posaconazole tablet delayed release
1 INDICATIONS AND USAGE Posaconazole delayed-release tablets are an azole antifungal indicated as follows: Posaconazole delayed-release tablets are 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) Posaconazole delayed-release tablets: adults and pediatric patients 13 years of age and older 1.2 Prophylaxis of Invasive Aspergillus and Candida Infections Posaconazole delayed-release tablets are 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: Posaconazole delayed-release tablets: adults and pediatric patients 13 years of age and older Additional Pediatric Use information is approved for Merck Sharp & Dohme Corp.’s NOXAFIL (posaconazole) delayed-release tablets. However, due to Merck Sharp & Dohme Corp.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
amneal pharmaceuticals ny llc
OVAL YELLOW AC71
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied
POSACONAZOLE Delayed-Release Tablets
POSACONAZOLE delayed-release tablets 100 mg are available as yellow, oblong, film coated, unscored tablets, debossed with "AC71" on one side and plain on other side. They are supplied as follows: Bottles of 30 with child-resistant closure: NDC 69238-1476-3. Bottles of 60 with child-resistant closure: NDC 69238-1476-6. 16.2 Storage and Handling
POSACONAZOLE Delayed-Release Tablets Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
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