Montelukast Sodium Prescribing Information
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)]. |
Montelukast sodium tablets are a leukotriene receptor antagonist indicated for:
- Prophylaxis and chronic treatment of asthma in patients 15 years of age and older ().1.1 Asthma
Montelukast sodium tablets are indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 15 years of age and older.
- Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 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.
- Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 15 years of age and older, and perennial allergic rhinitis (PAR) in patients 15 years of age and older. Reserve use for patients who have an inadequate response or intolerance to alternative therapies ().1.3 Allergic RhinitisMontelukast 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 tablet 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.
- Not indicated to treat an acute asthma attack ().5.2 Acute Asthma
Montelukast sodium is not indicated for use in the reversal of bronchospasm in acute asthma attacks, including status asthmaticus. Patients should be advised to have appropriate rescue medication available. Therapy with Montelukast Sodium can be continued during acute exacerbations of asthma. Patients who have exacerbations of asthma after exercise should have available for rescue a short-acting inhaled β-agonist.
Administration (by indications):
- Asthma: Once daily in the evening for patients 15 years and older ().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:
For adults and adolescents 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. - Acute prevention of EIB: One tablet at least 2 hours before exercise for patients 15 years of age and older ().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:
For adults and adolescents 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.
- Seasonal allergic rhinitis: Once daily for patients 15 years and older ().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:
For adults and adolescents 15 years of age and older: one 10-mg tablet.
The following doses for the treatment of symptoms of perennial allergic rhinitis are recommended:
For adults and adolescents 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. - Perennial allergic rhinitis: Once daily for patients 15 years and older ().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:
For adults and adolescents 15 years of age and older: one 10-mg tablet.
The following doses for the treatment of symptoms of perennial allergic rhinitis are recommended:
For adults and adolescents 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.
Dosage (by age):
- 15 years and older: one 10-mg tablet ().2 DOSAGE AND ADMINISTRATION
Administration (by indications):
- Asthma: Once daily in the evening for patients 15 years and older .
- Acute prevention of EIB: One tablet at least 2 hours before exercise for patients 15 years of age and older .
- Seasonal allergic rhinitis: Once daily for patients 15 years and older .
- Perennial allergic rhinitis: Once daily for patients 15 years and older .
Dosage (by age):
- 15 years and older: one 10-mg tablet .
Patients with both asthma and allergic rhinitis should take only one dose daily in the evening .
2.1 AsthmaFor 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:
For adults and adolescents 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:
For adults and adolescents 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 RhinitisFor 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:
For adults and adolescents 15 years of age and older: one 10-mg tablet.
The following doses for the treatment of symptoms of perennial allergic rhinitis are recommended:
For adults and adolescents 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 RhinitisFor patients with both asthma and allergic rhinitis, administer only one montelukast sodium tablets dose 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.
Patients with both asthma and allergic rhinitis should take only one dose daily in the evening (
For patients with both asthma and allergic rhinitis, administer only one montelukast sodium tablets dose 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.
Montelukast Sodium Tablets USP, 10 mg are yellow, round, film-coated tablets debossed with 10 on one side and plain on the other.
Available data from published prospective and retrospective cohort studies over decades with montelukast use in pregnant women have not established a drug-associated risk of major birth defects
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
Poorly or moderately controlled asthma in pregnancy increases the maternal risk of perinatal adverse outcomes such as preeclampsia and infant prematurity, low birth weight, and small for gestational age.
Published data from prospective and retrospective cohort studies have not identified an association with Montelukast Sodium use during pregnancy and major birth defects.
Available studies have methodologic limitations, including small sample size, in some cases retrospective data collection, and inconsistent comparator groups.
In embryo-fetal development studies, montelukast administered to pregnant rats and rabbits during organogenesis (gestation days 6 to 17 in rats and 6 to 18 in rabbits) did not cause any adverse developmental effects at maternal oral doses up to 400 and 300 mg/kg/day in rats and rabbits, respectively (approximately 100 and 110 times the AUC in humans at the MRHDOD, respectively).