Montelukast Chewable Tablets

Name: Montelukast Chewable Tablets

Uses of Montelukast Chewable Tablets

  • It is used to ease allergy signs.
  • It is used to prevent exercise-induced breathing problems.
  • It is used to treat or prevent asthma.
  • It may be given to you for other reasons. Talk with the doctor.

For asthma:

  • Do not use this medicine (montelukast chewable tablets) to treat an asthma attack. Use a rescue inhaler. Talk with your doctor.

How is this medicine (Montelukast Chewable Tablets) best taken?

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Take with or without food.
  • Chew well before swallowing.
  • Take even during sign-free periods.
  • If working out or playing sports causes signs, use at least 2 hours before doing it.
  • If this medicine (montelukast chewable tablets) is for asthma, take in the evening.
  • To gain the most benefit, do not miss doses.
  • Take this medicine at the same time of day.
  • Keep taking this medicine (montelukast chewable tablets) as you have been told by your doctor or other health care provider, even if you feel well.

What do I do if I miss a dose?

  • Skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
  • Signs of low mood (depression), thoughts of killing yourself, nervousness, emotional ups and downs, thinking that is not normal, anxiety, or lack of interest in life.
  • Hallucinations (seeing or hearing things that are not there).
  • Change in how you act.
  • Memory problems or loss.
  • Feeling confused.
  • Not able to focus.
  • Bad dreams.
  • Not able to sleep.
  • Sleepwalking.
  • Shakiness.
  • Seizures.
  • Trouble breathing that is new or worse.
  • Fever.
  • Flu-like signs.
  • Sinus pain.
  • Chest pain.
  • A heartbeat that does not feel normal.
  • Any unexplained bruising or bleeding.
  • A burning, numbness, or tingling feeling that is not normal.
  • Ear pain.
  • A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

Drug Interactions


No dose adjustment is needed when montelukast sodium is co-administered with theophylline, prednisone, prednisolone, oral contraceptives, terfenadine, 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)].

Overdosage


No specific information is available on the treatment of overdosage with montelukast sodium. In chronic asthma studies, montelukast has been administered at doses up to 200 mg/day to adult patients for 22 weeks and, in short-term studies, up to 900 mg/day to patients for approximately a week without clinically important adverse experiences. 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.
There have been reports of acute overdosage in post-marketing experience and clinical studies with montelukast sodium. These include reports in adults and children with a dose as high as 1000 mg. The clinical and laboratory findings observed were consistent with the safety profile in adults and pediatric patients. There were no adverse experiences in the majority of overdosage reports. The most frequently occurring adverse experiences were consistent with the safety profile of montelukast sodium and included abdominal pain, somnolence, thirst, headache, vomiting and psychomotor hyperactivity.
It is not known whether montelukast is removed by peritoneal dialysis or hemodialysis.


Clinical Studies

Asthma


Adults and Adolescents 15 Years of Age and Older with Asthma
Clinical trials in adults and adolescents 15 years of age and older demonstrated there is no additional clinical benefit to montelukast doses above 10 mg once daily.
The efficacy of montelukast sodium for the chronic treatment of asthma in adults and adolescents 15 years of age and older was demonstrated in two (U.S. and Multinational) similarly designed, randomized, 12-week, double-blind, placebo-controlled trials in 1576 patients (795 treated with montelukast sodium, 530 treated with placebo, and 251 treated with active control). The median age was 33 years (range 15 to 85); 56.8% were females and 43.2% were males. The ethnic/racial distribution in these studies was 71.6% Caucasian, 17.7% Hispanic, 7.2% other origins and 3.5% Black. Patients had mild or moderate asthma and were non-smokers who required approximately 5 puffs of inhaled β-agonist per day on an "as-needed" basis. The patients had a mean baseline percent of predicted forced expiratory volume in 1 second (FEV1) of 66% (approximate range, 40 to 90%). The co-primary endpoints in these trials were FEV1 and daytime asthma symptoms. In both studies after 12 weeks, a random subset of patients receiving montelukast sodium was switched to placebo for an additional 3 weeks of double-blind treatment to evaluate for possible rebound effects.
The results of the U.S. trial on the primary endpoint, morning FEV1, expressed as mean percent change from baseline averaged over the 12-week treatment period, are shown in FIGURE 2. Compared with placebo, treatment with one montelukast sodium 10-mg tablet daily in the evening resulted in a statistically significant increase in FEV1 percent change from baseline (13%-change in the group treated with montelukast sodium vs. 4.2%-change in the placebo group, p<0.001); the change from baseline in FEV1 for montelukast sodium was 0.32 liters compared with 0.10 liters for placebo, corresponding to a between-group difference of 0.22 liters (p<0.001, 95% CI 0.17 liters, 0.27 liters). The results of the Multinational trial on FEV1 were similar.
Figure 2: FEV1 Mean Percent Change from Baseline (U.S. Trial: Montelukast Sodium N=406; Placebo N=270) (ANOVA Model)


