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Zileuton Dosage

Medically reviewed by Drugs.com. Last updated on Dec 1, 2021.

Applies to the following strengths: 600 mg

Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Asthma - Maintenance

Immediate Release:

  • 600 mg orally four times a day
  • Maximum daily dose: 2400 mg

Extended Release:
  • 1200 mg orally twice a day, within one hour after morning and evening meals
  • Maximum daily dose: 2400 mg

Comments:
  • Immediate release tablets may be taken with meals and at bedtime.
  • Assess hepatic function enzymes prior to initiating this drug and periodically during treatment.

Use: Prophylaxis and chronic treatment of asthma

Usual Pediatric Dose for Asthma - Maintenance

Less than 12 years: Not recommended.

12 years or older:

  • Immediate Release: 600 mg orally four times a day
  • Extended Release: 1200 mg orally twice a day, within one hour after morning and evening meals
  • Maximum daily dose: 2400 mg

Comments:
  • Immediate release tablets may be taken with meals and at bedtime.
  • Assess hepatic function enzymes prior to initiating this drug and periodically during treatment.

Use: Prophylaxis and chronic treatment of asthma

Renal Dose Adjustments

No adjustment recommended.

Liver Dose Adjustments

Active liver disease or persistent hepatic transaminase elevations greater than or equal to 3 times the upper limit of normal (ULN): Contraindicated

Precautions

Safety and efficacy have not been established in patients younger than 12 years.

Consult WARNINGS section for additional precautions.

Dialysis

Hemodialysis: No adjustment recommended.
Peritoneal dialysis: Data not available

Other Comments

Administration advice:

  • Immediate-release tablets can be taken with or without food.
  • Extended-release tablets should be taken within one hour after morning and evening meals; tablets should not be chewed, cut or crushed.
  • If a dose is missed, the next dose should be taken at the scheduled time; dose should not doubled.
  • Assess hepatic function enzymes prior to initiating this drug and monitor periodically during treatment.

General:
  • This drug should not be used to treat an acute asthma attack.

Monitoring:
  • Hepatic: Serum ALT
  • Hematologic: Prothrombin time if co-administered with warfarin

Patient advice:
  • Immediately report any symptoms of hepatic dysfunction (e.g., right upper quadrant, pain, nausea, fatigue, lethargy, pruritus, jaundice, flu-like symptoms, and anorexia).
  • This drug is indicated for the chronic treatment of asthma and should be taken regularly as prescribed, even during symptom-free periods.
  • Patients should not decrease the dose of this drug or stop taking any other antiasthma medications unless instructed by a physician.
  • The physician should be notified if neuropsychiatric events occur while using this drug.
  • This drug can interact with other drugs; therefore, patients should consult their doctors before starting or stopping any prescription or non-prescription medicines.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.