ZYFLO (zileuton)
ORAL ADMINISTRATION
Indications for Prior Authorization:
- Asthma: For the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older
All of the following must be met as a condition for coverage:
- Patient is 12 years of age or older, AND
- Patient has a diagnosis of asthma, AND
- Patient must have tried/failed montelukast (Singulair®)
This Medication is Not Approvable for the following condition(s):
- Any condition not listed above as an approved indication
Dosing:
Adult Asthma
- Immediate-release tablets: One 600 mg tablet 4 times a day for a total daily dose of 2,400 mg
- Extended-release tablets: Two 600 mg tablets twice daily, within 1 hour of morning and evening meals, for a total daily dose of 2,400 mg
Pediatric Asthma (12 years of age and older)
- Immediate-release tablets: One 600 mg tablet 4 times a day for a total daily dose of 2,400 mg
- Extended-release tablets: Two 600 mg tablets twice daily, within 1 hour of morning and evening meals, for a total daily dose of 2,400 mg
- Younger than 12 years of age: Safety and efficacy in children younger than 12 years of age have not been established
Approval:
One year
Last review date: August 21, 2020