Singulair 5mg Chewable 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
Antiasthmatic, Antiallergic
Pharmacologic Class
Leukotriene Receptor Antagonist (LTRA)
Pregnancy Category
Category B
FDA Approved
Feb 1998
DEA Schedule
Not Controlled
Overview
What is this medicine?
Montelukast is a medication 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 it well before swallowing. 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 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 the medication in its original container.
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 it well before swallowing. 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 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 the medication in its original container.
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 this medication once daily in the evening, even if you feel well. It is not for treating sudden asthma attacks.
- Always carry your rescue inhaler (e.g., albuterol) for sudden asthma attacks.
- Do not stop taking other asthma medications unless directed by your doctor.
- Chew the tablet completely before swallowing. Do not swallow whole.
- Be aware of potential mood or behavior changes. If you notice any unusual changes, such as agitation, aggression, depression, or suicidal thoughts, contact your doctor immediately.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Not applicable for 5mg chewable tablets (typically 10mg for adults)
Condition-Specific Dosing:
asthma_or_allergic_rhinitis:
10 mg oral tablet once daily in the evening (for adults and adolescents âĨ15 years of age)
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established for chewable tablets (4 mg oral granules for 6-23 months)
Child:
5 mg chewable tablet once daily in the evening (for children 6 to 14 years of age); 4 mg chewable tablet once daily in the evening (for children 2 to 5 years of age)
Adolescent:
5 mg chewable tablet once daily in the evening (for children 6 to 14 years of age); 10 mg oral tablet once daily in the evening (for adolescents âĨ15 years of age)
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment necessary
Moderate:
No dosage adjustment necessary
Severe:
No dosage adjustment necessary
Dialysis:
No dosage adjustment necessary; Montelukast is not removed by dialysis
Hepatic Impairment:
Mild:
No dosage adjustment necessary
Moderate:
No dosage adjustment necessary
Severe:
Not studied; use with caution
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, LTR4) are potent inflammatory eicosanoids released from various cells, including mast cells and eosinophils. These mediators 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 associated with asthma and allergic rhinitis.
Pharmacokinetics
Absorption:
Bioavailability:
64% (for 10 mg oral tablet in adults); 73% (for 5 mg chewable tablet in adults)
Tmax:
2-4 hours (for 10 mg tablet); 2-2.5 hours (for 5 mg chewable tablet in children 6-14 years); 2 hours (for 4 mg chewable tablet in children 2-5 years)
FoodEffect:
The 5 mg chewable tablet is not significantly affected by food. The 10 mg tablet's Cmax and AUC are decreased by food, but clinical efficacy is not affected.
Distribution:
Vd:
8-11 liters
ProteinBinding:
>99%
CnssPenetration:
Limited (low concentrations found in CSF)
Elimination:
HalfLife:
2.7-5.5 hours
Clearance:
Not available (primarily hepatic clearance)
ExcretionRoute:
Primarily in feces (86%), <0.2% in urine
Unchanged:
<0.2% in urine
Pharmacodynamics
OnsetOfAction:
Within 1 day (for clinical improvement in asthma symptoms)
PeakEffect:
Not directly applicable for chronic use; 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 agitation, aggression, depression, sleep disturbances, and suicidal thoughts and actions. 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 those with mild symptoms or those who can be adequately treated with other medications.
Side Effects
Serious Side Effects: Seek Medical Attention 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 help 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 unusual 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 help 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 unusual 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:
- Worsening asthma or allergy symptoms
- Signs of an allergic reaction (e.g., rash, hives, swelling of face/lips/tongue/throat, difficulty breathing)
- Neuropsychiatric symptoms: agitation, aggression, anxiety, depression, disorientation, abnormal dreams, hallucinations, insomnia, irritability, memory impairment, obsessive-compulsive symptoms, restlessness, somnambulism, suicidal thoughts and behavior, tremor, tic.
- Symptoms of Churg-Strauss Syndrome (rare but serious): flu-like illness, worsening pulmonary symptoms, rash, tingling or numbness in limbs.
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 and pharmacist 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 it is safe to take this medication 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 and pharmacist 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 it is safe to take this medication 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 have phenylketonuria (PKU), consult with your doctor before taking this medication, as some products contain phenylalanine.
Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of this medication 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 increase in the frequency of using your rescue inhaler, contact your doctor immediately.
Asthma and Allergy
Do not take an additional dose of this medication to prevent exercise-induced breathing problems if you are taking it for asthma or allergies.
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 a Steroid
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 to minimize potential side effects.
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 before taking this medication, as some products contain phenylalanine.
Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of this medication 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 increase in the frequency of using your rescue inhaler, contact your doctor immediately.