The effect of montelukast sodium on other primary and secondary endpoints, represented by the Multinational study is shown in TABLE 2. Results on these endpoints were similar in the US study.
Table 2: Effect of Montelukast Sodium on Primary and Secondary Endpoints in a Multinational Placebo-controlled Trial (ANOVA Model)

 
Montelukast sodium
Placebo
Endpoint
N
Baseline
Mean change from Baseline
N
Baseline
Mean change from Baseline
Daytime Asthma symptoms(0 to 6 scale)
372
2.35
-0.49*
245
2.4
-0.26
β-agonist(puffs per day)
371
5.35
-1.65*
241
5.78
-0.42
AM PEFR(L/min)
372
339.57
25.03*
244
335.24
1.83
PM PEFR(L/min)
372
355.23
20.13*
244
354.02
-0.49
Nocturnal Awakenings(#/week)
285
5.46
-2.03*
195
5.57
-0.78


















Both studies evaluated the effect of montelukast sodium on secondary outcomes, including asthma attack (utilization of health-care resources such as an unscheduled visit to a doctor's office, emergency room, or hospital; or treatment with oral, intravenous, or intramuscular corticosteroid), and use of oral corticosteroids for asthma rescue. In the Multinational study, significantly fewer patients (15.6% of patients) on montelukast sodium experienced asthma attacks compared with patients on placebo (27.3%,p < 0.001). In the US study,7.8% of patients on montelukast sodium and 10.3% of patients on placebo experienced asthma attacks, but the difference between the two treatment groups was not significant (p = 0.334). In the Multinational study, significantly fewer patients (14.8% of patients) on montelukast sodium were prescribed oral corticosteroids for asthma rescue compared with patients on placebo (25.7%, p < 0.001). In the US study, 6.9% of patients on montelukast sodium and 9.9% of patients on placebo were prescribed oral corticosteroids for asthma rescue, but the difference between the two treatment groups was not significant (p = 0.196).
Onset of Action and Maintenance of Effects
In each placebo-controlled trial in adults, the treatment effect of montelukast sodium, measured by daily diary card parameters, including symptom scores, "as-needed" β-agonist use, and PEFR measurements, was achieved after the first dose and was maintained throughout the dosing interval (24 hours). No significant change in treatment effect was observed during continuous once-daily evening administration in non-placebo-controlled extension trials for up to one year. Withdrawal of montelukast sodium in asthmatic patients after 12 weeks of continuous use did not cause rebound worsening of asthma.
Pediatric Patients 6 to 14 Years of Age with Asthma
The efficacy of montelukast sodium in pediatric patients 6 to 14 years of age was demonstrated in one 8-week, double-blind, placebo-controlled trial in 336 patients (201 treated with montelukast sodium and 135 treated with placebo) using an inhaled β-agonist on an "as-needed" basis. The patients had a mean baseline percent predicted FEV1 of 72% (approximate range, 45 to 90%) and a mean daily inhaled β-agonist requirement of 3.4 puffs of albuterol. Approximately 36% of the patients were on inhaled corticosteroids. The median age was 11 years (range 6 to 15); 35.4% were females and 64.6% were males. The ethnic/racial distribution in this study was 80.1% Caucasian, 12.8% Black, 4.5% Hispanic, and 2.7% other origins.
Compared with placebo, treatment with one 5-mg montelukast sodium chewable tablets daily resulted in a significant improvement in mean morning FEV1 percent change from baseline (8.7% in the group treated with montelukast sodium vs. 4.2% change from baseline in the placebo group, p<0.001). There was a significant decrease in the mean percentage change in daily "as-needed" inhaled β-agonist use (11.7% decrease from baseline in the group treated with montelukast sodium vs. 8.2% increase from baseline in the placebo group, p<0.05). This effect represents a mean decrease from baseline of 0.56 and 0.23 puffs per day for the montelukast and placebo groups, respectively. Subgroup analyses indicated that younger pediatric patients aged 6 to 11 had efficacy results comparable to those of the older pediatric patients aged 12 to 14.
Similar to the adult studies, no significant change in the treatment effect was observed during continuous once-daily administration in one open-label extension trial without a concurrent placebo group for up to 6 months.
Pediatric Patients 2 to 5 Years of Age with Asthma
