Montelukast Uses

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What is Montelukast?

Montelukast is a leukotriene (loo-koe-TRY-een) inhibitor. Leukotrienes are chemicals your body releases when you breathe in an allergen (such as pollen). These chemicals cause swelling in your lungs and tightening of the muscles around your airways, which can result in asthma symptoms.

Montelukast is used to prevent asthma attacks in adults and children as young as 12 months old. Montelukast is also used to prevent exercise-induced bronchospasm in adults and children who are at least 6 years old.

Montelukast is also used to treat symptoms of year-round (perennial) allergies in adults and children who are at least 6 months old. It is also used to treat symptoms of seasonal allergies in adults and children who are at least 2 years old.

Do not give this medicine to a child without a doctor's advice.

Montelukast is also used to prevent exercise-induced bronchoconstriction (narrowing of the air passages in the lungs) in adults and teenagers who are at least 15 years old and are not already taking this medicine for other conditions.

If you already take Montelukast to prevent asthma or allergy symptoms, do not use an extra dose to treat exercise-induced bronchoconstriction.

Montelukast may also be used for purposes not listed in this medication guide.

Montelukast indications

An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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It is indicated for: The prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months of age or older; the prevention of exercise-induced bronchoconstriction in patients 15 years of age and older; the relief of symptoms of allergic rhinitis (seasonal allergic rhinitis in adults and pediatric patients 2 years of age and older, and perennial allergic rhinitis in adult and pediatric patients 6 months of age and older).

Montelukast 4 mg: Montelukast is indicated in the treatment of asthma as add­ on therapy in those 2 to 5 year old patients with mild to moderate persistent asthma who are inadequately controlled on inhaled corticosteroids and in whom as-needed short-acting β-agonists provide inadequate clinical control of asthma.

Montelukast may also be an alternative treatment option to low-dose inhaled corticosteroids for 2 to 5 year old patients with mild persistent asthma who do not have a recent history of serious asthma attacks that required oral corticosteroid use, and who have demonstrated that they are not capable of using inhaled corticosteroids.

Montelukast is also indicated in the prophylaxis of asthma from 2 years of age to 5 years in which the predominant component is exercise-induced bronchoconstriction.

Montelukast 5 mg: Montelukast is indicated in the treatment of asthma as add­ on therapy in those 6 to 14 year old patients with mild to moderate persistent asthma who are inadequately controlled on inhaled corticosteroids and in whom as-needed short-acting β-agonists provide inadequate clinical control of asthma.

Montelukast may also be an alternative treatment option to low-dose inhaled corticosteroids for 6 to 14 year old patients with mild persistent asthma who do not have a recent history of serious asthma attacks that required oral corticosteroid use, and who have demonstrated that they are not capable of using inhaled corticosteroids.

Montelukast is also indicated in the prophylaxis of asthma in those 6 to 14 years old which the predominant component is exercise-induced bronchoconstriction.

Montelukast 10 mg: Montelukast sodium (Montelukast) is indicated in the treatment of asthma as add-on therapy in patients 15 years and older with mild to moderate persistent asthma who are inadequately controlled on inhaled corticosteroids and in whom "as-needed" short-acting β-agonists provide inadequate clinical control of asthma. In those asthmatic patients in whom Montelukast sodium (Montelukast) is indicated in asthma, Montelukast sodium (Montelukast) can also provide symptomatic relief of seasonal allergic rhinitis.

Montelukast sodium (Montelukast) is also indicated in the prophylaxis of asthma in which the predominant component is exercise-induced bronchoconstriction in patients 15 years and older.

How should I use Montelukast?

Use Montelukast granules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ask your health care provider any questions you may have about how to use Montelukast granules.

Uses of Montelukast in details

There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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Use: Labeled Indications

Allergic rhinitis (perennial or seasonal): Relief of symptoms of seasonal allergic rhinitis and perennial allergic rhinitis

Asthma: Prophylaxis and chronic treatment of asthma

Bronchoconstriction, exercise-induced (prevention): Prevention of exercise-induced bronchoconstriction.

Note: American Academy of Otolaryngology, Head and Neck Surgery (AAO-HNS) and American Academy of Allergy, Asthma, and Immunology (AAAAI) and American College of Allergy, Asthma, and Immunology (ACAAI) guidelines recommend against Montelukast use as first-line therapy for allergic rhinitis (except in patients with concurrent asthma) (Dykewicz 2017; Seidman 2015). The Global Initiative for Asthma recommends Montelukast in patients with concomitant allergic rhinitis or those who cannot take inhaled corticosteroids (GINA 2019).

