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FLUCONAZOLE is a brand name for Fluconazole. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Fluconazole is indicated in the following fungal infections (see section 5.1). Fluconazole is indicated in adults for the treatment of: • Cryptococcal meningitis (see section 4.4). • Coccidioidomycosis (see section 4.4). • Invasive candidiasis. • Mucosal candidiasis including oropharyngeal, oesophageal candidiasis,…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology The dose should be based on the nature and severity of the fungal infection. Treatment of infections requiring multiple dosing should be continued until clinical parameters or laboratory tests indicate that active fungal infection has subsided.
An inadequate period of treatment may lead to recurrence of active infection. Adults Indications Posology Duration of treatment - Treatment of cryptococcal meningitis Loading dose: 400 mg on Day 1 Subsequent dose: 200 mg to 400 mg once daily Usually at least 6 to 8 weeks.
In life threatening infections the daily dose can be increased to 800 mg Cryptococcosis - Maintenance therapy to prevent relapse of cryptococcal meningitis in patients with high risk of recurrence. 200 mg once daily Indefinitely at a daily dose of 200 mg Coccidioidomycosis 200 mg to 400 mg once daily 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 once 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 once daily 7 to 21 days (until oropharyngeal candidiasis is in remission). Longer periods may be used in patients with severely compromised immune function Treatment of mucosal candidiasis - Oesophageal candidiasis Loading dose: 200 mg to 400 mg on Day 1 Subsequent dose: 100 mg to 200 mg once 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 once daily 7 to 21 days. Longer periods may be used in patients with severely compromised immune function. - Chronic atrophic candidiasis 50 mg once daily 14 days - Chronic mucocutaneous candidiasis 50 mg to 100 mg once daily Up to 28 days.
Longer periods depending on both the severity of infection or underlying immune compromisation and infection - Oropharyngeal candidiasis 100 mg to 200 mg once daily or 200 mg 3 times per week. An indefinite period for patients with chronic immune suppression Prevention of relapse of mucosal candidiasis in patients infected with HIV who are at high risk of experiencing relapse - Oesophageal candidiasis 100 mg to 200 mg once 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.
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):
Neonates excrete fluconazole slowly. 2). Age group Posology Recommendations Term newborn infants (0 The same mg/kg dosing as A maximum dosage of 12 to 14 days) for infants, toddlers and mg/kg every 72 hours children should be used but should not be exceeded administered every 72 hours Term newborn infants The same mg/kg dosing as A maximum dosage of (from 15 to 27 days) for infants, toddlers and 12mg/kg every 48 hours children should be used but should not be exceeded administered every 48 hours Method of administration Fluconazole can be taken with or without food.
6. The reconstituted suspension will provide a white to off-white orange- flavoured suspension after reconstitution. For dose conversion of the powder for oral suspension from mg/ml to ml/kg body weight (BW) for paediatric patients, see section 6 For adult patients, please calculate the dose in ml to administer according to the posology in mg recommended and the product strength.
1. Coadministration of terfenadine is contraindicated in patients receiving Fluconazole at multiple doses of 400 mg per day or higher based upon results of a multiple dose interaction study. 5). albicans. g. C. auris) or show reduced susceptibility to fluconazole (C.
glabrata). Such infections may require alternative antifungal therapy secondary to treatment failure. Therefore, prescribers are advised to take into account the prevalence of resistance in various Candida species to fluconazole. 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.
albicans. g. C. auris) or show reduced susceptibility to fluconazole (C. glabrata). Such infections may require alternative antifungal therapy secondary to treatment failure. Therefore, prescribers are advised to take into account the prevalence of resistance in various Candida species to fluconazole.
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.
2). 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'. 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, duration of therapy, sex or age of 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.
1. Coadministration of terfenadine is contraindicated in patients receiving Fluconazole at multiple doses of 400 mg per day or higher based upon results of a multiple dose interaction study. 5).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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- 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 - tinea versicolor 300 mg to 400 mg once weekly 1 to 3 weeks 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.
