Montelukast 5mg 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
Cysteinyl Leukotriene Type 1 (CysLT1) 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 your body called leukotrienes, which can cause inflammation and narrowing of airways in your lungs, and 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 with your prescription and follow the instructions closely. You can take this medication with or without food. Be sure to chew the medication thoroughly 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 exercise-induced breathing problems, 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 and safety of your medication, store it at room temperature, away from light and moisture. Keep it in a dry place, such as a closet or drawer, and avoid storing it in the bathroom. Always store your medication in its original container to ensure it remains protected and easy to identify.
What to Do If You Miss a Dose
If you miss a dose, skip it and take your next dose at the scheduled time. Do not take two doses at the same time or take extra doses to make up for the missed one. Return to your regular dosing schedule as soon as possible to maintain the effectiveness of your medication.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. You can take this medication with or without food. Be sure to chew the medication thoroughly 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 exercise-induced breathing problems, 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 and safety of your medication, store it at room temperature, away from light and moisture. Keep it in a dry place, such as a closet or drawer, and avoid storing it in the bathroom. Always store your medication in its original container to ensure it remains protected and easy to identify.
What to Do If You Miss a Dose
If you miss a dose, skip it and take your next dose at the scheduled time. Do not take two doses at the same time or take extra doses to make up for the missed one. Return to your regular dosing schedule as soon as possible to maintain the effectiveness of your medication.
Lifestyle & Tips
- Take Montelukast once daily in the evening, even if you feel well, to maintain its protective effect.
- Do not use Montelukast for sudden asthma attacks; it is not a rescue inhaler. Always carry your rescue inhaler (e.g., albuterol) for acute symptoms.
- Chew the tablet completely before swallowing.
- Continue to avoid known asthma or allergy triggers (e.g., pollen, dust mites, pet dander, smoke).
- Inform your doctor about all other medications you are taking, including over-the-counter drugs and herbal supplements.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Not applicable for 5mg chewable tablets; adults typically use 10mg oral tablets.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
For children 6 to 14 years of age: 5 mg once daily in the evening. For children 2 to 5 years of age: 4 mg chewable tablet or oral granule once daily in the evening.
Adolescent:
For adolescents 15 years of age and older: Not applicable for 5mg chewable tablets; typically use 10mg oral tablets.
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:
Use with caution; specific dosing recommendations are not available, but Montelukast is extensively metabolized by the liver. Consider clinical monitoring.
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 and are involved in the pathophysiology of asthma and allergic rhinitis, including bronchoconstriction, mucus secretion, vascular permeability, and eosinophil recruitment. By blocking the CysLT1 receptor, montelukast inhibits the actions of these leukotrienes, leading to bronchodilation and reduction of inflammatory processes.
Pharmacokinetics
Absorption:
Bioavailability:
64% (10 mg oral tablet in adults)
Tmax:
2-4 hours (oral tablet)
FoodEffect:
Food does not significantly affect the bioavailability of the 5 mg chewable tablet.
Distribution:
Vd:
8-11 liters
ProteinBinding:
Greater than 99%
CnssPenetration:
Limited
Elimination:
HalfLife:
2.7-5.5 hours
Clearance:
Not available (primarily hepatic metabolism)
ExcretionRoute:
Primarily via bile in feces (approximately 86%), less than 0.2% in urine
Unchanged:
Less than 0.2% (in urine)
Pharmacodynamics
OnsetOfAction:
Within 1 day (for clinical improvement in asthma)
PeakEffect:
Not directly measurable for clinical effect; plasma concentrations peak 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, suicidal thoughts and behavior. Patients and caregivers should be advised to be alert for these events and to discontinue Montelukast and contact their healthcare provider immediately if they occur.
Side Effects
Serious Side Effects: Seek Medical Help Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention right away:
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), such as:
+ 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 symptoms that bother you or do not go away, contact your doctor:
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, 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, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention right away:
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), such as:
+ 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 symptoms that bother you or do not go away, contact your doctor:
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, 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:
- New or worsening mood changes (e.g., agitation, aggression, anxiety, depression)
- Sleep disturbances (e.g., insomnia, nightmares)
- Behavioral changes (e.g., restlessness, tremor)
- Suicidal thoughts or behavior
- Rash, hives, or itching
- Swelling of the face, lips, tongue, or throat (signs of allergic reaction)
- Worsening asthma symptoms
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.
All medications you are currently taking, including prescription and over-the-counter (OTC) medications, natural products, and vitamins.
* Any existing health problems, as this medication may interact with other drugs or health conditions.
To ensure your safety, it is crucial to verify that this medication can be taken with all your other medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication.
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.
All medications you are currently taking, including prescription and over-the-counter (OTC) medications, natural products, and vitamins.
* Any existing health problems, as this medication may interact with other drugs or health conditions.
To ensure your safety, it is crucial to verify that this medication can be taken with all your other medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication.