Off Label Uses

Chronic urticaria

Data from controlled, double-blind trials regarding the use of Montelukast in combination with antihistamines for the management of chronic urticaria are conflicting. Based on clinical practice guidelines from the American Academy of Allergy, Asthma and Immunology (AAAAI); the American College of Allergy, Asthma, and Immunology (ACAAI); the Joint Council of Allergy, Asthma and Immunology (JCAAI); and the World Allergy Organization for the diagnosis and management of acute and chronic urticaria, a leukotriene receptor antagonist may be added to antihistamine therapy in patients who do not respond to antihistamines. Access Full-Off Label Monograph

Urticaria (nonsteroidal anti-inflammatory drug-induced)

Data from a double-blind, placebo-controlled comparison of Montelukast and cetirizine in patients with chronic urticaria and intolerance to food additives and/or aspirin supports the use of Montelukast in the treatment of patients experiencing urticaria related to the use of nonsteroidal anti-inflammatory drugs.

Montelukast description

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Each 10-mg film-coated tablet contains 10.4 mg Montelukast sodium, which is the molar equivalent to 10.0 mg of free acid. Each 5-mg chewable tablet contains 5.2 mg Montelukast sodium, which is the molar equivalent to 5.0 mg of free acid. Each 4-mg chewable tablet and each packet of 4-mg oral granules contains 4.2 mg Montelukast sodium, which is the molar equivalent to 4.0 mg of free acid.

Montelukast is a selective and orally active leukotriene receptor antagonist that specifically inhibits the cysteinyl leukotriene CysLT1 receptor.

Montelukast is described chemically as [R-(E)]-1-[[[1-[3-[2-(7-chloro-2-quinolinyl)ethenyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]thio]methyl]cyclopropane acetic acid, monosodium salt.

The empirical formula is C35H35ClNNaO3S, and its molecular weight is 608.18.

Montelukast sodium is a hygroscopic, optically active, white to off-white powder. Montelukast sodium is freely soluble in ethanol, methanol, and water and practically insoluble in acetonitrile.

Montelukast dosage

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Chewable Tablet 4-mg: Children 2 to 5 years: One 4 mg chewable tablet daily to be taken in the evening. Montelukast Sandoz Chewable Tablet 4 mg should not be taken immediately with food. It should be taken at least 1 hour before or 2 hours after a meal.

Montelukast Sandoz Chewable Tablets 4 mg are not recommended in children below 2 years of age.

Chewable Tablet 5-mg: Children 6 to 14 years: One 5 mg chewable tablet daily to be taken in the evening. Montelukast Sandoz Chewable Tablet 5 mg should not be taken immediately with food. It should be taken at least 1 hour before or 2 hours after a meal.

Montelukast Sandoz Chewable Tablets 5 mg are not recommended in children below 6 years of age.

Film-Coated Tablet 10-mg: Asthma or Asthma and Concomitant Seasonal Allergic Rhinitis: Adults and Adolescents ≥15 years: One 10-mg tablet daily to be taken in the evening.

Oral Granules:

Children 6 months to 5 years: 1 sachet each evening.

Missed Dose: Resume the usual schedule of 1 tablet/sachet once daily. Do not give double dose to make up for a missed dose.

Administration: For oral use.

Chewable Tablets: It should be given to a child under adult supervision. It should be taken even when the child has no symptoms or if he/she has an acute asthma attack.

If the child is taking Montelukast Sandoz Chewable Tablet, be sure that he/she does not take any other medicines that contain the same active ingredient, i.e. Montelukast.

If the child takes more Montelukast Sandoz Chewable Tablet than he/she should, contact the child’s physician immediately for advice.

Discontinuation of Treatment: Montelukast Sandoz Chewable Tablet can treat the child’s asthma only if the child continues taking it. It is important for the child to continue taking Montelukast Sandoz Chewable Tablet for as long as the physician prescribes. It will help control the child’s asthma.

Film-Coated Tablet 10-mg: The therapeutic effect of Montelukast Sandoz Film-Coated Tab 10 mg on parameters of asthma control occurs within one day. Montelukast Sandoz Film-Coated Tab 10 mg may be taken with or without food. Patients should be advised to continue taking Montelukast Sandoz even if asthma is under control, as well as during periods of worsening asthma.

Montelukast Sandoz Film-Coated Tab 10 mg should not be used concomitantly with other products containing the same active ingredient, Montelukast.

No dosage adjustment is necessary for the elderly or for the patients with renal insufficiency or mild to moderate hepatic impairment. There are no data on patients with severe hepatic impairment. The dosage is the same for both male and female patients.

