Truzole SB 65 capsule: Each capsule contains Itraconazole BP 65 mg.
Truzole 100 capsule: Each capsule contains Itraconazole BP 100 mg as pellets.
Truzole 200 tablet: Each film coated tablet contains Itraconazole BP 200 mg.
Itraconazole is an orally active truzole antifungal drug that has demonstrated a broad spectrum of activity & favorable pharmacokinetic profile. 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.
Itraconazole is used for the treatment of:
For non-systemic fungal disease:
Indication:
Dose & Duration.
Vulvovaginal candidiasis.
200 mg twice daily for 01 day.
Pityriasis versicolor.
200 mg once daily for 07 days.
Tinea corporis, Tinea cruris.
100 mg once daily for 15 days or 200 mg once daily for 7 days.
Tinea pedis, Tinea manuum.
100 mg once daily for 30 days.
Oropharyngeal candidiasis.
100 mg once daily for 15 days. Increase dose to 200 mg once daily for 15 days in AIDS or neutropenic patients because of impaired absorption in these groups.
Onychomycosis.
Either 200 mg daily for 3 months or course (puise) of 200 mg twice daily for 7 days, subsequent courses repeated after 21 days interval. Fingernails two courses, toenails three courses.
For systemic fungal disease:
Indication:
Dose & Duration.
Aspergillosis.
200 mg once daily for 2-5 months. Increase dose to 200 mg twice daily in case of invasive or disseminated disease.
Candidiasis.
100-200 mg once daily for 3 weeks-7 months. Increase dose to 200 mg twice daily in case of invasive or disseminated disease.
Non-meningeal Cryptococcosis.
200 mg once daily for 10 weeks.
Cryptococcal meningitis.
200 mg twice daily for 2-6 months.
Histoplasmosis.
200 mg once daily - twice daily for 8 months.
Maintenance in AIDS.
200 mg once daily until immune recovery.
Prophylaxis in neutropenia.
200 mg once daily until immune recovery.
a) With Medicine: Itraconazole inhibits the metabolism of Cyclosporine and Warfarin. interaction with Terfenadine, Phenobarbitone and Midazolam has been reported.
b) With Food & Others: Itraconazole is for oral administration and must be taken immediately after a meal for maximum absorption.
Overdose:
There is no experience of over dosage with Itraconazole.
Hepatic enzyme value should be monitored in patients with pre-existing hepatic function abnormalities. It should also be done periodically in all patients receiving continuous treatment for more than one month or at any time a patient develops sign and symptoms of suggestive liver dysfunction.
Store below 30°C. Protect from light & moisture. Keep all medicines out of reach of children.