Itraconazole

SOURCE CAVEAT — this dose is from US prescribing information (ITRACONAZOLE capsules, Alembic Pharmaceuticals Inc., label date 2025-03-10) and must be verified against the UK capsule SPC. The eMC record retrieved in this bundle is a DIFFERENT product and a different indication: 'Itraconazole 10mg/ml Sugar Free Oral Solution' (https://www.medicines.org.uk/emc/product/10049/smpc), licensed for oral and/or oesophageal candidosis and for prophylaxis of fungal infections in neutropenic patients — not for skin or nail infection. Both labels state that itraconazole capsules and itraconazole oral solution are NOT interchangeable ('Only the oral solution has been demonstrated effective for oral and/or esophageal candidiasis'). Note the opposite food rules: capsules with a full meal; oral solution without food, refraining from eating for at least 1 hour after intake. OTHER DERMATOLOGICAL INDICATIONS (e.g. tinea corporis/cruris/pedis, pityriasis versicolor) are NOT covered by either label in this bundle — clinician to source the UK capsule SPC before publishing those regimens. CRITICAL SAFETY FOR THIS PAGE: itraconazole capsules must NOT be given for onychomycosis in patients with evidence of ventricular dysfunction such as congestive heart failure or a history of CHF; and itraconazole must not be used during pregnancy for non-life-threatening indications — women of childbearing potential should use contraceptive precautions, continued until the menstrual period following the end of therapy. FOR REFERENCE, the eMC ORAL SOLUTION regimens (different indication — do not apply to skin/nail disease): oral and/or oesophageal candidosis 200 mg (20 mL) per day in two intakes or alternatively in one intake for 1 week, continued for another week if there is no response; fluconazole-resistant oral and/or oesophageal candidosis 100 to 200 mg (10-20 mL) twice daily for 2 weeks, continued for another 2 weeks if there is no response, and the 400 mg (40 mL) daily dose should not be used for longer than 14 days if there are no signs of improvement; prophylaxis of fungal infections 5 mg/kg (0.5 mL/kg) per day in two intakes. For the swished oral candidosis dose the liquid should be swished around the oral cavity for approximately 20 seconds and swallowed, with no rinsing afterwards. US capsule label, other (non-derm) indications: blastomycosis and histoplasmosis 200 mg once daily, increased in 100 mg increments to a maximum of 400 mg daily if there is no obvious improvement (doses above 200 mg/day in two divided doses); aspergillosis 200 to 400 mg daily; in life-threatening situations a loading dose of 200 mg three times daily (600 mg/day) for the first 3 days is recommended. PAEDIATRIC: the eMC oral solution SPC states safety and efficacy in children have not been established and NO RECOMMENDATION ON A POSOLOGY CAN BE MADE, and use in paediatric patients is not recommended unless the potential benefit outweighs the potential risks; the US label states efficacy and safety have not been established in paediatric patients and that long-term effects on bone growth in children are unknown. Hence paedDose is null — verify any paediatric use against a children's formulary. ELDERLY: use only if the potential benefit outweighs the potential risks, reflecting the greater frequency of decreased hepatic, renal or cardiac function. HEPATIC IMPAIRMENT: limited data — exercise caution.