Montelukast

MONTELUKAST- montelukast sodium tablet
BluePoint Laboratories

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 immediately [see Warnings and Precautions (5.1)].

1 INDICATIONS & USAGE

1.1 Asthma

Montelukast sodium tablets are indicated for the prophylaxis and chronic treatment of asthma 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.

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 to alternative therapies.

2 DOSAGE & ADMINISTRATION

2.1 Asthma

Montelukast sodium should be taken once daily in the evening. The following dose is recommended:
For adults and adolescents 15 years of age and older: one 10-mg tablet.
Safety and effectiveness in pediatric patients less than 12 months of age with asthma have not been established.

Patients who miss a dose should take the next dose at their regular time and should not take 2 doses at the same time.
There have been no clinical trials in patients with asthma to evaluate 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)

For prevention of EIB, a single 10 mg dose of montelukast should be taken at least 2 hours before exercise.

The following dose is recommended :
For adults and adolescents 15 years of age and older: one 10-mg tablet.

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 ß-agonist. Safety and efficacy 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.

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 dose 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.
Safety and efficacy in pediatric patients younger than 2 years of age with seasonal allergic rhinitis have not been established.
The following dose 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.
Safety and effectiveness in pediatric patients younger than 6 months of age with perennial allergic rhinitis have not been established.

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

Patients with both asthma and allergic rhinitis should take only one montelukast sodium 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.

3 DOSAGE FORMS & STRENGTHS

Montelukast sodium Film-Coated Tablets, USP 10 mg, are beige, rounded square-shaped biconvex tablets, debossed ‘CL 26’ on one side of the tablet and having plain surface on other side.

4 CONTRAINDICATIONS

Hypersensitivity to any component of this product.

5 WARNINGS AND PRECAUTIONS

5.1 Neuropsychiatric Events

Serious n europsychiatric (NP) events have been reported with the use of montelukast sodium. These post-marketing reports have been highly variable and included, but were not limited to, agitation, aggressive behavior or hostility, anxiousness, depression, disorientation, disturbance in attention, dream abnormalities, dysphemia (stuttering), hallucinations, insomnia, irritability, memory impairment, obsessive-compulsive symptoms, restlessness, somnambulism, suicidal thoughts and behavior (including suicide), tic, and tremor. NP events have been reported in adult, adolescent, and pediatric patients with and without a previous history of psychiatric disorder. NP events have been reported mostly during montelukast sodium treatment, but some were reported after montelukast sodium discontinuation. Animal studies showed that montelukast distributes into the brain in rats [see Clinical Pharmacology (12.3)]; however, the mechanisms underlying montelukast sodium-associated NP events are currently not well understood. Based upon the available data, it is difficult to identify risk factors for or quantify the risk of NP events with montelukast sodium use.

Because of the risks 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 exercised-induced bronchoconstriction, consider the benefits and risks before prescribing montelukast sodium.

Discuss the benefits and risks of montelukast sodium use with patients and caregivers when prescribing montelukast sodium. Advise patients and/ or caregivers to be alert for changes in behavior or for 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. In many cases, symptoms resolved after stopping montelukast sodium therapy; however, in some cases symptoms persisted after discontinuation of montelukast sodium.

Therefore, continue to monitor and provide supportive care until symptoms resolve. Re-evaluate the benefits and risks of restarting treatment with montelukast sodium if such events occur.

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