Loading…
FLUCONAZOLE is a brand name for Fluconazole. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Therapy may be started before the results of the cultures and other laboratory studies are known; however, once results become available, anti-infective therapy should be adjusted accordingly. Fluconazole is indicated in adults for the treatment of the following conditions: Genital candidiasis. Vaginal candidiasis,…
Verbatim from this product's MHRA label. Tap a section to expand.
Method of administrati on Fluconazole is administered orally. The capsules should be swallowed whole and independent of food intake. Posology The daily dose of fluconazole should be based on the nature and severity of the fungal infection.
Most cases of vaginal candidiasis respond to single dose therapy. Therapy for those types of infections requiring multiple dose treatment should be continued until clinical parameters or laboratory tests indicate that active fungal infection has subsided.
An inadequate period of treatment may lead to the recurrence of active infection. Patients with AIDS and cryptococcal meningitis usually require maintenance therapy to prevent relapse. Adults Indications Posology Duration of treatment Cryptococcosis - Treatment of cryptococcal meningitis.
Loading dose: 400 mg on Day 1 Subsequent dose: 200 mg to 400 mg daily Usually at least 6 to 8 weeks. In life threatening infections the daily dose can be increased to 800 mg - Maintenance therapy to prevent relapse of cryptococcal meningitis in patients with high risk of recurrence.
200 mg daily Indefinitely at a daily dose of 200 mg Coccidioidomycosis 200 mg to 400 mg 11 months up to 24 months or longer depending on the patient. 800 mg daily may be considered for some infections and especially for meningeal disease Invasive candidiasis Loading dose: 800 mg on Day 1 Subsequent dose: 400 mg daily In general, the recommended duration of therapy for candidemia is for 2 weeks after first negative blood culture result and resolution of signs and symptoms attributable to candidemia.
- Oropharyngeal candidiasis Loading dose: 200 mg to 400 mg on Day 1 Subsequent dose: 100 mg to 200 mg daily 7 to 21 days (until oropharyngeal candidiasis is in remission). Longer periods may be used in patients with severely compromised immune function - Oesophageal candidiasis Loading dose: 200 mg to 400 mg on Day 1 Subsequent dose: 100 mg to 200 mg daily 14 to 30 days (until oesophageal candidiasis is in remission).
Longer periods may be used in patients with severely compromised immune function - Candiduria 200 mg to 400 mg daily 7 to 21 days. Longer periods may be used in patients with severely compromised immune function. - Chronic atrophic candidiasis 50 mg daily 14 days Treatment of mucosal candidiasis -Chronic mucocutaneous candidiasis 50 mg to 100 mg daily Up to 28 days.
8. If treatment for genital candidiasis is imperative in adolescents (from 12 to 17 years old), the posology should be the same as adults posology. Term newborn infants (0 to 27 days): (capsule form not suitable for this age group) Neonates excrete fluconazole slowly.
In the first two weeks of life the same mg/kg dosing as in infants, toddlers and older children should be used but administered every 72 hours. During weeks 2 – 4 of life the same dosing as in older children should be used but administered every 48 hours.
A maximum dosage of 12 mg/kg every 72 hours should not be exceeded in children in the first two weeks of life. For children between 2 – 4 weeks of life 12 mg/kg every 48 hours should not be exceeded. For children with impaired renal function the daily dose should be reduced in accordance with the guidelines given for adults.
To facilitate accurate measurement of doses less than 10 mg, fluconazole should only be administered to children in hospital using preparations available as oral suspension or intravenous infusion, depending on the clinical condition of the child.
On transferring from the intravenous to the oral route, or vice versa, there is no need to change the daily dose. The physician should prescribe the most appropriate pharmaceutical dorm and strength according to age, weight and dose.
The capsule formulation is not adapted for use in infants and small children. Oral liquid formulation of fluconazole are available that are more suitable in this population. Special populations Elderly The normal dose should be used if there is no evidence of renal impairment.
In patients with renal impairment (creatinine clearance less than 50 ml/min) the dosage schedule should be adjusted as described below. Use in renal impairment Fluconazole is excreted predominantly in the urine as unchanged drug. No adjustments in single dose therapy are required.
Adrenal insufficiency Ketoconazole is known to cause adrenal insufficiency, and this could also, although rarely seen, be applicable to fluconazole. Adrenal insufficiency relating to concomitant treatment with Prednisone is described in section
1. Co-administration with terfenadine is contra-indicated in patients receiving fluconazole at multiple doses of 400mg per day or higher based on results of a multiple dose interaction study. 5). Fluconazole should not be used in patients with Porphyria.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Fluconazole in United Kingdom.
Know a brand we are missing in United Kingdom? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Longer periods depending on both the severity of infection or underlying immune compromisation and infection Prevention of relapse of mucosal candidiasis in - Oropharyngeal candidiasis 100 mg to 200 mg daily or 200 mg 3 times per week An indefinite period for patients with chronic immune suppression patients infected with HIV who are at high risk of experiencing relapse - Oesophageal candidiasis 100 mg to 200 mg daily or 200 mg 3 times per week An indefinite period for patients with chronic immune suppression - Acute vaginal candidiasis - Candidal balanitis 150 mg Single doseGenital candidiasis - Treatment and prophylaxis of recurrent vaginal candidiasis (4 or more episodes a year).