Therapy with Montelukas Sandoz Film-Coated Tab 10 mg in relation to other treatment for asthma. It can be added to a patient's existing treatment regimen.

Inhaled Corticosteroids: Treatment with Montelukast Sandoz Film-Coated Tab 10 mg can be used as add-on therapy in patients when inhaled corticosteroids plus "as needed" short-acting β-agonist provide inadequate clinical control. Montelukast Sandoz Film-Coated Tab 10 mg should not be subtituted for inhaled corticosteriods.

Montelukast Sandoz Film-Coated Tab 10 mg should not be used in children <15 years due to the high content of active substance.

Other dosage forms with appropriate strengths are available for young children.

Oral Granules:

Montelukast Sandoz can be given either directly in the mouth or mixed with a spoonful of cold or room temperature soft food (eg, applesauce, ice cream, carrots and rice).

Do not dissolve granules in water. However, the patient may take liquids after swallowing the granules.

Montelukast interactions

See also:
What other drugs will affect Montelukast?

Montelukast may be administered with other therapies routinely used in the prophylaxis and chronic treatment of asthma, and in the treatment of allergic rhinitis. In drug-interactions studies, the recommended clinical dose of Montelukast did not have clinically important effects on the pharmacokinetics of the following drugs: Theophylline, prednisone, prednisolone, oral contraceptives (ethinyl estradiol/norethindrone 35/1), terfenadine, digoxin and warfarin.

The area under the plasma concentration-time curve (AUC) for Montelukast was decreased approximately 40% in subjects with co-administration of phenobarbital. No dosage adjustment for Montelukast is recommended.

In vitro studies have shown that Montelukast is an inhibitor of CYP2C8. However, data from a clinical drug-drug interaction study involving Montelukast and rosiglitazone (a probe substrate representative of drugs primarily metabolized by CYP2C8) demonstrated that Montelukast does not inhibit CYP2C8 in vivo. Therefore, Montelukast is not anticipated to alter the metabolism of drugs metabolized by this enzyme (e.g. paclitaxel, rosiglitazone, and repaglinide.)

In vitro studies have shown that Montelukast is a substrate of CYP 2C8, 2C9, and 3A4. Data from a clinical drug-drug interaction study involving Montelukast and gemfibrozil (an inhibitor of both CYP 2C8 and 2C9) demonstrated that gemfibrozil increased the systemic exposure of Montelukast by 4.4-fold.

Co-administration of itraconazole, a strong CYP 3A4 inhibitor, with gemfibrozil and Montelukast did not further increase the systemic exposure of Montelukast. The effect of gemfibrozil on systemic exposure of Montelukast is not considered to be clinically meaningful based on clinical safety data with doses greater than the 10 mg approved dose in adults (e.g., 200 mg/day to adult patients for 22 weeks, and up to 900 mg/day to patients for approximately one week) where clinically important adverse experiences were not observed. Therefore, no dosage adjustment of Montelukast is required upon co-administration with gemfibrozil. Based on in vitro data, clinically important drug interactions with other known inhibitors of CYP 2C8 (e.g., trimethoprim) are not anticipated. In addition, co-administration of Montelukast with itraconazole alone resulted in no significant increase in the systemic exposure of Montelukast.

Montelukast side effects

See also:
What are the possible side effects of Montelukast?

Montelukast has been generally well tolerated. Side effects, which usually were mild, generally did not require discontinuation of therapy. The overall incidence of side effects reported with Montelukast was comparable to placebo.

Adults 15 Years of Age and Older with Asthma: Montelukast has been evaluated in approximately 2600 adult patients 15 years of age and older in clinical studies. In two similarly designed, 12-week placebo-controlled clinical studies, the only adverse experiences reported as drug related in ≥ 1% of patients treated with Montelukast and at a greater incidence than in patients treated with placebo were abdominal pain and headache. The incidences of these events were not significantly different in the two treatment groups.

Cumulatively, 544 patients were treated with Montelukast for at least 6 months, 253 for one year and 21 for 2 years in clinical studies. With prolonged treatment, the adverse experience profile did not change.

Pediatric Patients 6 to 14 Years of Age with Asthma: Montelukast has been evaluated in approximately 475 pediatric patients 6 to 14 years of age. The safety profile in pediatric patients is generally similar to the adult safety profile and to placebo.

In an 8-week, placebo-controlled clinical study, the only adverse experience reported as drug related in > 1% of patients treated with Montelukast and at a greater incidence than in patients treated with placebo was headache. The incidence of headache was not significantly different in the two treatment groups.

