EMA: Posaconazole Tablet, Oral Suspension Not Interchangeable

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has warned that the tablet and oral suspension forms of posaconazole (Noxafil, Merck) are not interchangeable because they have different doses, and prescriptions should specify which dose form is intended. The company will update its product information to strengthen this warning and change the packaging to distinguish the two forms more clearly.

Posaconazole is a medication belonging to the triazole antifungal group. It is used to treat the serious fungal infections invasive aspergillosis, fusariosis, chromoblastomycosis, mycetoma, or coccidioidomycosis when other medications cannot be used or are infective. It is also used to treat thrush or prevent invasive fungal infections in patients with weakened immune systems (such as transplant patients).

It is available in a tablet form containing 100 mg and an oral suspension containing 40 mg/mL; however, the two forms have different recommended doses. The usual dose of the tablet form is three tablets (300 mg) twice daily on the first day, followed by 300 mg once daily. The usual dose of the liquid form (200 mg, 5 mL) is taken three or four times daily. Posaconazole is also available as a solution for intravenous use.

Some patients mistakenly have received the oral solution instead of tablets, and this has led to underdosing and potential ineffectiveness. Other patients have received tablets instead of the oral solution, and this has led to overdosage and adverse effects.

A letter will be sent to healthcare professionals to remind them of the problem. Prescribers should specify the dosage form and the relevant dose on the prescription, and pharmacists should ensure that the correct oral dosage form is dispensed.

Patients are instructed not to switch between the forms without talking to their physician or pharmacist first.

The committee conducted the review in the context of a type II variation procedure. The committee's opinion will go next to the European Commission for a legally binding decision that will be applicable in all European Union Member States.

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Cite this article: EMA: Posaconazole Tablet, Oral Suspension Not Interchangeable. Medscape. Jun 28, 2016.

Source: EMA: Posaconazole Tablet, Oral Suspension Not Interchangeable