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AZOCAN-P is a brand name for Fluconazole. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Azocan-P is indicated for the treatment of the following conditions:- Vaginal candidiasis, acute or recurrent; or candidal 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 candidal balanitis – 150mg 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.
4). 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), dermatitis exfoliative, angioedema, face oedema, alopecia Skin & subcutaneous tissue disorders Not Known Drug reaction with eosinophilia and systemic symptoms (DRESS) Musculoskeletal and connective tissue disorders Uncommon Myalgia General disorders and administration site conditions Uncommon 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 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. 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 drugs. If a rash develops in a patient treated for a superficial fungal infection which is considered attributable to fluconazole, further therapy with this agent 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). 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.
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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During post-marketing surveillance, there have been very rare cases of QT prolongation and torsade 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 hypokalaemia 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 these potentially proarryhthmic conditions.
5). 2). 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