Usual Adult Dose for Asthma - Maintenance

Immediate Release:

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

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

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

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

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

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.

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

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

• 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.