Precautions & Cautions
Important Warnings and Cautions
General Precautions
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, plan to become pregnant, or are breastfeeding, discuss the benefits and risks with your doctor to ensure the best outcome 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. Furthermore, if you have asthma and experience worsening symptoms when taking aspirin, avoid aspirin and nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen and naproxen while taking this medication.
Special Considerations for Asthma Patients
If you are switching to this medication from a steroid, do not abruptly stop taking the steroid. Instead, consult with your doctor to gradually taper the steroid dose and minimize potential side effects.
General Precautions
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, plan to become pregnant, or are breastfeeding, discuss the benefits and risks with your doctor to ensure the best outcome 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. Furthermore, if you have asthma and experience worsening symptoms when taking aspirin, avoid aspirin and nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen and naproxen while taking this medication.
Special Considerations for Asthma Patients
If you are switching to this medication from a steroid, do not abruptly stop taking the steroid. Instead, consult with your doctor to gradually taper the steroid dose and minimize potential side effects.
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 or emergency services immediately. Call 1-800-222-1222.
Drug Interactions
Moderate Interactions
- Phenobarbital (may decrease montelukast plasma concentrations)
- Rifampin (may decrease montelukast plasma concentrations)
Monitoring
Routine Monitoring
Asthma/Allergic Rhinitis Symptoms
Frequency: Regularly (e.g., daily symptom diary, at follow-up visits)
Target: Improved symptom control, reduced frequency of exacerbations
Action Threshold: Worsening symptoms, increased rescue inhaler use, or new/worsening neuropsychiatric symptoms
Neuropsychiatric Symptoms
Frequency: Ongoing, especially during initial treatment and dose changes
Target: Absence of behavioral changes, agitation, aggression, depression, suicidal thoughts/behavior, sleep disturbances
Action Threshold: Any new or worsening neuropsychiatric symptoms; discontinue montelukast and seek medical advice immediately.
Symptom Monitoring
- Asthma symptoms (wheezing, shortness of breath, cough, chest tightness)
- Allergic rhinitis symptoms (sneezing, runny nose, nasal congestion, itching)
- Mood changes (agitation, aggression, anxiety, depression)
- Sleep disturbances (insomnia, nightmares)
- Behavioral changes (restlessness, tremor)
- Suicidal thoughts or behavior
Special Patient Groups
Pregnancy
Montelukast is Pregnancy Category B. Studies in animals have not shown harm to the fetus, but there are no adequate and well-controlled studies in pregnant women. Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. Uncontrolled asthma during pregnancy poses risks to both mother and fetus.
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 in breast milk in animal studies. It is not known if it is excreted in human milk. The decision to breastfeed while taking montelukast should consider the importance of the drug to the mother and the potential risks to the infant. The amount transferred to milk is likely low.
Infant Risk:
L3 (Moderate risk - no human data, but animal data suggest excretion into milk; potential for adverse effects is possible but unlikely to be clinically significant at typical doses).
Pediatric Use
Montelukast 5mg chewable tablets are specifically formulated and dosed for children 6 to 14 years of age. Lower strengths (4mg chewable tablets or oral granules) are available for younger children (2 to 5 years). Safety and efficacy in children younger than 6 months of age have not been established. Close monitoring for neuropsychiatric events is crucial in pediatric patients.
Geriatric Use
No dosage adjustment is generally required based on age. Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. However, the pharmacokinetic profile in elderly patients is similar to that in young adults. Monitor for adverse effects, particularly neuropsychiatric events.
Clinical Information
Clinical Pearls
- Montelukast is a maintenance therapy for asthma and allergic rhinitis, not a rescue medication for acute attacks.
- Administer once daily in the evening for optimal effect, especially for asthma.
- The 5mg chewable tablet is specifically for children 6-14 years old. Ensure correct strength and formulation for the patient's age.
- Counsel patients and caregivers extensively on the potential for neuropsychiatric side effects, including mood changes, sleep disturbances, and suicidal ideation. Emphasize immediate discontinuation and medical consultation if these occur.
- Montelukast can be taken with or without food.
- Patients should continue to use their inhaled corticosteroids and other asthma medications as prescribed, unless advised otherwise by their physician.
Alternative Therapies
- Inhaled corticosteroids (e.g., fluticasone, budesonide) for asthma
- Long-acting beta-agonists (LABAs) in combination with inhaled corticosteroids for asthma
- Short-acting beta-agonists (SABAs) for asthma rescue
- Cromolyn sodium (mast cell stabilizer) for asthma
- Omalizumab (anti-IgE monoclonal antibody) for severe allergic asthma
- Antihistamines (e.g., loratadine, fexofenadine, cetirizine) for allergic rhinitis
- Nasal corticosteroids (e.g., fluticasone nasal spray, mometasone nasal spray) for allergic rhinitis
Cost & Coverage
Average Cost:
$10 - $50 per 30 tablets (generic)
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 is essential to contact your doctor promptly. 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 is a valuable patient fact sheet. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, we encourage you 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 seeking help, be prepared to provide information about the medication taken, the amount, and the time it occurred.