Usual Adult Dose for Allergic Rhinitis

• 10 mg orally once a day

Comments:

• For asthma, efficacy has been demonstrated when this drug was administered in the EVENING without regard to time of food ingestion.
• For allergic rhinitis, efficacy has been demonstrated for asthma when this drug was administered in the MORNING or EVENING without regard to time of food ingestion.
• Patients with both asthma and allergic rhinitis should take only one dose daily in the evening.

Uses:

• Prophylaxis and chronic treatment of asthma
• Relief of symptoms of seasonal allergic rhinitis and perennial allergic rhinitis

Usual Adult Dose for Asthma - Maintenance

• 10 mg orally once a day

Comments:

• For asthma, efficacy has been demonstrated when this drug was administered in the EVENING without regard to time of food ingestion.
• For allergic rhinitis, efficacy has been demonstrated for asthma when this drug was administered in the MORNING or EVENING without regard to time of food ingestion.
• Patients with both asthma and allergic rhinitis should take only one dose daily in the evening.

Uses:

• Prophylaxis and chronic treatment of asthma
• Relief of symptoms of seasonal allergic rhinitis and perennial allergic rhinitis

Usual Adult Dose for Bronchospasm Prophylaxis

• 10 mg orally once a day at least 2 hours before exercise

Comments:

• An additional dose should not be taken within 24 hours of a previous dose.
• Patients already taking this drug daily for another indication (including chronic asthma) should not take an additional dose to prevent EIB.
• A rescue short-acting beta-agonist should be available at all times.
• Daily administration for the chronic treatment of asthma has not been established to prevent acute episodes of EIB.

Use: Prevention of exercise-induced bronchoconstriction (EIB)

Usual Pediatric Dose for Asthma - Maintenance

Less than 12 months: Not approved.

12 to 23 months:

• One sachet of 4 mg oral granules once a day

2 to 5 years:

• 4 mg chewable tablet or one sachet oral granules once a day

6 to 14 years:

• 5 mg chewable tablet orally once a day

15 years or older:

• 10 mg tablet orally once a day

Comments:

• Doses should be taken in the evening.
• Efficacy has been demonstrated for asthma when this drug was administered in the evening without regard to time of food ingestion.

Use: Prophylaxis and chronic treatment of asthma in pediatric patients 12 months of age and older

Usual Pediatric Dose for Allergic Rhinitis

Seasonal Allergic Rhinitis:
Less than 2 years: Not approved.

2 to 5 years:

• 4 mg chewable tablet or one sachet of 4 mg oral granules once a day

6 to 14 years:

• 5 mg chewable tablet orally once a day

15 years or older:

• 10 mg tablet orally once a day

Perennial Allergic Rhinitis:
Less than 6 months: Not approved.

6 to 23 months:

• One sachet of 4 mg oral granules once a day

2 to 5 years:

• 4 mg chewable tablet orally once a day

6 to 14 years:

• 5 mg chewable tablet orally once a day

15 years or older:

• 10 mg tablet orally once a day

Comments:

• Efficacy has been demonstrated for asthma when this drug was administered in the MORNING or EVENING without regard to time of food ingestion.
• The time of administration may be individualized to suit patient needs.

Uses:

• Relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older
• Relief of symptoms of perennial allergic rhinitis in patients 6 months of age and older

Usual Pediatric Dose for Bronchospasm Prophylaxis

Less than 6 years: Not approved.

6 to 14 years:

• 5 mg chewable tablet orally once a day

15 years or older:

• 10 mg tablet orally once a day

Comments:

• Dose should be taken at least 2 hours before exercise.
• An additional dose should not be taken within 24 hours of a previous dose.
• Patients already taking this drug daily for another indication (including chronic asthma) should not take an additional dose to prevent EIB.
• A rescue short-acting beta-agonist should be available at all times.
• Daily administration for the chronic treatment of asthma has not been established to prevent acute episodes of EIB.

Use: Prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older

Renal Dose Adjustments

No adjustment recommended.

Liver Dose Adjustments

Mild or moderate liver dysfunction: No adjustment recommended.
Severe liver dysfunction: No clinical data is available.

Precautions

US FDA requires a medication guide to assure safe use. For additional information: www.fda.gov/drugs/drug-safety-and-availability/medication-guides

US BOXED WARNING(S):
SERIOUS MENTAL HEALTH SIDE EFFECTS INCLUDING SUICIDAL THOUGHTS OR ACTIONS:

• Mental health adverse effects, including suicidal thoughts or actions may occur.
• Benefit may not outweigh risks, particularly when disease is mild and adequately controlled with other medicines.
• Reserve use in hay fever for when other medicines are inadequate or not tolerated.
• Have mental health professionals consider the benefits and risks of mental health side effects before prescribing in asthma patients for behavior or mood related changes including agitation, aggressive behavior or hostility, attention problems, bad or vivid dreams, depression, disorientation or confusion, feeling anxious, hallucinations, irritability, memory problems, obsessive-compulsive symptoms, restlessness, sleepwalking, stuttering, suicidal thoughts or actions, tremor or shakiness, trouble sleeping, or uncontrolled muscle movements.

CONTRAINDICATIONS: Hypersensitivity to any of the ingredients

Safety and efficacy have not been established in patients younger than 12 months, for asthma; in younger than 2 years, for allergic rhinitis; and in younger than 6 years, for exercise induced bronchoconstriction (EIB).

Consult WARNINGS section for additional precautions.

Dialysis

It is not known whether this drug is removed by peritoneal dialysis or hemodialysis.

Other Comments

Administration advice:

• Patients with both asthma and allergic rhinitis should take only one dose daily in the evening.
• This drug can be taken with or without food.
• Oral granules: Administer within 15 minutes after opening the sachet (with or without mixing with food).

Storage requirements:

• Protect from moisture and light.
• Store in original package.

Reconstitution/preparation techniques: The manufacturer product information should be consulted for the oral granules formulation.

General:

• Daily administration for the chronic treatment of asthma has not been established to prevent acute episodes of EIB.

Patient advice:

• Take this drug daily as prescribed, even when asymptomatic and during periods of worsening asthma; the physician should be contacted if asthma is not well controlled.
• Appropriate short-acting inhaled beta-agonist medication should be available to treat asthma exacerbations.
• Seek medical attention if short-acting inhaled bronchodilators are needed more often than usual, or if more than the maximum number of inhalations of short-acting bronchodilator for a 24-hour period is needed.
• Report occurrence of neuropsychiatric events while using this drug.
• Patients should not decrease the dose or stop taking any other anti-asthma medications unless instructed by a physician.
• Patients with known aspirin sensitivity should continue avoiding aspirin or non-steroidal anti-inflammatory agents while taking this drug.