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Montelukast Dosage

Applies to the following strength(s): 10 mg ; 5 mg ; 4 mg

The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.

Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

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

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.

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