Montelukast 10mg Tablets
WARNING: For all uses of this drug:Severe mental health problems have happened with this drug or after it has been stopped. These problems include depression or suicidal thoughts or actions. These problems can happen in people with and without a history of mental or mood problems. Watch people who take this drug closely. Call the doctor right away if any changes in mood or behavior that are new or worse occur. This includes signs like depression; thoughts or actions of suicide; not able to focus; bad or strange dreams; anxiety; hallucinations (seeing or hearing things that are not there); memory problems; sleep walking; stuttering; shakiness; trouble sleeping; trouble controlling body movements; or feeling agitated, confused, irritable, or restless. Talk with the doctor to be sure that the benefits of this drug are more than the risks.For allergic reasons:This drug must only be used when other drugs cannot be used or have not worked. If you have questions, talk with the doctor. @ COMMON USES: It is used to prevent breathing problems that happen with exercise.It is used to treat or prevent asthma.It is used to ease allergy signs.It may be given to you for other reasons. Talk with the doctor.For breathing problems:Do not use this drug to treat intense flare-ups of shortness of breath. Use a rescue inhaler. If you have questions, talk with the doctor.
Drug Class
Leukotriene Receptor Antagonist
Pharmacologic Class
Cysteinyl Leukotriene Receptor Antagonist
Pregnancy Category
Not available
FDA Approved
Aug 1998
DEA Schedule
Not Controlled
Overview
What is this medicine?
Montelukast is a medicine that helps prevent and treat asthma symptoms and allergy symptoms like sneezing and runny nose. It works by blocking natural substances in your body called leukotrienes, which can cause inflammation and tightening of the airways. By blocking them, it helps keep your airways open and reduces allergy symptoms.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely. You can take this medication with or without food. It's essential to continue taking this medication even when you're not experiencing symptoms.
If you're taking this medication to prevent breathing problems that occur with exercise, be sure to take it at least 2 hours before exercising. If you're using this medication to manage asthma, take it in the evening as directed.
Storing and Disposing of Your Medication
To maintain the quality and effectiveness of your medication, store it at room temperature, protected from light. Keep it in a dry place, avoiding storage in a bathroom. Store your medication in its original container to preserve its integrity.
What to Do If You Miss a Dose
If you miss a dose, skip it and return to your regular schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely. You can take this medication with or without food. It's essential to continue taking this medication even when you're not experiencing symptoms.
If you're taking this medication to prevent breathing problems that occur with exercise, be sure to take it at least 2 hours before exercising. If you're using this medication to manage asthma, take it in the evening as directed.
Storing and Disposing of Your Medication
To maintain the quality and effectiveness of your medication, store it at room temperature, protected from light. Keep it in a dry place, avoiding storage in a bathroom. Store your medication in its original container to preserve its integrity.
What to Do If You Miss a Dose
If you miss a dose, skip it and return to your regular schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Take montelukast once daily, usually in the evening, even if you feel well. Consistency is key for its effectiveness.
- Montelukast is a preventive medicine and is NOT for treating sudden asthma attacks. Always carry your rescue inhaler (e.g., albuterol) for acute symptoms.
- Do not stop taking montelukast without talking to your doctor, even if you feel better.
- If you are taking it for exercise-induced bronchoconstriction, take it at least 2 hours before exercise and do not take another dose for 24 hours.
- Be aware of and report any changes in mood or behavior, including anxiety, depression, agitation, sleep problems, or thoughts of self-harm, to your doctor immediately.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
10 mg orally once daily in the evening
Dose Range:
10 - 10 mg
Condition-Specific Dosing:
asthma:
10 mg orally once daily in the evening
allergicRhinitis:
10 mg orally once daily (timing can be flexible for allergic rhinitis, but evening for asthma)
exerciseInducedBronchoconstriction:
10 mg orally at least 2 hours before exercise, not to exceed one dose in 24 hours
Pediatric Dosing
Neonatal:
Not established
Infant:
6 to 23 months: 4 mg oral granules once daily (for allergic rhinitis only, not asthma)
Child:
2 to 5 years: 4 mg chewable tablet or oral granules once daily; 6 to 14 years: 5 mg chewable tablet once daily
Adolescent:
15 years and older: 10 mg orally once daily in the evening
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No adjustment needed; Montelukast is highly protein bound and not removed by dialysis.
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
Caution advised; specific dose adjustment not established, but monitor for adverse effects due to extensive hepatic metabolism. Use with caution in patients with severe hepatic impairment (Child-Pugh score >9).
Pharmacology
Mechanism of Action
Montelukast is a selective and orally active leukotriene receptor antagonist that specifically inhibits the cysteinyl leukotriene CysLT1 receptor. Cysteinyl leukotrienes (LTC4, LTD4, LPE4) are potent inflammatory eicosanoids released from various cells, including mast cells and eosinophils. These leukotrienes bind to CysLT1 receptors in the airways and on other pro-inflammatory cells, causing bronchoconstriction, mucus secretion, vascular permeability, and eosinophil recruitment. By blocking the CysLT1 receptor, montelukast inhibits these actions, leading to bronchodilation, reduced airway inflammation, and improved asthma and allergic rhinitis symptoms.