The efficacy of montelukast sodium for the chronic treatment of asthma in pediatric patients 2 to 5 years of age was explored in a 12-week, placebo-controlled safety and tolerability study in 689 patients, 461 of whom were treated with montelukast sodium. The median age was 4 years (range 2 to 6); 41.5% were females and 58.5% were males. The ethnic/racial distribution in this study was 56.5% Caucasian, 20.9% Hispanic, 14.4% other origins, and 8.3% Black.
While the primary objective was to determine the safety and tolerability of montelukast sodium in this age group, the study included exploratory efficacy evaluations, including daytime and overnight asthma symptom scores, β-agonist use, oral corticosteroid rescue, and the physician's global evaluation. The findings of these exploratory efficacy evaluations, along with pharmacokinetics and extrapolation of efficacy data from older patients, support the overall conclusion that montelukast sodium is efficacious in the maintenance treatment of asthma in patients 2 to 5 years of age.
Effects in Patients on Concomitant Inhaled Corticosteroids
Separate trials in adults evaluated the ability of montelukast sodium to add to the clinical effect of inhaled corticosteroids and to allow inhaled corticosteroid tapering when used concomitantly.
One randomized, placebo-controlled, parallel-group trial (n=226) enrolled adults with stable asthma with a mean FEV1 of approximately 84% of predicted who were previously maintained on various inhaled corticosteroids (delivered by metered-dose aerosol or dry powder inhalers). The median age was 41.5 years (range 16 to 70); 52.2% were females and 47.8% were males. The ethnic/racial distribution in this study was 92% Caucasian, 3.5% Black, 2.2% Hispanic, and 2.2% Asian. The types of inhaled corticosteroids and their mean baseline requirements included beclomethasone dipropionate (mean dose, 1203 mcg/day), triamcinolone acetonide (mean dose, 2004 mcg/day), flunisolide (mean dose, 1971 mcg/day), fluticasone propionate (mean dose, 1083 mcg/day), or budesonide (mean dose, 1192 mcg/day). Some of these inhaled corticosteroids were non-U.S.-approved formulations, and doses expressed may not be ex-actuator. The pre-study inhaled corticosteroid requirements were reduced by approximately 37% during a 5- to 7-week placebo run-in period designed to titrate patients toward their lowest effective inhaled corticosteroid dose. Treatment with montelukast sodium resulted in a further 47% reduction in mean inhaled corticosteroid dose compared with a mean reduction of 30% in the placebo group over the 12-week active treatment period (p≤0.05). It is not known whether the results of this study can be generalized to patients with asthma who require higher doses of inhaled corticosteroids or systemic corticosteroids.
In another randomized, placebo-controlled, parallel-group trial (n=642) in a similar population of adult patients previously maintained, but not adequately controlled, on inhaled corticosteroids (beclomethasone 336 mcg/day), the addition of montelukast sodium to beclomethasone resulted in statistically significant improvements in FEV1 compared with those patients who were continued on beclomethasone alone or those patients who were withdrawn from beclomethasone and treated with montelukast or placebo alone over the last 10 weeks of the 16-week, blinded treatment period. Patients who were randomized to treatment arms containing beclomethasone had statistically significantly better asthma control than those patients randomized to montelukast sodium alone or placebo alone as indicated by FEV1, daytime asthma symptoms, PEFR, nocturnal awakenings due to asthma, and "as-needed" β- agonist requirements.
In adult patients with asthma with documented aspirin sensitivity, nearly all of whom were receiving concomitant inhaled and/or oral corticosteroids, a 4-week, randomized, parallel-group trial (n=80) demonstrated that montelukast sodium, compared with placebo, resulted in significant improvement in parameters of asthma control. The magnitude of effect of montelukast sodium in aspirin-sensitive patients was similar to the effect observed in the general population of asthma patients studied. The effect of montelukast sodium on the bronchoconstrictor response to aspirin or other non-steroidal anti-inflammatory drugs in aspirin-sensitive asthmatic patients has not been evaluated [see Warnings and Precautions (5.3)].

