category: Antifungal
Version approved leaflet: 614/QĐ-QLD_27/08/2024_209
INDICATIONS
Fluconazole is indicated for the treatment of the following fungal infections:
Adults - Treatment:
- Cryptococcal meningitis.
- Coccidioidomycosis.
- Cryptococcal meningitis.
- Coccidioides infection.
- Invasive Candida infections.
- Mucosal Candida infections, including oropharyngeal candidiasis, esophageal candidiasis, candiduria, and chronic mucocutaneous candidiasis.
- Chronic atrophic oral candidiasis (denture-related stomatitis) when oral hygiene measures or topical therapy are inadequate.
- Vaginal Candida infections, acute or chronic, when topical therapy is not appropriate.
- Candida balanitis, when topical therapy is not appropriate.
- Dermal fungal infections, including tinea pedis, tinea corporis, tinea cruris, pityriasis versicolor, and cutaneous Candida infections when systemic therapy is indicated.
- Onychomycosis when other medicinal products are considered inappropriate.
Adults – Prophylaxis
- Prevention of relapse of cryptococcal meningitis in patients at high risk of recurrence.
- Prevention of relapse of oropharyngeal or esophageal candidiasis in HIV-infected patients at high risk of recurrence.
- Reduction in the incidence of recurrent vaginal candidiasis (four or more episodes per year).
- Prevention of Candida infections in patients with prolonged neutropenia (such as patients with hematological malignancies receiving chemotherapy or patients undergoing hematopoietic stem cell transplantation).
Fluconazole is indicated for use in term neonates, infants, toddlers, children, and adolescents aged 0–17 years:
Fluconazole is used for the treatment of mucosal Candida infections (oropharyngeal and esophageal), invasive Candida infections, cryptococcal meningitis, and for the prevention of Candida infections in immunocompromised patients. Fluconazole may also be used as maintenance therapy to prevent relapse of cryptococcal meningitis in children at high risk of recurrence.
Treatment may be initiated before the results of cultures and other laboratory tests are available; however, once results are available, antifungal therapy should be adjusted accordingly. Official guidance on the appropriate use of antifungal agents should be consulted.
DOSAGE AND ADMINISTRATION
Dosage:
The dosage must be based on the nature and severity of the fungal infection. When treating fungal infections that require multiple-dose regimens, treatment should be continued until clinical parameters or laboratory tests indicate that the active fungal infection has resolved. Insufficient duration of treatment may result in relapse of active fungal infection. A product with an appropriate strength should be selected for each indication.
The capsule dosage form is not suitable for neonates and young children. An oral suspension formulation should be used for this population.
| Indication | Dose | Duration of treatment | |
| Cryptococcal infection | Treatment of cryptococcal meningitis | Loading dose: 400 mg on Day 1; Maintenance dose: 200–400 mg once daily | Usually 6–8 weeks. In cases of life-threatening fungal infection, the daily dose may be increased to 800 mg. |
| Maintenance treatment to prevent relapse of cryptococcal meningitis in patients at high risk of recurrence | 200mg x 1 once daily | No fixed duration; long-term treatment at a daily dose of 200 mg is recommended. | |
| Coccidioidomycosis | 200–400 mg once daily | 11–24 months or longer, depending on patient response. A dose of 800 mg/day may be considered in certain fungal infections, particularly meningeal involvement. | |
| Invasive Candida infection | Loading dose: 800 mg on Day 1 Maintenance dose: 400 mg once daily | In general, treatment is recommended for at least 2 weeks after documented clearance of Candida from the bloodstream and resolution of symptoms attributable to candidiasis. | |
| Mucosal Candidiasis | Oropharyngeal Candidiasis | Loading dose: 200–400 mg on Day 1 Maintenance dose: 100–200 mg once daily | 7–21 days (longer treatment may be required in patients with severe immunocompromise). |
| Esophageal Candidiasis | Loading dose: 200–400 mg on Day 1 Maintenance dose: 100–200 mg once daily | 14–30 days (longer treatment may be required in patients with severe immunocompromise). | |
| Candiduria | 200–400 mg once daily | 7–21 days; treatment duration may be extended in patients with severe immunocompromise. | |
| Chronic atrophic oral candidiasis | 50 mg once daily | 14 days | |
| Chronic mucocutaneous candidiasis | 50 – 100 mg x 1 lần/ngày | Up to 28 days. A longer duration of treatment may be required depending on the severity of fungal infection, the degree of immunosuppression, and the presence of pre-existing fungal infection. | |
| Prevention of relapse of mucosal candidiasis in HIV-infected patients at high risk of recurrence – | Oropharyngeal candidiasis | 100–200 mg once daily or 200 mg three times per week | No fixed duration in patients with chronic immunosuppression. |
| Oropharyngeal candidiasis | 100–200 mg once daily or 200 mg three times per week | No fixed duration in patients with chronic immunosuppression. | |
| Genital Candidiasis | Acute vulvovaginal candidiasis Acute Candida balanitis | 150 mg | Single dose. |
| Treatment and prophylaxis of recurrent vulvovaginal candidiasis (≥4 episodes/year) | 150 mg once daily for 3 days (Days 1, 4, and 7), followed by 150 mg once weekly | Maintenance treatment: 6 months. | |
| Cutaneous Fungal Infections | Tinea pedis (athlete’s foot) Tinea corporis Tinea cruris Cutaneous candidiasis | 150 mg once weekly or 50 mg once daily | 2–4 weeks; treatment may be extended up to 6 weeks for tinea pedis. |
| Tinea versicolor (pityriasis versicolor) | 300–400 mg once weekly | 1–3 weeks. | |
| 50 mg x once daily | 2 – 4 weeks | ||
| Onychomycosis | 150 mg once weekly | Treatment should be continued until the infected nail is replaced by new nail growth (mycological cure). Nail regrowth usually requires 3–6 months for fingernails and 6–12 months for toenails. The rate of nail growth varies among inpiduals and with age. After treatment of long-standing chronic infections, nails may remain deformed. | |
| Prophylaxis of Candida infections in patients with prolonged neutropenia | 200 – 400 mg once daily | Treatment should be initiated several days before the anticipated onset of neutropenia and continued for 7 days after recovery from neutropenia, once the neutrophil count has risen above 1,000 cells/mm³. | |
Special population
Elderly:
The dosage should be adjusted based on renal function (see the dosage table for patients with renal impairment below).