In studies evaluating growth rate, the safety profile in these pediatric patients was consistent with the safety profile previously described for Montelukast.

Cumulatively, 263 pediatric patients 6 to 14 years of age were treated with Montelukast for at least 3 months and 164 for 6 months or longer. With prolonged treatment, the adverse experience profile did not change.

Pediatric Patients 2 to 5 Years of Age with Asthma: Montelukast has been evaluated in 573 pediatric patients 2 to 5 years of age. In a 12-week, placebo-controlled clinical study, the only adverse experience reported as drug related in > 1% of patients treated with Montelukast and at a greater incidence than in patients treated with placebo was thirst. The incidence of thirst was not significantly different in the two treatment groups.

Cumulatively, 426 pediatric patients 2 to 5 years of age were treated with Montelukast for at least 3 months, 230 for 6 months or longer, and 63 patients for 12 months or longer. With prolonged treatment, the adverse experience profile did not change.

Pediatric Patients 6 Months to 2 Years of Age with Asthma: Montelukast has been evaluated in 175 pediatric patients 6 months to 2 years of age. In a 6-week, placebo-controlled clinical study, the adverse experiences reported as drug related in > 1% of patients treated with Montelukast and at a greater incidence than in patients treated with placebo were diarrhea, hyperkinesia, asthma, eczematous dermatitis and rash.

The incidences of these adverse experiences were not significantly different in the two treatment groups.

Adults 15 Years of Age and Older with Seasonal Allergic Rhinitis: Montelukast has been evaluated in 2199 adult patients 15 years of age and older for the treatment of seasonal allergic rhinitis in clinical studies. Montelukast administered once daily in the morning or in the evening was generally well tolerated with a safety profile similar to that of placebo. In placebo-controlled clinical studies, no adverse experiences reported as drug related in 1% of patients treated with Montelukast and at a greater incidence than in patients treated with placebo were observed. In a 4-week, placebo-controlled clinical study, the safety profile was consistent with that observed in 2-week studies. The incidence of somnolence was similar to that of placebo in all studies.

Pediatric Patients 2 to 14 Years of Age with Seasonal Allergic Rhinitis: Montelukast has been evaluated in 280 pediatric patients 2 to 14 years of age for the treatment of seasonal allergic rhinitis in a 2-week, placebo-controlled, clinical study. Montelukast administered once daily in the evening was generally well tolerated with a safety profile similar to that of placebo. In this study, no adverse experiences reported as drug related in 1% of patients treated with Montelukast and at a greater incidence than in patients treated with placebo were observed.

Adults 15 Years of Age and Older with Perennial Allergic Rhinitis: Montelukast has been evaluated in 3235 adult and adolescent patients 15 years of age and older with perennial allergic rhinitis in two, 6-week, placebo-controlled, clinical studies.

Montelukast administered once daily was generally well tolerated, with a safety profile consistent with that observed in patients with seasonal allergic rhinitis and similar to that of placebo. In these two studies, no adverse experiences reported as drug related in 1% of patients treated with Montelukast and at a greater incidence than in patients treated with placebo were observed. The incidence of somnolence was similar to that of placebo.

Pooled Analyses of Clinical Trials Experience: A pooled analysis of 41 placebo-controlled clinical studies (35 studies in patients 15 years of age and older; 6 studies in pediatric patients 6 to 14 years of age) was performed using a validated assessment method of suicidality. Among the 9929 patients who received Montelukast and 7780 patients who received placebo in these studies, there was one patient with suicidal ideation in the group taking Montelukast. There were no completed suicides, suicide attempts or preparatory acts toward suicidal behavior in either treatment group.

A separate pooled analysis of 46 placebo-controlled clinical studies (35 studies in patients 15 years of age and older; 11 studies in pediatric patients 3 months to 14 years of age) assessing behavior-related adverse experiences (BRAEs) was performed. Among the 11,673 patients who received Montelukast and 8827 patients who received placebo in these studies, the frequency of patients with at least one BRAE was 2.73% in patients who received Montelukast and 2.27% in patients who received placebo; the odds ratio was 1.12 [95% CI (0.93; 1.36)].

The clinical trials included in these pooled analyses were not designed specifically to examine suicidality or BRAEs.

Postmarketing Experience: The following side effects have been reported in postmarketing use: Infections and Infestations: Upper respiratory infection.

Blood and Lymphatic System Disorders: Increased bleeding tendency.

Immune System Disorders: Hypersensitivity reactions including anaphylaxis, very rarely hepatic eosinophilic infiltration.

