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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: Adults Treatment of mycoses caused by Candida, Cryptococci and other susceptible yeasts, in particular: • Systemic candidiasis (including disseminated deep infections and peritonitis) • Severe mucosal candidiasis (including oropharyngeal candidiasis, oesophageal candidiasis and non-invasive bronchopulmonary…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Treatment with fluconazole should be initiated by a physician experienced in the management of invasive fungal infections. The dose is dependent on the type and severity of the infection. The treatment of infections requiring multiple-dosing must be continued until clinical parameters or laboratory results show that the active infection has declined.
An insufficient treatment period may lead to recurrence of the active infection. Fluconazole is also available for oral therapy. The patient should be switched from dosing by the intravenous route to dosing by the oral route as soon as possible.
It is not necessary to change the daily dose of fluconazole when changing the route of administration from intravenous to oral. Adults Please refer to Table 1 for specific dosage recommendations. Elderly The normal adult dose should be given if there is no evidence of renal impairment.
Please refer to Table 1. Table 1 - Guidance On The Dose To Administer For An Adult Treated By The Intravenous Route Treatment with fluconazole should be initiated by a physician experienced in the management of invasive fungal infections.
Indication Initial daily dose (mg) Subsequent daily dose (mg) Recommended duration of treatment Additional guidance Invasive candidiasis - Candidaemia, disseminated candidiasis and other forms of invasive candida infection 800 400 Dependent upon clinical response 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 of candidema.
Severe mucosal candidiasis Use only when oral dosing is not possible. - Oropharyngeal candidiasis - Oesophageal candidiasis - Candiduria - Chronic atrophic candidiasis - Chronic mucocutaneous candidiasis 200-400 200-400 200-400 50 50-100 100-200 100-200 200-400 50 50-100 7-21 days 14-30 days 7-21 days 14 days up to 28 days Use until oropharyngeal candidiasis is in remission.
Longer periods may be used in patients with severely compromised immune function. Use until oesophageal candidiasis is in remission. Longer periods may be used in patients with severely compromised immune function. Longer periods may be used in patients with severely compromised immune function.
Longer periods depending on both the severity of infection or underlying immune compromisation and infection. Prevention of relapse in patients infected with HIV who are at high risk of relapse - Oropharyngeal candidiasis - Oesophageal candidiasis 100-200 100-200 100-200 daily or 200 3 times per week 100-200 daily or 200 3 times per week Indefinitely Indefinitely Treatment may be for an indefinite period for patients with chronic immune suppression Treatment may be for an indefinite period for patients with chronic immune suppression Treatment of cryptococcal meningitis • Initial therapy • Maintenance therapy to prevent relapse in patients with high risk of recurrence 400 200-400 200 Typical 6-8 weeks Indefinitely Duration of treatment will depend upon clinical and mycological response.
Side-effects associated with fluconazole observed in clinical trials and post-marketing studies are listed below. Frequencies are defined as Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000), not known (cannot be estimated from the available data).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. 4). System Organ Classes Very common ≥1/10 Common ≥1/100, <1/10 Uncommon ≥1/1,000, <1/100 Rare ≥1/10,000, <1/1,000 Very rare <1/10,000 Not known (cannot be estimated from the available data) Blood and lymphatic system disorders Anaemia Agranulocytosi s, leukopenia, neutropenia, thrombocyto- penia Immune system disorders Anaphylactic reactions, itching Angioedema, face oedema Urticaria Metabolism and nutrition disorders Decreased appetite Hypercholester olemia, hypertriglycerid emia, hypokalaemia Psychiatric disorders Insomnia, somnolence Nervous system disorders Headache Convulsions, seizures, dizziness, paraesthesia, taste perversion, Tremor Ear and labyrinth disorders Vertigo Cardiac disorders Ventricular arrthythmia (QT prolongation, Torsade de Pointes) Gastrointestin al disorders Nausea, vomiting, abdominal pain and diarrhoea Dyspepsia, flatulence, anorexia, constipation, dry mouth Hepatobiliary disorders Elevated alkaline phosphatase, ASAT and ALAT Cholestasis, hepatocellular damage, jaundice, clinically significant increase of total bilirubin Hepatic toxicity, hepatic nacrosis, hepatic failure, hepatitis, hepatocellular necrosis, hepatocellular damage.
Skin and subcutaneous tissue disorders (maculopapul ar erythema) rash Drug eruption*, urticaria, pruritis, increased sweating Angioedema, toxic epidermal necrolysis, Stevens - Johnson syndrome, acute generalized exanthematous pustulosis dermatitis exfoliative, face oedema, alopecia Drug reaction with eosinophilia and systemic symptoms (DRESS) Musculoskele tal and connective tissue disorders Myalgia Renal and urinary disorders Changes in renal function tests General disorders and administratio n site conditions Fatigue, malaise, asthenia, fever * including Fixed Drug Eruption Adverse clinical events were reported more frequently in HIV infected patients (21%) than in non-HIV infected patients (13%).
