Superltra Capsule: Each capsule contains Itraconazole BP 65 mg.
SUBA (Super Bioavailable Formulation) is a novel technology for enhancing the bioavailability of poorly soluble drugs. This formulation utilizes a solid dispersion of drug in a polymer that improves the dissolution profile. SUBA-Tech Itraconazole (Superltra) is an orally active triazole antifungal drug that has demonstrated a broad spectrum of activity and favorable pharmacokinetic profile.
Itraconazole inhibits Cytochrome P450 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.
Must be administered with food. Swallow the capsule whole without chewing, crushing or breaking it.
For non-systemic fungal disease:
For systemic fungal disease:
The dose and duration of treatment for systemic antifungal disease should be adjusted depending on the clinical response.
is mainly metabolized through CYP3A4. Other substances that either share this metabolic pathway or modify CYP3A4 activity may influence the pharmacokinetics of Itraconazole. 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.
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. Breastfeeding while receiving Itraconazole is not recommended.
Pediatric Use:
The efficacy and safety of Itraconazole have not been established in pediatric patients.
Physicians should carefully review the risks and benefits of Itraconazole for patients with evidence of Congestive Heart Failure. If clinical signs or symptoms of hepatotoxicity develop that are consistent with liver disease, discontinue treatment and perform testing for liver disease. Concomitant administration of the drugspimozide, methadone, or quinidine with oral Itraconazole is contraindicated.
Store below 25°C temperature. Keep away from light and wet place. Keep out of the reach of children.