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Montelukast sodium Tablets and Chewable Tablets
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use Montelukast sodium safely and effectively. See full prescribing information for Montelukast sodium.
Montelukast sodium Tablets and Chewable Tablets
Initial U.S. approval: 1998
--------- RECENT MAJOR CHANGES---------------
Warnings and Precautions Neuropsychiatric Events (5.4) 03/2013
INDICATIONS AND USAGE
Montelukast sodium tablets are a leukotriene receptor antagonist indicated for:
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Prophylaxis and chronic treatment of asthma in patients 2 years of age and older (1.1).
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Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older (1.2).
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Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 2 years of age and older, and perennial allergic rhinitis (PAR) in patients 2 years of age or older (1.3).
DOSAGE AND ADMINISTRATION
Administration (by indications):
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Asthma (2.1): Once daily in the evening for patients 2 years and older.
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Acute prevention of EIB (2.2): 10 mg tablet at least 2 hours before exercise for patients 15 years of age and older.
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Seasonal allergic rhinitis (2.3): Once daily for patients 2 years and older.
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Perennial allergic rhinitis (2.3): Once daily for patients 2 years and older.
Dosage (by age) (2):
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15 years and older: one 10-mg tablet.
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6 to 14 years: one 5-mg chewable tablet.
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2 to 5 years: one 4-mg chewable tablet.
Patients with both asthma and allergic rhinitis should take only one dose daily in the evening (2.4).
DOSAGE FORMS AND STRENGTHS
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Montelukast sodium Film-Coated Tablets, 10-mg.
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Montelukast sodium Chewable Tablets, 4-mg and 5-mg.
CONTRAINDICATIONS
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Hypersensitivity to any component of this product (4).
WARNINGS AND PRECAUTIONS
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Do not prescribe montelukast sodium to treat an acute asthma attack (5.1).
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Advise patients to have appropriate rescue medication available (5.1).
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Inhaled corticosteroid may be reduced gradually. Do not abruptly substitute montelukast sodium for inhaled or oral corticosteroids (5.2).
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Patients with known aspirin sensitivity should continue to avoid aspirin or non-steroidal anti-inflammatory agents while taking montelukast sodium (5.3).
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Neuropsychiatric events have been reported with montelukast sodium. Instruct patients to be alert for neuropsychiatric events. eva luate the risks and benefits of continuing treatment with montelukast sodium if such events occur (5.4 and 6.2).
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Systemic eosinophilia, sometimes presenting with clinical features of vasculitis consistent with Churg-Strauss syndrome, has been reported. These events usually, but not always, have been associated with the reduction of oral corticosteroid therapy (5.5 and 6.2).
ADVERSE REACTIONS
Most common adverse reactions (incidence ≥ 5% and greater than placebo listed in descending order of frequency): upper respiratory infection, fever, headache, pharyngitis, cough, abdominal pain, diarrhea, otitis media, influenza, rhinorrhea, sinusitis, otitis (6.1).
To report SUSPECTED ADVERSE REACTIONS, contact AvKARE at 1-855-361-3993 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 11/2013
FULL PRESCRIBING INFORMATION: CONTENTS*
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 15 years of age and older.
Pediatric use information for patients ages 6 to 14 years of age for acute prevention of exercise-induced bronchoconstriction (EIB) is approved for Merck Sharp & Dohme Corp's montelukast tablet products. However, due to Merck Sharp & Dohme Corp's marketing exclusivity rights, this drug product is not labeled with that pediatric information.
1.3 Allergic Rhinitis
Montelukast sodium is indicated for the relief of symptoms of seasonal and perennial allergic rhinitis in patients 2 years of age and older.
2 DOSAGE AND ADMINISTRATION
2.1 Asthma
Montelukast sodium should be taken once daily in the evening. The following doses are recommended:
For adults and adolescents 15 years of age and older: one 10-mg tablet.
For pediatric patients 6 to 14 years of age: one 5-mg chewable tablet.
For pediatric patients 2 to 5 years of age: one 4-mg chewable tablet.
Safety and effectiveness in pediatric patients less than 12 months of age with asthma have not been established.
There have been no clinical trials in patients with asthma to eva luate the relative efficacy of morning versus evening dosing. The pharmacokinetics of montelukast are similar whether dosed in the morning or evening. Efficacy has been demonstrated for asthma when montelukast was administered in the evening without regard to time of food ingestion.
