Candidiasis, Pityriasis Versicolor, Tinea, histoplasmosis. It is indicated in the treatment of systemic candidiasis, aspergillosis, cryptococcosis, in AIDS patients to prevent relapse of underlying fungal infections & in the prevention of fungal infection during prolonged neutropenia.
Itraconazole inhibits Cytochrome P-450 dependent enzymes resulting in impairment of the biosynthesis of ergosterol, a major component of the cell membrane of yeast and fungal cells. Being integral to the proper functioning of the cell membrane, inhibition of the synthesis of ergosterol leads to a cascade of abnormalities in permeability, membrane bound enzyme activity, and co-ordination of chitin synthesis leading to inhibition of growth, abnormal cell wall formation and accumulation of intracellular lipids and membranous vesicles.
SUBA (Super Bio-available) technology is a novel technology for enhancing the bioavailability of poorly soluble drugs. This technology utilizes a solid dispersion of drug in a polymer that improves the dissolution of poorly soluble drugs compared to their normal crystalline form. SUBA technology Itraconazole is an orally active triazole antifungal drug that has demonstrated a broad spectrum of activity and favorable pharmacokinetic profile.
ORAL Oesophageal candidiasis; Oral candidiasis: Adult: As oral liquid: 200 mg daily in 1 or 2 divided doses held in the mouth for 20 sec before swallowing. Double the dose in resistant infections. Prophylaxis of fungal infections in immunocompromised patients: Adult: As oral liquid: 5 mg/kg daily in 2 divided doses. Oropharyngeal candidiasis: Adult: As capsule: 100 mg daily for 15 days. Vulvovaginal candidiasis: Adult: As capsule: 200 mg bid for 1 day. Pityriasis versicolor: Adult: As capsule: 200 mg daily for 7 days. Tinea cruris;Tinea corporis: Adult: As capsule: 100 mg daily for 15 days or 200 mg daily for 7 days. Nail fungal infections: Adult: As capsule: 200 mg daily for 3 mth. Alternatively, pulse therapy w/ 200 mg bid for 7 days, repeated once for fingernail infections & twice for toenail infections after drug-free intervals of 21-days. Systemic fungal Infections: Adult: As capsule: 100-200 mg once daily, increased to 200 mg bid for invasive or disseminated infections. For lifethreatening infections: Loading dose of 200 mg tid for 3 days has been given. Primary or secondary prophylaxis of infections in neutropenic or AIDS patients: Adult: As capsule: 200 mg daily increased to 200 mg bid if necessary. Tinea pedis; Tinea manuum: Adult: As capsule: 100 mg daily for 30 days or 200 mg bid for 7 days INTRAVENOUS Systemic fungal infections: Adult: 200 mg infused bid over 1 hr for 2 days. Maintenance: 200 mg daily.
The drugs like terfenadine, astemizole, cisapride, HMG-CoA reductase inhibitors such as simvastatin, oral midazolam or triazolam should not be given concurrently with Itraconazole. Significant interactions also observed during co-administration of rifampin, phenytoin, phenobarbital, digoxin, and calcium channel blockers. There is no experience of overdosage with itraconazole.
Known hypersensitivity, severe hepatic disease.
Nausea, abdominal pain, dyspepsia, constipation, headache, dizziness, raised liver enzymes, menstrual disorders, allergic reactions (including pruritus, rash, urticaria & angioedema), hepatitis & cholestatic jaundice, peripheral neuropathy & Stevens-Johnson syndrome reported. On prolonged use hypokalaemia, oedema & hair loss reported.
Itraconazole is contraindicated in pregnancy. Breast feeding while receiving Itraconazole is not recommended.
Store below 25°C, in a cool & dry place. Keep away from light. Keep all the medicine out of the reach of children.