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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 capsules are indicated in the following fungal infections in adults (see section 5.1). Vaginal candidiasis, acute or recurrent; or candida balanitis associated with vaginal candidiasis.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology In adults aged 16-60 years:
Vaginal candidiasis or candida balanitis – 150 mg single oral dose. Paediatric population Not recommended in children aged under 16 years. Elderly Not recommended in patients aged over 60 years. Renal impairment Fluconazole is excreted predominantly in the urine as unchanged drug.
No adjustments in single dose therapy are required. Method of administration For oral use.
The most frequently (≥1/100 to <1/10) reported adverse reactions are headache, abdominal pain, diarrhoea, nausea, vomiting, alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased and rash.
4). The following adverse reactions have been observed and reported during treatment with Fluconazole capsules with the following frequencies: 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).
4), dermatitis exfoliative, angioedema, face oedema, alopecia Drug reaction with eosinophilia and systemic symptoms (DRESS) Musculoskeletal and connective tissue disorders Myalgia General disorders and administration site conditions Fatigue, malaise, asthenia, fever *Including Fixed Drug Eruption Paediatric Population The pattern and incidence of adverse reactions and laboratory abnormalities recorded during paediatric clinical trials, excluding the genital candidiasis indication, are comparable to those seen in adults.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation 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.
Hepatobiliary system Fluconazole capsules should be administered with caution to patients with liver dysfunction. Fluconazole capsules have 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 should be monitored 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 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. 5). 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.
1. Co-administration 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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3). 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 medications that may have been contributory. Patients with hypokalaemia and advanced cardiac failure are at an increased risk for the occurrence of life threatening ventricular arrhythmias and torsades de pointes.
Fluconazole capsules should be administered with caution to patients with these potentially proarrhythmic conditions. 5). 2). Adrenal insufficiency Ketoconazole is known to cause adrenal insufficiency, and this could also although rarely 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 capsules 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.
Halofantrine Halofantrine has been shown to prolong QTc interval at the recommended therapeutic dose and is a substrate of CYP3A4. 5). Cytochrome P450 Fluconazole is a moderate CYP2C9 and CYP3A4 inhibitor. Fluconazole is also a strong inhibitor of CYP2C19.
5). Excipients Fluconazole capsules contain lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the total lactase deficiency or glucose-galactose malabsorption should not take this medicine. Fluconazole capsules contain less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.
The product intended for pharmacy availability without prescription will carry a leaflet which will advise the patient: Do not use Fluconazole without first consulting your doctor: • If you are under 16 or over 60 years of age. • If you are allergic to any of the ingredients in Fluconazole or other antifungals and other thrush treatments.
• If you are taking any medicine […]