Itra® Nova 65: Each capsule contains Super Bioavailable Itraconazole BP 65 mg.
SUBA (Super Bioavailability) 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 Itraconazole is an orally active triazole antifungal drug that has demonstrated a broad spectrum of activity and 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.
Itra® Nova 65 (SUBA Itraconazole) is used for the treatment of oropharyngeal candidiasis, vulvovaginal candidiasis, pityriasis versicolor, tinea pedis, tinea cruris, tinea corporis, tinea maniurum, orychomycosis and histoplasmosis. It is indicated in the treatment of systemic candidiasis, aspergillosis, and cryptococcosis (including cryptococcal meningitis). It is also used for maintenance therapy in AIDS patients to prevent relapse of underlying fungal infections and in the prevention of fungal infection during prolonged neutropenia.
For non-systemic fungal disease:
Indication:
Dose & Duration.
Vulvovaginal candidiasis.
130 mg (2 x 65 mg capsules) twice daily for 01 day.
Pityriasis versicolor.
130 mg (2 x 65 mg capsules) twice daily for 07 days.
Tinea corporis and tinea cruris.
65 mg once daily for 15 days or 130 mg (2 x 65 mg capsules) once daily for 07 days.
Tinea pedis and tinea maniurum.
65 mg once daily for 30 days.
Oropharyngeal Candidiasis.
65 mg once daily for 15 days. Increase dose to 130 mg (2 x 65 mg capsules) once daily for 15 days in AIDS or neutropenic patients because of impaired absorption in these groups.
Orychomycosis (toxvials with or without fingernail involvement).
Either 130 mg (2 x 65 mg capsules) once daily for 3 months or course (pulse) of 130 mg (2 x 65 mg capsules) twice daily for 7 days, subsequent courses repeated after 21 day’s interval. Fingernails two courses, toenails three courses.
For systemic fungal disease:
Indication:
Dose & Duration.
Aspergillosis.
130 mg (2 x 65 mg capsules) once daily for 2-6 months. Increase dose to 130 mg (2 x 65 mg capsules) twice daily in case of invasive or disseminated disease.
Candidiasis.
65-130 mg once daily for 03 weeks-07 months. Increase dose to 130 mg (2 x 65 mg capsules) twice daily in case of invasive or disseminated disease</.