Pharmacokinetics
Absorption:
Bioavailability:
64% (for 10 mg tablet)
Tmax:
3-4 hours (for 10 mg tablet)
FoodEffect:
Food does not significantly affect the bioavailability or AUC of montelukast, but Tmax may be delayed.
Distribution:
Vd:
8-11 liters
ProteinBinding:
>99%
CnssPenetration:
Limited
Elimination:
HalfLife:
2.7-5.5 hours
Clearance:
Not readily quantifiable due to extensive metabolism and biliary excretion
ExcretionRoute:
Primarily fecal (86% via bile); <0.2% renal
Unchanged:
<0.2% (in urine)
Pharmacodynamics
OnsetOfAction:
Within 1 day (for asthma symptom improvement)
PeakEffect:
Not directly applicable as it's a prophylactic agent; sustained effect with daily dosing.
DurationOfAction:
24 hours (allows for once-daily dosing)
Safety & Warnings
BLACK BOX WARNING
Serious neuropsychiatric events have been reported with the use of montelukast. These include, but are not limited to, agitation, aggression, depression, sleep disturbances, tremor, hallucinations, and suicidal thoughts and behavior. Patients and caregivers should be advised to be alert for these changes and to seek medical advice immediately if they occur. The benefits of montelukast may not outweigh the risks in some patients, particularly when the symptoms of allergic rhinitis are mild and can be adequately treated with other therapies.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of a severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis), including:
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Red or irritated eyes
+ Sores in the mouth, throat, nose, or eyes
New or worsening trouble breathing
Fever
Flu-like symptoms
Sinus pain
Abnormal burning, numbness, or tingling sensations
Ear pain
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or persist, contact your doctor for guidance:
Headache
Stomach pain or diarrhea
Signs of a common cold
Cough
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of a severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis), including:
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Red or irritated eyes
+ Sores in the mouth, throat, nose, or eyes
New or worsening trouble breathing
Fever
Flu-like symptoms
Sinus pain
Abnormal burning, numbness, or tingling sensations
Ear pain
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or persist, contact your doctor for guidance:
Headache
Stomach pain or diarrhea
Signs of a common cold
Cough
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Agitation or aggressive behavior
- Anxiety
- Depression or suicidal thoughts/actions
- Difficulty sleeping or nightmares
- Hallucinations
- Irritability
- Restlessness
- Tremor
- Unusual dreams
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions or exacerbate underlying health issues.
To ensure your safety, it is crucial to verify that this medication can be taken safely with all your current medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions or exacerbate underlying health issues.
To ensure your safety, it is crucial to verify that this medication can be taken safely with all your current medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
Important Information About This Medication
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
If you are pregnant, plan to become pregnant, or are breastfeeding, you must discuss the benefits and risks of this medication with your doctor to ensure the best possible outcome for you and your baby.
Special Considerations for Breathing Problems
If you experience worsening breathing problems, a decrease in the effectiveness of your rescue inhaler, or an increase in the frequency of use of your rescue inhaler, contact your doctor immediately.
If you are taking this medication for asthma or allergies, do not take an additional dose to prevent exercise-induced breathing problems.
If you have asthma and experience worsening symptoms when taking aspirin, it is recommended that you avoid aspirin and nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen and naproxen, while taking this medication.
Transitioning from Steroid Medication
If you are switching to this medication from a steroid, do not abruptly stop taking the steroid. Instead, your doctor may need to gradually taper the steroid dose to minimize potential side effects. It is crucial to consult with your doctor to determine the best course of action.
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
If you are pregnant, plan to become pregnant, or are breastfeeding, you must discuss the benefits and risks of this medication with your doctor to ensure the best possible outcome for you and your baby.
Special Considerations for Breathing Problems
If you experience worsening breathing problems, a decrease in the effectiveness of your rescue inhaler, or an increase in the frequency of use of your rescue inhaler, contact your doctor immediately.
If you are taking this medication for asthma or allergies, do not take an additional dose to prevent exercise-induced breathing problems.
If you have asthma and experience worsening symptoms when taking aspirin, it is recommended that you avoid aspirin and nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen and naproxen, while taking this medication.
Transitioning from Steroid Medication
If you are switching to this medication from a steroid, do not abruptly stop taking the steroid. Instead, your doctor may need to gradually taper the steroid dose to minimize potential side effects. It is crucial to consult with your doctor to determine the best course of action.
Overdose Information
Overdose Symptoms:
- Abdominal pain
- Somnolence (drowsiness)
- Thirst
- Headache
- Vomiting
- Psychomotor hyperactivity
What to Do:
In case of suspected overdose, contact a poison control center immediately (e.g., 1-800-222-1222 in the US) or seek emergency medical attention. Treatment is generally supportive.
Drug Interactions
Moderate Interactions
- Phenobarbital
- Rifampin
Monitoring
Baseline Monitoring
Baseline assessment of asthma/allergic rhinitis symptoms
Rationale: To establish a starting point for evaluating treatment efficacy.
