Drug makers to add Itraconazole linked Photosensitivity in package insert: CDSCO panel

This came in line with the recommendation of signal review panel, Pharmacovigilance Programme of India (PvPI), Indian Pharmacopoeia Commission (IPC) which was placed before the committee.

Sold under top brand names such as Lupin's Itrazole, Cipla's Itranox, Sun Pharma's ALCROS, Glenmark's Syntran and Canditral capsules, Itraconazole is an antifungal agent used for the treatment of various fungal infections in immunocompromised and non-immunocompromised patients, such as pulmonary and extrapulmonary blastomycosis, histoplasmosis, and onychomycosis.

Itraconazole interacts with 14-α demethylase, a cytochrome P-450 enzyme necessary to convert lanosterol to ergosterol. As ergosterol is an essential component of the fungal cell membrane, inhibition of its synthesis results in increased cellular permeability causing leakage of cellular contents. Itraconazole may also inhibit endogenous respiration, interact with membrane phospholipids, inhibit the transformation of yeasts to mycelial forms, inhibit purine uptake, and impair triglyceride and/or phospholipid biosynthesis.

At recent SEC meeting for Antimicrobial & Antiviral, the recommendation of signal review panel, PVPI, IPC was placed before the committee regarding the adverse reaction related to antifungal agent, Itraconazole.

In view of the above, after detailed deliberation, the committee recommended,

"CDSCO may request State Drugs Controllers to direct the manufacturers of the drug to incorporate drug associated Photosensitivity in the package insert of the drug."