Check Drug InteractionsCheck known drug interactions.
Check Drug InteractionsMontelukast Prescribing Information
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
)].
neuropsychiatric (NP) events have been reported with use of montelukast sodium. These postmarketing reports have been highly variable and included, but were not limited to, agitation, aggressive behavior or hostility, anxiousness, depression, disorientation, disturbance in attention, dream
dysphemia (stuttering), hallucinations, insomnia, irritability, memory impairment, obsessive-compulsive symptoms, restlessness,
, suicidal thoughts and behavior (including suicide), tic, and tremor. NP events have been reported in adult, adolescent, and pediatric patients with and without a
history of psychiatric disorder. NP events have been reported mostly during montelukast sodium treatment, but some were reported after
sodium discontinuation. Animal studies showed that montelukast distributes into the brain in rats
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
for or quantify the risk of NP events with montelukast sodium use.
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
and adequately treated with alternative therapies. Reserve use of montelukast sodium for patients with allergic rhinitis who have an inadequate
or intolerance to alternative therapies
In patients with asthma or exercise-induced bronchoconstriction, consider the benefits and
before prescribing montelukast sodium.
the benefits and risks of montelukast sodium use with patients and caregivers when prescribing montelukast sodium. Advise patients and/or caregivers to be
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
behavior occur, advise patients to discontinue montelukast sodium and contact a healthcare provider immediately. In many cases,
resolved after stopping montelukast sodium therapy; however, in some cases symptoms persisted after discontinuation of montelukast sodium.
continue to monitor and provide supportive care until symptoms resolve. Re-evaluate the benefits and risks of restarting treatment with
sodium if such events occur.
Serious neuropsychiatric (NP) events have been reported with use of montelukast sodium. These postmarketing 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
factors for or quantify the risk of NP events with montelukast sodium use.
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
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.
dysphemia (stuttering), hallucinations, insomnia, irritability, memory impairment, obsessive-compulsive symptoms, restlessness,
, suicidal thoughts and behavior (including suicide), tic, and tremor. NP events have been reported in adult, adolescent, and pediatric patients with and without a
history of psychiatric disorder. NP events have been reported mostly during montelukast sodium treatment, but some were reported after
sodium discontinuation. Animal studies showed that montelukast distributes into the brain in rats
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
for or quantify the risk of NP events with montelukast sodium use.
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
and adequately treated with alternative therapies. Reserve use of montelukast sodium for patients with allergic rhinitis who have an inadequate
or intolerance to alternative therapies
In patients with asthma or exercise-induced bronchoconstriction, consider the benefits and
before prescribing montelukast sodium.
the benefits and risks of montelukast sodium use with patients and caregivers when prescribing montelukast sodium. Advise patients and/or caregivers to be
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
behavior occur, advise patients to discontinue montelukast sodium and contact a healthcare provider immediately. In many cases,
resolved after stopping montelukast sodium therapy; however, in some cases symptoms persisted after discontinuation of montelukast sodium.
continue to monitor and provide supportive care until symptoms resolve. Re-evaluate the benefits and risks of restarting treatment with
sodium if such events occur.
Serious neuropsychiatric (NP) events have been reported with use of montelukast sodium. These postmarketing 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 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 andrisks 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.
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 (
)].
In patients with asthma or exercise-induced bronchoconstriction, consider the benefits and risks before prescribing 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
of age and older. Because the benefits of montelukast sodium tablets may not outweigh the risk of neuropsychiatric symptoms in patients with
reserve use for patients who have an inadequate response or intolerance to alternative therapies.
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
of age and older. Because the benefits of montelukast sodium tablets may not outweigh the risk of neuropsychiatric symptoms in patients with
reserve use for patients who have an inadequate response or intolerance to alternative therapies.
