Montelukast Sodium

MONTELUKAST SODIUM — montelukast sodium tablet, chewable
RPK Pharmaceuticals, Inc.

WARNING: SERIOUS NEUROPSYCHIATRIC EVENTS

Serious neuropsychiatric (NP) events have been reported with the use of montelukast sodium. The types of events reported were highly variable, and included, but were not limited to, agitation, aggression, depression, sleep disturbances, suicidal thoughts and behavior (including suicide). The mechanisms underlying NP events associated with montelukast sodium use are currently not well understood [see Warnings and Precautions (5.1)].

Because of the risk of NP events, the benefits of montelukast sodium may not outweigh the risks in some patients, particularly when the symptoms of disease may be mild and adequately treated with alternative therapies. Reserve use of montelukast sodium for patients with allergic rhinitis who have an inadequate response or intolerance to alternative therapies [see Indications and Usage (1.3)]. In patients with asthma or exercise-induced bronchoconstriction, consider the benefits and risks before prescribing montelukast sodium.

Discuss the benefits and risks of montelukast sodium with patients and caregivers when prescribing montelukast sodium. Advise patients and/or caregivers to be alert for changes in behavior or new NP symptoms when taking montelukast sodium. If changes in behavior are observed, or if new NP symptoms or suicidal thoughts and/or behavior occur, advise patients to discontinue montelukast sodium and contact a healthcare provider immediately [see Warnings and Precautions (5.1)].

1 INDICATIONS AND USAGE

1.1 Asthma


Montelukast sodium is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 2 years of age and older.

1.2 Exercise-Induced Bronchoconstriction (EIB)

Montelukast sodium is indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older.

1.3 Allergic Rhinitis

Montelukast sodium is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 2 years of age and older. Because the benefits of montelukast sodium may not outweigh the risk of neuropsychiatric symptoms in patients with allergic rhinitis [see Warnings and Precautions (5.1)] , reserve use for patients who have an inadequate response or intolerance to alternative therapies.

1.4 Limitations of Use

Montelukast sodium is not indicated for the treatment of an acute asthma attack.

2 DOSAGE AND ADMINISTRATION

2.1 Asthma

For asthma, administer montelukast sodium orally once daily in the evening, with or without food. There have been no clinical trials in patients with asthma to evaluate the relative efficacy of morning versus evening dosing.

The following doses are recommended:

Table 1: Recommended Dosage in Asthma

Age Dose
Adult and adolescent patients 15 years of age and older one 10 mg tablet
Pediatric patients 6 to 14 years of age one 5 mg chewable tablet
Pediatric patients 2 to 5 years of age one 4 mg chewable tablet

Patients who miss a dose should take the next dose at their regular time and should not take 2 doses at the same time.

2.2 Exercise-Induced Bronchoconstriction (EIB)

For prevention of EIB, administer a single dose of montelukast sodium orally at least 2 hours, before exercise. The following doses are recommended:

Table 2: Recommended Dosage in Exercise-Induced Bronchoconstriction (EIB)

Age Dose
Adult and adolescent patients 15 years of age and older one 10 mg tablet
Pediatric patients 6 to 14 years of age* one 5 mg chewable tablet

* Safety and effectiveness in patients younger than 6 years of age have not been established.

An additional dose of montelukast sodium should not be taken within 24 hours of a previous dose. Patients already taking montelukast sodium daily for another indication (including chronic asthma) should not take an additional dose to prevent EIB. All patients should have available for rescue a short-acting β-agonist.

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

2.3 Allergic Rhinitis

For allergic rhinitis, administer montelukast sodium orally once daily without regard to time of food ingestion. Time of administration in patients with allergic rhinitis can be individualized to suit patient needs.

The following doses for the treatment of symptoms of seasonal allergic rhinitis are recommended:

Table 3: Recommended Dosage in Seasonal Allergic Rhinitis

Age Dose
Adult and adolescent patients 15 years of age and older one 10 mg tablet
Pediatric patients 6 to 14 years of age one 5 mg chewable tablet
Pediatric patients 2 to 5 years of age* one 4 mg chewable tablet

* Safety and effectiveness in pediatric patients younger than 2 years of age with seasonal allergic rhinitis have not been established.

The following doses for the treatment of symptoms of perennial allergic rhinitis are recommended:

Table 4: Recommended Dosage in Perennial Allergic Rhinitis

Age Dose
Adult and adolescent patients 15 years of age and older one 10 mg tablet
Pediatric patients 6 to 14 years of age one 5 mg chewable tablet
Pediatric patients 2 to 5 years of age one 4 mg chewable tablet

Patients who miss a dose should take the next dose at their regular time and should not take 2 doses at the same time.

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