Renal impairment:
Fluconazole is predominantly excreted in the urine as unchanged active substance. No dosage adjustment is required for single-dose therapy. In patients (including paediatric patients) with impaired renal function who require multiple-dose treatment, an initial loading dose of 50–400 mg should be administered, based on the recommended daily dose for the indication. Following this initial loading dose, the daily dose (according to indication) should be adjusted according to the table below.
| Creatinin clearnace (ml/min) | Percentage of recommended dose |
| > 50 | 100% |
| ≤ 50 (not receiving haemodialysis) | 50% |
| Haemodialysis | 100% after each haemodialysis session |
Patients receiving haemodialysis should be administered 100% of the recommended dose after each haemodialysis session. On non-dialysis days, the dose should be reduced according to creatinine clearance.
Hepatic Impairment
Data in patients with hepatic impairment are limited; therefore, fluconazole should be used with caution in patients with liver dysfunction.
Paediatric Population
- The maximum daily dose of 400 mg should not be exceeded in paediatric patients.
- As with similar infections in adults, the duration of treatment should be based on clinical and mycological response. Fluconazole should be administered as a single daily dose.
- In paediatric patients with renal impairment, refer to the dosage recommendations for patients with renal impairment. The pharmacokinetics of fluconazole have not been studied in paediatric patients with renal impairment. In term neonates, renal function is often not fully developed (see below).
- Neonates, Infants, and Children (from 28 days to 11 years)
| Indication | Dose | Recommendations |
| Mucosal candidiasis | Loading dose: 6 mg/kg once daily Maintenance dose: 3 mg/kg once daily | A loading dose may be used on the first day to achieve steady-state concentrations more rapidly. |
| Invasive candidiasis Cryptococcal meningitis | 6–12 mg/kg once daily | Depending on the severity of the infection. |
| Maintenance therapy to prevent relapse of cryptococcal meningitis in children at high risk of recurrence | 6 mg/kg once daily | Depending on the severity of the disease. |
| Prophylaxis of Candida infections in immunocompromised patients | 3–12 mg/kg once daily | Depending on the degree and duration of neutropenia due to cytotoxic chemotherapy (see adult dosing). |
- Adolescents (12–17 years of age)
- Depending on body weight and pubertal development, the prescriber should assess whether the adult dose or the paediatric dose is the most appropriate. Clinical data indicate that children have a higher fluconazole clearance than that observed in adults. To achieve comparable systemic exposure, an adult dose of 100, 200, and 400 mg corresponds respectively to 3, 6, and 12 mg/kg in paediatric patients.
- The safety and efficacy of fluconazole for the treatment of genital Candida infections in the paediatric population have not been established. Available safety data for other paediatric indications are described in section Undesirable effects. If treatment of genital Candida infection is considered necessary in adolescents (12–17 years of age), the dosage should be the same as that used in adults.
- Term Neonates (0–27 days of age): Neonates eliminate fluconazole slowly. There are limited pharmacokinetic data to support dosing in term neonates (see section Pharmacokinetic properties).
| Age group | Dose | Recommendations |
| Term neonates (0–14 days of age) | mg/kg dose as for infants and children, administered every 72 hours | The maximum dose of 12 mg/kg every 72 hours should not be exceeded. |
| Term neonates (15–27 days of age) | mg/kg dose as for infants and children, administered every 48 hours | The maximum dose of 12 mg/kg every 48 hours should not be exceeded. |
Method of Administration:
Fluconazole may be administered orally (capsules) or by intravenous infusion (solution for infusion). The route of administration should be determined by the clinical condition of the patient. When switching from intravenous to oral administration, or vice versa, no change in the daily dose is required.
Capsules should be swallowed whole and taken independently of meals.
CONTRAINDICATIONS
Hypersensitivity to fluconazole, to related azole compounds, or to any component of the product.
Based on the results of a multiple-dose interaction study, concomitant use with terfenadine is contraindicated in patients receiving fluconazole at doses of 400 mg/day or higher.
Concomitant use of fluconazole with medicinal products that prolong the QT interval and are metabolized via cytochrome P450 (CYP) 3A4 is contraindicated, such as cisapride, astemizole, pimozide, quinidine, and erythromycin.
WARNINGS AND PRECAUTIONS
Prescription only medicine. Read the instructions before use. Consult a physician or pharmacist if needed.
Keep out of the reach of children.
