API

Itraconazole (1% w/w)

Drug classification

Antifungal agent; triazole subclass.

Dosage form

Topical gel containing 1% w/w itraconazole for external use.

API strength per dosage

Dose

Itracoe Gel (Itraconazole 1% w/w) is typically applied topically to affected skin areas once or twice daily. Duration depends on infection type and response. Safety and efficacy in children have not been established. Use with caution in patients with hepatic impairment; avoid contact with eyes. Not for ophthalmic, oral, or intravaginal use.

Mechanism of action

Itraconazole inhibits fungal cytochrome P450 enzyme 14α-demethylase, blocking the conversion of lanosterol to ergosterol, an essential component of fungal cell membranes. This disruption increases membrane permeability, impairs cellular processes, and inhibits fungal growth.

Indications

Treatment of Fungal skin infections

Side effects

Application site reactions burning irritation itching and redness

Pregnancy category

Itraconazole topical use in pregnancy should be avoided unless clearly needed; systemic absorption is minimal, but safety data are limited. Consult a healthcare provider.

Precautions

Avoid contact with eyes, mucous membranes, or broken skin, discontinue if irritation or hypersensitivity occurs, use with caution in pregnancy and lactation, monitor for local adverse reactions, do not use for ophthalmic or oral administration, ensure full course completion, avoid occlusive dressings unless directed.

Contraindications

Hypersensitivity to itraconazole or any excipients, use in patients with known ventricular dysfunction or heart failure, concomitant use with certain CYP3A4 substrates (e.g., cisapride, pimozide, quinidine, dofetilide, ergot alkaloids).