150 mg every third day for a total of 3 doses (day 1, 4, and 7) followed by 150 mg once weekly maintenance dose Maintenance dose: 6 months. - tinea pedis, - tinea corporis, - tinea cruris, - candida infections 150 mg once weekly or 50 mg once daily 2 to 4 weeks, tinea pedis may require treatment for up to 6 weeks 300 mg to 400 mg once weekly 1 to 3 weeks- tinea versicolor 50 mg once daily 2 to 4 weeks Dermatomycosis - tinea unguium(onychomycosis) 150 mg once weekly Treatment should be continued until infected nail is replaced (uninfected nail grows in).
Regrowth of fingernails and toenails normally requires 3 to 6 months and 6 to 12 months, respectively. However, growth rates may vary widely in individuals, and by age. After successful treatment of long- term chronic infections, nails occasionally remain disfigured.
Prophylaxis of candidal infections in patients with prolonged neutropenia 200 mg to 400 mg once daily Treatment should start several days before the anticipated onset of neutropenia and continue for 7 days after recovery from neutropenia after the neutrophil count rises above 1000 cells per mm3.
Paediatric population As with similar infections in adults, the duration of treatment is based on the clinical and mycological response. Fluconazole is administered as a single daily dose each day. A maximum dose of 400mg daily should not be exceeded in paediatric population.
For paediatric patients with impaired renal function, see dosing in “Renal impairment”. The pharmacokinetics of fluconazole has not been studied in paediatric population with renal insufficiency (for “Term newborn infants” who often exhibit primarily renal immaturity please see below).
Infants, toddlers and children (from 28 days to 11 years old):
Indication Posology Recommendations - Mucosal candidiasis Initial dose: 6 mg/kg Subsequent dose: 3 mg/kg daily Initial dose may be used on the first day to achieve steady state levels more rapidly - Invasive candidiasis - Cryptococcal meningitis - Maintenance therapy to prevent relapse of cryptococcal meningitis in children with high risk of recurrence - Prophylaxis of Candida in immunocompromised patients Dose: 6 to 12 mg/kg daily Depending on the severity of the disease Dose: 6 mg/kg daily Depending on the severity of the disease Dose: 3 to 12 mg/kg daily Depending on the extent and duration of the induced neutropenia (see Adults posology) Prevention of fungal infections in immunocompromised patients considered at risk as a consequence of neutropenia following cytotoxic chemotherapy or radiotherapy: The dose should be 3 – 12 mg/kg daily, depending on the extent and duration of the induced neutropenia (see adult dosing).
A maximum dosage of 400 mg daily should not be exceeded. Despite extensive data supporting the use of fluconazole in children there are limited data available on the use of fluconazole for genital candidiasis in children below 16 years.
Use at present is […]
In patients (including paediatric population) with impaired renal function who will receive multiple doses of fluconazole, the normal recommended dose (according to indication) 50 mg to 400 mg as an initial dose should be given on day 1, followed by a daily dose based on the following table: Creatinine clearance Percent of recommended dose > 50 100 % ≤ 50 (no dialysis) 50 % Patients receiving regular 100% after each dialysis Patients on regular dialysis (haemodialysis)should receive 100% of the recommended dose after each haemodialysis; on non- dialysis days, patients should receive a reduced dose according to their creatinine clearance.
8). 1. Co-administration with terfenadine is contra-indicated in patients receiving fluconazole at multiple doses of 400mg per day or higher based on results of a multiple dose interaction study. 5). Fluconazole should not be used in patients with Porphyria.
4 Special warnings and precautions for use Adrenal insufficiency Ketoconazole is known to cause adrenal insufficiency, and this could also, although rarely seen, be applicable to fluconazole. 5. The effect of fluconazole on other medicinal products.
Tinea capitis Fluconazole has been studied for treatment of tinea capitis in children. It was shown not to be superior to griseofulvin and the overall success rate was less than 20%. Therefore, Fluconazole should not be used for tinea capitis.
g. pulmonary and cutaneous cryptococcosis) is limited, which prevents dosing recommendations. Deep endemic mycoses The evidence for efficacy of fluconazole in the treatment of other forms of endemic mycoses such as paracoccidioidomycosis, lymphocutaneous sporotrichosis and histoplasmosis is limited, which prevents specific dosing recommendations.
Hepatobiliary System 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 of fluconazole, duration of therapy, sex or age of the patient has been observed. Fluconazole hepatotoxicity has usually been reversible on discontinuation of therapy.
Patients who develop abnormal liver function tests during fluconazole therapy must be monitored closely for the development of more serious hepatic injury. The patient should be informed of suggestive symptoms of serious hepatic effect (important asthenia, anorexia, persistent nausea, vomiting and jaundice).
Treatment of fluconazole should be immediately discontinued and the patient should consult a physician. Dermatological Reactions Patients have rarely developed exfoliative cutaneous reactions, such as Stevens- Johnson Syndrome and toxic epidermal necrolysis, during treatment with fluconazole.
Drug reaction with eosinophilia and systemic symptoms (DRESS) has been reported. AIDS patients are more prone to the development of more severe cutaneous reactions to many medicinal drugs. If a rash, which is considered attributable to fluconazole, develops in a patient treated for a superficial fungal infection, further therapy with this […]