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.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
)].
neuropsychiatric (NP) events have been reported with use of montelukast sodium. These postmarketing reports have been highly variable and included, but were not limited to, agitation, aggressive behavior or hostility, anxiousness, depression, disorientation, disturbance in attention, dream
dysphemia (stuttering), hallucinations, insomnia, irritability, memory impairment, obsessive-compulsive symptoms, restlessness,
, suicidal thoughts and behavior (including suicide), tic, and tremor. NP events have been reported in adult, adolescent, and pediatric patients with and without a
history of psychiatric disorder. NP events have been reported mostly during montelukast sodium treatment, but some were reported after
sodium discontinuation. Animal studies showed that montelukast distributes into the brain in rats
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
for or quantify the risk of NP events with montelukast sodium use.
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
and adequately treated with alternative therapies. Reserve use of montelukast sodium for patients with allergic rhinitis who have an inadequate
or intolerance to alternative therapies
In patients with asthma or exercise-induced bronchoconstriction, consider the benefits and
before prescribing montelukast sodium.
the benefits and risks of montelukast sodium use with patients and caregivers when prescribing montelukast sodium. Advise patients and/or caregivers to be
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
behavior occur, advise patients to discontinue montelukast sodium and contact a healthcare provider immediately. In many cases,
resolved after stopping montelukast sodium therapy; however, in some cases symptoms persisted after discontinuation of montelukast sodium.
continue to monitor and provide supportive care until symptoms resolve. Re-evaluate the benefits and risks of restarting treatment with
sodium if such events occur.
Serious neuropsychiatric (NP) events have been reported with use of montelukast sodium. These postmarketing 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
factors for or quantify the risk of NP events with montelukast sodium use.
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
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.
dysphemia (stuttering), hallucinations, insomnia, irritability, memory impairment, obsessive-compulsive symptoms, restlessness,
, suicidal thoughts and behavior (including suicide), tic, and tremor. NP events have been reported in adult, adolescent, and pediatric patients with and without a
history of psychiatric disorder. NP events have been reported mostly during montelukast sodium treatment, but some were reported after
sodium discontinuation. Animal studies showed that montelukast distributes into the brain in rats
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
for or quantify the risk of NP events with montelukast sodium use.
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
and adequately treated with alternative therapies. Reserve use of montelukast sodium for patients with allergic rhinitis who have an inadequate
or intolerance to alternative therapies
In patients with asthma or exercise-induced bronchoconstriction, consider the benefits and
before prescribing montelukast sodium.
the benefits and risks of montelukast sodium use with patients and caregivers when prescribing montelukast sodium. Advise patients and/or caregivers to be
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
behavior occur, advise patients to discontinue montelukast sodium and contact a healthcare provider immediately. In many cases,
resolved after stopping montelukast sodium therapy; however, in some cases symptoms persisted after discontinuation of montelukast sodium.
continue to monitor and provide supportive care until symptoms resolve. Re-evaluate the benefits and risks of restarting treatment with
sodium if such events occur.
Serious neuropsychiatric (NP) events have been reported with use of montelukast sodium. These postmarketing 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 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 andrisks 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.
Boxed Warning 04/2020
Indications and Usage, Allergic Rhinitis
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
of age and older. Because the benefits of montelukast sodium tablets may not outweigh the risk of neuropsychiatric symptoms in patients with
reserve use for patients who have an inadequate response or intolerance to alternative therapies.
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
of age and older. Because the benefits of montelukast sodium tablets may not outweigh the risk of neuropsychiatric symptoms in patients with
reserve use for patients who have an inadequate response or intolerance to alternative therapies.
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.Dosage and Administration, Asthma
Montelukast sodium tablets 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.
Safety and effectiveness in pediatric patients less than 12 months of age with asthma have not been established.
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.
Montelukast sodium tablets 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.
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.
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.
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.
Montelukast sodium tablets 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.
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.
Allergic Rhinitis
For allergic rhinitis, montelukast sodium tablets 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.
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.
Safety and effectiveness in pediatric patients younger than 6 months of age with perennial allergic rhinitis have not been established.
who miss a dose should take the next dose at their regular time and should not take 2 doses at the same time.
For allergic rhinitis, montelukast sodium tablets 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.
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.
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.
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.
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.
Safety and effectiveness in pediatric patients younger than 6 months of age with perennial allergic rhinitis have not been established.
who miss a dose should take the next dose at their regular time and should not take 2 doses at the same time.