In some patients, particularly those with serious underlying diseases such as AIDS and cancer, abnormalities of hepatic, renal, haematological and other biochemical function tests have been observed during treatment with Fluconazole Pharmathen 2mg/ml solution for infusion but the clinical significance and relationship to treatment is uncertain.
Tinea capitis Fluconazole has been studied for the 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. Candidiasis Studies have shown an increasing prevalence of infections with Candida species other than C. albicans. g. C. krusei and 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. 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 Severe liver toxicity, including death, has been reported in rare cases, most often in patients with serious underlying illnesses. No obvious connection, however, has been found between daily dose, duration of treatment, gender or age.
Patients that develop abnormal liver function tests or significant increases from already abnormal levels during treatment should be carefully monitored. Fluconazole hepatotoxicity has usually been reversible on discontinuation of therapy.
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.
5).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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In life threatening infections the daily dose can be increased to 800mg. Prophylaxis against deep candida infections • In patients with neutropenia due to bone marrow transplantation 400 200-400 See additional guidance Fluconazole administration should start several days before the anticipated onset of neutropenia, and continue for seven days after the neutrophil count rises above 1000 cells per mm3.
• Coccidioidomycosis 200-400 200-400 11-24 months or longer depending on the patient 800mg daily may be considered for some infections and especially meningeal disease. Paediatric population A maximum daily dose of 400mg should not be exceeded in paediatric population.
Fluconazole 2 mg/ml Solution for Infusion should not be used in children and adolescents under the age of 16 years unless there is no therapeutic alternative, because efficacy and safety have not been sufficiently demonstrated. Please refer to Table 2 for specific dosage recommendations.
As with similar infections in adults, the duration of treatment is based upon the clinical and mycological response. Note that due to a slower elimination in newborn infants, the dosing intervals are increased. For paediatric patients with impaired renal function, see dosing in “Patients with impaired renal function”.
The pharmacokinetics of fluconazole have not been studied in paediatric population with renal insufficiency. 2). Table 2 - Guidance On The Dose To Administer In Paediatrics Treated By The Intravenous Route Age range Indication(s) Recommended dosage Additional Guidance Neonates (0-27 days) Note: Neonates excrete fluconazole slowly.
All indications listed below 6-12 mg/kg every 72 hours A maximum dose of 12 mg/kg every 72 hours should not be exceeded in children in the first two weeks of life. • 2 weeks or less • 3-4 weeks All indications listed below 6-12 mg/kg every 48 hours.
For children between 3 and 4 weeks of life, 12 mg/kg every 48 hours should not be exceeded. • Mucosal candidiasis 3 mg/kg/day. On the first day a loading dose of 6 mg/kg may be given in order to more rapidly reach steady state. • Invasive candidiasis •Cryptococcal meningitis 6-12 mg/kg/day Depending on the severity of the disease Children aged 4 weeks to 11 years • Maintenance therapy to prevent relapse of Cryptococcal meningitis in children with high risk of recurrence 6mg/kg/day Depending on the severity of the disease • Prophylaxis of Candida in immunocompromised patients 3-12 mg/kg/day Depending on the extent and duration of the induced neutropenia (see Adults posology) Adolescents (from 12 to 17 years old): Depending on the weight and pubertal development, the prescriber would need to assess which posology (adults or children) is the most appropriate.
Clinical data indicate that children have a higher fluconazole clearance than observed for adults. A dose of 100, 200, and 400mg […]
However, the patterns of adverse events in HIV infected and non-HIV infected patients were similar.
Paediatric patients:
Adverse events have been reported with a greater frequency in children as compared to all patients. Moreover, irritability and anaemia have been reported as specific for children. Reporting of suspected adverse reactions Reporting of suspected adverse reactions after authorisations of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
Cardiovascular system Certain azoles, including fluconazole, have been associated with prolongation of the QT-interval. During post marketing surveillance, there have been rare cases of torsade de pointes during treatment with fluconazole.
5). Electrolyte disturbances such as hypokalaemia, hypomagnesaemia and hypocalcaemia should be corrected prior to initiation of fluconazole treatment. Dermatological reactions In rare cases patients have developed exfoliative skin reactions including Stevens- Johnson syndrome and toxic epidermal necrolysis in treatment with fluconazole.
AIDS-patients have a higher tendency for the development of serious skin reactions from various drugs. Where patients with minor fungal infections that are being treated with fluconazole develop a skin rash, considered to be connected to treatment with fluconazole, the treatment should be stopped.
If patients who are being treated for invasive fungal infections or systemic infections develop a skin rash, they should be closely monitored and the treatment discontinued if bullous skin reactions or erythema multiforme develop. Drug reaction with eosinophilia and systemic symptoms (DRESS) has been reported.
Halofantrine Halofantrine has been shown to prolong QTc interval at the recommended therapeutic dose and is a substrate of CYP3A4. 5). 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