API

Itraconazole (100mg)

Drug classification

Antifungal agent; triazole subclass.

Dosage form

Hard gelatin capsule containing 100 mg itraconazole for oral administration.

API strength per dosage

Dose

Itraderm Capsule (itraconazole 100 mg) dosing varies by indication. For adults, typical regimens are 100–200 mg once or twice daily. Capsules should be taken with food. Use in children is not well established. Caution is advised in hepatic or renal impairment; dose adjustment or alternative therapy may be necessary. Always consult specific guidelines.

Mechanism of action

Itraconazole inhibits fungal cytochrome P450 enzyme 14α-demethylase, blocking conversion of lanosterol to ergosterol, an essential component of fungal cell membranes. This disrupts membrane synthesis and function, increasing permeability and inhibiting fungal growth.

Indications

Treatment of Fungal infections

Side effects

Nausea Abdominal pain Constipation Dizziness Headache Indigestion Vomiting

Pregnancy category

Itraconazole may cause fetal harm; avoid use in pregnancy unless potential benefit justifies risk. Effective contraception recommended during and after treatment.

Precautions

Assess liver function before and during treatment, monitor for signs of hepatotoxicity, avoid in patients with ventricular dysfunction or heart failure, check for drug interactions (CYP3A4 substrate), monitor for neuropathy, use caution in renal impairment, avoid in pregnancy, monitor therapeutic response, assess for gastrointestinal adverse effects.

Contraindications

Hypersensitivity to itraconazole or excipients, coadministration with drugs metabolized by CYP3A4 that prolong QT interval (e.g., cisapride, pimozide, quinidine), ventricular dysfunction or heart failure, pregnancy (except for life-threatening infections).