For allergic rhinitis, montelukast sodium tablets 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.
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.
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.
Patients with both asthma and allergic rhinitis should take only one montelukast sodium tablets dose daily in the evening.
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 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.
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 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.
Warnings and Precautions, Neuropsychiatric Events
neuropsychiatric (NP) events have been reported with use of montelukast sodium. These postmarketing reports have been highly variable and included, but were not limited to, agitation, aggressive behavior or hostility, anxiousness, depression, disorientation, disturbance in attention, dream
dysphemia (stuttering), hallucinations, insomnia, irritability, memory impairment, obsessive-compulsive symptoms, restlessness,
, suicidal thoughts and behavior (including suicide), tic, and tremor. NP events have been reported in adult, adolescent, and pediatric patients with and without a
history of psychiatric disorder. NP events have been reported mostly during montelukast sodium treatment, but some were reported after
sodium discontinuation. Animal studies showed that montelukast distributes into the brain in rats
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
for or quantify the risk of NP events with montelukast sodium use.
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
and adequately treated with alternative therapies. Reserve use of montelukast sodium for patients with allergic rhinitis who have an inadequate
or intolerance to alternative therapies
In patients with asthma or exercise-induced bronchoconstriction, consider the benefits and
before prescribing montelukast sodium.
the benefits and risks of montelukast sodium use with patients and caregivers when prescribing montelukast sodium. Advise patients and/or caregivers to be
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
behavior occur, advise patients to discontinue montelukast sodium and contact a healthcare provider immediately. In many cases,
resolved after stopping montelukast sodium therapy; however, in some cases symptoms persisted after discontinuation of montelukast sodium.
continue to monitor and provide supportive care until symptoms resolve. Re-evaluate the benefits and risks of restarting treatment with
sodium if such events occur.
Serious neuropsychiatric (NP) events have been reported with use of montelukast sodium. These postmarketing 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
factors for or quantify the risk of NP events with montelukast sodium use.
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
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.
dysphemia (stuttering), hallucinations, insomnia, irritability, memory impairment, obsessive-compulsive symptoms, restlessness,
, suicidal thoughts and behavior (including suicide), tic, and tremor. NP events have been reported in adult, adolescent, and pediatric patients with and without a
history of psychiatric disorder. NP events have been reported mostly during montelukast sodium treatment, but some were reported after
sodium discontinuation. Animal studies showed that montelukast distributes into the brain in rats
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
for or quantify the risk of NP events with montelukast sodium use.
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
and adequately treated with alternative therapies. Reserve use of montelukast sodium for patients with allergic rhinitis who have an inadequate
or intolerance to alternative therapies
In patients with asthma or exercise-induced bronchoconstriction, consider the benefits and
before prescribing montelukast sodium.
the benefits and risks of montelukast sodium use with patients and caregivers when prescribing montelukast sodium. Advise patients and/or caregivers to be
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
behavior occur, advise patients to discontinue montelukast sodium and contact a healthcare provider immediately. In many cases,
resolved after stopping montelukast sodium therapy; however, in some cases symptoms persisted after discontinuation of montelukast sodium.
continue to monitor and provide supportive care until symptoms resolve. Re-evaluate the benefits and risks of restarting treatment with
sodium if such events occur.
Serious neuropsychiatric (NP) events have been reported with use of montelukast sodium. These postmarketing 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 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 andrisks 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.
Montelukast sodium tablets are a leukotriene receptor antagonist indicated for:
• Prophylaxis and chronic treatment of asthma in patients 15 years of age and older
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
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
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
of age and older. Because the benefits of montelukast sodium tablets may not outweigh the risk of neuropsychiatric symptoms in patients with
reserve use for patients who have an inadequate response or intolerance to alternative therapies.
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
of age and older. Because the benefits of montelukast sodium tablets may not outweigh the risk of neuropsychiatric symptoms in patients with
reserve use for patients who have an inadequate response or intolerance to alternative therapies.
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.Administration (by indications):
• Asthma
Montelukast sodium tablets 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.
