ZYFLO (zileuton)

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: