Montelukast 4mg Chew Tabs
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
Leukotriene Receptor Antagonist
Pregnancy Category
B
FDA Approved
Feb 1998
DEA Schedule
Not Controlled
Overview
What is this medicine?
Montelukast is a medicine used to prevent and treat asthma symptoms, and to relieve symptoms of seasonal and year-round allergies. It works by blocking natural substances in the body called leukotrienes, which can cause inflammation and narrowing of the airways in asthma, and allergy symptoms like sneezing and runny nose.
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. Be sure to chew the medication well before swallowing. 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, 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 effectiveness of your medication, store it at room temperature, protected from light. Keep it in a dry place, avoiding storage in a bathroom. Store the medication in its original container to preserve its quality.
What to Do If You Miss a Dose
If you miss a dose, skip it and return to your regular dosing 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. Be sure to chew the medication well before swallowing. 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, 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 effectiveness of your medication, store it at room temperature, protected from light. Keep it in a dry place, avoiding storage in a bathroom. Store the medication in its original container to preserve its quality.
What to Do If You Miss a Dose
If you miss a dose, skip it and return to your regular dosing 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 in the evening for asthma or exercise-induced bronchoconstriction, or once daily at any time for allergic rhinitis.
- Do not use montelukast for sudden asthma attacks; it is a preventive medicine. Always carry a rescue inhaler for acute attacks.
- Continue taking montelukast even if you feel well, as it helps prevent symptoms.
- Avoid known asthma triggers (e.g., allergens, irritants, cold air, exercise without pre-treatment if applicable).
- Maintain good indoor air quality and avoid exposure to smoke.
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
allergic_rhinitis:
10 mg orally once daily (timing not critical for allergic rhinitis)
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established (not recommended for children under 6 months)
Child:
6 months to 5 years: 4 mg chewable tablet or oral granules once daily in the evening; 6 to 14 years: 5 mg chewable tablet once daily in the evening
Adolescent:
15 years and older: 10 mg tablet 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 not removed by dialysis
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
Use with caution; specific recommendations not available due to limited data. Consider monitoring for adverse effects.
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 and reduction of inflammatory processes in the airways, thereby improving asthma control and allergic rhinitis symptoms.
Pharmacokinetics
Absorption:
Bioavailability:
64% (10 mg tablet), 73% (5 mg chewable), 63% (4 mg chewable)
Tmax:
2-4 hours (10 mg tablet), 2-2.5 hours (5 mg chewable), 2 hours (4 mg chewable)
FoodEffect:
Food does not significantly affect the bioavailability of the 10 mg tablet. For the 4 mg chewable tablet, a high-fat meal decreases Cmax by 35% and prolongs Tmax from 2 to 6 hours, but AUC is not significantly affected.
Distribution:
Vd:
8-11 liters
ProteinBinding:
Greater than 99%
CnssPenetration:
Limited (low concentrations found in CSF)
Elimination:
HalfLife:
2.7-5.5 hours
Clearance:
Not available (primarily hepatic metabolism)
ExcretionRoute:
Primarily bile/feces (approximately 86%), less than 0.2% in urine
Unchanged:
Less than 0.2% (in urine)
Pharmacodynamics
OnsetOfAction:
Within 1 day (for clinical effect in asthma/allergic rhinitis)
PeakEffect:
Not directly applicable as it's a chronic treatment; peak plasma concentrations reached in 2-4 hours.
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 agitation, aggression, depression, sleep disturbances, and suicidal thoughts and behavior. Patients and caregivers should be advised to be alert for neuropsychiatric changes and to seek medical advice if these changes occur. The benefits of montelukast may not outweigh the risks in patients with mild allergic rhinitis.
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
+ Difficulty 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. However, many people do not experience any side effects or only have mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical help:
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. If you have questions or concerns about side effects, contact 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
+ Difficulty 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. However, many people do not experience any side effects or only have mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical help:
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. If you have questions or concerns about side effects, contact 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:
- Any new or worsening mood changes (e.g., feeling sad, anxious, irritable)
- Aggressive behavior
- Agitation
- Sleep problems (insomnia, nightmares, sleepwalking)
- Hallucinations
- Memory problems
- Thoughts of harming yourself or others
- Unusual dreams
- Tremors
- Stuttering
- Signs of liver problems (e.g., yellowing of skin/eyes, dark urine, severe stomach pain)
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, any of its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
Potential interactions with other medications or health conditions. This drug may interact with other prescription or over-the-counter (OTC) medications, natural products, or vitamins, which could affect its safety and efficacy.
All medications you are currently taking, including prescription and OTC drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions and ensure safe use.
Any existing health problems, as they may impact the safety and effectiveness of this medication.
To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is crucial to verify that it is safe to take this medication with all your other medications and health conditions.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, any of its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
Potential interactions with other medications or health conditions. This drug may interact with other prescription or over-the-counter (OTC) medications, natural products, or vitamins, which could affect its safety and efficacy.
All medications you are currently taking, including prescription and OTC drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions and ensure safe use.
Any existing health problems, as they may impact the safety and effectiveness of this medication.
To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is crucial to verify that it is safe to take this medication with all your other medications and health conditions.
Precautions & Cautions
Important Warnings and Cautions
General Information
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you have phenylketonuria (PKU), consult with your doctor, as some products contain phenylalanine. Additionally, if you are pregnant, planning to become pregnant, or breastfeeding, discuss the benefits and risks with your doctor to ensure the best decision for you and your baby.
Breathing Problems
If you experience worsening breathing problems, a decrease in the effectiveness of your rescue inhaler, or an increased need to use 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, avoid taking aspirin and nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen and naproxen while using this medication.