Exercise-Induced Bronchoconstriction (EIB)

Exercise-Induced Bronchoconstriction (Adults, Adolescents, and Pediatric Patients 6 years of age and older)
The efficacy of montelukast sodium, 10 mg, when given as a single dose 2 hours before exercise for the prevention of EIB was investigated in three (U.S. and Multinational), randomized, double-blind, placebo-controlled crossover studies that included a total of 160 adult and adolescent patients 15 years of age and older with EIB. Exercise challenge testing was conducted at 2 hours, 8.5 or 12 hours, and 24 hours following administration of a single dose of study drug (montelukast sodium 10 mg or placebo). The primary endpoint was the mean maximum percent fall in FEV1 following the 2 hours post-dose exercise challenge in all three studies (Study A, Study B, and Study C). In Study A, a single dose of montelukast sodium 10 mg demonstrated a statistically significant protective benefit against EIB when taken 2 hours prior to exercise. Some patients were protected from EIB at 8.5 and 24 hours after administration; however, some patients were not. The results for the mean maximum percent fall at each timepoint in Study A are shown in TABLE 3 and are representative of the results from the other two studies.
Table 3: Mean Maximum Percent Fall in FEV1 Following Exercise Challenge in Study A (N=47) ANOVA Model

Time of exercise challenge
following medication
administration
Mean Maximum percent fall in FEV1 *
Treatment difference
 % for montelukast sodium versus Placebo (95% CI)*
Montelukast sodium
Placebo
2 hours
13
22
-9(-12,-5)
8.5 hours
12
17
-5(-9,-2)
24 hours
10
14
-4(-7,-1)









* Least squares-mean
The efficacy of montelukast sodium 5-mg chewable tablets, when given as a single dose 2 hours before exercise for the prevention of EIB, was investigated in one multinational, randomized, double-blind, placebo-controlled crossover study that included a total of 64 pediatric patients 6 to 14 years of age with EIB. Exercise challenge testing was conducted at 2 hours and 24 hours following administration of a single dose of study drug (montelukast sodium 5 mg or placebo). The primary endpoint was the mean maximum percent fall in FEV1 following the 2 hours post-dose exercise challenge. A single dose of montelukast sodium 5 mg demonstrated a statistically significant protective benefit against EIB when taken 2 hours prior to exercise (TABLE 4). Similar results were shown at 24 hours post-dose (a secondary endpoint). Some patients were protected from EIB at 24 hours after administration; however, some patients were not. No timepoints were assessed between 2 and 24 hours post-dose.
Table 4: Mean Maximum Percent Fall in FEV1 Following Exercise Challenge in Pediatric Patients (N=64) ANOVA Model

 

Time of exercise challenge following medication administration


Mean  Maximum percent fall in FEV1*

Treatment difference % formontelukast sodium
versus Placebo (95% CI)*


Montelukast sodium

Placebo


2 hours

15

20

-5 (-9, -1)

24 hours

13

17

-4 (-7, -1)

*Least squares-mean
The efficacy of montelukast sodium for prevention of EIB in patients below 6 years of age has not been established.
Daily administration of montelukast sodium for the chronic treatment of asthma has not been established to prevent acute episodes of EIB.
In a 12-week, randomized, double-blind, parallel group study of 110 adult and adolescent asthmatics 15 years of age and older, with a mean baseline FEV1 percent of predicted of 83% and with documented exercise-induced exacerbation of asthma, treatment with montelukast sodium, 10 mg, once daily in the evening, resulted in a statistically significant reduction in mean maximal percent fall in FEV1 and mean time to recovery to within 5% of the pre-exercise FEV1. Exercise challenge was conducted at the end of the dosing interval (i.e., 20 to 24 hours after the preceding dose). This effect was maintained throughout the 12-week treatment period indicating that tolerance did not occur. Montelukast sodium did not, however, prevent clinically significant deterioration in maximal percent fall in FEV1 after exercise (i.e., ≥20% decrease from pre-exercise baseline) in 52% of patients studied. In a separate crossover study in adults, a similar effect was observed after two once-daily 10-mg doses of montelukast sodium.
In pediatric patients 6 to 14 years of age, using the 5-mg chewable tablet, a 2-day crossover study demonstrated effects similar to those observed in adults when exercise challenge was conducted at the end of the dosing interval (i.e., 20 to 24 hours after the preceding dose).

