Capsule Flucon 50 mg

Information: Capsule Flucon 50 mg

Therapeutic action – Antifungal Indications – Oesophageal candidiasis – Moderate to severe oropharyngeal candidiasis – Secondary prophylaxis of recurrent candidiasis in immunocompromised patients – Cryptococcocal meningitis, after treatment with amphotericin B + flucytosine or in combination with amphotericin B – Secondary prophylaxis of cryptococcocal infections Presentation – 50 mg, 100 mg and 200 mg capsules or tablets – 50 mg/5 ml oral solution Dosage and duration – Oesophageal candidiasis, oropharyngeal candidiasis, secondary prophylaxis of candidiasis Child over 1 week: 3 to 6 mg/kg once daily Adult: 50 to 200 mg once daily These doses may be increased up to 400 mg/day if necessary. The treatment lasts 14 to 21 days for oesophageal candidiasis; 7 to 14 days for oropharyngeal candidiasis; as long as required for secondary prophylaxis. – Cryptococcocal meningitis After treatment with amphotericin B + flucytosine Child > 1 week 6 to 12 mg/kg once daily (max. 800 mg/day) for 8 weeks Adult 400 to 800 mg once daily for 8 weeks or In combination with amphotericin B Child > 1 week 12 mg/kg once daily (max. 800 mg/day) for 2 weeks (with amphotericin B) then 6 to 12 mg/kg once daily for 8 weeks Adult 800 mg once daily for 2 weeks (with amphotericin B) then 400 to 800 mg once daily for 8 weeks – Secondary prophylaxis of cryptococcocal infections Child: 6 mg/kg once daily (max. 200 mg/day), as long as required Adult: 200 mg once daily, as long as required contra-indications, adverse effects, precautions – Administer with caution to patients with hepatic or renal impairment, cardiac disorders (bradycardia, heart rhythm disorders, etc.). Reduce the dose by half in patients with renal impairment. – May cause: gastrointestinal disturbances, headache, skin reactions sometimes severe, anaphylactic reactions; severe hepatic disorders, haematologic (leukopenia, thrombocytopenia) and cardiac disorders (QT-prolongation). Stop treatment in the event of anaphylactic reaction, hepatic disorders or severe skin reaction. – In the event of prolonged treatment, monitor hepatic function. – Do not administer simultaneously with rifampicin, administer 12 hours apart (rifampicin in the morning, fluconazole in the evening). – Avoid or monitor combination with: • drugs that prolong the QT interval (amiodarone, chloroquine, erythromycin, haloperidol, mefloquine, pentamidine, quinine); • warfarin, carbamazepine, phenytoin, rifabutin, benzodiazepines, calcium-channel blockers, certain antiretrovirals (e.g. nevirapine, saquinavir, zidovudine): increased blood concentration of these drugs. – Pregnancy and breast-feeding: to be used only in severe or life-threatening infections, particularly during the first trimester of pregnancy (risk of foetal malformations). Remarks – For cryptococcocal meningitis, when amphotericin B is not available or not tolerated, fluconazole may be administered alone: Child over 1 week: 12 mg/kg once daily (max. 1200 mg/d) for 2 weeks then, 12 mg/kg once daily (max. 800 mg/d) for 8 weeks Adult: 1200 mg once daily for 2 weeks then, 800 mg once daily for 8 weeks – For the treatment of histoplasmosis, fluconazole is less effective than itraconazole. It should be used (child: 10 to 12 mg/kg once daily, max. 400 mg/d ; adult: 400 mg on Day 1 then 200 to 400 mg once daily, for 6 to 12 weeks) only in patients unable to tolerate itraconazole. – For the treatment of dermatophytosis of the scalp, fluconazole may be used as a secondary option (child: 6 mg/kg once daily, max. 200 mg/d; adult: 200 mg once daily, for 2 to 4 weeks) but itraconazole is preferred for this indication. – For the treatment of genital candidiasis (vulvovaginitis, balanitis), fluconazole is only used if local treatment fails: 150 mg as a single dose in adults. – Storage: below 25°C – Once reconstituted, oral solution keeps for 2 weeks. http://www.opsonin-pharma.com/product-details.php?pid=244 https://medlineplus.gov/druginfo/meds/a690002.html https://en.wikipedia.org/wiki/Fluconazole