Switching from Steroids
If you are transitioning to this medication from a steroid, do not abruptly stop taking the steroid. Instead, consult with your doctor to gradually taper the steroid dose, as sudden cessation may lead to side effects. Your doctor will guide you through this process to minimize potential complications.
General Information
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you have phenylketonuria (PKU), consult with your doctor, as some products contain phenylalanine. Additionally, if you are pregnant, planning to become pregnant, or breastfeeding, discuss the benefits and risks with your doctor to ensure the best decision for you and your baby.
Breathing Problems
If you experience worsening breathing problems, a decrease in the effectiveness of your rescue inhaler, or an increased need to use 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, avoid taking aspirin and nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen and naproxen while using this medication.
Switching from Steroids
If you are transitioning to this medication from a steroid, do not abruptly stop taking the steroid. Instead, consult with your doctor to gradually taper the steroid dose, as sudden cessation may lead to side effects. Your doctor will guide you through this process to minimize potential complications.
Overdose Information
Overdose Symptoms:
- Abdominal pain
- Somnolence (drowsiness)
- Thirst
- Headache
- Vomiting
- Psychomotor hyperactivity
What to Do:
There is no specific antidote. Treatment is symptomatic and supportive. Contact a poison control center immediately or seek emergency medical attention. Call 1-800-222-1222.
Drug Interactions
Moderate Interactions
- Phenobarbital (may decrease montelukast AUC by approximately 40%)
- Rifampin (may decrease montelukast AUC by approximately 40%)
Monitoring
Routine Monitoring
Asthma/Allergic Rhinitis Symptoms
Frequency: Regularly (e.g., daily symptom diary, at follow-up visits)
Target: Improved symptom control, reduced rescue inhaler use, improved quality of life
Action Threshold: Persistent or worsening symptoms, increased rescue inhaler use, frequent nocturnal symptoms
Neuropsychiatric Symptoms
Frequency: Ongoing, especially during initial treatment and dose changes
Target: Absence of new or worsening behavioral changes, mood disturbances, or suicidal ideation
Action Threshold: Any new or worsening neuropsychiatric symptoms (e.g., agitation, aggression, depression, sleep disturbances, suicidal thoughts/behavior). Discontinue montelukast and evaluate.
Symptom Monitoring
- Wheezing
- Shortness of breath
- Cough
- Chest tightness
- Nasal congestion
- Sneezing
- Runny nose
- Itchy nose/eyes
- Mood changes
- Agitation
- Aggression
- Anxiety
- Depression
- Disorientation
- Dream abnormalities
- Hallucinations
- Insomnia
- Irritability
- Memory impairment
- Obsessive-compulsive symptoms
- Restlessness
- Somnambulism (sleepwalking)
- Stuttering
- Suicidal thoughts and behavior
- Tremor
- Unusual dreams
Special Patient Groups
Pregnancy
Montelukast is Pregnancy Category B. Studies in animals have not shown harm to the fetus, and there are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if clearly needed.
Trimester-Specific Risks:
First Trimester:
Generally considered low risk based on animal data and limited human data.
Second Trimester:
Generally considered low risk.
Third Trimester:
Generally considered low risk.
Lactation
Montelukast is excreted in breast milk in very low concentrations. The amount ingested by an infant is estimated to be very small. Generally considered compatible with breastfeeding, but caution is advised.
Infant Risk:
Low risk of adverse effects in breastfed infants. Monitor for potential irritability or sleep disturbances, though these are rare.
Pediatric Use
Montelukast is approved for use in pediatric patients 6 months of age and older. Dosing is weight/age-dependent. The 4mg chewable tablet is specifically for children 2-5 years of age. Neuropsychiatric events, including behavioral changes, have been reported in pediatric patients; caregivers should be vigilant for these symptoms.
Geriatric Use
No dosage adjustment is generally required in elderly patients. Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Monitor for adverse effects, as elderly patients may be more sensitive to drug effects.
Clinical Information
Clinical Pearls
- Montelukast is a maintenance therapy, not a rescue medication for acute asthma attacks.
- Administer the evening dose for asthma or exercise-induced bronchoconstriction to maximize effect during nocturnal symptoms.
- Counsel patients and caregivers extensively on the potential for neuropsychiatric side effects, including mood changes, agitation, and suicidal ideation, and to report any such symptoms immediately.
- Consider the risk-benefit profile, especially for mild allergic rhinitis, given the neuropsychiatric warning.
- Chewable tablets should be chewed thoroughly before swallowing. Oral granules can be administered directly into the mouth or mixed with a spoonful of soft food (e.g., applesauce, carrots, rice, or ice cream) or in cold or room temperature breast milk or formula. Do not open the packet until ready to use, and use within 15 minutes of opening.
Alternative Therapies
- Other leukotriene receptor antagonists (e.g., Zafirlukast, Zileuton - less commonly used)
- Inhaled corticosteroids (first-line for persistent asthma)
- Long-acting beta-agonists (LABAs, often in combination with ICS for asthma)
- Short-acting beta-agonists (SABAs, for rescue in asthma)
- Antihistamines (for allergic rhinitis)
- Nasal corticosteroids (for allergic rhinitis)
- Cromolyn sodium (mast cell stabilizer)
- Omalizumab (anti-IgE antibody, for severe allergic asthma)
Cost & Coverage
Average Cost:
$10 - $50 per 30 tablets (generic 4mg chewable)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, which provides crucial information about its use. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't 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 details about the medication taken, the amount, and the time it occurred.
This medication is accompanied by a Medication Guide, which provides crucial information about its use. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't 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 details about the medication taken, the amount, and the time it occurred.