Allergic Rhinitis (Seasonal and Perennial)


Seasonal Allergic Rhinitis
The efficacy of montelukast sodium tablets for the treatment of seasonal allergic rhinitis was investigated in 5 similarly designed, randomized, double-blind, parallel-group, placebo- and active-controlled (loratadine) trials conducted in North America. The 5 trials enrolled a total of 5029 patients, of whom 1799 were treated with montelukast sodium tablets. Patients were 15 to 82 years of age with a history of seasonal allergic rhinitis, a positive skin test to at least one relevant seasonal allergen, and active symptoms of seasonal allergic rhinitis at study entry.
The period of randomized treatment was 2 weeks in 4 trials and 4 weeks in one trial. The primary outcome variable was mean change from baseline in daytime nasal symptoms score (the average of individual scores of nasal congestion, rhinorrhea, nasal itching, sneezing) as assessed by patients on a 0 to 3 categorical scale.
Four of the five trials showed a significant reduction in daytime nasal symptoms scores with montelukast sodium 10-mg tablets compared with placebo. The results of one trial are shown below. The median age in this trial was 35 years (range 15 to 81); 65.4% were females and 34.6% were males. The ethnic/racial distribution in this study was 83.1% Caucasian, 6.4% other origins, 5.8% Black, and 4.8% Hispanic. The mean changes from baseline in daytime nasal symptoms score in the treatment groups that received montelukast sodium tablets, loratadine, and placebo are shown in TABLE 5. The remaining three trials that demonstrated efficacy showed similar results.
Table 5: Effects of Montelukast Sodium on Daytime Nasal Symptoms Score* in a Placebo- and Active-controlled Trial in Patients with Seasonal Allergic Rhinitis (ANCOVA Model)

Treatment
Group (N)
Baseline Mean
Score
Mean Change
from Baseline
Difference
Between Treatment
and Placebo (95% CI)
Least-Squares
Mean
Montelukast Sodium 10 mg
(344)
2.09
-0.39
-0.13† (-0.21,-0.06)
Placebo (351)
2.10
-0.26
N.A.
Active Control‡
(Loratadine 10 mg) (599)
2.06
-0.46
-0.24 † (-0.31,-0.17)

* Average of individual scores of nasal congestion, rhinorrhea, nasal itching, sneezing as assessed by patients on a 0 to 3 categorical scale.
† Statistically different from placebo (p≤0.001).
‡  The study was not designed for statistical comparison between montelukast sodium and  the active control (loratadine).
Perennial Allergic Rhinitis
The efficacy of montelukast sodium tablets for the treatment of perennial allergic rhinitis was investigated in 2 randomized, double-blind, placebo-controlled studies conducted in North America and Europe. The two studies enrolled a total of 3357 patients, of whom 1632 received montelukast sodium 10-mg tablets. Patients 15 to 82 years of age with perennial allergic rhinitis as confirmed by history and a positive skin test to at least one relevant perennial allergen (dust mites, animal dander, and/or mold spores), who had active symptoms at the time of study entry, were enrolled.
In the study in which efficacy was demonstrated, the median age was 35 years (range 15 to 81); 64.1% were females and 35.9% were males. The ethnic/racial distribution in this study was 83.2% Caucasian, 8.1% Black, 5.4% Hispanic, 2.3% Asian, and 1% other origins. Montelukast sodium  10-mg tablets once daily was shown to significantly reduce symptoms of perennial allergic rhinitis over a 6-week treatment period (TABLE 6); in this study the primary outcome variable was mean change from baseline in daytime nasal symptoms score (the average of individual scores of nasal congestion, rhinorrhea, and sneezing).
Table 6: Effects of Montelukast Sodium on Daytime Nasal Symptoms Score* in a Placebo-controlled Trial in Patients with Perennial Allergic Rhinitis (ANCOVA Model)



Treatment Group (N)

Baseline mean Score

Mean Change
from Baseline

Difference between Treatment
 and Placebo (95% CI)
 Least-Squares Mean

Montelukast Sodium 10 mg
(1000)

2.09

-0.42

-0.08† (-0.12, -0.04)

Placebo
(980)

2.10

-0.35

N.A.

*   Average of individual scores of nasal congestion, rhinorrhea, sneezing as assessed by patients on a 0 to 3 categorical scale.
†   Statistically different from placebo (p≤0.001).
The other 6-week study evaluated montelukast sodium 10 mg (n=626), placebo (n=609), and an active-control (cetirizine 10 mg; n=120). The primary analysis compared the mean change from baseline in daytime nasal symptoms score for montelukast sodium vs. placebo over the first 4 weeks of treatment; the study was not designed for statistical comparison between montelukast sodium and the active-control. The primary outcome variable included nasal itching in addition to nasal congestion, rhinorrhea, and sneezing. The estimated difference between montelukast sodium and placebo was -0.04 with a 95% CI of (-0.09, 0.01). The estimated difference between the active-control and placebo was -0.10 with a 95% CI of (-0.19, -0.01).