Special populations Elderly Dosage should be adjusted based on the renal function (see “Renal impairment”). Renal impairment Fluconazole is predominantly excreted in the urine as unchanged active substance. No adjustments in single dose therapy are necessary.
In patients (including paediatric population) with impaired renal function who will receive multiple doses of fluconazole, an initial dose of 50 mg to 400 mg should be given, based on the recommended daily dose for the indication. After this initial loading dose, the daily dose (according to indication) should be based on the following table: Patients on 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) Paediatric population A maximum dose of 400 mg daily should not be exceeded in 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.
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: 6mg/kg Subsequent dose: 3 mg/kg once daily Initial dose may be used on the first day to achieve steady state levels more rapidly.
Creatinine clearance (ml/min) Percent of recommended dose > 50 100% ≤ 50 (no haemodialysis) 50% Haemodialysis 100% after each haemodialysis -Invasive candidiasis -Cryptococcal meningitis 6-12 mg/kg once daily Depending on the severity of the disease Prophylaxis of Candida in […]
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.
2). 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'. 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, duration of therapy, sex or age of 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.
Cardiovascular system 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 Channel current (Ikr).
The QT prolongation caused by other medicinal products (such as amiodarone) may be amplified via the inhibition of cytochrome P450 (CYP) 3A4. During post- marketing surveillance, there have been very rare cases of QT prolongation and torsades de pointes in patients taking Fluconazole.
These reports included seriously ill patients with multiple confounding risk factors, such as structural heart disease, electrolyte abnormalities and concomitant treatment that may have been contributory. Patients with hypokalemia and advanced cardiac failure are at an increased risk for the occurrence of life threatening ventricular arrhythmias and torsades de pointes.
Fluconazole should be administered with caution to patients with potentially proarrhythmic conditions. 5). Halofantrine Halofantrine has been shown to prolong QTc interval at the recommended therapeutic dose and is a substrate of CYP3A4.
5). Dermatological reactions Patients have rarely developed exfoliative […]
Cardiovascular system 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 Channel current (Ikr).
The QT prolongation caused by other medicinal products (such as amiodarone) may be amplified via the inhibition of cytochrome P450 (CYP) 3A4. During post- marketing surveillance, there have been very rare cases of QT prolongation and torsades de pointes in patients taking Fluconazole.
These reports included seriously ill patients with multiple confounding risk factors, such as structural heart disease, electrolyte abnormalities and concomitant treatment that may have been contributory. Patients with hypokalemia and advanced cardiac failure are at an increased risk for the occurrence of life threatening ventricular arrhythmias and torsades de pointes.
Fluconazole should be administered with caution to patients with potentially proarrhythmic conditions. 5). Halofantrine Halofantrine has been shown to prolong QTc interval at the recommended therapeutic dose and is a substrate of CYP3A4.
5). 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 severe cutaneous reactions to many medicinal products. If a rash, which is considered attributable to fluconazole, develops in a patient treated for a superficial fungal infection, further therapy with this medicinal product should be discontinued.
If patients with invasive/systemic fungal infections develop rashes, they should be monitored closely and fluconazole discontinued if bullous lesions or erythema multiforme develop. 3). Cytochrome P450 Fluconazole is a moderate CYP2C9 and CYP3A4 inhibitor.
Fluconazole is also a strong inhibitor of CYP2C19. 5). 5). Excipients Fluconazole 50 mg/5 ml powder for oral suspension contains respectively 2881 mg/5 ml of sucrose as an excipient. This should be taken into account in patients with diabetes mellitus.
Patients with rare hereditary problems of fructose intolerance, glucose/galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. The medicinal product may be harmful to teeth if used for periods of longer than 2 weeks.
e. essentially ‘sodium-free’. 8mg sodium benzoate per 5ml. Sodium benzoate may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks old).