2.2 Exercise-Induced Bronchoconstriction (EIB) in Patients 15 Years of Age and Older
For prevention of EIB, a single 10 mg dose of montelukast should be taken at least 2 hours before exercise. An additional dose of montelukast 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. Safety and effectiveness in patients younger than 15 years of age have not been established. Daily administration of montelukast sodium for the chronic treatment of asthma has not been established to prevent acute episodes of EIB.
Pediatric use information for patients ages 6 to 14 years of age for acute prevention of exercise-induced bronchoconstriction (EIB) is approved for Merck Sharp & Dohme Corp's montelukast tablet products. However, due to Merck Sharp & Dohme Corp's marketing exclusivity rights, this drug product is not labeled with that pediatric information.
2.3 Allergic Rhinitis
For allergic rhinitis, montelukast sodium should be taken once daily. Efficacy was demonstrated for seasonal allergic rhinitis when montelukast was administered in the morning or the evening without regard to time of food ingestion. The time of administration may 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.
For pediatric patients 6 to 14 years of age: one 5-mg chewable tablet.
For 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:
For adults and adolescents 15 years of age and older: one 10-mg tablet
For pediatric patients 6 to 14 years of age: one 5-mg chewable tablet
For 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 perennial allergic rhinitis have not been established.
2.4 Asthma and Allergic Rhinitis
Patients with both asthma and allergic rhinitis should take only one montelukast sodium dose daily in the evening.
3 DOSAGE FORMS AND STRENGTHS
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Montelukast sodium Tablets, 10-mg are round, white, film-coated, convex tablets, debossed with "KU" on one side and "210" on the other.
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Montelukast sodium Chewable Tablets, 5-mg are round, light pink, convex tablets, debossed with "KU" on one side and "205" on the other.
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Montelukast sodium Chewable Tablets, 4-mg are round, light pink, convex tablets, debossed with "KU" on one side and "204" on the other.
4 CONTRAINDICATIONS
Hypersensitivity to any component of this product.
5 WARNINGS AND PRECAUTIONS
5.1 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.
5.2 Concomitant Corticosteroid Use
While the dose of inhaled corticosteroid may be reduced gradually under medical supervision, montelukast sodium should not be abruptly substituted for inhaled or oral corticosteroids.
5.3 Aspirin Sensitivity
Patients with known aspirin sensitivity should continue avoidance of aspirin or non-steroidal anti-inflammatory agents while taking montelukast sodium. Although montelukast sodium is effective in improving airway function in asthmatics with documented aspirin sensitivity, it has not been shown to truncate bronchoconstrictor response to aspirin and other non-steroidal anti-inflammatory drugs in aspirin-sensitive asthmatic patients [see Clinical Studies (14.1)].
5.4 Neuropsychiatric Events
Neuropsychiatric events have been reported in adult, adolescent, and pediatric patients taking montelukast sodium. Post-marketing reports with montelukast sodium use include agitation, aggressive behavior or hostility, anxiousness, depression, disorientation,disturbance in attention, dream abnormalities, hallucinations, insomnia, irritability, memory impairment, restlessness, somnambulism, suicidal thinking and behavior (including suicide), and tremor. The clinical details of some post-marketing reports involving montelukast sodium appear consistent with a drug-induced effect.
Patients and prescribers should be alert for neuropsychiatric events. Patients should be instructed to notify their prescriber if these changes occur. Prescribers should carefully eva luate the risks and benefits of continuing treatment with montelukast sodium if such events occur [see Adverse Reactions (6.2)].
5.5 Eosinophilic Conditions
Patients with asthma on therapy with montelukast sodium may present with systemic eosinophilia, sometimes presenting with clinical features of vasculitis consistent with Churg-Strauss syndrome, a condition which is often treated with systemic corticosteroid therapy. These events usually, but not always, have been associated with the reduction of oral corticosteroid therapy. Physicians should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients. A causal association between montelukast sodium and these underlying conditions has not been established [see Adverse Reactions (6.2)].
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. In the following description of clinical trials experience, adverse reactions are listed regardless of causality assessment.
The most common adverse reactions (incidence ≥ 5% and greater than placebo; listed in descending order of frequency) in controlled clinical trials were: upper respiratory infection, fever, headache, pharyngitis, cough, abdominal pain, diarrhea, otitis media, influenza, rhinorrhea, sinusitis, otitis.
Adults and Adolescents 15 Years of Age and Older with Asthma
Montelukast sodium has been eva luated for safety in approximately 2950 adult and adolescent patients 15 years of age and older in clinical trials. In placebo-controlled clinical trials, the following adverse experiences reported with montelukast sodium occurred in greater than or equal to 1% of patients and at an incidence greater than that in patients treated with placebo:
The frequency of less common adverse events was comparable between montelukast sodium and placebo.