Patient information


Patient Information
Montelukast Sodium Chewable Tablets
(mon-tell-OO-kast)
Read the Patient Information Leaflet that comes with montelukast sodium chewable tablets before you start taking them and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your healthcare provider about your medical condition or your treatment.
What are montelukast sodium chewable tablets?
• Montelukast sodium chewable tablets are a prescription medicine that blocks substances in the body called leukotrienes. This may help to improve symptoms of asthma and allergic rhinitis. Montelukast sodium chewable tablets do not contain a steroid.
Montelukast sodium chewable tablets are used to:
1.Prevent asthma attacks and for the long-term treatment of asthma in adults and children ages 2 years and older.
Do not take montelukast sodium chewable tablets if you need relief right away for a sudden asthma attack. If you get an asthma attack, you should follow the instructions your healthcare provider gave you for treating asthma attacks.
2.Prevent exercise-induced asthma in people 6 years of age and older.
3.Help control the symptoms of allergic rhinitis (sneezing, stuffy nose, runny nose,itching of the nose). Montelukast sodium chewable tablets are used to treat:
• outdoor allergies that happen part of the year (seasonal allergic rhinitis) in  adults and children ages 2 years and older, and
• indoor allergies that happen all year (perennial allergic rhinitis) in adults and children ages 2 years and older.
Who should not take montelukast sodium chewable tablets?
Do not take montelukast sodium chewable tablets if you are allergic to any of their ingredients.
See the end of this leaflet for a complete list of the ingredients in montelukast sodium chewable tablets.
What should I tell my healthcare provider before taking montelukast sodium chewable tablets?
Before taking montelukast sodium chewable tablets, tell your healthcare provider if you:
• are allergic to aspirin
• have phenylketonuria. Montelukast sodium chewable tablets contain aspartame, a source of phenylalanine
• have any other medical conditions
• are pregnant or plan to become pregnant. Talk to your doctor if you are pregnant or plan to become pregnant, as montelukast sodium chewable tablets may not be right for you.
• are breast-feeding or plan to breast-feed.  It is not known if montelukast sodium passes into your breast milk.  Talk to your healthcare provider about the best way to feed your baby while taking montelukast sodium chewable tablets.
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Some medicines may affect how montelukast sodium chewable tablets works, or montelukast sodium chewable tablets may affect how your other medicines work.
How should I take montelukast sodium chewable tablets?
For anyone who takes montelukast sodium chewable tablets:
• Take montelukast sodium chewable tablets exactly as prescribed by your healthcare provider. Your healthcare provider will tell you how much montelukast sodium chewable tablets to take, and when to take them.
• Do not stop taking montelukast sodium chewable tablets or change when you take them without talking with your healthcare provider.
• You can take montelukast sodium chewable tablets with food or without food.
• If you or your child misses a dose of montelukast sodium chewable tablets, just take the next dose at your regular time. Do not take 2 doses at the same time.
• If you take too much montelukast sodium chewable tablets, call your healthcare provider or a Poison Control Center right away.
For adults and children 2 years of age and older with asthma:
• Take montelukast sodium chewable tablets 1 time each day, in the evening. Continue to take montelukast sodium chewable tablets every day for as long as your healthcare provider prescribes it, even if you have no asthma symptoms.
• Tell your healthcare provider right away if your asthma symptoms get worse, or if you need to use your rescue inhaler medicine more often for asthma attacks.
• Do not take montelukast sodium chewable tablets if you need relief right away from a sudden asthma attack. If you get an asthma attack, you should follow the instructions your healthcare provider gave you for treating asthma attacks.
• Always have your rescue inhaler medicine with you for asthma attacks.
• Do not stop taking or lower the dose of your other asthma medicines unless your healthcare provider tells you to.
For patients 6 years of age and older for the prevention of exercise-induced asthma:
• Take montelukast sodium chewable tablets at least 2 hours before exercise.
• Always have your rescue inhaler medicine with you for asthma attacks.
• If you take montelukast sodium chewable tablets every day for chronic asthma or allergic rhinitis, do not take another dose to prevent exercise-induced asthma. Talk to your healthcare provider about your treatment for exercise-induced asthma.
• Do not take 2 doses of montelukast sodium tablets within 24 hours (1day).
For adults and children 2 years of age and older with seasonal allergic rhinitis , or for adults and children 2 years of age and older with perennial allergic rhinitis :
• Take montelukast sodium chewable tablets 1 time each day, at about the same time each day.
What is the dose of montelukast sodium chewable tablets?
The dose of montelukast sodium chewable tablets prescribed for your or your child's condition is based on age:
• 2 to 5 years: one 4-mg chewable tablet.
• 6 to 14 years: one 5-mg chewable tablet.
• 15 years and older: one10-mg tablet.
What should I avoid while taking montelukast sodium chewable tablets?
If you have asthma and aspirin makes your asthma symptoms worse, continue to avoid taking aspirin or other medicines called non-steroidal anti-inflammatory drugs (NSAIDs) while taking montelukast sodium chewable tablets.
What are the possible side effects of montelukast sodium chewable tablets?
Montelukast sodium chewable tablets may cause serious side effects.
• Behavior and mood-related changes. Tell your healthcare provider right away if you or your child have any of these symptoms while taking montelukast sodium chewable tablets:
• agitation including aggressive behavior or hostility 
• irritability
• memory problems                                                          • attention problems
• restlessness                                                                   • bad or vivid dreams 
• sleep walking                                                                  • depression 
• suicidal thoughts and actions                                          • disorientation (confusion) (including suicide)
• feeling  anxious                                                               • tremor
• hallucinations (seeing or hearing things that are             • trouble sleeping
 not really there)                    
  • uncontrolled muscle movements