Timing: Prior to initiation of therapy
Mental health history
Rationale: To identify pre-existing neuropsychiatric conditions, given the boxed warning.
Timing: Prior to initiation of therapy
Routine Monitoring
Asthma/allergic rhinitis symptom control
Frequency: Regularly (e.g., at follow-up visits, patient self-monitoring)
Target: Improved symptom control, reduced exacerbations, improved quality of life
Action Threshold: Worsening symptoms, lack of improvement, or increased need for rescue medication
Neuropsychiatric symptoms (e.g., agitation, aggression, depression, sleep disturbances, suicidal ideation)
Frequency: Ongoing, at each patient contact and through patient/caregiver education
Target: Absence of new or worsening neuropsychiatric symptoms
Action Threshold: Any new or worsening neuropsychiatric symptoms; discontinue montelukast and evaluate patient immediately.
Adherence to therapy
Frequency: At each follow-up visit
Target: Consistent daily dosing
Action Threshold: Poor adherence may lead to suboptimal symptom control.
Symptom Monitoring
- Worsening asthma symptoms (e.g., increased wheezing, shortness of breath, cough)
- Increased use of rescue inhaler
- New or worsening mood changes (e.g., depression, anxiety, agitation)
- Sleep disturbances (e.g., insomnia, nightmares)
- Behavioral changes (e.g., aggression, hostility)
- Suicidal thoughts or actions
- Tremor
- Hallucinations
Special Patient Groups
Pregnancy
Montelukast is generally considered to have a low risk during pregnancy. Human data from observational studies and registries have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Use during pregnancy should be based on a careful assessment of the benefits and risks.
Trimester-Specific Risks:
First Trimester:
No increased risk of major birth defects observed in human studies.
Second Trimester:
No specific risks identified.
Third Trimester:
No specific risks identified.
Lactation
Montelukast is excreted into human milk in very small amounts. The amount ingested by a breastfed infant is very low and unlikely to cause adverse effects. It is generally considered compatible with breastfeeding. Monitor the infant for potential adverse effects such as diarrhea or rash, though these are rare.
Infant Risk:
Low risk
Pediatric Use
Montelukast is approved for use in pediatric patients as young as 6 months for allergic rhinitis and 12 months for asthma. Dosing varies by age and formulation (oral granules, chewable tablets, film-coated tablets). The neuropsychiatric risk applies to all age groups, and caregivers should be educated on monitoring for these symptoms.
Geriatric Use
No dosage adjustment is generally required in elderly patients. Clinical studies did not identify differences in safety or efficacy between elderly and younger patients. However, elderly patients may be more sensitive to drug effects, and careful monitoring for adverse reactions, including neuropsychiatric events, is prudent.
Clinical Information
Clinical Pearls
- Montelukast is a maintenance therapy, not a rescue medication for acute asthma attacks. Patients must understand this distinction.
- Emphasize the importance of taking the medication consistently, ideally in the evening for asthma, to maximize its prophylactic effect.
- Due to the boxed warning for neuropsychiatric events, thoroughly counsel patients and caregivers on potential mood and behavior changes. Advise them to report any such symptoms immediately and consider discontinuation if they occur.
- While generally well-tolerated, monitor for less common side effects like eosinophilia, vasculitic rash, and worsening pulmonary symptoms, which could indicate Churg-Strauss syndrome (though rare and causality not definitively established).
- Consider the risk-benefit profile, especially for mild allergic rhinitis, where alternative therapies with lower neuropsychiatric risk might be preferred.
Alternative Therapies
- Inhaled corticosteroids (e.g., fluticasone, budesonide) - cornerstone for asthma control
- Long-acting beta-agonists (LABAs) - often combined with ICS for asthma
- Short-acting beta-agonists (SABAs) - for rescue relief of asthma symptoms
- Other leukotriene modifiers (e.g., zafirlukast, zileuton - less commonly used)
- Oral antihistamines (e.g., loratadine, cetirizine) - for allergic rhinitis
- Nasal corticosteroids (e.g., fluticasone nasal, mometasone nasal) - for allergic rhinitis
- Cromolyn sodium (mast cell stabilizer) - for asthma and allergic rhinitis
- Omalizumab (anti-IgE monoclonal antibody) - for severe allergic asthma
- Mepolizumab, Reslizumab, Benralizumab (anti-IL-5 monoclonal antibodies) - for severe eosinophilic asthma
Cost & Coverage
Average Cost:
Varies widely, typically $10-$50 per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (Generic)
General Drug Facts
If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, which is a patient fact sheet that provides crucial information about its safe use. It is vital to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, do not hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount consumed, and the time it occurred. This information will help healthcare professionals provide you with the most appropriate care and treatment.
This medication is accompanied by a Medication Guide, which is a patient fact sheet that provides crucial information about its safe use. It is vital to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, do not hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount consumed, and the time it occurred. This information will help healthcare professionals provide you with the most appropriate care and treatment.