Asthma and Allergy
Do not take an additional dose of this medication to prevent exercise-induced breathing problems if you are taking it for asthma or allergies.
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 a Steroid
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 to minimize potential side effects.
Overdose Information
Overdose Symptoms:
- Abdominal pain
- Somnolence (drowsiness)
- Thirst
- Headache
- Vomiting
- Psychomotor hyperactivity
What to Do:
Seek immediate medical attention or call a poison control center. In the US, call 1-800-222-1222.
Drug Interactions
Moderate Interactions
- Phenobarbital (may decrease montelukast plasma concentrations)
- Rifampin (may decrease montelukast plasma concentrations)
Monitoring
Baseline Monitoring
Baseline asthma/allergy symptom control
Rationale: To establish a starting point for assessing treatment efficacy.
Timing: Prior to initiation of therapy
Mental health history (including depression, anxiety, suicidal ideation)
Rationale: Due to the risk of neuropsychiatric events associated with montelukast.
Timing: Prior to initiation of therapy
Routine Monitoring
Asthma/allergy symptom control (e.g., frequency of symptoms, rescue inhaler use, quality of life)
Frequency: Regularly, at follow-up visits (e.g., every 3-6 months or as clinically indicated)
Target: Improved symptom control, reduced exacerbations
Action Threshold: Worsening symptoms, increased rescue inhaler use, or lack of improvement may indicate need for dose adjustment or alternative therapy.
Neuropsychiatric symptoms (e.g., agitation, aggression, depression, sleep disturbances, suicidal thoughts/behavior)
Frequency: Ongoing, at every patient contact and through patient/caregiver education
Target: Absence of new or worsening neuropsychiatric symptoms
Action Threshold: Any new or worsening neuropsychiatric symptoms should prompt immediate evaluation and consideration of discontinuing montelukast.
Symptom Monitoring
- Worsening asthma symptoms (e.g., increased wheezing, shortness of breath, cough)
- Increased need for rescue medication
- Signs of allergic reaction (e.g., rash, itching, swelling)
- Neuropsychiatric changes: agitation, aggression, anxiety, depression, disorientation, abnormal dreams, hallucinations, insomnia, irritability, memory impairment, obsessive-compulsive symptoms, restlessness, somnambulism, suicidal thoughts and behavior (including suicide), tremor, tic
- Eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy (Churg-Strauss Syndrome, rare)
Special Patient Groups
Pregnancy
Montelukast is classified as 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. It should be used during pregnancy only if clearly needed.
Trimester-Specific Risks:
First Trimester:
No increased risk of major birth defects observed in human epidemiological studies.
Second Trimester:
No specific risks identified.
Third Trimester:
No specific risks identified.
Lactation
Montelukast is excreted in human milk. The amount of montelukast excreted in breast milk is very low. The American Academy of Pediatrics considers montelukast to be compatible with breastfeeding. Monitor breastfed infants for potential adverse effects.
Infant Risk:
Low risk; monitor for irritability, poor feeding, or sleep disturbances, though these are rare.
Pediatric Use
Montelukast chewable tablets are specifically formulated and dosed for pediatric patients. The 5 mg chewable tablet is indicated for children 6 to 14 years of age. The 4 mg chewable tablet is indicated for children 2 to 5 years of age. Oral granules are available for infants 6 to 23 months. Safety and effectiveness in infants 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 necessary 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 and safety profile in elderly patients are generally similar to those in younger adults.
Clinical Information
Clinical Pearls
- Montelukast is a maintenance therapy for asthma and allergic rhinitis; it is NOT for acute asthma attacks. Patients should always have a rescue inhaler available.
- Administer once daily in the evening for both asthma and allergic rhinitis, as symptoms often worsen at night.
- Emphasize the importance of chewing the tablet completely before swallowing.
- Educate patients and caregivers thoroughly about the potential for neuropsychiatric side effects and the need to report any changes immediately. This is a critical safety message.
- Consider the risk-benefit profile carefully, especially for patients with mild symptoms or those who have other effective treatment options, given the black box warning.
- Montelukast can be used in conjunction with inhaled corticosteroids and bronchodilators.
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)
- Antihistamines (e.g., loratadine, fexofenadine, cetirizine) - for allergic rhinitis
- Nasal corticosteroids (e.g., fluticasone nasal spray) - for allergic rhinitis
- Cromolyn sodium (mast cell stabilizer)
- Omalizumab (Xolair) - anti-IgE monoclonal antibody for severe allergic asthma
Cost & Coverage
Average Cost:
Varies widely, typically $10-$50 for generic per 30 tablets
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 provides crucial information. Please read this guide carefully and review it again whenever you receive a refill. 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 reporting the incident, be prepared to provide details about the medication taken, the quantity, and the time it occurred.