• Increase in certain white blood cells (eosinophils) and possible inflamed blood vessels throughout the body (systemic vasculitis). Rarely, this can happen in people with asthma who take montelukast sodium chewable tablets. This sometimes happens in people who also take a steroid medicine by mouth that is being stopped or the dose is being lowered.
Tell your healthcare provider right away if you get one or more of these symptoms:
• a feeling of pins and needles or numbness of arms or legs
• a flu-like illness
• rash
• severe inflammation (pain and swelling) of the sinuses (sinusitis)
The most common side effects with montelukast sodium include:
• upper respiratory infection
• fever
• headache
• sore throat
• cough
• stomach pain
• diarrhea
• earache or ear infection
• flu
• runny nose
• sinus infection
Other side effects with montelukast sodium include:
• increased bleeding tendency, low blood platelet count
• allergic reactions [including swelling of the face, lips, tongue, and/or throat (which may cause trouble breathing or swallowing), hives and itching]
• dizziness, drowsiness, pins and needles/numbness, seizures (convulsions or fits)
• palpitations
• nose bleed, stuffy nose, swelling (inflammation)of the lungs
• heartburn, indigestion, inflammation of the pancreas, nausea, stomach or intestinal upset, vomiting
• hepatitis
• bruising, rash, severe skin reactions (erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis) that may occur without warning
• joint pain, muscle aches and muscle cramps
• bedwetting in children
• tiredness, swelling
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of montelukast sodium chewable tablets. For more information ask your healthcare provider or pharmacist.
Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store montelukast sodium chewable tablets?
• Store montelukast sodium chewable tablets at 20° to 25° C (68° to 77° F) [see USP Controlled Room Temperature].
• Keep montelukast sodium chewable tablets in the container it comes in.
• Keep montelukast sodium chewable tablets in a dry place and away from light.
General Information about the safe and effective use of montelukast sodium chewable tablets
Medicines are sometimes prescribed for purposes other than those mentioned in Patient Information Leaflets. Do not use montelukast sodium chewable tablets for a condition for which it was not prescribed. Do not give montelukast sodium chewable tablets to other people even if they have the same symptoms you have. It may harm them. Keep montelukast sodium chewable tablets and all medicines out of the reach of children.
This leaflet summarizes information about montelukast sodium chewable tablets. If you would like more information, talk to your healthcare provider. You can ask your pharmacist or healthcare provider for information about montelukast sodium chewable tablets that is written for health professionals.
What are the ingredients in montelukast sodium chewable tablets?
Active ingredient: montelukast sodium, USP 
Inactive ingredients: art cherry flavor, aspartame, croscarmellose sodium, ferric oxide red, hydroxypropyl cellulose, magnesium stearate, mannitol and microcrystalline cellulose.
People with Phenylketonuria: Montelukast sodium chewable tablets 4-mg (equivalent to 4-mg montelukast) contain 0.672 mg of phenylalanine, and montelukast sodium chewable tablets 5-mg (equivalent to 5-mg montelukast) contain 0.84 mg of phenylalanine.
Manfactured for:



Manufactured for:

Camber Pharmaceuticals, Inc.

