Montelukast

Brand names: Montelukast Sodium, SINGULAIR, Montelukast, MONTELUKAST, MONTELUKAST SODIUM

Boxed warning

WARNING: SERIOUS NEUROPSYCHIATRIC EVENTS WARNING: SERIOUS NEUROPSYCHIATRIC EVENTS Serious neuropsychiatric (NP) events have been reported with the use of montelukast sodium tablets. 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 tablets use are currently not well understood [ see Warnings and Precautions ( 5.1 ) ]. Because of the risk of NP events, the benefits of montelukast sodium tablets 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 tablets 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 tablets. Discuss the benefits and risks of montelukast sodium tablets with patients and caregivers when prescribing montelukast sodium tablets. Advise patients and/or caregivers to be alert for changes in behavior or new NP symptoms when taking montelukast sodium tablets. If changes in behavior are observed, or if new NP symptoms or suicidal thoughts and/or behavior occur, advise patients to discontinue montelukast sodium tablets and contact a healthcare provider immediately [ see Warnings and Precautions ( 5.1 ) ]. WARNING: SERIOUS NEUROPSYCHIATRIC EVENTS See full prescribing information for complete boxed warning. • Serious neuropsychiatric events have been reported in patients taking montelukast sodium tablets. ( 5.1 ). • Discuss benefits and risks of montelukast sodium tablets with patients and caregivers ( 5.1 ). • Monitor for neuropsychiatric symptoms in patients taking montelukast sodium tablets ( 5.1 ). • Discontinue montelukast sodium tablets immediately if neuropsychiatric symptoms occur ( 5.1 ). • Because the benefits of montelukast sodium tablets may not outweigh the potential risk of neuropsychiatric symptoms in patients with allergic rhinitis, reserve use for patients who have an inadequate response or intolerance to alternative therapies( 1.3 , 5.1 ).

Warnings

Key warnings include: - "Do not prescribe montelukast sodium to treat an acute asthma attack" - Do not abruptly substitute for inhaled or oral corticosteroids; gradual reduction only - Patients with aspirin sensitivity should continue avoiding aspirin and NSAIDs - "Neuropsychiatric events have been reported" including agitation, depression, suicidal thinking/behavior, hallucinations, and sleep-related issues - Systemic eosinophilia and vasculitis (Churg-Strauss syndrome) reported, sometimes linked to corticosteroid reduction - Chewable tablets contain phenylalanine; inform phenylketonuria patients

Contraindications

4 CONTRAINDICATIONS Montelukast sodium is contraindicated in patients with hypersensitivity to any of its components. Hypersensitivity to any component of montelukast sodium ( 4 ).

Overdose

10 OVERDOSAGE No specific information is available on the treatment of overdosage with montelukast sodium. In the event of overdose, it is reasonable to employ the usual supportive measures; e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute supportive therapy, if required. It is not known whether montelukast is removed by peritoneal dialysis or hemodialysis.

Drug interactions

7 DRUG INTERACTIONS No dose adjustment is needed when montelukast sodium is co-administered with theophylline, prednisone, prednisolone, oral contraceptives, fexofenadine, digoxin, warfarin, gemfibrozil, itraconazole, thyroid hormones, sedative hypnotics, non-steroidal anti-inflammatory agents, benzodiazepines, decongestants, and Cytochrome P450 (CYP) enzyme inducers [see Clinical Pharmacology ( 12.3 )].

Uses

Montelukast sodium is indicated for: - "Prophylaxis and chronic treatment of asthma in patients 12 months of age and older" - "Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older" - Relief of allergic rhinitis symptoms: seasonal form in patients 2+ years old, perennial form in patients 6+ months old

Dosage forms & strengths

Tablet, Chewable Tablet, Coated Tablet, Film Coated TABLET, FILM COATED TABLET, CHEWABLE TABLET POWDER

MONTELUKAST SODIUM 10 mg MONTELUKAST SODIUM 4 mg MONTELUKAST SODIUM 5 mg Montelukast Sodium 10 mg montelukast sodium 10 mg montelukast sodium 4 mg montelukast sodium 5 mg MONTELUKAST SODIUM 10 mg/1 MONTELUKAST SODIUM 5 mg/1 MONTELUKAST SODIUM 4 mg/1 MONTELUKAST SODIUM 1 kg/kg

2 DOSAGE & ADMINISTRATION Administration (by indications): Asthma: Once daily in the evening for patients 15 years of age and older ( 2.1 ). Acute prevention of EIB: One tablet at least 2 hours before exercise for patients 15 years of age and older ( 2.2 ). Seasonal allergic rhinitis: Once daily for patients 15 years and older ( 2.3 ). Perennial allergic rhinitis: Once daily for patients 15 years and older ( 2.3 ). 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 ( 2.4 ). 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 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 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 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 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.