Itra®

Itraconazole
Antifungals (Systemic Antifungal)

Indication:
Itra® (Itraconazole) is used for the treatment of oropharyngeal candidiasis, vulvovaginal candidiasis, pityriasis versicolor, tinea pedis, tinea cruris, tinea corporis, tinea manuum, onychomycosis, 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.

Dosage & Administration:
Tinea corporis, Tinea cruris: Tablet/Capsule: 100 mg once daily for 15 days or 200 mg once daily for 07 days; Solution: Child 1 month–11 years: 3–5 mg/kg once daily (max. per dose 100 mg) for 15 days.
Child 12–17 years: 100 mg once daily for 15 days, alternatively 200 mg once daily for 7 days. Tinea pedis, Tinea manuum: Tablet/Capsule: 100 mg once daily for 30 days; Solution: Child 1 month–11 years: 3–5 mg/kg once daily (max. per dose 100 mg) for 30 days. Child 12–17 years: 100 mg once daily for 30 days, alternatively 200 mg twice daily for 7 days. Tinea capitis: Child 1–17 years: 3–5 mg/kg once daily (max. per dose 200 mg) for 2–6 weeks. Onychomycosis: Tablet/Capsule: Either 200 mg daily for 3 months or course (pulse) of 200 mg twice daily for 7 days, subsequent courses repeated after 21 days’ interval. Fingernails two courses, toenails three courses. Solution: Child 1–11 years: 5 mg/kg daily (max. per dose 200 mg) for 7 days, subsequent courses repeated after 21-day intervals; fingernails 2 courses, toenails 3 courses. Child 12–17 years: 200 mg once daily for 3 months, alternatively 200 mg twice daily for 7 days, subsequent courses repeated after 21-day intervals; fingernails 2 courses, toenails 3 courses. Pityriasis versicolor: Tablet/Capsule: 200 mg once daily for 07 days; Solution: Child 1 month–11 years: 3–5 mg/kg once daily (max. per dose 200 mg) for 7 days. Child 12–17 years: 200 mg once daily for 7 days. Oropharyngeal candidiasis: Tablet/Capsule: 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. Solution: Child 1 month–11 years: 3–5 mg/kg once daily for 15 days; maximum 100 mg per day. Child 12–17 years: 100 mg once daily for 15 days. Systemic candidiasis: Tablet/Capsule: 100-200 mg once daily for 3 weeks-7 months. Increase dose to 200 mg twice daily in case of invasive or disseminated disease; Solution: Child: 5 mg/kg once daily (max. per dose 200 mg), dose increased in invasive or disseminated disease and in Cryptococcal meningitis, increased to 5 mg/kg twice daily (max. per dose 200 mg). Vulvovaginal candidiasis: Tablet/Capsule: 200 mg twice daily for 01 days. Aspergillosis: Tablet/Capsule: 200 mg once daily for 2-5 months Increase dose to 200 mg twice daily in case of invasive or disseminated disease; Solution: Child: 5 mg/kg once daily (max. per dose 200 mg), increased to 5 mg/kg twice daily (max. per dose 200 mg), dose increased in invasive or disseminated disease and in cryptococcal meningitis. Systemic cryptococcosis including cryptococcal meningitis: Tablet/Capsule: 200 mg twice daily for 2-6 months; Solution: Child: 5 mg/kg once daily (max. per dose 200 mg), dose increased in invasive or disseminated disease and in cryptococcal meningitis, increased to 5 mg/kg twice daily (max. per dose 200 mg). Histoplasmosis: Tablet/Capsule: 200 mg once daily-twice daily for 8 months; Solution: Child: 5 mg/kg 1–2 times a day (max. per dose 200 mg). Maintenance in AIDS: Tablet/Capsule: 200 mg once daily until immune recovery; Solution: Child: 5 mg/kg once daily (max. per dose 200 mg), then increased to 5 mg/kg twice daily (max. per dose 200 mg), dose increased only if low plasma Itraconazole concentration. Prophylaxis in neutropenia: Tablet/Capsule: 200 mg once daily until immune recovery; Child: 2.5 mg/kg twice daily, to be started before transplantation or before chemotherapy (taking care to avoid interaction with cytotoxic drugs) and continued until neutrophil count recovers, safety and efficacy not established.

Preparation:
Itra® 100 Capsule: Box containing 24 capsules in Alu-Alu blister.
Itra® 200 Tablet: Box containing 18 tablets in Alu-Alu blister.
Itra® Oral Solution: Each bottle contains 100 ml solution with a measuring cup.



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