Piscataway, NJ 08854.


By: HETEROTM

Hetero Labs Limited Unit V, Polepally, Jadcherla,
Mahaboob Nagar-509 301, India.                     
Revised: 05/2017

Package label.principal display panel

Montelukast Sodium Chewable Tablets 4 mg 30s Container Label:



Montelukast Sodium Chewable Tablets 4 mg 90s Container Label:



Montelukast Sodium Chewable Tablets 4 mg 100s Container Label:




Montelukast Sodium Chewable Tablets 4 mg 1000s Container Label:




Montelukast Sodium Chewable Tablets 4 mg Blister carton Label:




Montelukast Sodium Chewable Tablets 4 mg Foil carton Label:




Montelukast Sodium Chewable Tablets 5 mg 30s Container Label:




Montelukast Sodium Chewable Tablets 5 mg 90s Container Label:




Montelukast Sodium Chewable Tablets 5 mg 100s Container Label:




Montelukast Sodium Chewable Tablets 5 mg 1000s Container Label:




Montelukast Sodium Chewable Tablets 5 mg Blister carton Label:




Montelukast Sodium Chewable Tablets 5 mg Foil carton Label:



MONTELUKAST SODIUM 
montelukast sodium tablet, chewable
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:31722-727
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MONTELUKAST (MONTELUKAST) MONTELUKAST 4 mg
Inactive Ingredients
Ingredient Name Strength
ASPARTAME  
CROSCARMELLOSE SODIUM  
FERRIC OXIDE RED  
HYDROXYPROPYL CELLULOSE (TYPE H)  
MAGNESIUM STEARATE  
MANNITOL  
CELLULOSE, MICROCRYSTALLINE  
CHERRY  
Product Characteristics
Color PINK (light pink) Score no score
Shape OVAL Size 11mm
Flavor Imprint Code I;112
Contains     
Packaging
# Item Code Package Description
1 NDC:31722-727-30 30 TABLET, CHEWABLE in 1 BOTTLE
2 NDC:31722-727-01 100 TABLET, CHEWABLE in 1 BOTTLE
3 NDC:31722-727-10 1000 TABLET, CHEWABLE in 1 BOTTLE
4 NDC:31722-727-31 10 TABLET, CHEWABLE in 1 BLISTER PACK
5 NDC:31722-727-32 100 TABLET, CHEWABLE in 1 CARTON
6 NDC:31722-727-90 90 TABLET, CHEWABLE in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204093 05/27/2015
MONTELUKAST SODIUM 
montelukast sodium tablet, chewable
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:31722-728
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MONTELUKAST (MONTELUKAST) MONTELUKAST 5 mg
Inactive Ingredients
Ingredient Name Strength
ASPARTAME  
CROSCARMELLOSE SODIUM  
FERRIC OXIDE RED  
HYDROXYPROPYL CELLULOSE (TYPE H)  
MAGNESIUM STEARATE  
MANNITOL  
CELLULOSE, MICROCRYSTALLINE  
CHERRY  
Product Characteristics
Color PINK (light pink) Score no score
Shape ROUND Size 10mm
Flavor Imprint Code I;113
Contains     
Packaging
# Item Code Package Description
1 NDC:31722-728-30 30 TABLET, CHEWABLE in 1 BOTTLE
2 NDC:31722-728-01 100 TABLET, CHEWABLE in 1 BOTTLE
3 NDC:31722-728-10 1000 TABLET, CHEWABLE in 1 BOTTLE
4 NDC:31722-728-31 10 TABLET, CHEWABLE in 1 BLISTER PACK
5 NDC:31722-728-32 100 TABLET, CHEWABLE in 1 CARTON
6 NDC:31722-728-90 90 TABLET, CHEWABLE in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204093 05/27/2015
Labeler - Camber Pharmaceuticals, Inc. (826774775)
Establishment
Name Address ID/FEI Operations
Hetero Labs Limited Unit V 650452530 ANALYSIS(31722-727, 31722-728), MANUFACTURE(31722-727, 31722-728)
Revised: 06/2017   Camber Pharmaceuticals, Inc.
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