zileuton (Zyflo®)

ORAL ADMINISTRATION

Indications for Prior Authorization:

  • Asthma: For the prophylaxis and long-term 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 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: July 25, 2016