Each capsule contains Itraconazole USP 65 mg (Super Bioavailable Formulation).
SUBA (Super Bioavailable Formulation) is a novel technology for enhancing the bioavailability of poorly soluble drugs. This formulation utilizes a solid disperse of drug in a polymer that improves the dissolution of poorly soluble drugs compared to their normal crystalline form. SUBA formulation Itraconazole is an orally active triazole 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.
For non-systemic fungal disease:Indication:
Dose & Duration.
Tinea corporis, Tinea cruris.
65 mg once daily for 15 days 130 mg (2 x 65 mg capsules) once daily for 7 days.
Tinea pedis, Tinea manuum.
65 mg once daily for 30 days.
Pityriasis versicolor.
130 mg (2 x 65 mg capsules) twice daily for 7 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.
Onychomycosis (toenails 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 days’ interval. Fingernails two courses, toenails three courses.
Vulvovaginal candidiasis.
130 mg (2 x 65 mg capsules) twice daily for 1 day.
For Systemic fungal disease:Indication:
Dose & Duration.
Aspergillosis.
130 mg (2 x 65 mg capsules) once daily for 2-5 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 3 weeks-7 months. Increase dose to 130 mg (2 x 65 mg capsules) twice daily in case of invasive or disseminated disease.
Non-meningeal Cryptococcosis.
130 mg (2 x 65 mg capsules) once daily for 10 weeks.
Cryptococcal meningitis.
130 mg (2 x 65 mg capsules) twice daily for 2-6 months.
Histoplasmosis.
130 mg (2 x 65 mg capsules) once daily - twice daily for 8 months.
Maintenance in AIDS.
130 mg (2 x 65 mg capsules) once daily until immune recovery.
Prophylaxis in neutropenia.
130 mg (2 x 65 mg capsules) once daily until immune recovery.
Capsule:
The drugs like Tefenadine, 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.
Overdose:
Itraconazole is not removed by dialysis. In the event of accidental overdosage, supportive measures should be employed. Activated charcoal may be given if considered appropriate.
Itraconazole is contraindicated in pregnancy. Breast feeding while receiving Itraconazole is not recommended.
The efficacy and safety of the Itraconazole capsule have not been established in pediatric patients.
Absorption is impaired when gastric acidity is reduced. In patients receiving acid neutralizing medicines (e.g. aluminium hydroxide), these should be administered at least 2 hours after the intake of Itraconazole. The drug should be administered after a full meal. Rarely, cases of hepatitis and jaundice have been reported mainly in patients treated for longer than one month. It is therefore, advised to monitor liver function in patients receiving continuous treatment of more than one month.
Store below 25°C temperature and dry place, protected from light. Keep all medicine out of reach of children.