Safety and effectiveness in pediatric patients less than 12 months of age with asthma have not been established.
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.
Montelukast sodium tablets 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.
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.
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.
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.
Montelukast sodium tablets 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.
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.
• Acute prevention of EIB
For prevention of EIB, a single dose of montelukast sodium tablets should be taken 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. Safety and efficacy in patients younger than 6 years of age have not been established. 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
For allergic rhinitis, montelukast sodium tablets 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.
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.
Safety and effectiveness in pediatric patients younger than 6 months of age with perennial allergic rhinitis have not been established.
who miss a dose should take the next dose at their regular time and should not take 2 doses at the same time.
For allergic rhinitis, montelukast sodium tablets 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.
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.
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.
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.
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.
Safety and effectiveness in pediatric patients younger than 6 months of age with perennial allergic rhinitis have not been established.
who miss a dose should take the next dose at their regular time and should not take 2 doses at the same time.
For allergic rhinitis, montelukast sodium tablets 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.
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.
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.
• Perennial allergic rhinitis
For allergic rhinitis, montelukast sodium tablets 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.
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.
Safety and effectiveness in pediatric patients younger than 6 months of age with perennial allergic rhinitis have not been established.
who miss a dose should take the next dose at their regular time and should not take 2 doses at the same time.
For allergic rhinitis, montelukast sodium tablets 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.
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.
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.
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.
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.
Safety and effectiveness in pediatric patients younger than 6 months of age with perennial allergic rhinitis have not been established.
who miss a dose should take the next dose at their regular time and should not take 2 doses at the same time.
For allergic rhinitis, montelukast sodium tablets 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.
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.
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.
Dosage (by age)
Administration (by indications):
• Asthma (2.1):Once daily in the evening for patients 15 years and older.
• Acute prevention of EIB (2.2):One tablet at least 2 hours before exercise for patients 15 years of age and older.
• Seasonal allergic rhinitis (2.3):Once daily for patients 15 years and older.
• Perennial allergic rhinitis (2.3):Once daily for patients 15 years and older.
Dosage (by age) (2):
• 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).
Montelukast sodium tablets 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.
Safety and effectiveness in pediatric patients less than 12 months of age with asthma have not been established.
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.
Montelukast sodium tablets 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.
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.
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.
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.
Montelukast sodium tablets 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.
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.
For prevention of EIB, a single dose of montelukast sodium tablets should be taken 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. Safety and efficacy in patients younger than 6 years of age have not been established. Daily administration of montelukast sodium tablets for the chronic treatment of asthma has not been established to prevent acute episodes of EIB.
For allergic rhinitis, montelukast sodium tablets 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.
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.
Safety and effectiveness in pediatric patients younger than 6 months of age with perennial allergic rhinitis have not been established.
who miss a dose should take the next dose at their regular time and should not take 2 doses at the same time.
For allergic rhinitis, montelukast sodium tablets 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.
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.
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.
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.
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.
Safety and effectiveness in pediatric patients younger than 6 months of age with perennial allergic rhinitis have not been established.
who miss a dose should take the next dose at their regular time and should not take 2 doses at the same time.
For allergic rhinitis, montelukast sodium tablets 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.
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.
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.
Patients with both asthma and allergic rhinitis should take only one montelukast sodium tablets dose daily in the evening.
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 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.
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 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.
• 15 years and older: one 10 mg tablet.
Patients with both asthma and allergic rhinitis should take only one dose daily in the evening
Patients with both asthma and allergic rhinitis should take only one montelukast sodium tablets dose daily in the evening.
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 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.
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 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 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.
Risk Summary
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
[see Data].
In animal reproduction studies, no adverse developmental effects were observed with oral administration of montelukast to pregnant rats and rabbits during organogenesis at doses approximately 100 and 110 times, respectively, the maximum recommended human daily oral dose (MRHDOD) based on AUCs [see Data].
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 to 4% and 15 to 20%, respectively.
Clinical Considerations
Disease-associated maternal and/or embryo/fetal risk
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.
Data
Human Data
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.
Animal Data
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).
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