Psychiatric Disorders: Agitation including aggressive behavior or hostility, anxiousness, depression, disorientation, disturbance in attention, dream abnormalities, hallucinations, insomnia, memory impairment, psychomotor hyperactivity (including irritability, restlessness, and tremor) somnambulism, suicidal thinking and behavior (suicidality).

Nervous System Disorders: Dizziness, drowsiness, paraesthesia/hypoesthesia, very rarely seizure.

Cardiac Disorders: Palpitations.

Respiratory, Thoracic and Mediastinal Disorders: Epistaxis.

Gastrointestinal Disorders: Diarrhea, dyspepsia, nausea, vomiting; pulmonary eosinophilia.

Hepatobiliary Disorders: Increased ALT and AST, very rarely hepatitis (including cholestatic, hepatocellular, and mixed-pattern liver injury).

Skin and Subcutaneous Tissue Disorders: Angioedema, bruising, erythema multiforme, erythema nodosum, pruritus, rash, urticaria.

Musculoskeletal and Connective Tissue Disorders: Arthralgia, myalgia including muscle cramps.

Renal and Urinary Disorders: Enuresis in children.

General Disorders and Administration Site Conditions: Asthenia/fatigue, edema, pyrexia.

Montelukast contraindications

See also:
What is the most important information I should know about Montelukast?

Hypersensitivity to Montelukast sodium or to any of the excipients of Montelukast.

Use in children: Montelukast should not be used in children <15 years due to high content of Montelukast. Other dosage forms with appropriate strengths are available for younger children.

Active ingredient matches for Montelukast:

Montelukast


Unit description / dosage (Manufacturer)Price, USD
Singulair 30 4 mg Chew Tabs Bottle$ 145.91
Singulair 30 4 mg Packets Packet$ 145.91
Singulair 30 5 mg Chew Tabs Bottle$ 145.91
Singulair 10 mg tablet$ 4.77
Montelukast tablet 10 mg (Ranbaxy Pharmaceuticals Canada Inc. (Canada))
Montelukast tablet / chewable 4 mg (Pro Doc Limitee (Canada))
Montelukast tablet / chewable 5 mg (Pro Doc Limitee (Canada))
Montelukast tablet, film coated 10 mg/1 (Kemwell Biopharma Private Limited (US))
Montelukast tablet, chewable 5 mg/1 (Ase Direct, Inc. (US))
Montelukast tablet 10 mg/1 (Macleods Pharmaceuticals Limited (US))
Montelukast tablet, chewable 4 mg/1 (Sandoz Inc (US))

List of Montelukast substitutes (brand and generic names):

MONTELUKAST 10MG TABLET 1 strip / 10 tablets each (Jan Aushadhi)$ 0.28
MONTELUKAST 5MG TABLET 1 strip / 10 tablets each (Jan Aushadhi)$ 0.17
Montelukast Actavis chewable tab 4 mg 28's (Actavis)
Montelukast Actavis chewable tab 5 mg 28's (Actavis)
Montelukast Actavis FC tab 10 mg 28's (Actavis)

References

  1. PubChem. "montelukast". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  2. DrugBank. "montelukast". http://www.drugbank.ca/drugs/DB00471 (accessed September 17, 2018).
  3. MeSH. "Anti-Asthmatic Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Montelukast are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Montelukast. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

User reports

2 consumers reported useful

Was the Montelukast drug useful in terms of decreasing the symptom or the disease?
According to the reports released by ndrugs.com website users, the below mentioned percentages of users say the drug is useful / not useful to them in decreasing their symptoms/disease. The usefulness of the drug depends on many factors, like severity of the disease, perception of symptom, or disease by the patient, brand name used [matters only to a certain extent], other associated conditions of the patient. If the drug is not effective or useful in your case, you need to meet the doctor to get re-evaluated about your symptoms/disease, and he will prescribe an alternative drug.
Users%
Useful2
100.0%


Consumer reported price estimates

No survey data has been collected yet


2 consumers reported time for results

To what extent do I have to use Montelukast before I begin to see changes in my health conditions?
As part of the reports released by ndrugs.com website users, it takes 2 days and a few days before you notice an improvement in your health conditions.
Please note, it doesn't mean you will start to notice such health improvement in the same time frame as other users. There are many factors to consider, and we implore you to visit your doctor to know how long before you can see improvements in your health while taking Montelukast. To get the time effectiveness of using Montelukast drug by other patients, please click here.
Users%
2 days1
50.0%
> 3 month1
50.0%


3 consumers reported age

Users%
16-292
66.7%
6-151
33.3%


Consumer reviews


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Information checked by Dr. Sachin Kumar, MD Pharmacology

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