posaconazole
Drug Details
- Generic Name
- posaconazole
- Brand Names
- NOXAFIL, POSACONAZOLE, posaconazole
- Application Number
- NDA022003
- Sponsor
- Merck Sharp & Dohme LLC
- NDC Codes
- 18
- Dosage Forms
- SUSPENSION, TABLET, COATED, SOLUTION, INJECTION, SOLUTION, GRANULE, TABLET, DELAYED RELEASE, POWDER, FOR SUSPENSION
- Routes
- ORAL, INTRAVENOUS
- Active Ingredients
- POSACONAZOLE
Indications and Usage
1 INDICATIONS AND USAGE Posaconazole is an azole antifungal indicated as follows: • Posaconazole is indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy as follows: ( 1.2 ) o Posaconazole injection : adults and pediatric patients 2 years of age and older 1.2 Prophylaxis of Invasive Aspergillus and Candida Infections Posaconazole is indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy [see Clinical Studies ( 14.1 )] as follows: • Posaconazole injection: adults and pediatric patients 2 years of age and older.