Montelukast
MONTELUKAST — montelukast sodium tablet, film coated
Quallent Pharmaceuticals Health LLC
WARNING: SERIOUS NEUROPSYCHIATRIC EVENTS
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 tablets are indicated for the prophylaxis and chronic treatment of asthma in adults and adolescents 15 years of age and older.
1.2 Exercise-Induced Bronchoconstriction (EIB)
Montelukast sodium tablets are indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older.
1.3 Allergic Rhinitis
Montelukast sodium tablets are indicated for the relief of symptoms of seasonal allergic rhinitis in patients 15 years of age and older and perennial allergic rhinitis in patients 15 years of age and older. Because the benefits of montelukast sodium tablets 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 tablets are not indicated for the treatment of an acute asthma attack.
2 DOSAGE AND ADMINISTRATION
2.1 Asthma
For
asthma, administer montelukast sodium tablets 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 |
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 tablets 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 |
An additional dose of montelukast sodium tablets should not be taken within 24 hours of a previous dose. Patients already taking montelukast sodium tablets 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 tablets 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 tablets 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 |
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 |
Patients who miss a dose should take the next dose at their regular time and should not take 2 doses at the same time.
2.4 Asthma and Allergic Rhinitis
For patients with both asthma and allergic rhinitis, administer only one montelukast sodium tablets dose orally once daily in the evening. Patients who miss a dose should take the next dose at their regular time and should not take 2 doses at the same time.
3 DOSAGE FORMS AND STRENGTHS
- Montelukast sodium film-coated tablets, USP 10 mg are beige, rounded square-shaped, film-coated tablets debossed with ‘I’ on one side and ‘114’ on the other side.
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