Zileuton Dosage

Medically reviewed by Drugs.com. Last updated on Nov 21, 2024.

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.

Medical Disclaimer