The safety profile of montelukast sodium, when administered as a single dose for prevention of EIB in adult and adolescent patients 15 years of age and older, was consistent with the safety profile previously described for montelukast sodium.
Cumulatively, 569 patients were treated with montelukast sodium for at least 6 months, 480 for one year, and 49 for two years in clinical trials. With prolonged treatment, the adverse experience profile did not significantly change.
Pediatric Patients 6 to 14 Years of Age with Asthma
Montelukast sodium has been eva luated for safety in 476 pediatric patients 6 to 14 years of age. Cumulatively, 289 pediatric patients were treated with montelukast sodium for at least 6 months, and 241 for one year or longer in clinical trials. The safety profile of montelukast sodium in the 8-week, double-blind, pediatric efficacy trial was generally similar to the adult safety profile. In pediatric patients 6 to 14 years of age receiving montelukast sodium, the following events occurred with a frequency ≥ 2% and more frequently than in pediatric patients who received placebo: pharyngitis, influenza, fever sinusitis, nausea, diarrhea, dyspepsia, otitis, viral infection, and laryngitis. The frequency of less common adverse events was comparable between montelukast sodium and placebo. With prolonged treatment, the adverse experience profile did not significantly change.
Pediatric use information for patients ages 6 to 14 years of age for acute prevention of exercise-induced bronchoconstriction (EIB) is approved for Merck Sharp & Dohme Corp's montelukast tablet products. However, due to Merck Sharp & Dohme Corp's marketing exclusivity rights, this drug product is not labeled with that pediatric information.
In studies eva luating growth rate, the safety profile in these pediatric patients was consistent with the safety profile previously described for montelukast sodium. In a 56-week, double-blind study eva luating growth rate in pediatric patients 6 to 8 years of age receiving montelukast sodium, the following events not previously observed with the use of montelukast sodium in this age group occurred with a frequency >2% and more frequently than in pediatric patients who received placebo: headache, rhinitis (infective), varicella, gastroenteritis, atopic dermatitis, acute bronchitis, tooth infection, skin infection, and myopia.
Pediatric Patients 2 to 5 Years of Age with Asthma
Montelukast sodium has been eva luated for safety in 573 pediatric patients 2 to 5 years of age in single- and multiple-dose studies. Cumulatively, 426 pediatric patients 2 to 5 years of age were treated with montelukast sodium for at least 3 months, 230 for 6 months or longer, and 63 patients for one year or longer in clinical trials. In pediatric patients 2 to 5 years of age receiving montelukast sodium, the following events occurred with a frequency >2% and more frequently than in pediatric patients who received placebo: fever, cough, abdominal pain, diarrhea, headache, rhinorrhea, sinusitis, otitis, influenza, rash, ear pain, gastroenteritis, eczema, urticaria, varicella, pneumonia, dermatitis, and conjunctivitis.
Adults and Adolescents 15 Years of Age and Older with Seasonal Allergic Rhinitis
Montelukast sodium has been eva luated for safety in 2199 adult and adolescent patients 15 years of age and older in clinical trials. Montelukast sodium administered once daily in the morning or in the evening had a safety profile similar to that of placebo. In placebo-controlled clinical trials, the following event was reported with montelukast sodium with a frequency ≥1 % and at an incidence greater than placebo: upper respiratory infection, 1.9% of patients receiving montelukast sodium vs. 1.5% of patients receiving placebo. In a 4-week, placebo-controlled clinical study, the safety profile was consistent with that observed in 2-week studies. The incidence of somnolence was similar to that of placebo in all studies.
Pediatric Patients 2 to 14 Years of Age with Seasonal Allergic Rhinitis
Montelukast sodium has been eva luated in 280 pediatric patients 2 to 14 years of age in a 2-week, multicenter, double-blind, placebo-controlled, parallel-group safety study. Montelukast sodium administered once daily in the evening had a safety profile similar to that of placebo. In this study, the following events occurred with a frequency ≥2% and at an incidence greater than placebo: headache, otitis media, pharyngitis, and upper respiratory infection.
Adults and Adolescents 15 Years of Age and Older with Perennial Allergic Rhinitis
Montelukast sodium has been eva luated for safety in 3357 adult and adolescent patients 15 years of age and older with perennial allergic rhinitis of whom 1632 received montelukast sodium in two, 6-week, clinical studies. Montelukast sodium administered once daily had a safety profile consistent with that |
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