Posaconazole is indicated in patients aged 13 years and above for the treatment of the following fungal infections:

• Invasive aspergillosis in patients with disease that is refractory or intolerant to Amphotericin B or Itraconazole.
• Fusariosis in patients with disease that is refractory or intolerant to Amphotericin B.
• Chromoblastomycosis and mycetoma in patients with disease that is refractory or intolerant to Itraconazole.
• Coccidioidomycosis in patients with disease that is refractory or intolerant to Amphotericin B, Itraconazole or Fluconazole, or in patients intolerant to these drugs.

Also indicated for prophylaxis of invasive fungal infections in:

• Patients receiving remission-induction chemotherapy for AML or MDS with prolonged neutropenia and high risk of invasive fungal infections.
• HSCT recipients receiving high-dose immunosuppressive therapy for graft-versus-host disease and at high risk of invasive fungal infections.

Refractoriness is defined as progression of infection or failure to improve after at least 7 days of effective antifungal therapy.

Posaconazole blocks the synthesis of ergosterol, an essential component of the fungal cell membrane. It inhibits the cytochrome P-450 dependent enzyme lanosterol 14-α-demethylase, which converts lanosterol to ergosterol. This leads to accumulation of methylated sterol precursors and depletion of ergosterol, resulting in weakening of the fungal cell membrane structure and function.

Posaconazole Tablets can be taken with or without food. The tablets should be swallowed whole with water and should not be crushed, chewed, or broken.

Loading Dose: 300 mg (3 Tablets) twice a day on the first day.

Maintenance Dose: 300 mg (3 Tablets) once a day from the second day.

Duration of therapy should be based on the severity of the underlying disease, recovery from immunosuppression and clinical response.

Posaconazole is a CYP3A4 inhibitor and should be used with caution when co-administered with drugs metabolized by CYP3A4 such as Midazolam, Triazolam, and Alprazolam. Plasma concentrations of posaconazole may be significantly reduced when used with rifamycin antibiotics (Rifampicin, Rifabutin) or certain anticonvulsants (Phenytoin, Carbamazepine, Phenobarbital, Primidone) and Efavirenz.

Posaconazole is contraindicated in patients with known hypersensitivity to posaconazole or other azole antifungal agents. Co-administration is contraindicated with ergot alkaloids, certain CYP3A4 substrates (Terfenadine, Astemizole, Cisapride, Pimozide, Halofantrine, Quinidine) due to risk of QT prolongation and torsades de pointes. Use with HMG-CoA reductase inhibitors such as Simvastatin, Lovastatin, and Atorvastatin is also contraindicated.

Common treatment-emergent adverse reactions include diarrhea, nausea, vomiting, fever, headache, cough, and hypokalemia.

Pregnancy: Posaconazole should be used during pregnancy only if the potential benefit outweighs the risk to the fetus. Lactation: Breastfeeding should be discontinued when treatment is initiated.

Pediatric use: Not recommended below 13 years of age.

Geriatric use: No dose adjustment required.

Hepatic impairment: Use with caution; monitor liver function tests.

Renal impairment: No dose adjustment for mild to moderate impairment; severe cases require close monitoring.

Aural Anti-fungal preparations

Store below 25°C. Keep out of the reach of children.